1999L0045 — EN — 11.09.2001 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE1999/45/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of31May1999
concerning the approximation of the laws, regulations and administrative provisions of the
MemberStatesrelatingtotheclassification,packagingandlabelling ofdangerouspreparations
(OJ L 200, 30.7.1999, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Directive 2001/60/EC of 7 August 2001 L 226 5 22.8.2001
Corrected by:
►C1Corrigendum, OJ L 6, 10.1.2002, p. 70 (1999/45/EC)
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DIRECTIVE 1999/45/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of31May1999
concerningtheapproximationofthelaws,regulationsandadminis-
trative provisions of the Member States relating to the
classification,packagingandlabelling ofdangerouspreparations
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 the Economic and Social
Committee(2),
Acting in accordance with the procedure laid down in Article 251 of
the Treaty(3),
(1)Whereas Council Directive 88/379/EEC of 7 June 1988 on theapproximation of the laws, regulations and administrative provi-sions of the Member States relating to the classification,packaging and labelling of dangerous preparations(
4) has been
amended on several occasions; whereas on the occasion of
further amendments, the said Directive should, for reasons ofclarity, be recast;
(2)Whereas, in spite of Community provisions, the rules applying tocertain dangerous preparations in the Member States exhibit
considerable differences as regards classification, packaging and
labelling; whereas these differences constitute a barrier to trade,create unequal competition conditions and directly affect thefunctioning of the internal market; whereas it is therefore neces-sary to remove this barrier to trade by approximating the
relevant legislation existing in the Member States;
(3)Whereas measures for the approximation of the provisions of the
Member States affecting the establishment and functioning of theinternal market 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 sametime, ensure protection for the general public, and, in particular,persons who come into contact with dangerous preparations inthe course of their work or in the pursuit of a hobby, protectionfor consumers and for the environment;
(4)Whereas containers containing certain categories of dangerouspreparations offered or sold to the general public must be fittedwith child-resistant fastenings and/or carry a tactile warning ofdanger; whereas certain preparations not falling within these
categories of danger may nevertheless, owing to their composi-
tion, present a danger for children; whereas the packaging ofsuch preparations should therefore be equipped with child-resis-tant fastenings;
(5)Whereas it is necessary to provide concentration limits expressedas a volume/volume percentage in the case of preparationsmarketed in gaseous form;1999L0045 — EN — 11.09.2001 — 001.001 — 2
(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).
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(6)Whereas this Directive contains special 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 certainpreparations which, although not dangerous within the meaningof this Directive, may nevertheless present a danger to the user;
(7)Whereas on 30 April 1992 the Council adopted Directive 92/32/EEC amending for the seventh time Directive 67/548/EEC onthe approximation of the laws, regulations and administrativeprovisions relating to the classification, packaging and labelling
of dangerous substances(
1); whereas on 27 April 1993 the
Commission adopted Directive 93/21/EEC(2) adapting to tech-
nical progress for the 18th time Council Directive 67/548/EEC;whereas new criteria developed for classifying and labellingsubstances dangerous for the environment were introduced bythose Directives, together with the appropriate symbols, indica-
tions of danger, risk phrases and safety advice required to
appear on labelling; whereas provisions should be adopted atCommunity level on the classification and labelling of prepara-tions to take account of their effects on the environment andwhereas it is therefore necessary to introduce a method for asses-
sing the hazards of a given preparation for the environment
either by a calculation method, or by determining the ecotoxico-logical properties by test methods under certain conditions;
(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 24 November 1986 on theapproximation of laws, regulations and administrative provisionsof the Member States regarding the protection of animals usedfor experimental and other scientific purposes(
3); whereas
Article 7(2) of that Directive stipulates that an experiment shall
not be performed if another scientifically satisfactory method ofobtaining the results sought, not entailing the use of an animal, isreasonably and practically available; whereas, therefore, thisDirective makes use of the results of assessments of toxicolo-gical and ecotoxicological properties only when these are
already known and entails no obligation to conduct further
experiments on animals;
(9)Whereas it is necessary to define what human experience mightbe 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 HelsinkiDeclaration and OECD Guidelines for Good Clinical Practice;
(10)Whereas the characteristics of alloys are such that it may not bepossible accurately to determine their properties using currentlyavailable conventional methods; whereas it is therefore necessaryto developa sp ecific method of classification which takes intoaccount their particular chemical properties; whereas theCommission, in consultation with Member States, will examine
this need and submit a proposal, if appropriate, before the imple-
mentation date of this Directive;
(11)Whereas classification, packaging and labelling of plant protec-
tion products covered by Council Directive 78/631/EEC of
26 June 1978 on the approximation of the laws of the MemberStates relating to the classification, packaging and labelling ofdangerous preparations (pesticides)(
4) need to be revised taking
into account technical and scientific developments as well asregulatory developments following implementation of Council1999L0045 — EN — 11.09.2001 — 001.001 — 3
(1) OJ L 154, 5. 6. 1992, p. 1.
(2) OJ L 110, 4.5.1993, p. 20.
(3) OJ L 358, 18.12.1986, p. 1.
(4) OJ L 206, 29.7.1978, p. 13. Directive as last amended by Council
Directive 92/32/EEC.
