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
Date: 1999-05-31
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, classification, dangerous substance, labelling, packaging

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I

(Acts whose publication is obligatory)

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

Having regard to the proposal of the Commission (1),

Having regard to the opinion of
Committee (2),

the Economic and Social

Acting in accordance with the procedure laid down in
Article 251 of the Treaty (3),

the laws,

(1) Whereas Council Directive 88/379/EEC of 7 June 1988
regulations and
on the approximation of
administrative provisions of the Member States relating
to the
labelling of
dangerous preparations (4) has been amended on several
occasions; whereas
further
amendments, the said Directive should, for reasons of
clarity, be recast;

classification, packaging

occasion

and

the

on

of

(2) Whereas,

exhibit

considerable differences

in spite of Community provisions, the rules
in the
applying to certain dangerous preparations
Member States
as
regards classification, packaging and labelling; whereas
these differences constitute a barrier to trade, create
unequal competition conditions and directly affect the
functioning of
is
therefore necessary to remove this barrier to trade by
approximating the relevant
legislation existing in the
Member States;

the internal market; whereas

it

(3) Whereas measures

of

States

the
for
the Member

the
approximation of
affecting
the
provisions
the internal market
establishment and functioning of
must,
in so far as they concern health, safety and
protection of man and the environment, adopt a high
level of protection as a basis; whereas this Directive
must, at
the
in particular, persons who come
general public, and,
into contact with dangerous preparations in the course
of their work or in the pursuit of a hobby, protection
for consumers and for the environment;

the same time, ensure protection for

(4) Whereas containers containing certain categories of
dangerous preparations offered or sold to the general
public must be fitted with child-resistant fastenings and/
or carry a tactile warning of danger; whereas certain
preparations not
falling within these categories of
danger may nevertheless, owing to their composition,
present a danger for children; whereas the packaging of
such preparations should therefore be equipped with
child-resistant fastenings;

(5) Whereas it is necessary to provide concentration limits
expressed as a volume/volume percentage in the case of
preparations marketed in gaseous form;

(6) Whereas

special

contains

this Directive

labelling
provisions applicable to certain preparations; whereas,
to ensure an adequate level of protection for man and
the environment, special labelling provisions must also
be introduced for certain preparations which, although
this Directive,
not dangerous within the meaning of
may nevertheless present a danger to the user;

(1) OJ C 283, 26.9.1996, p. 1, and
OJ C 337, 7.11.1997, p. 45.
(2) OJ C 158, 26.5.1997, p. 76.
(3) Opinion of the European Parliament of 26 June 1997 (OJ C 222,
21.7.1997, p. 26), Council common position of 24 September
1998 (OJ C 360, 23.11.1998, p. 1) and Decision of the European
Parliament of 10 February 1999 (OJ C 150, 28.5.1999). Council
Decision of 11 May 1999.

(4) OJ L 187, 16.7.1988, p. 14. Directive as

last amended by

Commission Directive 96/65/EC (OJ L 265, 18.10.1996, p. 15).

(7) Whereas on 30 April 1992 the Council adopted
Directive 92/32/EEC amending for the seventh time
Directive 67/548/EEC on the approximation of the laws,
regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous
substances (5); whereas
the
on
Commission adopted Directive 93/21/EEC (6) adapting

27 April

1993

(5) OJ L 154, 5. 6. 1992, p. 1.
(6) OJ L 110, 4.5.1993, p. 20.

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for

to technical progress
the 18th time Council
Directive 67/548/EEC; whereas new criteria developed
for classifying and labelling substances dangerous for
the environment were introduced by those Directives,
together with the appropriate symbols,
indications of
danger, risk phrases and safety advice required to appear
on labelling; whereas provisions should be adopted at
Community level on the classification and labelling of
preparations to take account of
their effects on the
environment and whereas it is therefore necessary to
introduce a method for assessing the hazards of a given
preparation for the environment either by a calculation
method,
ecotoxicological
determining
properties by test methods under certain conditions;

the

by

or

(8) Whereas the number of animals used for experiments
should be reduced to a minimum, in accordance with
the provisions of Council Directive 86/609/EEC of
laws,
24 November 1986 on the approximation of
regulations and administrative provisions of the Member
States regarding the protection of animals used for
experimental and other scientific purposes (1); whereas
an
Article 7(2) of
that
experiment
another
be
shall
scientifically satisfactory method of obtaining the results
sought, not entailing the use of an animal, is reasonably
and practically
this
available; whereas,
Directive makes use of the results of assessments of
toxicological and ecotoxicological properties only when
these are already known and entails no obligation to
conduct further experiments on animals;

stipulates
if

that Directive

performed

therefore,

not

(9) Whereas

it

is necessary

to define what human
experience might be considered for the evaluation of the
health hazards of a preparation; whereas,
if clinical
studies may be accepted, it is taken as given that such
studies comply with the Helsinki Declaration and OECD
Guidelines for Good Clinical Practice;

using

available

currently

(10) Whereas the characteristics of alloys are such that it
may not be possible accurately to determine their
properties
conventional
methods; whereas it is therefore necessary to develop a
specific method of
into
their particular chemical properties; whereas
account
in consultation with Member States,
the Commission,
if
will examine this need and submit a proposal,
this
appropriate, before the implementation date of
Directive;

classification which takes

(11) Whereas classification, packaging and labelling of plant
protection products covered by Council Directive 78/
631/EEC of 26 June 1978 on the approximation of the
laws of the Member States relating to the classification,
packaging and labelling of dangerous preparations
(pesticides) (2) need to be revised taking into account

and scientific developments

technical
as
regulatory developments following implementation of
Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on
the market (3);

as well

relating

and of

and an assessment

(12) Whereas Directive 91/414/EEC and Directive 98/8/EC of
the European Parliament
the Council of
16 February 1998 concerning the placing of biocidal
products on the market (4), in contrast to the provisions
applicable to chemical preparations covered by this
Directive, provide for an authorisation procedure for
each product on the basis of a dossier presented by the
applicant
carried out by the
competent authority in each Member State; whereas
furthermore that authorisation procedure includes a
classification,
control
is
packaging and labelling of each product before it
placed on the market; whereas it is appropriate, as part
of a clear and transparent
to
classify and label plant protection products according to
the provisions of
this Directive, and also to provide
instructions for use in accordance with the results of the
evaluation carried out in the framework of Directive 91/
414/EEC and to ensure that the labelling satisfies the
high level of protection sought by both this Directive
and Directive 91/414/EEC; whereas, in addition, a safety
data sheet has to be established for plant protectioon
products in accordance with this Directive;

information process,

specifically

the

to

(13) Whereas it

labelling,

is appropriate to provide,

in relation to
environmental
specific exemptions or
that
specific provisions may be decided upon in specific
cases where it can be demonstrated that
the overall
environmental impact of the product types in question
is lower than that of corresponding product types;

(14) Whereas, although munitions are not covered by this
Directive, explosives marketed to produce an explosive
or pyrotechnic effect may,
through their chemical
composition, present dangers to health; whereas it is
therefore necessary as part of a transparent information
process to classify them and assign to them a safety data
sheet in accordance with the provisions of this Directive
and also to label
them in accordance with the
international rules used for the transport of dangerous
goods;

(15) Whereas,

to

take

account

in order

certain
preparations which, although they are not considered
this Directive, may nevertheless
dangerous under
it is necessary to extend
present a danger for users,
such
certain provisions of
preparations;

this Directive to cover

of

(1) OJ L 358, 18.12.1986, p. 1.
(2) OJ L 206, 29.7.1978, p. 13. Directive as last amended by Council

(3) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 96/68/EC (OJ L 277, 30.10.1996, p. 25).

Directive 92/32/EEC.

(4) OJ L 123, 24.4.1998, p. 1.

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(16) Whereas the label constitutes a basic tool for users of
the dangerous preparations in so far as it provides them
with the initial essential concise information; whereas it
nevertheless needs to be supplemented by a two-fold
system of more detailed information, consisting firstly of
the safety data sheet, intended for professional users as
defined by Commission Directive 91/155/EEC of
5 March 1991 defining and laying down the detailed
arrangements for the system of specific information
relating to dangerous preparations in implementation of
Article 10 of Directive 88/379/EEC (1) and secondly of
the bodies appointed by the Member States which are
responsible for the provision of information solely for
medical purposes, both preventive and curative;

(17) Whereas, on the basis of information to be supplied by
the Member States and the various parties concerned,
the Commission will submit a report to the European
the
Parliament and the Council within two years of
entry into force of this Directive on experience with the
present overall approach to labelling of dangerous
preparations and in particular on its understanding and
publicity
application
campaigns and educational and training programmes;
whereas, on the basis of this report, the Commission
will, if appropriate, submit the necessary proposals;

experience with

users,

by

(18) Whereas it

but

is necessary to require safety data sheets
providing proportionate information on the dangers to
man and the environment arising from preparations not
this
classified as dangerous within the meaning of
Directive
as
classified
dangerous or having a Community exposure limit;
whereas the Commission, on the basis of information
submitted by Member States, will review Directive 91/
if appropriate, before
155/EEC and submit proposals,
the expiry of
this
Directive;

implementation of

the date for

containing

substances

(19) Whereas,

to labelling where

in the case of preparations classified as
dangerous within the meaning of this Directive,
it is
appropriate to permit Member States to allow certain
the
derogations with respect
packaging is too small, or otherwise unsuitable for
labelling, or where such small packaging or such small
quantities are involved that there is no reason to fear
any danger to man or the environment; whereas in such
cases appropriate consideration should also be given to
relevant provisions
the
at
the
Community
the Commission will
level; whereas
therefore examine the needs for harmonisation and, if
appropriate, submit proposals;

approximation of

(20) Whereas

the

confidentiality of

certain substances
contained in the preparations should be guaranteed and
whereas it is therefore necessary to institute a system
which allows the person responsible for placing the

preparation on the market to request confidentiality for
such substances;

(21) Whereas

commitment

entered into by

the provisions of

this Directive will have
the
regard to the
Community and its Member States, in accordance with
the goals
set under
Agenda 21, Chapter 19, at the UNCED conference held
in June 1992 in Rio de Janeiro, to strive for the future
the classification of
harmonisation of
dangerous substances and preparations;

sustainable development

systems

for

for

(22) Whereas the Commission should be given the powers
necessary to adapt all the Annexes to this Directive to
technical progress;

(23) Whereas the adoption of this Directive should not affect
the obligations of the Member States concerning the
deadlines for transposition into national
law and for
application of the Directives indicated in Annex VIII;

(24) Whereas the Directives indicated in Annex VIII should
be repealed, subject to certain conditions; whereas the
indicated in
repealing the Directives
conditions
Annex VIII should be specified for Austria, Finland and
Sweden in order to take account of the present level of
their legislation, in particular as regards the protection
of health and the protection of the environment,

for

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Objectives and scope

1.
This Directive aims at the approximation of the laws,
regulations and administrative provisions of the Member States
relating to:

(cid:151) the classification, packaging and labelling of dangerous

preparations, and to

(cid:151) the

approximation of

certain
preparations which may present hazards, whether or not
they are classified as dangerous within the meaning of this
Directive,

specific provisions

for

(1) OJ L 76, 22.3.1991, p. 35. Directive as

last amended by

Commission Directive 93/112/EEC (OJ L 314, 16.12.1993, p. 38).

when such preparations are placed on the market of
Member States.

the

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2.

This Directive shall apply to preparations which:

(f) preparations containing radioactive substances as defined

by Directive 80/836/Euratom (5);

(cid:151) contain at

least one dangerous

substance within the

meaning of Article 2,

and

(g) medical devices which are invasive or used in direct
physical contact with the human body in so far as
Community measures
the
classification and labelling of dangerous substances and
preparations which ensure the same level of information
provision and protection as this Directive.

lay down provisions

for

(cid:151) are considered dangerous within the meaning of Article 5,

6 or 7.

6.

This Directive shall not apply to:

3.

The specific provisions set out:

(cid:151) in Article 9 and defined in Annex IV,

(cid:151) in Article 10 and defined in Annex V, and

(cid:151) in Article 14

(cid:151) the carriage of dangerous preparations by rail, road, inland

waterway, sea or air,

(cid:151) preparations

customs
supervision, provided they do not undergo any treatment
or processing.

transit which

under

are

in

shall also apply to preparations which are not considered
dangerous within the meaning of Articles 5, 6 or 7 but may
nevertheless present a specific hazard.

Article 2

Definitions

4. Without prejudice to Directive 91/414/EEC, the articles
on classification, packaging, labelling and safety data sheets of
this Directive shall apply to plant protection products.

1.

For the purposes of this Directive:

This Directive

5.
preparations in the finished state, intended for the final user:

shall not

to the

apply

following

(a) medicinal products for human or veterinary use, as defined

in Directive 65/65/EEC (1);

(a)

and

elements

chemical

in the natural

their
(cid:145)substances(cid:146) means
state or obtained by any
compounds
production process,
including any additive necessary to
preserve the stability of the products and any impurity
deriving from the process used, but excluding any solvent
which may be separated without affecting the stability of
the substance or changing its composition;

(b) cosmetic products as defined in Directive 76/768/EEC (2);

(b)

(cid:145)preparations(cid:146) means mixtures or solutions composed of
two or more substances;

(c) mixtures of substances which, in the form of waste, are
covered by Directives 75/442/EEC (3) and 78/319/EEC (4);

(c)

(d) foodstuffs;

(e) animal feedingstuffs;

(1) OJ L 22, 9.2.1965, p. 369. Directive as

last amended by

Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

(2) OJ L 262, 27.9.1976, p. 169. Directive as last amended by

Directive 97/18/EC (OJ L 114, 1.5.1997, p. 43).
(3) OJ L 194, 25.7.1975, p. 39. Directive as

last amended by

least

covalently bound to at

(cid:145)polymer(cid:146) means a substance consisting of molecules
characterised by the sequence of one or more types of
monomer units and comprising a simple weight majority
three monomer units
of molecules containing at
which are
least one other
monomer unit or other reactant and consists of less than
the same
a simple weight majority of molecules of
molecular weight. Such molecules must be distributed
over a range of molecular weights wherein differences in
the molecular weight
to
differences in the number of monomer units.
In the
this definition a (cid:145)monomer unit(cid:146) means the
context of
reacted form of a monomer in a polymer;

are primarily

attributable

Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).

(5) OJ L 246, 17.9.1980, p. 1. Directive as amended by Directive 84/

(4) OJ L 84, 31.3.1978, p. 43.

467/Euratom (OJ L 265, 5.10.1984, p. 4).

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(d)

((cid:133)(cid:133)(cid:133));

(d) highly flammable substances and preparations:

(e)

(cid:145)placing on the market(cid:146) means making available to third
parties. Importation into the Community customs territory
shall be deemed to be placing on the market
for the
purposes of this Directive;

(f)

(cid:145)scientific research and development(cid:146) means
scientific
experimentation, analysis or chemical research carried out
under controlled conditions; it includes the determination
of intrinsic properties, performance and efficacy as well as
scientific investigation related to product development;

(g)

(cid:145)process-orientated research and development(cid:146) means the
further development of a substance in the course of which
pilot plant or production trials are used to test the fields
of application of the substance;

(h)

(cid:145)Einecs(cid:146) means
the European Inventory of Existing
Commercial Chemical Substances. This inventory contains
the definitive list of all chemical substances deemed to be
on the Community market on 18 September 1981.

The following are (cid:145)dangerous(cid:146) within the meaning of this

2.
Directive:

(cid:151) substances and preparations which may become hot
and finally catch fire in contact with air at ambient
temperature without any application of energy, or

(cid:151) solid substances and preparations which may readily
catch fire after brief contact with a source of ignition
and which continue to burn or to be consumed after
removal of the source of ignition, or

(cid:151) liquid substances and preparations having a very low

flash-point, or

(cid:151) substances and preparations which,

in contact with
water or damp air, evolve extremely flammable gases
in dangerous quantities;

(e)

flammable substances and preparations: liquid substances
and preparations having a low flash-point;

(f)

(g)

very toxic substances and preparations: substances and
preparations which in very low quantities cause death or
acute or
to health when inhaled,
swallowed or absorbed via the skin;

chronic damage

and

substances

toxic
and
preparations which in low quantities cause death or acute
or chronic damage to health when inhaled, swallowed or
absorbed via the skin;

preparations:

substances

(h) harmful

substances and preparations:

substances and
preparations which may cause death or acute or chronic
damage to health when inhaled, swallowed or absorbed
via the skin;

(a) explosive substances and preparations: solid, liquid, pasty
or gelatinous substances and preparations which may also
react exothermically without atmospheric oxygen thereby
quickly evolving gases, and which, under defined test
conditions, detonate, quickly deflagrate or upon heating
explode when partially confined;

(b) oxidising substances and preparations:

substances and
preparations which give rise to a highly exothermic
reaction in contact with other substances, particularly
flammable substances;

(i)

(j)

(k)

corrosive substances and preparations:
substances and
preparations which may, on contact with living tissues,
destroy them;

and

substances

non-corrosive
irritant
substances and preparations which,
through immediate,
prolonged or repeated contact with the skin or mucous
membrane, may cause inflammation;

preparations:

skin,

sensitising substances and preparations: substances and
preparations which, if they are inhaled or if they penetrate
the
reaction of
hypersensitisation such that on further exposure to the
substance of preparation, characteristic adverse effects are
produced;

capable of

eliciting

are

a

(c)

extremely flammable substances and preparations:
liquid
substances and preparations having an extremely low
flash-point and a low boiling-point and gaseous substances
and preparations which are flammable in contact with air
at ambient temperature and pressure;

(l)

carcinogenic substances and preparations: substances or
preparations which, if they are inhaled or ingested or if
they penetrate the skin, may induce cancer or increase its
incidence;

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(m) mutagenic substances and preparations: substances and
preparations which, if they are inhaled or ingested or if
they penetrate the skin, may induce heritable genetic
defects or increase their incidence;

(cid:151) are classified and labelled in accordance with Article 7 of
Directive 67/548/EEC and are not yet included in Elincs,

(n)

(o)

and

substances
for
preparations which
reproduction: substances and preparations which, if they
are inhaled or ingested or if they penetrate the skin, may
produce, or
increase the incidence of, non-heritable
adverse effects in the progeny and/or an impairment of
male or female reproductive functions or capacity;

toxic

are

(cid:151) are covered by Article 8 of Directive 67/548/EEC,

(cid:151) are classified and labelled in accordance with Article 13 of

Directive 67/548/EEC,

substances and preparations which are dangerous for the
environment: substances and preparations which, were
they to enter the environment, would or could present an
immediate or delayed danger for one or more components
of the environment.

shall be taken into consideration in accordance with the
provisions laid down in the method used.

Article 3

Determination of dangerous properties of preparations

The evaluation of the hazards of a preparation shall be

1.
based on the determination of:

3.
For preparations covered by this Directive, dangerous
substances as referred to in paragraph 2 which are classified as
dangerous on the basis of their health and/or environmental
effects, whether they are present as impurities or additives,
shall be taken into consideration when their concentrations are
equal to, or greater than, those defined in the following table
unless lower values are given in Annex I to Directive 67/548/
EEC, or in Part B of Annex II to this Directive or in Part B of
Annex III thereto, unless otherwise specified in Annex V to
this Directive.

(cid:151) physico-chemical properties,

(cid:151) properties affecting health,

(cid:151) environmental properties.

These different properties shall be determined in accordance
with the provisions laid down in Articles 5, 6 and 7.

Where laboratory tests are conducted, they shall be carried out
on the preparation as placed on the market.

is
2. Where the determination of dangerous properties
in accordance with Articles 5, 6 and 7, all
carried out
dangerous substances within the meaning of Article 2 and in
particular those which:

(cid:151) are listed in Annex I to Directive 67/548/EEC,

Category of danger
of the substance

Very toxic

Toxic

Carcinogenic
Category 1 or 2

Mutagenic
Category 1 or 2

Toxic for reproduction
Category 1 or 2

Harmful

Corrosive

(cid:151) are listed in Elincs in accordance with Article 21 of

Irritant

Directive 67/548/EEC,

(cid:151) are classified and labelled provisionally by the person
responsible for the placing on the market in accordance
with Article 6 of Directive 67/548/EEC,

Sensitising

Carcinogenic
Category 3

Concentration to take into
consideration for

gaseous
preparations
% vol/vol

other preparations
% w/w

¯ 0,02

¯ 0,02

¯ 0,1

¯ 0,1

¯ 0,02

¯ 0,1

¯ 0,02

¯ 0,1

¯ 0,02

¯ 0,2

¯ 0,02

¯ 0,2

¯ 0,2

¯ 0,2

¯ 0,1

¯ 1

¯ 1

¯ 1

¯ 1

¯ 1

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Category of danger
of the substance

Mutagenic
Category 3

Toxic for reproduction
Category 3

Dangerous for the
environment N

Dangerous for the environment
ozone

¯ 0,1

Dangerous for the environment

Concentration to take into
consideration for

gaseous
preparations
% vol/vol

other preparations
% w/w

¯ 0,2

¯ 0,2

¯ 1

¯ 1

¯ 0,1

¯ 0,1

¯ 1

Article 4

General principles of classification and labelling

1.
The classification of dangerous preparations according to
the degree and specific nature of the hazards involved shall be
based on the definitions of categories of danger laid down in
Article 2.

The general principles of the classification and labelling
2.
of preparations shall be applied in accordance with the criteria
laid down in Annex VI to Directive 67/548/EEC, save where
alternative criteria referred to in Article 5, 6, 7 or 10 and the
relevant Annexes of this Directive are applied.

(cid:151) none of the constituents possesses such properties and
the information available to the
the preparation is unlikely to present

that, on the basis of
manufacturer,
hazards of this kind,

(cid:151) in the event of a change in the composition of a
preparation of known composition, scientific evidence
indicates that a reassessment of the hazards will not lead
to a change in classification,

(cid:151) preparations placed on the market in the form of aerosols
satisfy the provisions of Article 9a of Directive 75/324/
EEC (1).

3.
For certain cases for which the methods laid down in
Part A of Annex V to Directive 67/548/EEC are not
appropriate, alternative calculation methods are laid down in
Part B of Annex I to this Directive.

Certain exemptions from the application of the methods
4.
laid down in Part A of Annex V to Directive 67/548/EEC are
referred to in Part A of Annex I to this Directive.

The

hazards

deriving

from the

assessed by determining

the preparation necessary for

physico-chemical
5.
properties of a preparation covered by Directive 91/414/EEC
the physico-chemical
shall be
appropriate
properties of
classification in accordance with the criteria set out
in
Annex VI to Directive 67/548/EEC. These properties shall be
determined by means of the methods laid down in Part A of
Annex V to Directive 67/548/EEC unless other internationally
recognised methods are acceptable in accordance with the
provisions of Annexes II and III to Directive 91/414/EEC.

Article 6

Evaluation of health hazards

Article 5

Evaluation of the hazards deriving from physico-chemical
properties

The health hazards of a preparation shall be assessed by

1.
one or more of the following procedures:

The hazards of a preparation deriving from its physico-
1.
chemical properties shall be assessed by determining, by means
of the methods specified in Part A of Annex V to Directive 67/
548/EEC, the physico-chemical properties of the preparation
classification and labelling in
necessary for
accordance with the criteria laid down in Annex VI to that
Directive.

appropriate

2.

By way of derogation from paragraph 1:

(a) by a conventional method described in Annex II;

(b) by determining

the

toxicological properties of

the
preparation necessary for appropriate classification in
accordance with the criteria in Annex VI to Directive 67/
548/EEC. These properties shall be determined by means
the methods laid down in Part B of Annex V to
of
case of plant
Directive 67/548/EEC, unless,
protection products, other
recognised
methods are acceptable in accordance with the provisions
of Annexes II and III to Directive 91/414/EEC.

in the
internationally

the determination of
extremely
flammable, highly flammable, or flammable properties is not
necessary provided that:

explosive, oxidising,

the

(1) OJ L 147, 9.6.1975, p. 40. Directive as
Directive 94/1/EC (OJ L 23, 28.1.1994, p. 28).

last amended by

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that

the toxicological properties of

2. Without prejudice to the requirements of Directive 91/
414/EEC, only where it can be scientifically demonstrated by
the person responsible for placing the preparation on the
market
the preparation
cannot correctly be determined by the method outlined in
paragraph 1(a), or on the basis of existing test results on
animals, the methods outlined in paragraph 1(b) may be used,
provided they are justified or specifically authorised under
Article 12 of Directive 86/609/EEC.

When a toxicological property is established by the methods
outlined in paragraph 1(b) to obtain new data, the test shall be
conducted in compliance with the principles of good
laboratory practice provided for in Council Directive 87/18/
EEC of 18 December 1986 on the harmonisation of
laws,
regulations and administrative provisions
relating to the
application of the principles of good laboratory practice and
the verification of
their applications for tests on chemical
substances (1) and the provisions of Directive 86/609/EEC, in
particular Articles 7 and 12 thereof.

Subject to the provisions of paragraph 3, where a toxicological
property has been established on the basis of both the
methods outlined in paragraphs 1(a) and (b), the results from
the methods outlined in paragraph 1(b) shall be used for
classifying the preparation, except in the case of carcinogenic,
mutagenic or toxic effects for reproduction for which only the
method outlined in 1(a) shall be used.

Any of the toxicological properities of the preparation which
are not assessed by the method outlined in paragraph 1(b)
shall be assessed in accordance with the method outlined in
paragraph 1(a).

those effects shall be taken into account in classifying the
preparation.

4.
For preparations of a known composition, with the
exception of those covered by Directive 91/414/EEC, classified
in accordance with paragraph 1(b), a new evaluation of health
hazard by the methods outlined in either paragraph 1(a) or (b)
shall be performed whenever:

(cid:151) changes of composition of the initial concentration, as a
weight/weight or volume/volume percentage, of one or
more of the dangerous constituents are introduced by the
manufacturer, in accordance with the following table:

Initial concentration range of the
constituent

Permitted variation in initial
concentration of the constituent

˜ 2,5 %

> 2,5 ˜ 10 %

> 10 ˜ 25 %

> 25 ˜ 100 %

– 30 %

– 20 %

– 10 %

– 5 %

(cid:151) changes of composition involving the substitution or
addition of one or more constituents, which may or may
not be dangerous within the meaning of the definitions set
out in Article 2, are introduced by the manufacturer.

3.

Furthermore, where it can be demonstrated:

This new evaluation will apply unless there is valid scientific
justification for considering that a re-evaluation of the hazard
will not result in a change of classification.

(cid:151) by epidemiological

statistically backed experience,

studies, by scientifically valid case
studies as specified by Annex VI to Directive 67/548/EEC
the
or by
assessment of data from poison information units or
concerning occupational diseases, that toxicological effects
on man differ from those suggested by the application of
the methods outlined in paragraph 1, then the preparation
shall be classified according to its effects on man,

such as

Article 7

Evaluation of environmental hazards

(cid:151) that, owing to effects such as potentiation, a conventional
assessment would underestimate the toxicological hazard,
those effects shall be taken into account in classifying the
preparation,

(a) by a conventional method described in Annex III to this

Directive;

The hazards of a preparation for the environment shall

1.
be assessed by one or more of the following procedures:

(cid:151) that, owing to effects such as antagonism, a conventional
assessment would overestimate the toxicological hazard,

(1) OJ L 15, 17.1.1987, p. 29.

(b) by

the

determining

the
hazardous
preparation for the environment necessary for appropriate
classification in accordance with the criteria set out in
Annex VI to Directive 67/548/EEC. These properties shall
be determined by means of the methods laid down in

properties

of

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Part C of Annex V to Directive 67/548/EEC unless, in the
case of plant protection products, other internationally
recognised methods are acceptable in accordance with the
provisions of Annexes II and III to Directive 91/414/EEC.
Without prejudice to the testing requirements set out in
Directive 91/414/EEC, the conditions for application of
the test methods are described in Part C of Annex III to
this Directive.

Article 8

Obligations and duties of the Member States

1. Member States shall take all necessary measures to ensure
that
the preparations covered by this Directive cannot be
placed on the market unless they comply with it.

2. Where an ecotoxicological property is established by one
of the methods outlined in paragraph 1(b) to obtain new data,
the test shall be conducted in compliance with the principles
of good laboratory practice provided for in Directive 87/18/
EEC and with the provisions of Directive 86/609/EEC.

2.
In order to ensure compliance with this Directive, the
authorities of the Member States may request information on
the composition of the preparation and any other pertinent
information from any person responsible for placing the
preparation on the market.

Where the environmental hazards have been assessed in
compliance with both the procedures mentioned above, the
results of the methods referred to in paragraph 1(b) shall be
used for classifying the preparation.

3. Member States shall take all necessary measures to ensure
those responsible for placing the preparation on the
that
market hold at the disposal of the authorities of the Member
States:

3.
For preparations of a known composition, with the
exception of those covered by Directive 91/414/EEC, classified
in accordance with the method outlined in paragraph 1(b), a
new evaluation of environmental hazard either by the method
outlined in paragraph 1(a) or that outlined in paragraph 1(b)
shall be performed whenever:

(cid:151) changes of composition of the initial concentration, as a
weight/weight or volume/volume percentage, of one or
more of the dangerous constituents are introduced by the
manufacturer, in accordance with the following table:

Initial concentration range of the
constituent

Permitted variation in initial
concentration of the constituent

˜ 2,5 %

> 2,5 ˜ 10 %

> 10 ˜ 25 %

> 25 ˜ 100 %

– 30 %

– 20 %

– 10 %

– 5 %

(cid:151) the data used for the classification and labelling of the

preparation,

(cid:151) any

pertinent

information

packaging
requirements in accordance with Article 9(1.3), including
the test certificate issued in accordance with Part A of
Annex IX to Directive 67/548/EEC,

relating

to

(cid:151) the data used for establishing the safety data sheet,

in

accordance with Article 14.

4. Member States and the Commission shall exchange
information concerning the name and full address of
the
national authority (authorities) responsible for communicating
practical
and
application of this Directive.

information

exchanging

relating

the

to

Article 9

Packaging

1.

Member States shall
ensure that:

take all necessary measures to

(cid:151) changes of composition involving the substitution or
addition of one or more constituents, which may or may
not be dangerous within the meaning of the definitions set
out in Article 2, are introduced by the manufacturer.

1.1.

preparations within the meaning of Article 1(2) and
preparations
to
Article 1(3) cannot be placed on the market unless their
packaging satisfies the following requirements:

covered by Annex

IV pursuant

This new evaluation will apply unless there is valid scientific
justification for considering that a re-evaluation of the hazard
will not result in a change of classification.

(cid:151) it shall be so designed and constructed that

its
contents cannot escape; this requirement shall not
apply where special safety devices are prescribed,

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(cid:151) the materials

constituting

and
fastenings must not be susceptible to adverse attack
by the contents, or
liable to form dangerous
compounds with the contents,

the packaging

(a) preparations within the meaning of Article 1(2)
cannot be placed on the market unless the labelling
on their packaging satisfies all the requirements of
this Article and the specific provisions of Part A
and B of Annex V;

(cid:151) packaging and fastenings must be strong and solid
throughout to ensure that they will not loosen and
will safely meet the normal stresses and strains of
handling,

(cid:151) containers fitted with replaceable fastening devices
shall be so designed that
the packaging can be
refastened repeatedly without the contents escaping;

1.2.

containers which contain preparations within the
meaning of Article 1(2) and preparations covered by
Annex IV pursuant to Article 1(3) offered or sold to the
general public do not have:

(cid:151) either a shape and/or graphic decoration likely to
attract or arouse the active curiosity of children or
to mislead consumers, or

(cid:151) a presentation and/or

a designation used for
foodstuffs or animal feedingstuffs or medicinal or
cosmetic products.