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Directive 91/414/EEC of 15 July 1991 concerning the placing of
plant protection products on the market(1);
(12)Whereas Directive 91/414/EEC and Directive 98/8/EC of theEuropean Parliament and of the Council of 16 February 1998concerning the placing of biocidal products on the market(
2), 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 appli-cant and an assessment carried out by the competent authority ineach Member State; whereas furthermore that authorisationprocedure includes a control relating specifically to the classifi-cation, packaging and labelling of each product before it is
placed on the market; whereas it is appropriate, as part of a clear
and transparent information process, to classify and label plantprotection products according to the provisions of this Directive,and also to provide instructions for use in accordance with theresults 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 andDirective 91/414/EEC; whereas, in addition, a safety data sheethas to be established for plant protectioon products in accor-dance with this Directive;
(13)Whereas it is appropriate to provide, in relation to environmentallabelling, that specific exemptions or specific provisions may bedecided upon in specific cases where it can be demonstrated thatthe overall environmental impact of the product types in ques-tion 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 pyrotechniceffect may, through their chemical composition, present dangersto health; whereas it is therefore necessary as part of a trans-
parent information process to classify them and assign to them
a safety data sheet in accordance with the provisions of thisDirective and also to label them in accordance with the interna-tional rules used for the transport of dangerous goods;
(15)Whereas, in order to take account of certain preparations which,although they are not considered dangerous under this Directive,may nevertheless present a danger for users, it is necessary toextend certain provisions of this Directive to cover such prepara-tions;
(16)Whereas the label constitutes a basic tool for users of thedangerous preparations in so far as it provides them with theinitial essential concise information; whereas it neverthelessneeds 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 detailedarrangements for the system of specific information relating todangerous preparations in implementation of Article 10 of
Directive 88/379/EEC(
3) and secondly of the bodies appointed
by the Member States which are responsible for the provisionof information solely for medical purposes, both preventive andcurative;
(17)Whereas, on the basis of information to be supplied by theMember States and the various parties concerned, the Commis-sion will submit a report to the European Parliament and theCouncil within two years of the entry into force of this Directiveon experience with the present overall approach to labelling ofdangerous preparations and in particular on its understanding1999L0045 — EN — 11.09.2001 — 001.001 — 4
(1) 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).
(2) OJ L 123, 24.4.1998, p. 1.
(3) 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).
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and application by users, experience with publicity campaigns
and educational and training programmes; whereas, on the basisof this report, the Commission will, if appropriate, submit the
necessary proposals;
(18)Whereas it is necessary to require safety data sheets providingproportionate information on the dangers to man and the envir-
onment arising from preparations not classified as dangerouswithin the meaning of this Directive but containing substancesclassified as dangerous or having a Community exposure limit;whereas the Commission, on the basis of information submitted
by Member States, will review Directive 91/155/EEC and submit
proposals, if appropriate, before the expiry of the date for imple-mentation of this Directive;
(19)Whereas, in the case of preparations classified as dangerouswithin the meaning of this Directive, it is appropriate to permitMember States to allow certain derogations with respect to label-ling where the packaging is too small, or otherwise unsuitablefor labelling, or where such small packaging or such small quan-
tities are involved that there is no reason to fear any danger to
man or the environment; whereas in such cases appropriateconsideration should also be given to the approximation of therelevant provisions at Community level; whereas the Commis-sion will therefore examine the needs for harmonisation and, ifappropriate, submit proposals;
(20)Whereas the confidentiality of certain substances contained inthe preparations should be guaranteed and whereas it is therefore
necessary to institute a system which allows the person respon-
sible for placing the preparation on the market to requestconfidentiality for such substances;
(21)Whereas the provisions of this Directive will have regard to thecommitment entered into by the Community and its MemberStates, in accordance with the goals for sustainable developmentset under Agenda 21, Chapter 19, at the UNCED conferenceheld in June 1992 in Rio de Janeiro, to strive for the future
harmonisation of systems for the classification of dangerous
substances and preparations;
(22)Whereas the Commission should be given the powers necessaryto adapt all the Annexes to this Directive to technical progress;
(23)Whereas the adoption of this Directive should not affect the obli-
gations of the Member States concerning the deadlines for
transposition into national law and for application of the Direc-tives indicated in Annex VIII;
(24)Whereas the Directives indicated in Annex VIII should berepealed, subject to certain conditions; whereas the conditionsfor repealing the Directives indicated in Annex VIII should bespecified for Austria, Finland and Sweden in order to takeaccount of the present level of their legislation, in particular as
regards the protection of health and the protection of the envir-
onment,
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Objectives andscope
1. This Directive aims at the approximation of the laws, regulations
and administrative provisions of the Member States relating to:
— the classification, packaging and labelling of dangerous prepara-
tions, and to
— the approximation of specific provisions for certain preparations
which may present hazards, whether or not they are classified asdangerous within the meaning of this Directive,
when such preparations are placed on the market of the Member States.1999L0045 — EN — 11.09.2001 — 001.001 — 5
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2. This Directive shall apply to preparations which:
— contain at least one dangerous substance within the meaning of
Article 2,
and
— are considered dangerous within the meaning of Article 5, 6 or 7.
3. The specific provisions set out:
— in Article 9 and defined in Annex IV,
— in Article 10 and defined in Annex V, and— in Article 14
shall also apply to preparations which are not considered dangerous
within the meaning of Articles 5, 6 or 7 but may nevertheless presenta specific hazard.
4. Without prejudice to Directive 91/414/EEC, the articles on classi-
fication, packaging, labelling and safety data sheets of this Directiveshall apply to plant protection products.
5. This Directive shall not apply to the following preparations in the
finished state, intended for the final user:
(a) medicinal products for human or veterinary use, as defined in
Directive 65/65/EEC(
1);
(b) cosmetic products as defined in Directive 76/768/EEC(2);
(c) mixtures of substances which, in the form of waste, are covered by
Directives 75/442/EEC(3) and 78/319/EEC(4);
(d) foodstuffs;
(e) animal feedingstuffs;
(f) preparations containing radioactive substances as defined by
Directive 80/836/Euratom(5);
(g) medical devices which are invasive or used in direct physical
contact with the human body in so far as Community measureslay down provisions for the classification and labelling of
dangerous substances and preparations which ensure the same level
of information provision and protection as this Directive.
6. This Directive shall not apply to:
— the carriage of dangerous preparations by rail, road, inland
waterway, sea or air,
— preparations in transit which are under customs supervision,
provided they do not undergo any treatment or processing.
Article 2
Definitions
1. For the purposes of this Directive:
(a) ‘substances’ means chemical elements and their compounds in the
natural state or obtained by any production process, including any
additive necessary to preserve the stability of the products and anyimpurity deriving from the process used, but excluding any solventwhich may be separated without affecting the stability of thesubstance or changing its composition;
(b) ‘preparations’ means mixtures or solutions composed of two or
more substances;1999L0045 — EN — 11.09.2001 — 001.001 — 6
(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 Commission
Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).
(4) OJ L 84, 31.3.1978, p. 43.
(5) OJ L 246, 17.9.1980, p. 1. Directive as amended by Directive 84/467/
Euratom (OJ L 265, 5.10.1984, p. 4).