(b) preparations within the meaning of Article 1(3) as
defined in Parts B and C of Annex V cannot be
placed on the market unless the labelling on their
of
packaging
paragraphs 2.1 and 2.2 and the specific provisions
of Parts B and C of Annex V.

requirements

satisfies

the

1.2. With respect to plant protection products subject to
Directive 91/414/EEC,
the labelling requirements in
accordance with this Directive shall be accompanied by
the following wording:

(cid:145)To avoid risks to man and the environment, comply
with the instructions for use.(cid:146)

labelling shall be without prejudice

to the
This
information required in accordance with Article 16 of,
and Annex V to, Directive 91/414/EEC.

2.

The following information shall be clearly and indelibly
marked on any package:

1.3.

containers which contain certain preparations offered
or sold to the general public covered by Annex IV to
this Directive:

2.1.

the trade name or designation of the preparation;

(cid:151) are fitted with child-resistant fastenings,

and/or

(cid:151) carry a tactile warning of danger.

devices must

The
technical
specifications given in Parts A and B of Annex IX to
Directive 67/548/EEC.

conform to

the

2.

The packaging of preparations shall be deemed to
satisfy the requirements of paragraph 1.1, first, second
and third indents, if it complies with the requirements
for carriage of dangerous goods by rail, road,
inland
waterway, sea or air.

Article 10

Labelling

2.2.

established

the name, full address and telephone number of the
person
is
responsible for placing the preparation on the market,
whether it be the manufacturer, the importer or the
distributor;

the Community who

in

2.3.

the chemical name of
present
following detailed rules:

the substance or substances
in the preparation in accordance with the

2.3.1.

for preparations classified T+, T, Xn in accordance with
Article 6, only the substances T+, T, Xn present
in
concentrations equal
the lowest
limit (limit Xn) for each of them laid down in Annex I
failing that, Part B of
to Directive 67/548/EEC or,
Annex II
to this Directive have to be taken into
consideration;

to, or greater than,

2.3.2.

classified C in accordance with
for preparations
Article 6, only C substances present in concentrations
equal to, or greater than, the lowest limit (limit Xi) laid
down in Annex I to Directive 67/548/EEC or, failing
that, Part B of Annex II to this Directive have to be
taken into consideration;

1.1. Member States shall

take all necessary measures to

ensure that:

2.3.3.

the name of the substances which have given rise to
the classification of the preparation in one or more of
the following danger categories:

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(cid:151) carcinogen category 1, 2 or 3,

2.4.

The danger symbol(s) and indication(s) of danger

(cid:151) mutagen category 1, 2 or 3,

(cid:151) toxic for reproduction category 1, 2 or 3,

(cid:151) very toxic,

toxic or harmful due to non-lethal

effects after a single exposure,

(cid:151) toxic or harmful due to severe effects after repeated

or prolonged exposure,

(cid:151) sensitising;

shall be mentioned on the label.

The danger symbols, where specified in this Directive,
and indications of the dangers involved in the use of
the preparation,
shall be in accordance with the
wording of Annexes II and VI to Directive 67/548/EEC
and shall be applied in accordance with the evaluation
of the hazards carried out in accordance with Annexes I,
II and III to this Directive.

Where more than one danger symbol must be assigned
to a preparation the obligation to apply the symbol:

(cid:151) T shall make the symbols C and X optional unless
otherwise specified in Annex I to Directive 67/548/
EEC,

The chemical name shall be one of the designations
to Directive 67/548/EEC or an
listed in Annex I
internationally recognised chemical nomenclature if no
corresponding designation is yet listed in that Annex.

(cid:151) C shall make the symbol X optional,

(cid:151) E shall make the symbols F and O optional,

2.3.4. As a consequence of the above provisions the name of
any substance which led to the classification of the
preparation in the following danger categories:

(cid:151) Xn shall make the symbol Xi optional.

(cid:151) explosive,

(cid:151) oxidising,

(cid:151) extremely flammable,

(cid:151) highly flammable,

(cid:151) flammable,

(cid:151) irritant,

(cid:151) dangerous for the environment,

need not be mentioned on the label unless
substance
pursuant
paragraphs 2.3.1, 2.3.2 or 2.3.3.

be mentioned

has

to

the
to

suffice

2.3.5. As a general rule, a maximum of four chemical names
substances primarily
to identify the
shall
responsible for the major health hazards which have
given rise to the classification and the choice of the
corresponding phrases referring to the risk involved. In
some cases, more than four chemical names may be
necessary.

The symbol(s) shall be printed in black on an orange-
yellow background.

2.5.

The risk phrases (R phrases)

The indications concerning special risks (R phrases)
shall comply with the wording in Annexes III and VI to
Directive 67/548/EEC and
in
accordance with the results of the hazard evaluation
carried out in accordance with Annexes I, II, and III to
this Directive.

shall be

assigned

for

this purpose,

As a general rule, a maximum of six R phrases shall
suffice to describe the risks;
the
combined phrases listed in Annex III to Directive 67/
548/EEC shall be regarded as single phrases. However,
if the preparation falls within more than one danger
the
category,
those standard phrases shall cover all
principal hazards associated with the preparation.
In
some cases more than six R phrases may be necessary.

The standard phrases (cid:145)extremely flammable(cid:146) or (cid:145)highly
flammable(cid:146) need not be used where they describe an
indication of danger used in accordance with 2.4.

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2.6.

The safety advice (S phrases)

question shall not appear on the packaging or labelling
of any preparation subject to this Directive.

The indications giving safety advice (S phrases) shall
comply with the wording in Annex IV and with
to Directive 67/548/EEC and shall be
Annex VI
assigned in accordance with the results of the hazard
evaluation carried out in accordance with Annexes I, II
and III to this Directive.

Article 11

Implementation of the labelling requirements

this purpose

As a general rule, a maximum of six S phrases shall
suffice to formulate the most appropriate safety advice;
for
listed in
Annex IV to Directive 67/548/EEC shall be regarded as
single phrases. However, in some cases more than six
S phrases may be necessary.

combined phrases

the

the packaging so that

1. Where the particulars required by Article 10 appear on a
label, that label shall be firmly affixed to one or more surfaces
of
those particulars can be read
horizontally when the package is set down normally. The
dimensions of
to
Directive 67/548/EEC and the label
is intended solely for
provision of the information required by this Directive and if
necessary of any supplementary health or safety information.

the label are laid down in Annex VI

Where it is physically impossible to include the advice
on the label or package itself, the package shall be
accompanied by safety advice on the use of
the
preparation.

2.
A label shall not be required when the particulars are
clearly shown on the package itself, as specified in paragraph 1.

2.7.

The nominal quantity (nominal mass or nominal
volume) of the contents in the case of preparations
offered or sold to the general public.

3.
The colour and presentation of the label (cid:151) or, in the
case of paragraph 2, of the package (cid:151) shall be such that the
danger symbol and its background stand out clearly from it.

3.

For certain preparations classified as dangerous within
the meaning of Article 7, by way of derogation from
paragraphs 2.4, 2.5, and 2.6 of this Article, exemptions
labelling or
to certain provisions on environmental
specific provisions
environmental
in relation
labelling may be determined in accordance with the
procedure referred to in Article 20, where it can be
demonstrated that there would be a reduction in the
environmental
impact. These exemptions or specific
provisions are defined and laid down in Part A or B of
Annex V.

to

4.

If the contents of the package do not exceed 125 ml:

(cid:151) in the case of preparations that are classified as
highly flammable, oxidising,
irritant, with the
exception of those assigned R41, or dangerous for
the environment and assigned the N symbol it shall
not be necessary to indicate the R phrases or the
S phrases,

(cid:151) in the case of preparations that are classified as
flammable or dangerous for the environment and
not assigned the N symbol it shall be necessary to
indicate the R phrases but it shall not be necessary
to indicate the S phrases.

4.
The information required on the label under Article 10
shall stand out clearly from its background and shall be of
such size and spacing as to be easily read.

Specific provisions regarding the presentation and format of
to
this
Directive 67/548/EEC.

laid down in Annex VI

information shall be

5. Member States may make the placing on the market of
preparations covered by this Directive within their territories
subject to use of their official language or languages in respect
of the labelling thereof.

For the purposes of this Directive, labelling requirements

6.
shall be deemed to be satisfied:

(a)

in the case of an outer package containing one or more
inner packages,
labelled in
accordance with international rules on the transport of
dangerous goods and the inner package or packages are
labelled in accordance with this Directive;

the outer package is

if

5.

Without prejudice to Article 16(4) of Directive 91/414/
EC, indications such as (cid:145)non-toxic(cid:146), (cid:145)non-harmful(cid:146), (cid:145)non-
polluting(cid:146), (cid:145)ecological(cid:146) or any other statement indicating
that the preparation is not dangerous or likely to lead
to underestimation of the dangers of the preparation in

(cid:151) if such a package is labelled in accordance with
international
rules on the transport of dangerous
goods and with Article 10(2.1), (2.2), (2.3), (2.5) and
(2.6); for preparations classified according to Article 7,

(b)

in the case of a single package:

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the provisions of Article 10(2.4) shall additionally
apply with respect to the property in question when it
has not been so identified on the label, or

(cid:151) where appropriate, for particular types of packaging
such as mobile
specific
requirements referred to in Annex VI to Directive 67/
548/EEC are complied with.

cylinders,

gas

the

if

Where dangerous preparations do not leave the territory
of a Member State,
labelling may be permitted which
complies with national rules instead of with international
rules on the transport of dangerous goods.

Article 12

Exemptions from the labelling and packaging
requirements

1.
Articles 9, 10 and 11 shall not apply to explosives placed
on the market with a view to obtaining an explosive or
pyrotechnic effect.

For certain dangerous preparations within the meaning
2.
of Article 5, 6 or 7 defined in Annex VII which, in the form in
which they are placed on the market, do not present any
physico-chemical risk, or risk to health or to the environment,
Articles 9, 10 and 11 shall not apply.

3. Member States may also:

(a) permit the labelling required by Article 10 to be applied in
some other appropriate manner on packages which are
either too small or otherwise unsuitable for labelling in
accordance with Article 11(1) and (2);

(b) by way of derogation from Articles 10 and 11 permit the
packaging of dangerous preparations which are classified
as harmful,
flammable,
flammable, irritant or oxidising to be unlabelled or to be
labelled in some other way,
if they contain such small
quantities that there is no reason to fear any danger to
persons handling such preparations or to other persons;

flammable, highly

extremely

(c) by way of derogation from Articles 10 and 11,

for
preparations classified according to Article 7, permit the
packaging of dangerous preparations to be unlabelled or
labelled in some other way if they contain such small
quantities that there is no reason to fear any dangers to
the environment;

(d) by way of derogation from Articles 10 and 11 permit the
packaging of dangerous preparations which are not
mentioned in (b) or (c) above to be labelled in some other
appropriate way,
for the
labelling provided for in Articles 10 and 11 and there is
no reason to fear any danger to persons handling such
preparations or to other persons.

if the packages are too small

this paragraph is

Where
symbols,
indications of danger, risk (R) phrases or safety (S) phrases
different
to those laid down in this Directive shall not be
permitted.

the use of

applied,

4.
If a Member State makes use of the options provided for
in paragraph 3, it shall forthwith inform the Commission and
Member States thereof. Where it is appropriate, measures shall
be decided upon in the framework of Annex V and in
accordance with the provisions of Article 20.

Article 13

Distance selling

Any advertisement for a preparation within the meaning of
this Directive which enables a member of the general public to
conclude a contract for purchase without first having sight of
the label for that preparation must make mention of the type
or types of hazard indicated on the label. This requirement is
without prejudice to Directive 97/7/EC of
the European
Parliament and of
the Council of 20 May 1997 on the
protection of consumers in respect of distance contracts (1).

Article 14

Safety data sheet

1.

The safety data sheet information is principally intended
for use by professional users and must enable them to
take the necessary measures as regards the protection of
health, safety and the environment at the place of work.

2.1. Member States shall take all the necessary measures to

ensure that:

(a)

the person responsible for placing on the market a
preparation within the meaning of Article 1(2)
provides a safety data sheet;

(b)

the person responsible for placing on the market a
preparation provides on request of a professional
user a safety data sheet providing proportionate

(1) OJ L 144, 4.6.1997, p. 19.

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for

information
as
preparations
dangerous within the meaning of Articles 5, 6 and 7
but containing in an individual concentration of ¯ 1 %
by weight for non-gaseous preparations and ¯ 0,2 %
by volume for gaseous preparations at least:

classified

not

(cid:151) one substance posing health or environmental

hazards, or

(cid:151) one substance for which there are Community

workplace exposure limits.

2.2. The safety data sheet and its supply must comply with

the provisions of Directive 91/155/EEC.

2.3. The necessary amendments required to adapt to technical
progress Directive 91/155/EEC shall be adopted in
accordance with the procedure laid down in Article 20 of
this Directive.

In particular, the necessary amendments to take account
of provisions in paragraph 2.1(b) shall be adopted before
the date specified in Article 22(1).

2.4. The safety data sheet may be supplied on paper or
the

addressee has

the

electronically, provided that
necessary means of receiving it.

procedure may not be applied where the substance concerned
has been assigned a Community exposure limit.

Where the person responsible for placing a preparation on the
market wishes to take advantage of confidentiality provisions,
he shall make a request to the competent authority of the
Member State in which the preparation is to be first placed on
the market.

This request must be made in accordance with the provisions
of Annex VI and must provide the information required in the
form in Part A of that Annex. The competent authority may
nevertheless
information from the person
responsible for placing the preparation on the market if such
information appears necessary in order to evaluate the validity
of the request.

request

further

The authority of the Member State receiving a request for
confidentiality shall notify the applicant of its decision. The
person responsible for placing the preparation on the market
shall forward a copy of this decision to each of the Member
States where he wishes to market the product.

information brought

Confidential
the
authorities of a Member State or of the Commission shall be
treated in accordance with Article 19(4) of Directive 67/548/
EEC.

to the attention of

Article 15

Confidentiality of chemical names

Article 16

Rights of Member States regarding safety of workers

Where the person responsible for placing the preparation on
the market can demonstrate that the disclosure on the label or
safety data sheet of the chemical identity of a substance which
is exclusively classified as:

(cid:151) irritant with the exception of

those assigned R41 or
irritant in combination with one or more of the other
properties mentioned in point 2.3.4 of Article 10, or

This Directive shall not affect the right of Member States to
specify, in compliance with the Treaty, the requirements they
deem necessary to ensure that workers are protected when
using the dangerous preparations in question, provided that
this does not mean that
the classification, packaging, and
labelling of dangerous preparations are modified in a way not
provided for in this Directive.

(cid:151) harmful or harmful in combination with one or more of
the properties mentioned in point 2.3.4 of Article 10
presenting acute lethal effects alone

Bodies responsible for receiving information relating
to health

Article 17

will put at risk the confidential nature of his intellectual
property, he may,
in accordance with the provisions of
Annex VI, be permitted to refer to that substance either by
means of a name that identifies the most important functional
chemical groups or by means of an alternative name. This

Member States shall appoint the body or bodies responsible for
receiving information, including chemical composition, relating
to preparations placed on the market
and considered
dangerous on the basis of their health effects or on the basis of
their physico-chemical effects.

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Member States shall take the necessary steps to ensure that the
for
appointed bodies provide all
maintaining the confidentiality of
the information received.
Such information may only be used to meet any medical
demand by formulating preventive and curative measures, in
particular in case of emergency.

the requisite guarantees

Member States shall ensure that the information is not used
for other purposes.

disposal

Member States shall ensure that the appointed bodies have at
their
from the
manufacturers or persons responsible for marketing to carry
out the tasks for which they are responsible.

information required

the

all

Article 18

Free movement clause

Without prejudice
in other
to the provisions
Community legislation, Member States may not prohibit,
restrict or impede the placing on the market of preparations
labelling or safety
because of their classification, packaging,
data sheets if such preparations comply with the provisions
laid down in this Directive.

set out

Article 19

Safeguard clause

the provisions of

although satisfying

1. Where a Member State has detailed evidence that a
preparation,
this
Directive, constitutes a hazard for man or the environment on
it may
grounds relating to the provisions of this Directive,
provisionally prohibit
that
preparation or subject it to special conditions in its territory. It
shall
immediately inform the Commission and the other
Member States of such action and give reasons for its decision.

the placing on the market of

procedure laid down in Article 29(4)(a) of Directive 67/548/
EEC.

The Commission shall be assisted by a committee composed of
the representatives of the Member States and chaired by the
representative of the Commission.

the Commission shall submit

The representative of
to the
committee a draft of the measures to be taken. The committee
shall deliver its opinion on the draft within a time limit which
the chairman may lay down according to the urgency of the
matter. The opinion shall be delivered by the majority laid
down in Article 205(2) of the Treaty in the case of decisions
which the Council is required to adopt on a proposal from the
Commission. The votes of the representatives of the Member
States within the committee shall be weighted in the manner
set out in that Article. The chairman shall not vote.

The Commission shall adopt the measures envisaged if they
are in accordance with the opinion of the committee.

the measures envisaged are not

in accordance with the
If
opinion of the committee, or if no opinion is delivered, the
Commission shall, without delay, submit
to the Council a
proposal relating to the measures to be taken. The Council
shall act by a qualified majority.

If the Council has not acted within three months of the date of
referral,
shall be adopted by the
Commission.

the proposed measures

Article 21

Repeal of Directives

In the case referred to in paragraph 1, the Commission

2.
shall consult the Member States as soon as possible.

The Commission shall take a decision in accordance with

3.
the procedure laid down in Article 20.

1.
The Directives listed in Part A of Annex VIII are hereby
repealed, without prejudice to the obligation of the Member
States concerning the deadlines for transposition into national
law and for application of the Directives indicated in Part B of
Annex VIII.

Article 20

Adaptation to technical progress

2.
The Directives listed in Part A of Annex VIII shall apply
to Austria, Finland and Sweden subject to provisions laid down
in Part C of that Annex and pursuant to the Treaty.

Amendments required to adapt the Annexes to this Directive
to technical progress shall be adopted in accordance with the

3.
References to the repealed Directives shall constitute
references to this Directive and should be read in accordance
with the correlation table set out in Annex IX.

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Article 22

Transposition

Article 23

Entry into force

1. Member States shall adopt and publish before 30 July
2002 the laws,
regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

2. Member States shall apply the laws, regulations and
administrative provisions referred to in paragraph 1:

(a)

(b)

to preparations not within the scope of Directive 91/414/
EEC or Directive 98/8/EC as from 30 July 2002; and

to preparations within the scope of Directive 91/414/EEC
or Directive 98/8/EC as from 30 July 2004.

3. When Member States adopt such measures, they shall
contain a reference to this Directive or shall be accompanied
by such reference at the time of their official publication. The
methods of making such reference shall be laid down by
Member States.

This Directive shall enter
publication in the Official Journal of the European Communities.

into force on the day of

its

Article 21(2) shall apply from 1 January 1999.

Article 24

Addressees

This Directive is addressed to the Member States.

Done at Brussels, 31 May 1999.

For the European Parliament

For the Council

The President

J. M. GIL-ROBLES

The President

J. FISCHER

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METHODS FOR THE EVALUATION OF PHYSICO-CHEMICAL PROPERTIES OF PREPARATIONS IN
ACCORDANCE WITH ARTICLE 5

ANNEX I

Exemptions to test methods of Annex V (cid:151) Part A to Directive 67/548/EEC

PART A

See 2.2.5 of Annex VI to Directive 67/548/EEC.

PART B

Alternative calculation methods

B.1. Non-gaseous preparations

1. Method for the determination of oxidising properties of preparations containing organic peroxides.

See point 2.2.2.1 of Annex VI to Directive 67/548/EEC.

B.2. Gaseous preparations

1. Method for the determination of oxidising properties

See 9.1.1.2 of Annex VI to Directive 67/548/EEC.

2. Method for the determination of flammability properties

See 9.1.1.1 of Annex VI to Directive 67/548/EEC.

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METHODS FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH
ARTICLE 6

ANNEX II

Introduction

An assessment must be made for all the health effects corresponding to the health effects of substances contained in a
preparation. This conventional method described in Parts A and B of this Annex is a calculation method which is
applicable to all preparations and which takes into consideration all the health hazards of substances contained in the
preparation. For that purpose the dangerous health effects have been subdivided into:

1.

acute lethal effects;

2. non-lethal irreversible effects after a single exposure;

3.

severe effects after repeated or prolonged exposure;

4.

corrosive effects, irritant effects;

5.

sensitising effects;

6.

carcinogenic effects, mutagenic effects, toxic effects for reproduction.

The health effects of a preparation are to be assessed in accordance with Article 6(1)(a) by the conventional method
described in parts A and B of this Annex using individual concentration limits.

(a) where the dangerous substances listed in Annex I to Directive 67/548/EEC are assigned concentration limits
necessary for the application of the method of assessment described in part A of this Annex, these concentration
limits must be used;

(b) where the dangerous substances do not appear in Annex I to Directive 67/548/EEC or appear there without the
concentration limits necessary for the application of the method of evaluation described in part A of this Annex,
the concentration limits must be assigned in accordance with the specifications in part B of this Annex.

The procedure for classification is set out in Part A of this Annex.

The classification of the substance(s) and the resulting classification of the preparation are expressed:

(cid:151) either by a symbol and one or more risk phrases, or

(cid:151) by categories (category 1, category 2 or category 3) also assigned risk phrases when substances and preparations
are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider,
in
addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under
consideration.

The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed
as a weight/weight percentage except
for gaseous preparations where they are expressed as a volume/volume
percentage and in conjunction with the classification of the substance.

Where they are not given in Annex I to Directive 67/548/EEC, the concentration limits to be taken into account for
the application of this conventional method are those set out in Part B of this Annex.

PART A

Procedure for evaluation of health hazards

The evaluation proceeds stepwise as follows:

1.

The following preparations are to be classified as very toxic:

1.1.

owing to their acute lethal effects and assigned the symbol (cid:145)T+(cid:146), the indication of danger (cid:145)very toxic(cid:146) and the risk
phrases R26, R27 or R28;

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1.1.1. preparations containing one or more substances classified as very toxic that produce such effects, in individual

concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 1 in Part B of this Annex (Table I and I A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.1.2. preparations containing more than one substance classified as very toxic in lower individual concentrations than

the limits specified under 1.1.1(a) or (b) if:

(cid:18) (cid:19)

X PT(cid:135)
LT(cid:135)

(cid:21) 1

where:

PT+ = is the percentage by weight or by volume of each very toxic substance in the preparation,

LT+ = is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by

volume;

1.2.

owing to their non-lethal irreversible effects after a single exposure and assigned the symbol (cid:145)T+(cid:146), the indication
of danger (cid:145)very toxic(cid:146) and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations
equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 2 in Part B of this Annex (Table II and II A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

2.

The following preparations shall be classified as toxic:

2.1.

owing to their acute lethal effects and assigned the symbol (cid:145)T(cid:146), the indication of danger (cid:145)toxic(cid:146) and the risk
phrases R23, R24 or R25;

2.1.1. preparations containing one or more substances classified as very toxic or toxic that produce such effects in

individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 1 in Part B of this Annex (Table I and I A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.1.2. preparations containing more than one substance classified as very toxic or toxic in lower individual

concentrations than the limits specified under 2.1.1(a) or (b) if:
(cid:19)

(cid:18)
X PT(cid:135)
LT

(cid:135)

PT
LT

(cid:21) 1

where:

PT+ = is the percentage by weight or by volume of each very toxic substance in the preparation,

PT = is the percentage by weight or by volume of each toxic substance in the preparation,

LT = is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by

weight or by volume;

2.2.

owing to their non-lethal irreversible effects after a single exposure and assigned the symbol (cid:145)T(cid:146), the indication
of danger (cid:145)toxic(cid:146) and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance classified as very toxic or toxic that produce such
effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

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(b)

the concentration specified at point 2 in Part B of this Annex (Table II and II A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.3.

owing to their long-term effects and assigned the symbol (cid:145)T(cid:146), the indication of danger (cid:145)toxic(cid:146) and the risk phrase
R48/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations
equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 3 in Part B of this Annex (Table III and III A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

3.

The following preparations shall be classified as harmful:

3.1.

owing to their acute lethal effects and assigned the symbol (cid:145)Xn(cid:146) and the indication of danger (cid:145)harmful(cid:146) and the
risk phrases R20, R21 or R22;

3.1.1. preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such

effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 1 in Part B of this Annex (Table I and I A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

3.1.2. preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual

concentrations than the limits specified under 3.1.1(a) or (b) if:

(cid:18)
X PT(cid:135)
LXn

(cid:135)

PT
LXn

(cid:135)

PXn
LXn

(cid:19)

(cid:21) 1

where:

PT+ = is the percentage by weight or by volume of each very toxic substance in the preparation,

PT = is the percentage by weight or by volume of each toxic substance in the preparation,

PXn = is the percentage by weight or by volume of each harmful substance in the preparation,

LXn = is the respective harmful limit specified for each very toxic, toxic or harmful substance, expressed as

percentage by weight or by volume;

3.2.

owing to their acute effects to the lungs if swallowed and assigned the symbol (cid:145)Xn(cid:146), and the indication of danger
(cid:145)harmful(cid:146) and the risk phrase R65.

Preparations classified as harmful according to the criteria specified in paragraph 3.2.3 of Annex VI
to
Directive 67/548/EEC. In applying the conventional method according to the above paragraph 3.1 no account
shall be taken of the classification of a substance as R65;

3.3.

owing to their non-lethal irreversible effects after a single exposure and assigned the symbol (cid:145)Xn(cid:146), the indication
of danger (cid:145)harmful(cid:146) and the risk phrase R40/route of exposure.

Preparations containing at least one dangerous substance classified as very toxic, toxic or harmful that produces
such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 2 in Part B of this Annex (Table II and II A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

3.4.

owing to their long-term effects and assigned the symbol (cid:145)Xn(cid:146), the indication of danger (cid:145)harmful(cid:146) and the risk
phrase R48/route of exposure.

Preparations containing at least one dangerous substance classified as toxic or harmful that produces such
effects in individual concentrations equal to or greater than:

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(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 3 in Part B of this Annex (Table III and III A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

4.

The following preparations are to be classified as corrosive

4.1.

and assigned the symbol (cid:145)C(cid:146), the indication of danger (cid:145)corrosive(cid:146) and the risk phrase R35;

4.1.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 in

individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

4.1.2. preparations containing more than one substance classified as corrosive to which is assigned phrase R35 in

lower individual concentrations than the limits specified under 4.1.1(a) or (b) if:

(cid:19)

(cid:18)
X PC;R35
LC;R35

(cid:21) 1

where:

PC, R35 = is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in

the preparation,

LC, R35 = is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35,

expressed as a percentage by weight or by volume;

4.2.

and assigned the symbol (cid:145)C(cid:146), the indication of danger (cid:145)corrosive(cid:146) and the risk phrase R34;

4.2.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 or

R34 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

4.2.2. preparations containing more than one of the substances classified as corrosive to which is assigned the

phrase R35 or R34 in lower individual concentrations than the limits specified under 4.2.1(a) or (b) if:

(cid:18)
X PC;R35
LC;R34

(cid:135)

PC;R34
LC;R34

(cid:19)

(cid:21) 1

where:

PC, R35 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35

in the preparation,

PC, R34 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34

in the preparation,

LC, R34 = is the respective corrosive limit R34 specified for each corrosive substance to which is assigned

phrase R35 or R34, expressed as a percentage by weight or by volume.

5.

The following preparations are to be classified as irritants:

5.1.

liable to cause serious eye damage and assigned the symbol (cid:145)Xi(cid:146), the indication of danger (cid:145)irritant(cid:146) and the risk
phrase R41;

5.1.1. preparations containing one or more substances classified as irritant to which is assigned phrase R41 in

individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

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(b)

the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

5.1.2. preparations containing more than one of

phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34,
concentrations than the limits specified under 5.1.1(a) or (b) if:

the substances classified as irritant and to which is assigned
in lower individual

(cid:18)
X PC; R35
LXi; R41

(cid:135)

PC; R34
LXi; R41

(cid:135)

PXi; R41
LXi; R41

(cid:19)

(cid:21) 1

where:

PC, R35 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35

in the preparation,

PC, R34 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34

in the preparation,

PXi, R41 = is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41

in the preparation,

LXi, R41 = is the respective irritant

limit R41 specified for each corrosive substance to which is assigned
phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed as percentage by
weight or by volume;

5.2.

irritant to eyes and assigned the symbol (cid:145)Xi(cid:146), the indication of danger (cid:145)irritant(cid:146) and the risk phrase R36;

5.2.1. preparations containing one or more substances classified as corrosive to which is assigned phrase R35 or R34
or as irritant and to which is assigned phrase R41 or R36 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

5.2.2. preparations containing more than one substance classified as irritant to which is assigned phrase R41 or R36,
or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits
specified under 5.2.1(a) or (b) if:

(cid:18)
X PC; R35
LXi; R36

(cid:135)

PC; R34
LXi; R36

(cid:135)

PXi; R41
LXi; R36

(cid:135)

PXi; R36
LXi; R36

(cid:19)

(cid:21) 1

where:

PC, R35 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35

in the preparation,

PC, R34 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34

in the preparation,

PXi, R41 = is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41

in the preparation,

PXi, R36 = is the percentage by weight or by volume of each irritant substance to which is assigned phrase R36

in the preparation,

LXi, R36 = is the respective irritant

limit R36 specified for each corrosive substance to which is assigned
phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as
percentage by weight or by volume;

5.3.

irritant to skin and assigned the symbol (cid:145)Xi(cid:146), the indication of danger (cid:145)irritant(cid:146) and the risk phrase R38;

5.3.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R38 or as

corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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5.3.2. preparations containing more than one of

the substances classified as irritant and to which is assigned
phrase R38, or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations
than the limits specified under 5.3.1(a) or (b) if:

(cid:18)
X PC; R35
LXi; R38

(cid:135)

PC; R34
LXi; R38

(cid:135)

PXi; R38
LXi; R38

(cid:19)

(cid:21) 1

where:

PC, R35 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35

in the preparation,

PC, R35 = is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34

in the preparation,

PXi, R38 = is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38

in the preparation,

LXi, R38 = is the respective irritant

limit R38 specified for each corrosive substance to which is assigned
phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by
weight or by volume;

5.4.

irritant to respiratory system and assigned the symbol
phrase R37;

(cid:145)Xi(cid:146), the indication of danger (cid:145)irritant(cid:146) and the risk

5.4.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R37 in

individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or
the substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration
limits;

5.4.2. preparations containing more than one substance classified as irritant and to which is assigned phrase R37 in

lower individual concentrations than the limits specified under 5.4.1(a) or (b) if:

(cid:19)

(cid:18)
X PXi; R37
LXi; R37

(cid:21) 1

where:

PXi, R37 = is the percentage by weight or by volume of each irritant substance to which is assigned phrase R37

in the preparation,

LXi, R37 = is the irritant limit R37 specified for each irritant substance to which is assigned phrase R37,

expressed as percentage by weight or by volume;

5.4.3. gaseous preparations containing more than one of the substances classified as irritant to which is assigned
phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than
the limits specified under 5.4.1(a) or (b) if:
(cid:18)
X PC; R35
LXi; R37

PXi; R37
LXi; R37

PC; R34
LXi; R37

(cid:21) 1

(cid:135)

(cid:135)

(cid:19)

where:

PC, R35 = is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the

preparation,

PC, R34 = is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the

preparation,

PXi, R37 = is the percentage by volume of each irritant substance to which is assigned phrase R37 in the

preparation,

LXi, R37 = is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned
phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as
percentage by weight or by volume.