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(c) ‘polymer’ means a substance consisting of molecules characterised
by the sequence of one or more types of monomer units andcomprising a simple weight majority of molecules containing at
least three monomer units which are covalently bound to at least
one other monomer unit or other reactant and consists of less thana simple weight majority of molecules of the same molecularweight. Such molecules must be distributed over a range of mole-cular weights wherein differences in the molecular weight are
primarily attributable to differences in the number of monomer
units. In the context of this definition a ‘monomer unit’ means thereacted form of a monomer in a polymer;
(d) (………);
(e) ‘placing on the market’ means making available to third parties.
Importation into the Community customs territory shall be deemedto be placing on the market for the purposes of this Directive;
(f) ‘scientific research and development’ means scientific experimenta-
tion, analysis or chemical research carried out under controlledconditions; it includes the determination of intrinsic properties,performance and efficacy as well as scientific investigation related
to product development;
(g) ‘process-orientated research and development’ 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 thesubstance;
(h) ‘Einecs’ means the European Inventory of Existing Commercial
Chemical Substances. This inventory contains the definitive list ofall chemical substances deemed to be on the Community market on18 September 1981.
2. The following are ‘dangerous’ within the meaning of this Direc-
tive:
(a) explosive substances and preparations: solid, liquid, pasty or gela-
tinous substances and preparations which may also react
exothermically without atmospheric oxygen thereby quickly evol-ving gases, and which, under defined test conditions, detonate,quickly deflagrate or upon heating explode when partiallyconfined;
(b) oxidising substances and preparations: substances and preparations
which give rise to a highly exothermic reaction in contact with
other substances, particularly flammable substances;
(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 preparationswhich are flammable in contact with air at ambient temperatureand pressure;
(d) highly flammable substances and preparations:
— substances and preparations which may become hot and finally
catch fire in contact with air at ambient temperature withoutany application of energy, or
— 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 igni-tion, or
— liquid substances and preparations having a very low flash-
point, or
— substances and preparations which, in contact with water or
dampair, evolve extremely flammable gases in dangerousquantities;
(e) flammable substances and preparations: liquid substances and
preparations having a low flash-point;
(f) very toxic substances and preparations: substances and prepara-
tions which in very low quantities cause death or acute or chronicdamage to health when inhaled, swallowed or absorbed via theskin;1999L0045 — EN — 11.09.2001 — 001.001 — 7
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(g) toxic substances and preparations: substances and preparations
which in low quantities cause death or acute or chronic damageto health when inhaled, swallowed or absorbed via the skin;
(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;
(i) corrosive substances and preparations: substances and preparations
which may, on contact with living tissues, destroy them;
(j) irritant substances and preparations: non-corrosive substances and
preparations which, through immediate, prolonged or repeated
contact with the skin or mucous membrane, may cause inflamma-tion;
(k) sensitising substances and preparations: substances and prepara-
tions which, if they are inhaled or if they penetrate the skin, arecapable of eliciting a reaction of hypersensitisation such that onfurther exposure to the substance of preparation, characteristicadverse effects are produced;
(l) carcinogenic substances and preparations: substances or prepara-
tions which, if they are inhaled or ingested or if they penetrate
the skin, may induce cancer or increase its incidence;
(m) mutagenic substances and preparations: substances and prepara-
tions which, if they are inhaled or ingested or if they penetrate
the skin, may induce heritable genetic defects or increase theirincidence;
(n) substances and preparations which are toxic for reproduction:
substances and preparations which, if they are inhaled or ingestedor if they penetrate the skin, may produce, or increase the inci-dence of, non-heritable adverse effects in the progeny and/or animpairment of male or female reproductive functions or capacity;
(o) substances and preparations which are dangerous for the environ-
ment: 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.
Article 3
Determination ofdangerouspropertiesofpreparations
1. The evaluation of the hazards of a preparation shall be based on
the determination of:
— physico-chemical properties,
— properties affecting health,— 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.
2. Where the determination of dangerous properties is carried out in
accordance with Articles 5, 6 and 7, all dangerous substances withinthe meaning of Article 2 and in particular those which:
— are listed in Annex I to Directive 67/548/EEC,
— are listed in Elincs in accordance with Article 21 of Directive 67/
548/EEC,
— 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,
— are classified and labelled in accordance with Article 7 of
Directive 67/548/EEC and are not yet included in Elincs,
— are covered by Article 8 of Directive 67/548/EEC,— are classified and labelled in accordance with Article 13 of
Directive 67/548/EEC,1999L0045 — EN — 11.09.2001 — 001.001 — 8
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shall be taken into consideration in accordance with the provisions laid
down in the method used.
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 arepresent as impurities or additives, shall be taken into considerationwhen their concentrations are equal to, or greater than, those definedin the following table unless lower values are given in Annex I toDirective 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.
Category of danger of the substanceConcentration to take into consideration
for
gaseous prepara-
tions
% vol/volother preparations
% w/w
Very toxic ≥0,02 ≥0,1
Toxic ≥0,02 ≥0,1
Carcinogenic
Category 1 or 2≥0,02 ≥0,1
Mutagenic
Category 1 or 2≥0,02 ≥0,1
Toxic for reproduction
Category 1 or 2≥0,02 ≥0,1
Harmful ≥0,2 ≥1
Corrosive ≥0,02 ≥1
Irritant ≥0,2 ≥1
Sensitising ≥0,2 ≥1
Carcinogenic
Category 3≥0,2 ≥1
Mutagenic
Category 3≥0,2 ≥1
Toxic for reproduction
Category 3≥0,2 ≥1
Dangerous for the environment N
Dangerous for the
environment N≥0,1
Dangerous for the environment
ozone≥0,1 ≥0,1
Dangerous for the environment ≥1
Article 4
General principlesofclassification andlabelling
1. The classification of dangerous preparations according to the
degree and specific nature of the hazards involved shall be based onthe definitions of categories of danger laid down in Article 2.
2. The general principles of the classification and labelling of
preparations shall be applied in accordance with the criteria laid downin Annex VI to Directive 67/548/EEC, save where alternative criteria1999L0045 — EN — 11.09.2001 — 001.001 — 9
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referred to in Article 5, 6, 7 or 10 and the relevant Annexes of this
Directive are applied.