6.

The following preparations are to be classified as sensitising:

6.1.

by skin contact and assigned the symbol (cid:145)Xi(cid:146), the indication of danger (cid:145)irritant(cid:146) and the risk phrase R43.

Preparations containing at least one substance classified as sensitising and to which is assigned phrase R43 that
produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

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(b)

the concentration specified at point 5 in Part B of this Annex (Table V and V A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

6.2.

by inhalation and assigned the symbol (cid:145)Xn(cid:146), the indication of danger (cid:145)harmful(cid:146) and the risk phrase R42.

Preparations containing at least one substance classified as sensitising to which is assigned phrase R42 that
produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 5 in Part B of this Annex (Table V and V A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

7.

The following preparations are to be classified as carcinogenic:

7.1.

those of category 1 or 2 which are assigned the symbol (cid:145)T(cid:146) and the phrase R45 or R49.

Preparations containing at least one substance producing such effects, classified as carcinogenic and to which is
assigned phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2, in individual
concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

7.2.

those of category 3 which are assigned the symbol (cid:145)Xn(cid:146) and the phrase R40.

Preparations containing at least one substance producing such effects classified as carcinogenic and to which is
assigned phrase R40 which denotes carcinogenic substances in category 3, in individual concentrations equal to
or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

8.

The following preparations are to be classified as mutagenic:

8.1.

those of category 1 or 2 which are assigned the symbol (cid:145)T(cid:146) and the phrase R46.

Preparations containing at least one substance producing such effects, classified as mutagenic and to which is
in individual
assigned phrase R46 which denotes mutagenic substances in category 1 and category 2,
concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

8.2.

those of category 3 which are assigned the symbol (cid:145)Xn(cid:146) and the phrase R40.

Preparations containing at least one substance, producing such effects, classified as mutagenic and to which is
assigned phrase R40 which denotes mutagenic substances in category 3, in individual concentrations equal to or
greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

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9.

The following preparations are to be classified as toxic for reproduction:

9.1.

those of category 1 or 2 which are assigned the symbol (cid:145)T(cid:146) and the phrase R60 (fertility).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to
which is assigned phrase R60 which denotes substances toxic for reproduction of category 1 and category 2, in
individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.2.

those of category 3 which are assigned the symbol (cid:145)Xn(cid:146) and the phrase R62 (fertility).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to
which is assigned phrase R62 which denotes substances toxic for reproduction of category 3, in individual
concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.3.

those of category 1 or 2 which are assigned the symbol (cid:145)T(cid:146) and the phrase R61 (development).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to
which is assigned phrase R61 which denotes substances toxic for reproduction of category 1 and category 2, in
individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.4.

those of category 3 which are assigned the symbol (cid:145)Xn(cid:146) and the phrase R63 (development).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to
which is assigned phrase R63 which denotes substances toxic for reproduction of category 3, in individual
concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

PART B

Concentration limits to be used in evaluation of health hazards

to be used for non-gaseous preparations and the second table (Tables I A to VI A) sets out

For each health effect, the first table (Tables I to VI) sets out the concentration limits (expressed as a weight/weight
percentage)
the
concentration limits
to be used for gaseous preparations. These
concentration limits are used in the absence of specific concentration limits for the substance under consideration in
Annex I to Directive 67/548/EEC.

(expressed as a volume/volume percentage)

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1.

Acute lethal effects

1.1.

N o n - g a s e o u s p r e p a r a t i o n s

The concentration limits fixed in Table I, expressed as a weight/weight percentage, determine the classification
of the preparation in relation to the individual concentration of the substance(s) present whose classification is
also shown.

Table I

Classification of the substance

Classification of the preparation

T+

T

Xn

T+ with R26, R27, R28

concentration ¯ 7 %

1 %
˜ concentration < 7 %

0,1 %
˜ concentration < 1 %

T with R23, R24, R25

concentration ¯ 25 %

3 %
˜ concentration < 25 %

Xn with R20, R21, R22

concentration ¯ 25 %

The R phrases denoting risk are to be assigned to the preparation in accordance with the following criteria:

(cid:151) the label shall include one or more of the abovementioned R phrases according to the classification used,

(cid:151) in general,

the R phrases selected should be those applicable to the substance(s) present

in the

concentration which gives rise to the most severe classification.

1.2.

G a s e o u s p r e p a r a t i o n s

The concentration limits expressed as a volume/volume percentage in Table I A below determine the
classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose
classification is also shown.

Table I A

Classification of the substance
(gas)

Classification of the gaseous preparation

T+

T

Xn

T+ with R26, R27, R28

concentration ¯ 1 %

0,2 %
˜ concentration < 1 %

0,02 %
˜ concentration < 0,2 %

T with R23, R24, R25

concentration ¯ 5 %

Xn with R20, R21, R22

0,5 %
˜ concentration < 5 %

concentration ¯ 5 %

The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:

(cid:151) the label shall include one or more of the abovementioned R phrases according to the classification used,

(cid:151) in general,

the R phrases selected should be those applicable to the substance(s) present

in the

concentration which gives rise to the most severe classification.

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2.

Non-lethal irreversible effects after a single exposure

2.1.

N o n - g a s e o u s p r e p a r a t i o n s

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/
route of exposure), the individual concentration limits specified in Table II, expressed as a weight/weight
percentage, determine, when appropriate, the classification of the preparation.

Classification of the substance

T+ with R39/route of exposure

T with R39/route of exposure

Xn with R40/route of exposure

Table II

Classification of the preparation

T+

T

Xn

concentration ¯ 10 %
R39 (*) obligatory

1 %
˜ concentration < 10 %
R39 (*) obligatory

0,1 %
˜ concentration < 1 %
R40 (*) obligatory

concentration ¯ 10 %
R39 (*) obligatory

1 %
˜ concentration < 10 %
R40 (*) obligatory

concentration ¯ 10 %
R40 (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points

3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

2.2.

G a s e o u s p r e p a r a t i o n s

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/route
of exposure),
the individual concentration limits specified in Table II A, expressed as a volume/volume
percentage, determine, when appropriate, the classification of the preparation.

Classification of the substance (gas)

T+ with R39/route of exposure

T with R39/route of exposure

Xn with R40/route of exposure

Table II A

Classification of the gaseous preparation

T+

T

Xn

concentration ¯ 1 %
R39 (*) obligatory

0,2 %
˜ concentration < 1 %
R39 (*) obligatory

0,02 %
˜ concentration < 0,2 %
R40 (*) obligatory

concentration ¯ 5 %
R39 (*) obligatory

0,5 % ˜ concentration
< 5 %
R40 (*) obligatory

concentration ¯ 5 %
R40 (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points

3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

3.

Severe effects after repeated or prolonged exposure

3.1.

N o n - g a s e o u s p r e p a r a t i o n s

For substances that produce severe effects after repeated or prolonged exposure (R 48/route of exposure), the
individual concentration limits specified in Table III, expressed as a weight/weight percentage, determine, when
appropriate, the classification of the preparation.

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Table III

Classification of the substance

Classification of the preparation

T

Xn

T with R48/route of exposure

concentration ¯ 10 %
R48 (*) obligatory

1 % ˜ concentration < 10 %
R48 (*) obligatory

Xn with R48/route of exposure

concentration ¯ 10 %
R48 (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points

3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

3.2.

G a s e o u s p r e p a r a t i o n s

For gases that produce severe effects after repeated or prolonged exposure (R48/route of exposure),
the
individual concentration limits specified in Table III A below, expressed as a volume/volume percentage,
determine, when appropriate, the classification of the preparation.

Table III A

Classification of the substance
(gas)

Classification of the gaseous preparation

T

Xn

T with R48/route of exposure

concentration ¯ 5 %
R48 (*) obligatory

0,5 % ˜ concentration < 5 %
R48 (*) obligatory

Xn with R48/route of exposure

concentration ¯ 5 %
R48 (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points

3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

4.

Corrosive and irritant effects including serious damage to the eye

4.1.

N o n - g a s e o u s p r e p a r a t i o n s

For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual
concentration limits
specified in Table IV, expressed as a weight/weight percentage, determine, when
appropriate, the classification of the preparation.

Classification of
the substance

Table IV

Classification of the preparation

C with R35

C with R34

Xi with R41

Xi with R36, R37, R38

C with R35

concentration ¯ 10 %
R35 obligatory

5 % ˜ concentration
< 10 %
R34 obligatory

5 % (*)

1 % ˜ concentration
< 5 %
R36/38 obligatory

C with R34

concentration ¯ 10 %
R34 obligatory

10 % (*)

5 % ˜ concentration
< 10 %
R36/38 obligatory

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Classification of
the substance

Xi with R41

Xi with R36,
R37, R38

Classification of the preparation

C with R35

C with R34

Xi with R41

Xi with R36, R37, R38

concentration
¯ 10 %
R41
obligatory

5 % ˜ concentration
< 10 %
R36 obligatory

concentration ¯ 20 %
R36, R37, R38 are
obligatory in the light
of the concentration
present if they apply to
the substances under
consideration

(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34
must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with
R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can
contribute to a classification of the preparation as irritant with R41 or irritant with R36.

4.2.

G a s e o u s p r e p a r a t i o n s

For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits
specified in Table IV A below, expressed as a volume/volume percentage determine, when appropriate, the
classification of the preparation.

Classification of
the substance
(gas)

Table IV A

Classification of the gaseous preparation

C with R35

C with R34

Xi with R41

Xi with R36, R37, R38

C with R35

concentration ¯ 1 %
R35 obligatory

0,2 % ˜ concentration
< 1 %
R34 obligatory

0,2 % (*)

0,02 % ˜ concentration
< 0,2 %
R36/37/38 obligatory

C with R34

Xi with R41

Xi with R36,
R37, R38

concentration ¯ 5 %
R34 obligatory

5 % (*)

0,5 % ˜ concentration
< 5 %
R36/37/38 obligatory

concentration
¯ 5 %
R41
obligatory

0,5 % ˜ concentration
< 5 %
R36 obligatory

concentration ¯ 5 %
R36, R37, R38
obligatory as appropriate

(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34
must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with
R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can
contribute to a classification of the preparation as irritant with R41 or irritant with R36.

5.

Sensitising effects

5.1.

N o n - g a s e o u s p r e p a r a t i o n s

Preparations that produce such effects are classified as sensitising and assigned:

(cid:151) the symbol Xn and phrase R42 if this effect can be produced by inhalation,

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(cid:151) the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

The individual concentration limits specified in Table V, expressed as a weight/weight percentage, determine,
when appropriate, the classification of the preparation.

Table V

Classification of the substance

Classification of the preparation

Sensitising with R42

Sensitising with R43

Sensitising with R42

Sensitising with R43

concentration ¯ 1 %
R42 obligatory

concentration ¯ 1 %
R43 obligatory

5.2.

G a s e o u s p r e p a r a t i o n s

Gaseous preparations that produce such effects are classified as sensitising and assigned:

(cid:151) the symbol Xn and phrase R42 if this effect can be produced by inhalation,

(cid:151) the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

The individual concentration limits specified in Table V A below, expressed as a volume/volume percentage,
determine, when appropriate, the classification of the preparation.

Table V A

Classification of the substance
(gas)

Classification of the gaseous preparation

Sensitising with R42

Sensitising with R43

Sensitising with R42

Sensitising with R43

concentration ¯ 0,2 %
R42 obligatory

concentration ¯ 0,2 %
R43 obligatory

6.

Carcinogenic/mutagenic/toxic effects for reproduction

6.1.

N o n - g a s e o u s p r e p a r a t i o n s

For substances which produce such effects, the concentration limits laid down in Table VI, expressed as a
weight/weight percentage, shall determine, where appropriate,
the preparation. The
following symbol and risk phrases are assigned:

the classification of

Carcinogenic categories 1 and 2:

Carcinogenic category 3:

Mutagenic categories 1 and 2:

Mutagenic category 3:

Toxic for reproduction fertility categories 1 and 2:

Toxic for reproduction development categories 1 and 2:

Toxic for reproduction fertility category 3:

Toxic for reproduction development category 3:

T; R45 or R49

Xn; R40

T; R46

Xn; R40

T; R60

T; R61

Xn; R62

Xn; R63

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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

concentration ¯ 0,1 %
mutagenic
R46 obligatory

mutagenic substances of category 3 with
R40

substances (cid:145)toxic for reproduction(cid:146) of
category 1 or 2 with R60 (fertility)

substances (cid:145)toxic for reproduction(cid:146) of
category 3 with R62 (fertility)

concentration ¯ 0,5 %
toxic for reproduction
(fertility)
R60 obligatory

substances (cid:145)toxic for reproduction(cid:146) of
category 1 or 2 with R61 (development)

concentration ¯ 0,5 %
toxic for reproduction
(development)
R61 obligatory

substances (cid:145)toxic for reproduction(cid:146) of
category 3 with R63 (Development)

concentration ¯ 1 %
carcinogenic
R40 obligatory

concentration ¯ 1 %
mutagenic
R40 obligatory

concentration ¯ 5 %
toxic for reproduction
(fertility)
R62 obligatory

concentration ¯ 5 %
toxic for reproduction
(development)
R63 obligatory

6.2.

G a s e o u s p r e p a r a t i o n s

For gases which produce such effects, the concentration limits laid down in Table VI A, expressed as a volume/
volume percentage, shall determine, where appropriate, the classification of the preparation. The following
symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2:

T; R45 or R49

Carcinogenic category 3:

Mutagenic categories 1 and 2:

Mutagenic category 3:

Toxic for reproduction fertility categories 1 and 2:

Toxic for reproduction development categories 1 and 2:

Toxic for reproduction fertility category 3:

Toxic for reproduction development category 3:

Xn; R40

T; R46

Xn; R40

T; R60

T; R61

Xn; R62

Xn; R63

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Table VI A

Classification of the substance
(gas)

Classification of the gaseous 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

concentration ¯ 0,1 %
mutagenic
R46 obligatory

mutagenic substances of category 3 with
R40

substances (cid:145)toxic for reproduction(cid:146) of
category 1 or 2 with R60 (fertility)

substances (cid:145)toxic for reproduction(cid:146) of
category 3 with R62 (fertility)

concentration ¯ 0,2 %
toxic for reproduction
(fertility)
R60 obligatory

substances (cid:145)toxic for reproduction(cid:146) of
category 1 or 2 with R61 (development)

concentration ¯ 0,2 %
toxic for reproduction
(development)
R61 obligatory

substances (cid:145)toxic for reproduction(cid:146) of
category 3 with R63 (development)

concentration ¯ 1 %
carcinogenic
R40 obligatory

concentration ¯ 1 %
mutagenic
R40 obligatory

concentration ¯ 1 %
toxic for reproduction
(fertility)
R62 obligatory

concentration ¯ 1 %
toxic for reproduction
(development)
R63 obligatory

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ANNEX III

METHODS FOR THE EVALUATION OF THE ENVIRONMENTAL HAZARDS OF PREPARATIONS IN
ACCORDANCE WITH ARTICLE 7

Introduction

The systematic assessment of all the dangerous properties for the environment is expressed by means of concentration
limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/
volume percentage and in conjunction with the classification of a substance.

Part A gives the calculation procedure according to Article 7(1)(a) and gives the R phrases to be assigned to the
classification of the preparation.

Part B gives the concentration limits to be used when applying the conventional method and relevant symbols and R
phrases for classification.

In accordance with Article 7(1)(a) the environmental hazards of a preparation shall be assessed by the conventional
method described in parts A and B of this Annex, using individual concentration limits.

(a) Where the dangerous substances listed in Annex 1 to Directive 67/548/EEC are assigned concentration limits
necessary for the application of the method of assessment described in Part A of this Annex, these concentration
limits must be used.

(b) Where the dangerous substances do not appear in Annex I to Directive 67/548/EEC or appear there without the
concentration limits necessary for the application of the method of evaluation described in Part A of this Annex,
the concentration limits shall be assigned in accordance with the specification in Part B of this Annex.

Part C gives the test methods for the evaluation of the hazards for the aquatic environment.

PART A

Procedure for the evaluation of environmental hazards

(a) Aquatic environment

I.

C o n v e n t i o n a l m e t h o d f o r t h e e v a l u a t i o n o f h a z a r d s t o t h e a q u a t i c e n v i r o n m e n t

The conventional method for the evaluation of hazards to the aquatic environment takes into account all the
hazards that a substance may entail for this medium according to the following specifications.

The following preparations are to be classified as dangerous for the environment:

1.

and assigned the symbol
phrases R50 and R53 (R50(cid:150)53):

(cid:145)N(cid:146), the indication of danger (cid:145)dangerous for the environment(cid:146) and the risk

1.1. preparations containing one or more substances classified as dangerous to the environment and to which

is assigned phrases R50(cid:150)53 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 1) where the substance or substances do
not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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1.2. preparations containing more than one substance classified as dangerous for the environment and to
which is assigned phrases R50(cid:150)53 in lower individual concentrations than the limits specified under
I.1.1(a) or (b) if:

(cid:19)

(cid:18)

X PN; R50(cid:255)(cid:255)53
LN; R50(cid:255)(cid:255)53

(cid:21) 1

where:

PN, R50(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R50(cid:150)53 in the preparation,

LN, R50(cid:151)53 = is the limit R50-53 for each substance dangerous for the environment to which is assigned

the phrases R50(cid:150)53, expressed as percentage by weight

2.

and assigned the symbol
phrases R51 and R53 (R51(cid:150)53) unless the preparation is already classified according to I.1 above;

(cid:145)N(cid:146), the indication of danger (cid:145)dangerous for the environment(cid:146) and the risk

2.1. preparations containing one or more than one substance classified as dangerous to the environment and
to which is assigned phrases R50(cid:150)53 or R51(cid:150)53 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 1) where the substance or substances do
not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.2. preparations containing more than one of the substances classified as dangerous for the environment and
to which is assigned phrases R50(cid:150)53 or R51(cid:150)53 in lower individual concentrations than the limits
specified under I.2. (a) or (b) if:

(cid:18)

X PN; R50(cid:255)(cid:255)53
LN; R51(cid:255)(cid:255)53

(cid:135)

PN; R51(cid:255)(cid:255)53
LN; R51(cid:255)(cid:255)53

(cid:19)

(cid:21) 1

where:

PN, R50(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R50(cid:150)53 in the preparation,

PN, R51(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R51(cid:150)53 in the preparation,

LN, R51(cid:151)53 = is the respective limit R51(cid:150)53 for each substance dangerous for the environment to which

is assigned phrases R50(cid:150)53 or R51(cid:150)53, expressed as percentage by weight

3.

and assigned the risk phrases R52 and R53 (R52(cid:150)53) unless the preparation is already classified according
to I.1 or I.2 above;

3.1. preparations containing one or more than one substance classified as dangerous to the environment and
to which is assigned phrases R50(cid:150)53 or R51(cid:150)53 or R52(cid:150)53 in individual concentrations equal to or
greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 1) where the substance or substances do
not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

3.2. preparations containing more than one of the substances classified as dangerous for the environment and
to which is assigned phrases R51(cid:150)53 or R50(cid:150)53 or R52(cid:150)53 in lower individual concentrations than the
limits specified under I.3.1(a) or (b) if:

(cid:18)

X PN; R50(cid:255)(cid:255)53
LR52(cid:255)(cid:255)53

(cid:135)

PN; R51(cid:255)(cid:255)53
LR52(cid:255)(cid:255)53

(cid:135)

PR52(cid:255)(cid:255)53
LR52(cid:255)(cid:255)53

(cid:19)

(cid:21) 1

where:

PN, R50(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R50(cid:150)53 in the preparation,

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PN, R51(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R51(cid:150)53 in the preparation,

PR52(cid:151)53

= is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R52(cid:150)53 in the preparation,

LR52(cid:151)53

= is the respective limit R52(cid:150)53 for each substance dangerous for the environment to which

is assigned phrases R50(cid:150)53 or R51(cid:150)53 or R52(cid:150)53, expressed as percentage by weight;

4.

and assigned the symbol (cid:145)N(cid:146), the indication of danger (cid:145)dangerous for the environment(cid:146) and the risk phrase
R50 unless the preparation is already classified according to I.1 above:

4.1. preparations containing one or more than one substance classified as dangerous to the environment and

to which is assigned phrase R50 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 2) where the substance or substances do
not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

4.2. preparations containing more than one substance classified as dangerous for the environment and to
which is assigned phrase R50 in lower individual concentrations than the limits specified under I.4.1(a) or
(b) if:

where:

(cid:19)

(cid:18)
X PN; R50
LN; R50

(cid:21) 1

PN, R50 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrase R50 in the preparation,

LN, R50 = is the limit R50 for each substance dangerous for the environment to which is assigned phrase

R50, expressed as percentage by weight.

4.3. preparations containing one or more than one of

the substances classified as dangerous for the
environment and to which is assigned phrase R50 not meeting the criteria under I.4.1 or I.4.2 and
containing one or more than one substance classified as dangerous for the environment and to which is
assigned phrases R50(cid:150)53 if:

(cid:18)
X PN; R50
LN; R50

(cid:135)

PN; R50(cid:255)(cid:255)53
LN; R50

(cid:19)

(cid:21) 1

where:

PN, R50

= is the percentage by weight of each substance dangerous for the environment to which is

assigned phrase R50 in the preparation,

PN, R50(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrases R50(cid:150)53 in the preparation,

LN, R50

= is the perspective limit R50 for each substance dangerous for the environment to which is

assigned phrases R50 or R50(cid:150)53, expressed as percentage by weight;

5.

and assigned the risk phrase R52 unless the preparation is already classified according to I.1, I.2, I.3, or
I.4 above:

5.1. preparations containing one or more than one substance classified as dangerous to the environment and

to which is assigned phrase R52 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 3) where the substance or substances do
not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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5.2. preparations containing more than one substance classified as dangerous for the environment and to
which is assigned phrase R52 in lower individual concentrations than the limits specified under I.5.1 (a)
or (b) if:

(cid:19)

(cid:18)
X PR52
LR52

(cid:21) 1

where:
PR52 = is the percentage by weight of each substance dangerous for the environment to which is assigned

phrase R52 in the preparation,

LR52 = is the limit R52 for each substance dangerous for the environment to which is assigned phrase

R52, expressed as percentage by weight;

6.

and assigned the risk phrase R53 unless the preparation is already classified according to I.1, I.2, or I.3
above:

6.1. preparations containing one or more than one substance classified as dangerous to the environment and

to which is assigned phrase R53 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances

under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 4) where the substance or substances do
not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

6.2. preparations containing more than one substance classified as dangerous for the environment and to
which is assigned phrase R 53 in lower individual concentrations than the limits specified under I.6.1(a)
or (b) if:

(cid:19)

(cid:18)
X PR53
LR53

(cid:21) 1

where:
PR53 = is the percentage by weight of each substance dangerous for the environment to which is assigned

phrase R53 in the preparation,

LR53 = is the limit R53 for each substance dangerous for the environment to which is assigned phrase

R53, expressed as percentage by weight;

6.3. preparations containing one or more than one of

the substances classified as dangerous for the
environment and to which is assigned phrase R53 not meeting the criteria under I.6.2 and containing one
or more than one substance classified as dangerous for the environment and to which is assigned phrases
R50(cid:150)53 or R51(cid:150)53 or R52(cid:150)53 if:

(cid:18)
X PR53
LR53

(cid:135)

PN; R50(cid:255)(cid:255)53
LR53

(cid:135)

PN; R51(cid:255)(cid:255)53
LR53

(cid:135)

PR52(cid:255)(cid:255)53
LR53

(cid:19)

(cid:21) 1

where:
PR53

= is the percentage by weight of each substance dangerous for the environment to which is

assigned phrase R53 in the preparation,

PN, R50(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrase R50(cid:150)53 in the preparation,

PN, R51(cid:151)53 = is the percentage by weight of each substance dangerous for the environment to which is

assigned phrase R51(cid:150)53 in the preparation,

PR52(cid:151)53

= is the percentage by weight of each substance dangerous for the environment to which is

assigned phrase R52(cid:150)53 in the preparation,

LR53

= is the respective limit R53 for each substance dangerous for the environment to which is
assigned phrase R53 or R50(cid:150)53 or R51(cid:150)53 or R52(cid:150)53, expressed as percentage by weight.

(b) Non-aquatic environment

(1) OZONE LAYER

I.

C o n v e n t i o n a l m e t h o d f o r
o z o n e l a y e r

t h e

e v a l u a t i o n o f p r e p a r a t i o n s d a n g e r o u s

f o r

t h e

The following preparations are to classified as dangerous for the environment:

1.

and assigned the symbol (cid:145)N(cid:146), the indication of danger (cid:145)dangerous for the environment(cid:146) and the risk
phrase R59;

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1.1. preparations containing one or more substances classified as dangerous to the environment and to
which is assigned the symbol (cid:145)N(cid:146) and the risk phrase R59 in individual concentrations equal to or
greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 5) where the substance or substances
do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.

and assigned the risk phrase R59:

2.1. preparations containing one or more substances classified as dangerous to the environment and to

which is assigned R59 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances under consideration, or

(b)

the concentration specified in Part B of this Annex (Table 5) where the substance or substances
do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

(2) TERRESTRIAL ENVIRONMENT

I.

E v a l u a t i o n o f p r e p a r a t i o n s d a n g e r o u s f o r t h e t e r r e s t r i a l e n v i r o n m e n t

Classification of preparations using the risk phrases below will follow after the detailed criteria for use of
the phrases have been incorporated in Annex VI to Directive 67/548/EEC.

R54

Toxic to flora

R55

Toxic to fauna

R56

Toxic to soil organisms

R57

Toxic to bees

R58 May cause long-term adverse effects in the environment.

Concentration limits to be used for the evaluation of environmental hazards

PART B

I.

For the aquatic environment

The concentration limits fixed in the following tables, expressed as a weight/weight percentage, determine the
classification of the preparation in relation to the individual concentration of the substance(s) present whose
classification is also shown.

Table 1

Acute aquatic toxicity and long-term adverse effects

Classification of the substance

Classification of the preparation

N, R50(cid:151)53

N, R51(cid:151)53

R52(cid:151)53

N, R50(cid:151)53

N, R51(cid:151)53

R52(cid:151)53

Cn ¯ 25 %

2,5 % ˜ Cn < 25 %

0,25 % ˜ Cn < 2,5 %

Cn ¯ 25 %

2,5 % ˜ Cn < 25 %

Cn ¯ 25 %

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Table 2

Acute aquatic toxicity

Classification of the substance

Classification of the preparation
N, R50

N, R50

N, R50(cid:151)53

Cn ¯ 25 %

Cn ¯ 25 %

Table 3

Aquatic toxicity

Classification of the substance

Classification of the preparation R52
R52

R52

Cn ¯ 25 %

Table 4

Long-term adverse effects

Classification of the substance

Classification of the preparation R53
R53

R53

N, R50(cid:151)53

N, R51(cid:151)53

R52(cid:151)53

Cn ¯ 25 %

Cn ¯ 25 %

Cn ¯ 25 %

Cn ¯ 25 %

II.

For the non-aquatic environment

The concentration limits fixed in the following tables, expressed as weight/weight percentage or, for gaseous
preparations as a volume/volume percentage, determine the classification of the preparation in relation to the
individual concentration of the substance(s) present whose classification is also shown.

Table 5

Dangerous for the ozone layer

Classification of the substance

Classification of preparation
N, R59

N with R59

C ¯ 0,1 %

Classification of the substance

Classification of preparation
R59

R59

C ¯ 0,1 %

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Test methods for the evaluation of the hazards for the aquatic environment

PART C

Normally, the classification of a preparation is made on the basis of the conventional method. However, for the
determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the
preparation.

The result of these tests on the preparation may only modify the classification concerning acute aquatic toxicity which
would have been obtained by the application of the conventional method.

If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality
criteria of the test methods in Part C of Annex V to Directive 67/548/EEC have been complied with.

Furthermore, the tests are to be carried out on all three species in conformity with the criteria of Annex VI to Directive
67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been
assigned to the preparation after testing on one of the species or a test result was already available before this Directive
entered into force.

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SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE
GENERAL PUBLIC

ANNEX IV

PART A

Containers to be fitted with child-resistant fastenings

1. Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very
toxic, toxic or corrosive in accordance with Article 10 and under the conditions laid down in Article 6 of this
Directive, are to fitted with child-resistant fastenings.

2. Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and classified
and labelled according to paragraph 3.2.3 of Annex VI to Directive 67/548/EEC with the exception of preparations
placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment.

3. Containers of whatever capacity, having at least one of the substances mentioned below present in a concentration

equal to or greater than the maximum individual concentration specified,

No

1

2

Identification of the substance

CAS-Reg No

Name

67-56-1

Methanol

Einecs No

2006596

75-09-2

Dichloromethane

2008389

Concentration limit

¯ 3 %

¯ 1 %

which are offered or sold to the general public are to be fitted with child-resistant fastenings.

PART B

Containers to be fitted with a tactile warning of danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very
toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Article 10 and under the
conditions laid down in Articles 5 and 6 of this Directive, are to carry a tactile warning of danger.

This provision does not apply to aerosols classified and labelled only as extremely flammable or highly flammable.

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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 labels on packages 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 package label 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 of the preparation
must carry the wording of
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.

this phrase as set out

in Annex III

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 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

Labels of packages 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:

(cid:145)Contains lead. Should not be used on surfaces liable to be chewed or sucked by children(cid:146).

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

(cid:145)Warning! Contains lead(cid:146).

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2.

Preparations containing cyanoacrylates

2.1. A d h e s i v e s

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

(cid:145)Cyanoacrylate

Danger

Bonds skin and eyes in seconds

Keep out of the reach of children(cid:146).

Appropriate advice on safety must accompany the package.

3.

Preparations containing isocyanates

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

(cid:145)Contains isocyanates.

See information supplied by the manufacturer.(cid:146)

4.

Preparations containing epoxy constituents with an average molecular weight ˜ 700

The package labels of preparations containing epoxy constituents with an average molecular weight
˜ 700 must bear the following inscriptions:

(cid:145)Contains epoxy constituents.

See information supplied by the manufacturer.(cid:146)

5.

Preparations sold to the general public which contain active chlorine

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

(cid:145)Warning! Do not use together with other products. May release dangerous gases (chlorine).(cid:146)

6.

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

The packaging of the abovementioned preparations must bear the following inscription printed in clearly
legible and indelible characters:

(cid:145)Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions.(cid:146)

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 (cid:145)Warning (cid:151) substance not yet
the
preparation must bear the inscription (cid:145)Warning (cid:151) this preparation contains a substance not yet tested
completely(cid:146) if this substance is present in a concentration ¯ 1 %.

tested completely(cid:146),

the label of

9.