Article 5
Evaluation of the hazards deriving from physico-chemical proper-
ties
1. The hazards of a preparation deriving from its physico-chemical
properties shall be assessed by determining, by means of the methodsspecified in Part A of Annex V to Directive 67/548/EEC, the physico-chemical properties of the preparation necessary for appropriate classi-fication and labelling in accordance with the criteria laid down in
Annex VI to that Directive.
2. By way of derogation from paragraph 1:
the determination of the explosive, oxidising, extremely flammable,
highly flammable, or flammable properties is not necessary provided
that:
— none of the constituents possesses such properties and that, on the
basis of the information available to the manufacturer, the prepara-tion is unlikely to present hazards of this kind,
— in the event of a change in the composition of a preparation of
known composition, scientific evidence indicates that a reassess-ment of the hazards will not lead to a change in classification,
— 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 Direc-tive.
4. Certain exemptions from the application of the methods laid
down in Part A of Annex V to Directive 67/548/EEC are referred toin Part A of Annex I to this Directive.
5. The hazards deriving from the physico-chemical properties of a
preparation covered by Directive 91/414/EEC shall be assessed bydetermining the physico-chemical properties of the preparation neces-
sary for appropriate classification in accordance with the criteria set
out in Annex VI to Directive 67/548/EEC. These properties shall bedetermined by means of the methods laid down in Part A of Annex Vto Directive 67/548/EEC unless other internationally recognisedmethods are acceptable in accordance with the provisions ofAnnexes II and III to Directive 91/414/EEC.
Article 6
Evaluationofhealthhazards
1. The health hazards of a preparation shall be assessed by one or
more of the following procedures:
(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 thecriteria in Annex VI to Directive 67/548/EEC. These propertiesshall be determined by means of the methods laid down in Part Bof 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 IIIto Directive 91/414/EEC.
2. Without prejudice to the requirements of Directive 91/414/EEC,
only where it can be scientifically demonstrated by the person respon-1999L0045 — EN — 11.09.2001 — 001.001 — 10
(1) OJ L 147, 9.6.1975, p. 40. Directive as last amended by Directive 94/1/EC
(OJ L 23, 28.1.1994, p. 28).
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sible for placing the preparation on the market that the toxicological
properties of the preparation cannot correctly be determined by themethod 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 underArticle 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 incompliance 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 provisionsrelating to the application of the principles of good laboratory practiceand the verification of their applications for tests on chemicalsubstances(
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 inparagraph 1(b) shall be used for classifying the preparation, except inthe case of carcinogenic, mutagenic or toxic effects for reproductionfor 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).
3. Furthermore, where it can be demonstrated:
— by epidemiological studies, by scientifically valid case studies as
specified by Annex VI to Directive 67/548/EEC or by statisticallybacked experience, such as the assessment of data from poison
information units or concerning occupational diseases, that toxicolo-
gical effects on man differ from those suggested by the applicationof the methods outlined in paragraph 1, then the preparation shallbe classified according to its effects on man,
— that, owing to effects such as potentiation, a conventional assess-
ment would underestimate the toxicological hazard, those effectsshall be taken into account in classifying the preparation,
— that, owing to effects such as antagonism, a conventional assess-
ment would overestimate the toxicological hazard, those effectsshall 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:
— 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 consti-
tuentPermitted variation in initial concentra-
tion of the constituent
≤2,5 % ± 30 %
> 2,5≤10 % ± 20 %
>1 0≤25 % ± 10 %
>2 5≤100 % ± 5 %
— changes of composition involving the substitution or addition of one
or more constituents, which may or may not be dangerous within1999L0045 — EN — 11.09.2001 — 001.001 — 11
(1) OJ L 15, 17.1.1987, p. 29.
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the meaning of the definitions set out in Article 2, are introduced by
the manufacturer.
This new evaluation will apply unless there is valid scientific justifica-
tion for considering that a re-evaluation of the hazard will not result ina change of classification.
Article 7
Evaluationofenvironmentalhazards
1. The hazards of a preparation for the environment shall be
assessed by one or more of the following procedures:
(a) by a conventional method described in Annex III to this Directive;
(b) by determining the hazardous properties of the 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 methodslaid down in Part C of Annex V to Directive 67/548/EEC unless,in the case of plant protection products, other internationally recog-nised 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, theconditions for application of the test methods are described inPart C of Annex III to this Directive.
2. Where an ecotoxicological property is established by one of the
methods outlined in paragraph 1(b) to obtain new data, the test shallbe conducted in compliance with the principles of good laboratorypractice provided for in Directive 87/18/EEC and with the provisions
of Directive 86/609/EEC.
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 prepara-
tion.
3. For preparations of a known composition, with the exception of
those covered by Directive 91/414/EEC, classified in accordance withthe method outlined in paragraph 1(b), a new evaluation of environ-mental hazard either by the method outlined in paragraph 1(a) or thatoutlined in paragraph 1(b) shall be performed whenever:
— 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, inaccordance with the following table:
Initial concentration range of the consti-
tuentPermitted variation in initial concentra-
tion of the constituent
≤2,5 % ± 30 %
> 2,5≤10 % ± 20 %
>1 0≤25 % ± 10 %
>2 5≤100 % ± 5 %
— changes of composition involving the substitution or addition of one
or more constituents, which may or may not be dangerous withinthe meaning of the definitions set out in Article 2, are introducedby the manufacturer.
This new evaluation will apply unless there is valid scientific justifica-
tion for considering that a re-evaluation of the hazard will not result ina change of classification.1999L0045 — EN — 11.09.2001 — 001.001 — 12
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Article 8
ObligationsanddutiesoftheMember States
1. Member States shall take all necessary measures to ensure that
the preparations covered by this Directive cannot be placed on themarket unless they comply with it.
2. In order to ensure compliance with this Directive, the authorities
of the Member States may request information on the composition ofthe preparation and any other pertinent information from any personresponsible for placing the preparation on the market.