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

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:

(cid:145)Contains (name of sensitising substance). May produce an allergic reaction.(cid:146)

10.

Liquid preparations containing halogenated hydrocarbons

For liquid preparations which show no flashpoint or a flashpoint higher than 55 (cid:176)C and contain a
halogenated hydrocarbon and more than 5 % flammable or highly flammable substances, the packaging must
bear the following inscription as appropriate:

(cid:145)Can become highly flammable in use(cid:146) or (cid:145)Can become flammable in use(cid:146).

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 the preparations referred to in Article 14.2.1(b) must bear the following
inscription:

(cid:145)Safety data sheet available for professional user on request(cid:146).

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ANNEX VI

CONFIDENTIALITY FOR THE CHEMICAL IDENTITY OF A SUBSTANCE

PART A

Information to be communicated in the request for confidentiality

Introductory notes

A. Article 15 indicates the conditions in which the person responsible for placing a preparation on the market may

avail himself of the confidentiality.

B. To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single

request for confidentiality may suffice if a certain number of preparations have:

(cid:151) the same dangerous constituents present in the same concentration range,

(cid:151) the same classification and labelling,

(cid:151) the same expected uses.

A single alternative denomination must be used to mask the chemical
identity of the same substance in the
preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the
following request, without forgetting the name or the trade name of each preparation.

C. The alternative designation used on the label must be the same as that given under heading 2 (cid:145)Composition/
information on ingredients(cid:146) of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

This implies that the alternative designation used will contain enough information about the substance to ensure
risk-free handling.

D.

In making the request to use an alternative designation the person responsible for placing on the market must take
into account the need to provide enough information for necessary health and safety precautions to be taken in
the workplace and to ensure that risks from handling the preparation can be minimised.

Request for confidentiality

In accordance with Article 15 the request for confidentiality must obligatorily contain the following information:

1. Name and full address (including telephone number) of

the person established in the Community who is

responsible for placing the preparation on the market (manufacturer, importer or distributor).

2.

Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.

CAS No

Einecs No

Chemical name according to international
nomenclature and classification
(Annex I to Council Directive 67/548/EEC or
provisional classification)

Alternative designation

(a)

(b)

(c)

NB: Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as
evidence that the provisional classification takes account of all existing pertinent information available on the properties of
the substance.

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3.

Justification for confidentiality (probability (cid:151) plausibility).

4. Designation(s) or commercial name(s) of the preparation(s).

5.

Is the designation or commercial name the same for all the Community?

YES n

NO n

If no, specify the designation(s) or commercial name(s) used in the different Member States:

Austria:

Belgium:

Denmark:

Germany:

Greece:

Finland:

France:

Spain:

Sweden:

Ireland:

Italy:

Luxembourg:

Netherlands:

Portugal:

United Kingdom:

6. Composition of the preparation(s) defined in point 2 of the Annex to Directive 91/155/EEC as last amended by

Directive 93/112/EEC.

7. Classification of the preparation(s) according to Article 6 of this Directive.

8.

Labelling of the preparation(s) according to Article 10 of this Directive.

9.

Intended uses for the preparation(s).

10.

Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

PART B

Lexicon guide for establishing the alternative designations (generic names)

1.

Introductory note

The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances
into families) which appears in Annex I to Directive 67/548/EEC.

Alternative designations to those based on this guide may be used. However, in all cases the names chosen must
provide enough information to ensure the preparation can be handled without risk and that necessary health and
safety precautions can be taken in the workplace.

The families are defined in the following manner:

(cid:151) inorganic or organic substances whose properties are identified by having a common chemical element as
their chief characteristic. The family name is derived from the name of the chemical element. These families
are identified as in Annex I by the atomic number of the chemical element (001 to 103),

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(cid:151) organic substances whose properties are identified by having a common functional group as their chief

characteristics.

The family name is derived from the functional group name.

These families are identified by the conventional number found in Annex I (601(cid:151)650).

Sub-families bringing together substances with a common specific character have been added in certain cases.

2.

Establishing the generic name

General principles

For the purposes of establishing the generic name, the following general approach,
stages, is adopted:

involving two successive

(i)

identification of the functional groups and chemical elements present in the molecule;

(ii) determination of the extent to which account should be taken of the most important functional groups and

chemical elements.

The identified functional groups and elements taken into account are the names of the families and sub-families
set out in point 3 in the form of a non-restrictive list.

3.

Division of substances into families and sub-families

Family No
Annex I to Directive
67/548/EEC

Families

001

Hydrogen compounds

Hydrides

Sub-families

002

003

004

005

006

Helium compounds

Lithium compounds

Beryllium compounds

Boron compounds

Boranes
Borates

Carbon compounds
Carbamates
Inorganic carbon compounds
Salts of hydrogen cyanide
Urea and derivatives

007

Nitrogen compounds

Quaternary ammonium compounds
Acid nitrogen compounds
Nitrates
Nitrites

008

009

Oxygen compounds

Fluorine compounds

Inorganic fluorides

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Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

010

011

012

Neon compounds

Sodium compounds

Magnesium compounds

Organometallic magnesium derivatives

013

Aluminium compounds

Organometallic aluminium derivatives

014

Silicon compounds

Silicones
Silicates

015

Phosphorus compounds

Acid phosphorus compounds
Phosphonium compounds
Phosphoric esters
Phosphates
Phosphites
Phosphoramides and derivatives

016

Sulphur compounds

Acid sulphur compounds
Mercaptans
Sulphates
Sulphites

017

Chlorine compounds

Chlorates
Perchlorates

Argon compounds

Potassium compounds

Calcium compounds

Scandium compounds

Titanium compounds

Vanadium compounds

Chromium compounds

Chromium VI compounds

018

019

020

021

022

023

024

025

Manganese compounds

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Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

026

027

028

029

030

031

032

033

034

035

036

037

038

039

040

041

042

043

044

045

046

047

Iron compounds

Cobalt compounds

Nickel compounds

Copper compounds

Zinc compounds

Organometallic zinc derivatives

Gallium compounds

Germanium compounds

Arsenic compounds

Selenium compounds

Bromine compounds

Krypton compounds

Rubidium compounds

Strontium compounds

Yttrium compounds

Zirconium compounds

Niobium compounds

Molybdenum compounds

Technetium compounds

Ruthenium compounds

Rhodium compounds

Palladium compounds

Silver compounds

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Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

048

049

050

051

052

053

054

055

056

057

058

059

060

061

062

063

064

065

066

067

068

Cadmium compounds

Indium compounds

Tin compounds

Organometallic tin derivatives

Antimony compounds

Tellurium compounds

Iodine compounds

Xenon compounds

Caesium compounds

Barium compounds

Lanthanum compounds

Cerium compounds

Praseodymium compounds

Neodymium compounds

Promethium compounds

Samarium compounds

Europium compounds

Gandolinium compounds

Terbium compounds

Dysprosium compounds

Holmium compounds

Erbium compounds

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Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

069

070

071

072

073

074

075

076

077

078

079

080

081

082

083

084

085

086

087

088

089

Thulium compounds

Ytterbium compounds

Lutetium compounds

Hafnium compounds

Tantalum compounds

Tungsten compounds

Rhenium compounds

Osmium compounds

Iridium compounds

Platinum compounds

Gold compounds

Mercury compounds

Organometallic mercury derivatives

Thallium compounds

Lead compounds

Organometallic lead derivatives

Bismuth compounds

Polonium compounds

Astate compounds

Radon compounds

Francium compounds

Radium compounds

Actinium compounds

30.7.1999

EN

Official Journal of the European Communities

L 200/51

Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

090

091

092

093

094

095

096

097

098

099

100

101

102

103

601

Thorium compounds

Protactinium compounds

Uranium compounds

Neptunium compounds

Plutonium compounds

Americium compounds

Curium compounds

Berkelium compounds

Californium compounds

Einsteinium compounds

Fermium compounds

Mendelevium compounds

Nobelium compounds

Lawrencium compounds

Hydrocarbons

Aliphatic hydrocarbons
Aromatic hydrocarbons
Alicyclic hydrocarbons
Polycyclic aromatic hydrocarbons (PAH)

602

Halogenated hydrocarbons (*)

Halogenated aliphatic hydrocarbons (*)
Halogenated aromatic hydrocarbons (*)
Halogenated alicyclic hydrocarbons (*)

(*) Specify according to the family corresponding to halogen.

603

Alcohols and derivatives
Aliphatic alcohols
Aromatic alcohols
Alicyclic alcohols
Alcanolamines
Epoxy derivatives
Ethers
Glycolethers
Glycols and polyols

L 200/52

EN

Official Journal of the European Communities

30.7.1999

Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

604

Phenols and derivatives

Halogenated phenol derivatives (*)

(*) Specify according to the family corresponding to halogen.

605

606

Aldehydes and derivatives
Aliphatic aldehydes
Aromatic aldehydes
Alicyclic aldehydes
Aliphatic acetals
Aromatic acetals
Alicyclic acetals

Ketones and derivatives
Aliphatic ketones
Aromatic ketones (*)
Alicyclic ketones

(*) Quinones included.

607

Organic acids and derivatives

Aliphatic acids
Halogenated aliphatic acids (*)
Aromatic acids
Halogenated aromatic acids (*)
Alicyclic acids
Halogenated alicyclic acids (*)
Aliphatic acid anhydrides
Halogenated aliphatic acid anhydrides (*)
Aromatic acid anhydrides
Halogenated aromatic acid anhydrides (*)
Alicyclic acid anhydrides
Halogenated alicyclic acid anhydrides (*)
Salts of aliphatic acid
Salts of halogenated aliphatic acid (*)
Salts of aromatic acid
Salts of halogenated aromatic acid (*)
Salts of alicyclic acid
Salts of halogenated alicyclic acid (*)
Esters of aliphatic acid
Esters of halogenated alicyclic acid (*)
Esters of aromatic acid
Esters of halogenated aromatic acid (*)
Esters of alicyclic acid
Esters of halogenated alicyclic acid (*)
Esters of glycol ether
Acrylates
Methacrylates
Lactones
Acyl halogenides

(*) Specify according to the family corresponding to halogen.

608

Nitriles and derivatives

609

Nitro compounds

610

Chlornitrated compounds

30.7.1999

EN

Official Journal of the European Communities

L 200/53

Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

611

612

613

Azoxy and azo compounds

Amine compounds

Aliphatic amines and derivatives
Alicyclic amines and derivatives
Aromatic amines and derivatives
Aniline and derivatives
Benzidine and derivatives

Heterocyclic bases and derivatives
Benzimidazole and derivatives
Imidazol and derivatives
Pyrethrinoids
Quinoline and derivatives
Triazine and derivatives
Triazole and derivatives

614

Glycosides and alkaloids

Alkaloid and derivatives
Glycosides and derivatives

615

Cyanates and isocyanates

Cyanates
Isocyanates

616

Amides and derivatives

Acetamide and derivatives
Anilides

617

647

648

Organic peroxides

Enzymes

Complex coal derivatives

Acid extract
Alkaline extract
Anthracene oil
Anthracene oil extract residue
Anthracene oil fraction
Carbolic oil
Carbolic oil extract residue
Coal liquids, liquid solvent extraction
Coal liquids, liquid solvent extraction solvents
Coal oil
Coal tar
Coal tar extract
Coal tar solids residue
Coke (coal tar) low temperature, high temperature pitch
Coke (coal tar), high temperature pitch
Coke (coal tar), mixed coal high temperature pitch
Crude benzole
Crude phenols
Crude tar bases
Distillate bases
Distillate phenols
Distillates
Distillates (coal), liquid solvent extraction, primary
Distillates (coal), solvent extraction, hydrocracked
Distillates (coal), solvent extraction, hydrocracked hydrogenated middle
Distillates (coal), solvent extraction, hydrocracked middle

L 200/54

EN

Official Journal of the European Communities

30.7.1999

Family No
Annex I to Directive
67/548/EEC

Families

Sub-families

648
(cont’d)

Extract residues (coal), low temperature coal tar alkaline
Fresh oil
Fuels, diesel, coal solvent extraction, hydrocracked, hydrogenated
Fuels, jet aircraft, coal solvent extraction, hydrocracked, hydrogenated
Gasoline, coal solvent extraction, hydrocracked naphtha
Heat treatment products
Heavy anthracene oil
Heavy anthracene oil redistillate
Light oil
Light oil extract residues, high boiling
Light oil extract residues, intermediate boiling
Light oil extract residues, low boiling
Light oil redistillate, high boiling
Light oil redistillate, intermediate boiling
Light oil redistillate, low boiling
Methylnaphthalene oil
Methylnaphthalene oil extract residue
Naphtha (coal), solvent extraction, hydrocracked
Naphthalene oil
Naphthalene oil extract residue
Naphthalene oil redistillate
Pitch
Pitch redistillate
Pitch residue
Pitch residue, heat treated
Pitch residue, oxidised
Pyrolysis products
Redistillates
Residues (coal), liquid solvent extractions
Tar brown coal
Tar brown coal, low temperature
Tar oil, high boiling
Tar oil, intermediate boiling
Wash oil
Wash oil extract residue
Wash oil redistillate

649

Complex oil derivatives

Crude oil
Petroleum gas
Low boiling point naphtha
Low boiling point modified naphtha
Low boiling point cat-cracked naphtha
Low boiling point cat-reformed naphtha
Low boiling point thermally cracked naphtha
Low boiling point hydrogen treated naphtha
Low boiling point naphtha (cid:151) unspecified
Straight-run kerosine
Kerosine (cid:151) unspecified
Cracked gas oil
Gas oil (cid:151) unspecified
Heavy fuel oil
Grease
Unrefined or mildly refined base oil
Base oil (cid:151) unspecified
Distillate aromatic extract
Distillate aromatic extract (treated)
Foots oil
Slack wax
Petrolatum

650

Various substances

Do not use this family. Instead, use the families or sub-families mentioned above.

30.7.1999

EN

Official Journal of the European Communities

L 200/55

4.

Practical application:

After having conducted a search to see if the substance belongs to one or more families or sub-families on the
list, the generic name can be established in the following way:

4.1.

If the name of a family or sub-family is sufficient to characterise the chemical elements or important functional
groups, this name will be chosen as the generic name.

Examples:

(cid:151) 1,4 dihydroxybenzen

family 604: phenols and derivatives
generic name: phenol derivatives

(cid:151) butanol

family 603: alcohols and derivatives
sub-family: aliphatic alcohols
generic name: aliphatic alcohol

(cid:151) 2-Isopropoxyethanol

family 603: alcohols and derivatives
sub-family: glycolethers
generic name: glycolether

(cid:151) methacrylate

family 607: organic acids and derivatives
sub-family: acrylates
generic name: acrylate

4.2.

If the name of a family or sub-family is not sufficient to characterise the chemical elements of important
functional groups, the generic name will be a combination of the corresponding different family or sub-family
names:

Examples:

(cid:151) chlorobenzene

family 602: halogenated hydrocarbons
sub-family: halogenated aromatic hydrocarbons
family 017: chlorine compounds
generic name: chlorinated aromatic hydrocarbon

(cid:151) 2,3,6-trichlorophenylacetic acid
family 607: organic acids
sub-family: halogenated aromatic acids
family 017: chlorine compounds
generic name: chlorinated aromatic acid

(cid:151) 1-chloro-1-nitropropane

family 610: chloronitrated derivatives
family 601: hydrocarbons
sub-family: aliphatic hydrocarbons
generic name: chlorinated aliphatic hydrocarbon

(cid:151) tetrapropyl dithiopyrophosphate

family 015: phosphorus compounds
sub-family: phosphoric esters
family 016: sulphur compounds
generic name: thiophosphoric ester

NB:

In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by
the words (cid:145)organic(cid:146) or (cid:145)inorganic(cid:146).