3. Member States shall take all necessary measures to ensure that
those responsible for placing the preparation on the market hold at the
disposal of the authorities of the Member States:
— the data used for the classification and labelling of the preparation,
— any pertinent information relating to packaging requirements in
accordance with Article 9(1.3), including the test certificate issuedin accordance with Part A of Annex IX to Directive 67/548/EEC,
— 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 (autho-rities) responsible for communicating and exchanging informationrelating to the practical application of this Directive.
Article 9
Packaging
1. Member States shall take all necessary measures to ensure that:1.1. preparations within the meaning of Article 1(2) and prepara-
tions covered by Annex IV pursuant to Article 1(3) cannot be
placed on the market unless their packaging satisfies thefollowing requirements:
— it shall be so designed and constructed that its contents
cannot escape; this requirement shall not apply wherespecial safety devices are prescribed,
— the materials constituting the packaging and fastenings must
not be susceptible to adverse attack by the contents, orliable to form dangerous compounds with the contents,
— packaging and fastenings must be strong and solid
throughout to ensure that they will not loosen and willsafely meet the normal stresses and strains of handling,
— containers fitted with replaceable fastening devices shall be
so designed that the packaging can be refastened repeatedlywithout the contents escaping;
1.2. containers which contain preparations within the meaning of
Article 1(2) and preparations covered by Annex IV pursuant toArticle 1(3) offered or sold to the general public do not have:
— either a shape and/or graphic decoration likely to attract or
arouse the active curiosity of children or to mislead consu-mers, or
— a presentation and/or a designation used for foodstuffs or
animal feedingstuffs or medicinal or cosmetic products.
1.3. containers which contain certain preparations offered or sold to
the general public covered by Annex IV to this Directive:
— are fitted with child-resistant fastenings,
and/or
— carry a tactile warning of danger.
The devices must conform to the technical specifications given
in Parts A and B of Annex IX to Directive 67/548/EEC.1999L0045 — EN — 11.09.2001 — 001.001 — 13
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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
1.1. Member States shall take all necessary measures to ensure that:
(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 specificprovisions of Part A and B of Annex V;
(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 packaging satisfies the
requirements of paragraphs 2.1 and 2.2 and the specificprovisions of Parts B and C of Annex V.
1.2. With respect to plant protection products subject to Directive 91/
414/EEC, the labelling requirements in accordance with thisDirective shall be accompanied by the following wording: ‘Toavoid risks to man and the environment, comply with theinstructions for use.’
This labelling shall be without prejudice to the 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:
2.1. the trade name or designation of the preparation;2.2. the name, full address and telephone number of the person
established in the Community who is responsible for placingthe preparation on the market, whether it be the manufacturer,the importer or the distributor;
2.3. the chemical name of the substance or substances present in the
preparation in accordance with the following detailed rules:
2.3.1. for preparations classified T
+,T ,Xnin accordance with
Article 6, only the substances T+,T ,Xnpresent in concentra-
tions equal to, or greater than, the lowest limit (limit Xn) for
each of them laid down in Annex I to Directive 67/548/EEC
or, failing that, Part B of Annex II to this Directive have to betaken into consideration;
2.3.2. for preparations classified C in accordance with Article 6, only
C substances present in concentrations equal to, or greater than,the lowest limit (limit X
i) laid down in Annex I to Directive 67/
548/EEC or, failing that, Part B of Annex II to this Directivehave to be taken into consideration;
2.3.3. the name of the substances which have given rise to the classi-
fication of the preparation in one or more of the following
danger categories:
— carcinogen category 1, 2 or 3,
— mutagen category 1, 2 or 3,
— toxic for reproduction category 1, 2 or 3,
— very toxic, toxic or harmful due to non-lethal effects after a
single exposure,
— toxic or harmful due to severe effects after repeated or
prolonged exposure,
— sensitising;
shall be mentioned on the label.1999L0045 — EN — 11.09.2001 — 001.001 — 14
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The chemical name shall be one of the designations listed in
Annex I to Directive 67/548/EEC or an internationally recog-nised chemical nomenclature if no corresponding designation
is yet listed in that Annex.
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:
— explosive,
— oxidising,
— extremely flammable,— highly flammable,
— flammable,
— irritant,— dangerous for the environment,
need not be mentioned on the label unless the substance has to
be mentioned pursuant to paragraphs 2.3.1, 2.3.2 or 2.3.3.
2.3.5. As a general rule, a maximum of four chemical names shall
suffice to identify the substances primarily responsible for themajor health hazards which have given rise to the classificationand the choice of the corresponding phrases referring to the riskinvolved. In some cases, more than four chemical names maybe necessary.
2.4.Thedangersymbol(s)andindication(s)ofdanger
The danger symbols, where specified in this Directive, and indi-
cations of the dangers involved in the use of the preparation,
shall be in accordance with the wording of Annexes II and VIto Directive 67/548/EEC and shall be applied in accordancewith the evaluation of the hazards carried out in accordancewith 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:
— T shall make the symbols C and X optional unless otherwise
specified in Annex I to Directive 67/548/EEC,
— C shall make the symbol X optional,
— E shall make the symbols F and O optional,
—X
nshall make the symbol Xioptional.
The symbol(s) shall be printed in black on an orange-yellow
background.
2.5.Theriskphrases(Rphrases)
The indications concerning special risks (R phrases) shall
comply with the wording in Annexes III and VI toDirective 67/548/EEC and shall be assigned in accordancewith the results of the hazard evaluation carried out in accor-
dance with Annexes I, II, and III to this Directive.
As a general rule, a maximum of six R phrases shall suffice to
describe the risks; for this purpose, the combined phrases listedin Annex III to Directive 67/548/EEC shall be regarded as
single phrases. However, if the preparation falls within more
than one danger category, those standard phrases shall coverall the principal hazards associated with the preparation. Insome cases more than six R phrases may be necessary.
The standard phrases ‘extremely flammable’ or ‘highly flam-
mable’ need not be used where they describe an indication ofdanger used in accordance with 2.4.
2.6.Thesafetyadvice(Sphrases)
The indications giving safety advice (S phrases) shall comply
with the wording in Annex IV and with Annex VI toDirective 67/548/EEC and shall be assigned in accordance1999L0045 — EN — 11.09.2001 — 001.001 — 15
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with the results of the hazard evaluation carried out in accor-
dance with Annexes I, II and III to this Directive.