Examples:

(cid:151) dimercury chloride

family 080: mercury compounds
generic name: inorganic mercury compound

L 200/56

EN

Official Journal of the European Communities

30.7.1999

(cid:151) barium acetate

family 056: barium compounds
generic name: organic barium compound

(cid:151) ethyl nitrite

family 007: nitrogen compounds
sub-family: nitrites
generic name: organic nitrite

(cid:151) sodium hydrosulphite

family 016: sulphur compounds
generic name: inorganic sulphur compound

(The examples cited are substances taken from Annex I to Directive 67/548/EEC (19th adaptation) in respect of
which requests for confidentiality may be submitted).

30.7.1999

EN

Official Journal of the European Communities

L 200/57

ANNEX VII

PREPARATIONS COVERED BY ARTICLE 12(2)

Preparations as specified by paragraph 9.3 of Annex VI to Directive 67/548/EEC.

L 200/58

EN

Official Journal of the European Communities

30.7.1999

ANNEX VIII

PART A

Directives repealed in accordance with Article 21

(cid:151) Directive 78/631/EEC on the approximation of the laws of the Member States relating to the classification,

packaging and labelling of dangerous preparations (pesticides)

(cid:151) Directive 88/379/EEC on the approximation of the laws of the Member States relating to the classification,

packaging and labelling of dangerous preparations and its following adaptations to technical progress:

(cid:151) Directive 89/178/EEC

(cid:151) Directive 90/492/EEC

(cid:151) Directive 93/18/EEC

(cid:151) Directive 96/65/EC

(cid:151) Directive 90/35/EEC defining in accordance with Article 6 of Directive 88/379/EEC the category of preparations
the packaging of which must be fitted with child-resistant fastenings and/or carry a tactile warning of danger

(cid:151) Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant

fastenings

PART B

Deadlines for transposition and for application in accordance with Article 22

Directive

Deadline for transposition

Deadline for application

78/631/EEC
(OJ L 206, 29.7.1978, p. 13)

88/379/EEC
(OJ L 187, 16.7.1988, p. 14)

89/178/EEC
(OJ L 64, 8.3.1989, p. 18)

90/492/EEC
(OJ L 275, 5.10.1990, p. 35)

93/18/EEC
(OJ L 104, 29.4.1993, p. 46)

90/35/EEC
(OJ L 19, 24.1.1990, p. 14)

91/442/EEC
(OJ L 238, 27.8.1991, p. 25)

96/65/EC
(OJ L 265, 18.10.1996, p. 15)

1 January 1981

1 January 1981

7 June 1991

7 June 1991

1 December 1990

1 June 1991

1 June 1991

8 June 1991

1 July 1994

1 July 1994

1 August 1992

1 November 1992

1 August 1992

1 November 1992

31 May 1998

31 May 1998

30.7.1999

EN

Official Journal of the European Communities

L 200/59

PART C

Special provisions for Austria, Finland and Sweden concerning the application of the following Directives in
accordance with Article 21

1. Austria, Finland and Sweden do not transpose or apply Council Directive 78/631/EEC of 26 June 1978 on the
approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous
preparations (pesticides), as last amended by Council Directive 92/32/EEC of 30 April 1992.

2. Austria is to apply Council Directive 88/379/EEC of 7 June 1988 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous preparations, as last
amended by Directive 96/65/EC of 11 October 1996 under the following conditions:

The following provisions of Directive 88/379/EEC will not apply to Austria

(a) Article 13 in conjunction with Articles 3 and 7 with respect to preparations containing substances listed in

Appendix 1;

(b) Article 13 in conjunction with Article 7 with respect to labelling respecting the Austrian provisions on:

(cid:151) safety advice for waste disposal,

(cid:151) pictogram for waste disposal until two years after the entry into force of this Directive,

(cid:151) safety advice for countermeasures in case of accidents;

(c) Article 13 in conjunction with Article 7(1)(c) concerning the chemical names of dangerous substances present

in dangerous preparations, until two years after the entry into force of this Directive.

3.

Sweden is to apply Council Directive 88/379/EEC of 7 June 1988 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous preparations, as last
amended by Directive 96/65/EC of 11 October 1996 under the following conditions:

The following provisions of Directive 88/379/EEC will not apply to Sweden:

(a) Article 13 in conjunction with Articles 3 and 7 with respect to preparations

(cid:151) containing substances listed in Appendix 2,

(cid:151) containing substances presenting neurotoxic effects and defatting effects on the skin not covered by
criteria for classification of Annex VI to Directive 67/548/EEC, and by risk phrases of Annex III to
Directive 67/548/EEC,

(cid:151) containing substances presenting acutely toxic effects not covered by criteria for classification of Annex VI
to Directive 67/548/EEC, and by risk phrases of Annex III to Directive 67/548/EEC, until two years after
the entry into force of this Directive,

(cid:151) which are not classified as dangerous according to the (cid:145)m(cid:229)ttligt skadliga(cid:146) (Swedish: (cid:145)moderately harmful(cid:146))

criteria of Directive 88/379/EEC.

(b) Article 13 in conjunction with Articles 3 and 7 with respect to

(cid:151) the criteria for classification and labelling of preparations containing carcinogenic substances classified on

the basis of criteria in point 4.2.1 of Annex VI to Directive 67/548/EEC,

(cid:151) labelling of preparations classified as carcinogenic, category 3, with a special R-phrase instead of

R-phrase 40.

L 200/60

EN

Official Journal of the European Communities

30.7.1999

Appendix 1

Substances referred to in Annex VIII, Part C, paragraph 2 (Austria)

Name of the substance

Index number in Annex I to
Directive 67/548/EEC

Linuron

Trichlorosilan

Phosphorus trichloride

Phosphorus pentachloride

Phosphorus oxychloride

Sodium polysulphides

Disulphur dichloride

Thionyl chloride

Calcium hypochlorite

Potassium hydroxide

2-Dimethylaminoethanol

2-Diethylaminoethanol

Diethanolamine

N-Methyl-2-ethanolamine

2-Ethylhexan-1,3-diol

Isophorone

6-Methyl-1,3-dithiolo(4,5-b)chinoxalin-2-one

Acetic anhydride

Methyl formate

Ethyl formate

Acrylic acid

Chloroacetyl chloride

Nitrofen

Quintozen; Pentachloronitrobenzol

Dichlofluanid

Cumene hydroperoxide

Monocrotophos

Edifenphos

Triazophos

Methanol

Trifenmorph; 4-Tritylmorpholin

Diuron

Fenbutanin oxide

1-Butanol, 2-Butanol, iso-Butanol

006-021-00-1

014-001-00-9

015-007-00-4

015-008-00-X

015-009-00-5

016-010-00-3

016-012-00-4

016-015-00-0

017-012-00-7

019-002-00-8

603-047-00-0

603-048-00-6

603-071-00-1

603-080-00-0

603-087-00-9

606-012-00-8

606-036-00-9

607-008-00-9

607-014-00-1

607-015-00-7

607-061-00-8

607-080-00-1

609-040-00-9

609-043-00-5

616-006-00-7

617-002-00-8

015-072-00-9

015-121-00-4

015-140-00-8

603-001-00-X

613-052-00-X

006-015-00-9

050-017-00-2

603-004-00-6

30.7.1999

EN

Official Journal of the European Communities

L 200/61

Appendix 2

Substances referred to in Annex VIII, Part C, paragraph 3 (Sweden)

Name of the substance

Index number in Annex I to
Directive 67/548/EEC

Acetone

Butanone

Amyl formate

Ethyl acetate

n-Butylacetate

sec-Butylacetate

tert-Butylacetate

iso-Butylacetate

Butylformate

Cyclohexane

1,4-Dimethylcyclohexane

Diethyl ether

Ethyl methyl ether

Amyl acetate

Ethyl lactate

Amyl propionate

2,4-Dimethylpentan-3-one

Di-n-propylether

Di-n-propyl ketone

Ethyl propionate

Heptane

Hexane (mixture of isomers) containing less than 5 % n-hexane

Isopropyl acetate

Isopropyl alcohol

4-Methoxy-4-methylpentane-2-one

Methyl acetate

Methyl cyclohexane

5-Methylhexane-2-one

Methyllactate

4-Methylpentan-2-one

Methyl propionate

Octane

Pentane

Pentan-3-one

Propan-1-ol

Propyl acetate

Propyl formate

Propyl propionate

606-001-00-8

606-002-00-3

607-018-00-3

607-022-00-5

607-025-00-1

607-026-00-7

607-026-00-7

607-026-00-7

607-017-00-8

601-017-00-1

601-019-00-2

603-022-00-4

603-020-00-3

607-130-00-2

607-129-00-7

607-131-00-8

606-028-00-5

603-045-00-X

606-027-00-X

607-028-00-8

601-008-00-2

601-007-00-7

607-024-00-6

603-003-00-0

606-023-00-8

607-021-00-X

601-018-00-7

606-026-00-4

607-092-00-7

606-004-00-4

607-027-00-2

601-009-00-8

601-006-00-1

606-006-00-5

603-003-00-0

607-024-00-6

607-016-00-2

607-030-00-9

L 200/62

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Official Journal of the European Communities

30.7.1999

Name of the substance

Index number in Annex I to
Directive 67/548/EEC

Sodium bisulphite = polysulphite

Toluene-2,4-diisocyanate

Toluene-2,6-diisocyanate

Cadmiumfluoride

1,2-Epoxy-3(tolyloxy)-propane

Diphenylmethane-2,2¡-diisocyanate

Diphenylmethane-2,4¡-diisocyanate

Diphenylmethane-4,4¡-diisocyanate

Hydroquinone

Hydroxypropyl acrylate

Turpentine

Butyl methyl ketone (2-Hexanone)

Hexane

Vanadium pentoxide

Sodium nitrate

Zinc oxide

016-010-00-3

615-006-00-4

615-006-00-4

048-006-00-2

603-056-00-X

615-005-00-9

615-005-00-9

615-005-00-9

604-005-00-4

607-108-00-2

650-002-00-6

606-030-00-6

601-007-00-7

023-001-00-8

30.7.1999

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Official Journal of the European Communities

L 200/63

ANNEX IX

CORRELATION TABLE

This Directive

88/379/EEC

Article 1

1.1

1.2

1.3

1.4

1.5

Article 2

Article 3

Article 4

Article 5

5.1

5.1, third indent

5.2(cid:151)5.3

5.4

Article 6

6.1

6.2

6.3

6.4

6.5

Article 7

Article 8

8.1

8.2

8.3

8.4

Article 9

9.1

9.2

9.3

Article 10

10.1.1(cid:151)1.2

10.2

10.2.3.

10.2.4.

10.2.5.

Article 11

Article 1

1.1

1.2

1.3

Article 2

Article 3.6

Article 3.1

Article 4

Article 3.2

3.2

3.2, paragraph 3(b)

Article 3.3

3.3, paragraphs (a) and (b)

3.3, paragraphs 3 and 4

3.4

3.5, paragraphs 1 to 3

Article 5

5.1

5.2

5.3

Article 6

6.1(a)

6.1(b)

6.2 and 6.3, second paragraph

Article 7

7.1

7.1(c)

7.1(d)

7.4

Article 8

L 200/64

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Official Journal of the European Communities

30.7.1999

This Directive

88/379/EEC

Article 12

Article 13

Article 14

Article 15

Article 16

Article 17

Article 18

Article 19

Article 20

Article 21

Article 22

Article 23

Article 24

Article 9

Article 10

Article 7

Article 11

Article 12

Article 13

Article 14

Article 15

Article 16

Article 16(3)

Article 17

CORRELATION TABLE

This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex I.A

Article 3.2(2)

Annex I.B

Annex II.A. introduction
(1(cid:151)3)

Annex II.A. introduction (4)

Annex II.A.1

Article 3.5(a)

Annex II.A.1.1.1

Article 3.5(a)(i)

Annex II.A.1.1.2

Article 3.5(a)(ii)

Annex I introduction

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Official Journal of the European Communities

L 200/65

This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex II.A.1.2

Article 3.5(a)(iii)

Annex II.A.2

Article 3.5(b)

Annex II.A.2.1.1

Article 3.5(b)(i)

Annex II.A.2.1.2

Article 3.5(b)(ii)

Annex II.A.2.2

Article 3.5(b)(iii)

Annex II.A.2.3

Article 3.5(b)(iv)

Annex II.A.3

Article 3.5(c)

Annex II.A.3.1.1

Article 3.5(c)(i)

Annex II.A.3.1.2

Article 3.5(c)(ii)

Annex II.A.3.2

Article 3.5(c)(iii)

Annex II.A.3.3

Article 3.5(c)(iv)

Annex II.A.4

Article 3.5(d)

Annex II.A.4.1.1

Article 3.5(d)(i)

Annex II.A.4.1.2

Article 3.5(d)(ii)

Annex II.A.4.2.1

Article 3.5(e)(i)

Annex II.A.4.2.2

Article 3.5(e)(ii)

Annex II.A.5

Article 3.5(f)

Annex II.A.5.1.1

Article 3.5(f)(i)

Annex II.A.5.1.2

Article 3.5(f)(ii)

L 200/66

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Official Journal of the European Communities

30.7.1999

This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex II.A.5.2.1

Article 3.5(h)(i)

Annex II.A.5.2.2

Article 3.5(h)(ii)

Annex II.A.5.3.1

Article 3.5(g)(i)

Annex II.A.5.3.2

Article 3.5(g)(ii)

Annex II.A.5.4.1

Article 3.5(i)(i)

Annex II.A.5.4.2

Article 3.5(i)(ii)

Annex II.A.6

Annex II.A.6.1

Article 3.5(g)(iii)

Annex II.A.6.2

Article 3.5(c)(v)

Annex II.A.7.1

Article 3.5(j)

Annex I.6

Annex II.A.7.2

Article 3.5(k)

Annex II.A.8.1

Article 3.5(l), (m)

Annex II.A.8.2

Article 3.5(n)
Article 3.5(o), (p)

Annex II.A.9.1(cid:151)9.4

Annex II.B. introduction

Annex II.B.1

Annex II.B.1.1

Annex II.B.1.2

Annex II.B.2

Annex II.B.2.1

Annex II.B.2.2

Annex I. introduction

Annex I.1

Annex I.1.1

Annex I.1.2

Annex I.2

Annex I.2.1

Annex I.2.2

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Official Journal of the European Communities

L 200/67

This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex II.B.3

Annex II.B.3.1

Annex II.B.3.2

Annex II.B.4

Annex II.B.4.1

Annex II.B.4.2

Annex II.B.5

Annex II.B.5.1

Annex II.B.5.2

Annex II.B.6

Annex II.B.6.1

Annex II.B.6.2

Annex III.A

Annex III.B

Annex III.C

Annex IV.B

Annex IV.A.1

Annex IV.A.2

Annex IV.A.3

Annex V.A.1

Annex V.A.2

Annex V.A.3

Annex V.A.4

Annex V.B.1

Annex V.B.2

Annex I.3

Annex I.3.1

Annex I.3.2

Annex I.4

Annex I.4.1

Annex I.4.2

Annex I.5

Annex I.5.1

Annex I.5.2

Annex I.6

Annex I.6.1

Annex I.6.2

Annex II.A.1

Annex II.A.2

Annex II.A.3

Annex II.A.4

Annex II.B.1

Annex II.B.2

Articles 1 and 2

Article 1(1)

Article 2; Annex (a)

Article 1; Annex (b)

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EN

Official Journal of the European Communities

30.7.1999

This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex II.B.3

Annex II.B.4

Annex II.B.5

Annex II.B.6

Annex V.B.3

Annex V.B.4

Annex V.B.5

Annex V.B.6

Annex V.B.7

Article 3.2(3)(b)

Annex V.B.8

Article 3.5(4)

Annex V.C

Annex VI

Annex VII

Annex VIII

Annex IX