As a general rule, a maximum of six S phrases shall suffice to
formulate the most appropriate safety advice; for this purpose
the combined phrases listed in Annex IV to Directive 67/548/EEC shall be regarded as single phrases. However, in somecases more than six S phrases may be necessary.
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.
2.7. The nominal quantity (nominal mass or nominal volume) of the
contents in the case of preparations offered or sold to thegeneral public.
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 tocertain provisions on environmental labelling or specific provi-sions in relation to environmental labelling may be determinedin 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 specificprovisions are defined and laid down in Part A or B ofAnnex V.
4. If the contents of the package do not exceed 125 ml:
— in the case of preparations that are classified as highly flam-
mable, oxidising, irritant, with the exception of thoseassigned R41, or dangerous for the environment andassigned the N symbol it shall not be necessary to indicate
the R phrases or the S phrases,
— 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 phrasesbut it shall not be necessary to indicate the S phrases.
5. Without prejudice to Article 16(4) of Directive 91/414/EC,
indications such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’,
‘ecological’ or any other statement indicating that the prepara-
tion is not dangerous or likely to lead to underestimation of thedangers of the preparation in question shall not appear on thepackaging or labelling of any preparation subject to this Direc-tive.
Article 11
Implementationofthelabelling requirements
1. Where the particulars required by Article 10 appear on a label,
that label shall be firmly affixed to one or more surfaces of the packa-ging so that those particulars can be read horizontally when thepackage is set down normally. The dimensions of the label are laiddown in Annex VI to Directive 67/548/EEC and the label is intendedsolely for provision of the information required by this Directive and if
necessary of any supplementary health or safety information.
2. A label shall not be required when the particulars are clearly
shown on the package itself, as specified in paragraph 1.
3. The colour and presentation of the label — or, in the case of
paragraph 2, of the package — shall be such that the danger symbol
and its background stand out clearly from it.
4. The information required on the label under Article 10 shall stand
out clearly from its background and shall be of such size and spacingas to be easily read.
Specific provisions regarding the presentation and format of this infor-
mation shall be laid down in Annex VI to Directive 67/548/EEC.1999L0045 — EN — 11.09.2001 — 001.001 — 16
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5. Member States may make the placing on the market of prepara-
tions covered by this Directive within their territories subject to use oftheir official language or languages in respect of the labelling thereof.
6. For the purposes of this Directive, labelling requirements shall be
deemed to be satisfied:
(a) in the case of an outer package containing one or more inner
packages, if the outer package is labelled in accordance with inter-
national rules on the transport of dangerous goods and the inner
package or packages are labelled in accordance with this Directive;
(b) in the case of a single package:
— 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, the provisions ofArticle 10(2.4) shall additionally apply with respect to the prop-erty in question when it has not been so identified on the label,or
— where appropriate, for particular types of packaging such as
mobile gas cylinders, if the specific requirements referred to inAnnex VI to Directive 67/548/EEC are complied with.
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 transportof dangerous goods.
Article 12
Exemptionsfromthelabelling andpackagingrequirements
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.
2. For certain dangerous preparations within the meaning 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 shallnot 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 withArticle 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, extre-
mely flammable, highly flammable, flammable, irritant or
oxidising to be unlabelled or to be labelled in some other way, ifthey contain such small quantities that there is no reason to fearany danger to persons handling such preparations or to otherpersons;
(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 theycontain such small quantities that there is no reason to fear anydangers 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, if the packagesare too small for the labelling provided for in Articles 10 and 11and there is no reason to fear any danger to persons handling suchpreparations or to other persons.
Where this paragraph is applied, the use of symbols, indications of
danger, risk (R) phrases or safety (S) phrases different to those laiddown in this Directive shall not be permitted.1999L0045 — EN — 11.09.2001 — 001.001 — 17
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4. If a Member State makes use of the options provided for in para-
graph 3, it shall forthwith inform the Commission and Member Statesthereof. 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
Distanceselling
Any advertisement for a preparation within the meaning of this Direc-
tive 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 indicatedon the label. This requirement is without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997on the protection of consumers in respect of distance contracts(
1).
Article 14
Safetydatasheet
1. The safety data sheet information is principally intended for use
by professional users and must enable them to take the neces-sary measures as regards the protection of health, safety and theenvironment 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 prepara-
tion within the meaning of Article 1(2) provides a safetydata sheet;
(b) the person responsible for placing on the market a prepara-
tion provides on request of a professional user a safety datasheet providing proportionate information for preparationsnot classified as dangerous within the meaning ofArticles 5, 6 and 7 but containing in an individual concen-tration of ≥1 % by weight for non-gaseous preparations
and≥0,2 % by volume for gaseous preparations at least:
— one substance posing health or environmental hazards,
or
— one substance for which there are Community work-
place 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 accordancewith 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 datespecified in Article 22(1).
2.4. The safety data sheet may be supplied on paper or electroni-
cally, provided that the addressee has the necessary means ofreceiving it.1999L0045 — EN — 11.09.2001 — 001.001 — 18
(1) OJ L 144, 4.6.1997, p. 19.
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Article 15
Confidentialityofchemical names
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:
— 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
— harmful or harmful in combination with one or more of the proper-
ties mentioned in point 2.3.4 of Article 10 presenting acute lethaleffects alone
will put at risk the confidential nature of his intellectual property, he
may, in accordance with the provisions of Annex VI, be permitted torefer to that substance either by means of a name that identifies the
most important functional chemical groups or by means of an alterna-
tive name. This procedure may not be applied where the substanceconcerned 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 inPart A of that Annex. The competent authority may neverthelessrequest further 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.
The authority of the Member State receiving a request for confidenti-
ality shall notify the applicant of its decision. The person responsiblefor placing the preparation on the market shall forward a copy of thisdecision to each of the Member States where he wishes to market the
product.
Confidential information brought to the attention of the authorities of a
Member State or of the Commission shall be treated in accordancewith Article 19(4) of Directive 67/548/EEC.
Article 16
RightsofMember Statesregardingsafetyofworkers
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 prepara-tions in question, provided that this does not mean that theclassification, packaging, and labelling of dangerous preparations aremodified in a way not provided for in this Directive.
Article 17
Bodiesresponsibleforreceiving informationrelatingtohealth
Member States shall appoint the body or bodies responsible for
receiving information, including chemical composition, relating topreparations placed on the market and considered dangerous on thebasis of their health effects or on the basis of their physico-chemicaleffects.
Member States shall take the necessary steps to ensure that the
appointed bodies provide all the requisite guarantees for maintaining
the confidentiality of the information received. Such information mayonly be used to meet any medical demand by formulating preventiveand curative measures, in particular in case of emergency.
Member States shall ensure that the information is not used for other
purposes.1999L0045 — EN — 11.09.2001 — 001.001 — 19
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Member States shall ensure that the appointed bodies have at their
disposal all the information required from the manufacturers or personsresponsible for marketing to carry out the tasks for which they are
responsible.
Article 18
Free movementclause
Without prejudice to the provisions set out in other Community legisla-
tion, Member States may not prohibit, restrict or impede the placing on
the market of preparations because of their classification, packaging,
labelling or safety data sheets if such preparations comply with theprovisions laid down in this Directive.
Article 19
Safeguardclause
1. Where a Member State has detailed evidence that a preparation,
although satisfying the provisions of this Directive, constitutes a hazardfor man or the environment on grounds relating to the provisions ofthis Directive, it may provisionally prohibit the placing on the marketof that preparation or subject it to special conditions in its territory. Itshall immediately inform the Commission and the other Member States
of such action and give reasons for its decision.
2. In the case referred to in paragraph 1, the Commission shall
consult the Member States as soon as possible.
3. The Commission shall take a decision in accordance with the
procedure laid down in Article 20.
Article 20
Adaptationtotechnical progress
Amendments required to adapt the Annexes to this Directive to tech-
nical progress shall be adopted in accordance with the procedure laiddown 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 representativeof the Commission.
The representative of the Commission shall submit 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 bedelivered by the majority laid down in Article 205(2) of the Treaty inthe case of decisions which the Council is required to adopt on aproposal 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.
If the measures envisaged are not in accordance with the 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 betaken. The Council shall act by a qualified majority.
If the Council has not acted within three months of the date of referral,
the proposed measures shall be adopted by the Commission.
Article 21
RepealofDirectives
1. The Directives listed in Part A of Annex VIII are hereby
repealed, without prejudice to the obligation of the Member Statesconcerning the deadlines for transposition into national law and forapplication of the Directives indicated in Part B of Annex VIII.1999L0045 — EN — 11.09.2001 — 001.001 — 20
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2. The Directives listed in Part A of Annex VIII shall apply to
Austria, Finland and Sweden subject to provisions laid down in Part Cof that Annex and pursuant to the Treaty.
3. References to the repealed Directives shall constitute references
to this Directive and should be read in accordance with the correlationtable set out in Annex IX.
Article 22
Transposition
1. Member States shall adopt and publish before 30 July 2002 the
laws, regulations and administrative provisions necessary to complywith this Directive. They shall forthwith inform the Commissionthereof.
2. Member States shall apply the laws, regulations and administra-
tive provisions referred to in paragraph 1:
(a) to preparations not within the scope of Directive 91/414/EEC or
Directive 98/8/EC as from 30 July 2002; and
(b) 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.
Article 23
Entryintoforce
This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities .
Article 21(2) shall apply from 1 January 1999.
Article 24
Addressees
This Directive is addressed to the Member States.1999L0045 — EN — 11.09.2001 — 001.001 — 21
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ANNEX I
METHODSFORTHEEVALUATIONOFPHYSICO-CHEMICALPROP-
ERTIESOFPREPARATIONSINACCORDANCEWITHARTICLE5
PART A
ExemptionstotestmethodsofAnnexV—PartAtoDirective 67/548/EEC
See 2.2.5 of Annex VI to Directive 67/548/EEC.
PART B
Alternativecalculationmethods
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.1999L0045 — EN — 11.09.2001 — 001.001 — 22
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ANNEX II
METHODS FORTHE EVALUATION OF HEALTH HAZAR DS OF
PREPARATIONSINACCORDANCEWITHARTICLE6
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 specifica-
tions 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:
— either by a symbol and one or more risk phrases, or
— 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 percen-
tage 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 forevaluationofhealthhazards
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 ‘T
+’, the
indication of danger ‘very toxic’ and the risk phrases R26, R27 or R28;
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 appear1999L0045 — EN — 11.09.2001 — 001.001 — 23
▼B
in Annex I to Directive 67/548/EEC or appear in it without concen-
tration 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:
XPTþ
LTþ/C18/C19
/C211
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 ‘T+’, the indication of danger ‘very toxic’ 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 concen-
tration limits.
2.The following preparations shall be classified as toxic:
2.1. owing to their acute lethal effects and assigned the symbol ‘T’, the indi-
cation of danger ‘toxic’ 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 concen-
tration 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:
XPTþ
LTþPT
LT/C18/C19
/C211
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 ‘T’, the indication of danger ‘toxic’ 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 concentra-
tions 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 concen-
tration limits;1999L0045 — EN — 11.09.2001 — 001.001 — 24
▼B
2.3. owing to their long-term effects and assigned the symbol ‘T’, the indi-
cation of danger ‘toxic’ 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 ‘Xn’ and the
indication of danger ‘harmful’ 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 concentra-
tions 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 concen-
tration 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:
XPTþ
LXnþPT
LXnþPXn
LXn/C18/C19
/C211
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 weightor by volume;
3.2. owing to their acute effects to the lungs if swallowed and assigned the
symbol ‘X
n’, and the indication of danger ‘harmful’ 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 ‘Xn’, the indication of danger ‘harmful’ and the
risk phrase ►M1R68◄/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 concen-
tration limits;1999L0045 — EN — 11.09.2001 — 001.001 — 25
▼B
3.4. owing to their long-term effects and assigned the symbol ‘Xn’, the indi-
cation of danger ‘harmful’ 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:
(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 ‘C’, the indication of danger ‘corrosive’ 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:
XPC;R35
LC;R35/C18/C19
/C211
where:
PC, R35= is the percentage by weight or by volume of each corro-
sive 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 ‘C’, the indication of danger ‘corrosive’ 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 indivi-
dual concentrations than the limits specified under 4.2.1(a) or (b) if:
XPC;R35
LC;R34þPC;R34
LC;R34/C18/C19
/C211
where:
PC, R35= is the percentage by weight or by volume of each corro-
sive substance to which is assigned phrase R35 in the
preparation,
PC, R34= is the percentage by weight or by volume of each corro-
sive 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.1999L0045 — EN — 11.09.2001 — 001.001 — 26
▼B
5.The following preparations are to be classified as irritants:
5.1. liable to cause serious eye damage and assigned the symbol ‘Xi’, the
indication of danger ‘irritant’ 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
(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 the substances classified as
irritant and to which is assigned phrase R41, or classified as corrosive
and to which is assigned phrase R35 or R34, in lower individual
concentrations than the limits specified under 5.1.1(a) or (b) if:
XPC;R35
LXi;R41þPC;R34
LXi;R41þPXi;R41
LXi;R41/C18/C19
/C211
where:
PC, R35= is the percentage by weight or by volume of each corro-
sive substance to which is assigned phrase R35 in the
preparation,
PC, R34= is the percentage by weight or by volume of each corro-
sive 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 prepara-
tion,
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 ‘Xi’, the indication of danger
‘irritant’ 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:
XPC;R35
LXi;R36þPC;R34
LXi;R36þPXi;R41
LXi;R36þPXi;R36
LXi;R36/C18/C19
/C211
where:
PC, R35= is the percentage by weight or by volume of each corro-
sive substance to which is assigned phrase R35 in the
preparation,
PC, R34= is the percentage by weight or by volume of each corro-
sive 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 prepara-
tion,
PXi, R36= is the percentage by weight or by volume of each irritant
substance to which is assigned phrase R36 in the prepara-
tion,1999L0045 — EN — 11.09.2001 — 001.001 — 27
▼B
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 ‘Xi’, the indication of danger
‘irritant’ 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;
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:
XPC;R35
LXi;R38þPC;R34
LXi;R38þPXi;R38
LXi;R38/C18/C19
/C211
where:
PC, R35= is the percentage by weight or by volume of each corro-
sive substance to which is assigned phrase R35 in the
preparation,
PC, R35= is the percentage by weight or by volume of each corro-
sive 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 prepara-
tion,
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 ‘Xi’, the indica-
tion of danger ‘irritant’ and the risk phrase R37;
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:
XPXi;R37
LXi;R37/C18/C19
/C211
where:
PXi, R37= is the percentage by weight or by volume of each irritant
substance to which is assigned phrase R37 in the prepara-
tion,
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 classi-
fied as irritant to which is assigned phrase R37 or as corrosive and to
which is assigned phrase R35 or R34 in lower individual concentrations1999L0045 — EN — 11.09.2001 — 001.001 — 28
▼B
than the limits specified under 5.4.1(a) or (b) if:
XPC;R35
LXi;R37þPC;R34
LXi;R37þPXi;R37
LXi;R37/C18/C19
/C211
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 ‘Xi’, the indication of danger
‘irritant’ 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 indi-
vidual 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 concen-
tration limits;
6.2. by inhalation and assigned the symbol ‘Xn’, the indication of danger
‘harmful’ 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 concen-
tration limits.
7.The following preparations are to be classified as carcinogenic:
7.1. those of category 1 or 2 which are assigned the symbol ‘T’ 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 ‘Xn’ 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 concentra-
tions 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 not1999L0045 — EN — 11.09.2001 — 001.001 — 29
▼B
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 ‘T’ and the
phrase R46.
Preparations containing at least one substance producing such effects,
classified as mutagenic and to which is assigned phrase R46 which
denotes mutagenic substances in category 1 and category 2, in indivi-
dual 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 ‘Xn’ and the
phrase►M1R68◄.
Preparations containing at least one substance, producing such effects,
classified as mutagenic and to which is assigned phrase ►M1R68◄
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.
9.The following preparations are to be classified as toxic for reproduc-
tion:
9.1. those of category 1 or 2 which are assigned the symbol ‘T’ 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 ‘Xn’ 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 indi-
vidual 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 ‘T’ 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, or1999L0045 — EN — 11.09.2001 — 001.001 — 30
▼B
(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 ‘Xn’ 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 indi-
vidual 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
Concentrationlimitstobeusedinevaluationofhealthhazards
For each health effect, the first table (Tables I to VI) sets out the concentration
limits (expressed as a weight/weight percentage) to be used for non-gaseous
preparations and the second table (Tables I A to VI A) sets out the concentration
limits (expressed as a volume/volume percentage) 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.
1.Acute lethal effects
1.1. Non-gaseous preparations
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 classifi-
cation is also shown.
TableI
Classification of the
substanceClassification of the preparation
T+TXn
T+with R26, R27,
R28concentration
≥7%1%≤concentra-
tion < 7 %0,1 %≤concentra-
tion < 1 %
T with R23, R24,
R25concentration
≥25 %3%≤concentration
<2 5%
Xnwith R20, R21,
R22concentration ≥25%
The R phrases denoting risk are to be assigned to the preparation in
accordance with the following criteria:
— the label shall include one or more of the abovementioned R phrases
according to the classification used,
— 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. Gaseous preparations
The concentration limits expressed as a volume/volume percentage in
Table I A below determine the classification of the gaseous prepara-
tions in relation to the individual concentration of the gas(es) present
whose classification is also shown.1999L0045 — EN — 11.09.2001 — 001.001 — 31
▼B
TableIA
Classification of the
substance
(gas)Classification of the gaseous preparation
T+TXn
T+with R26, R27,
R28concentration
≥1%0,2 %≤concen-
tration < 1 %0,02 %≤concentra-
tion < 0,2 %
T with R23, R24,
R25concentration
≥5%0,5 %≤concentra-
tion < 5 %
Xnwith R20, R21,
R22concentration ≥5%
The R phrases denoting risk shall be assigned to the preparation in
accordance with the following criteria:
— the label shall include one or more of the abovementioned R phrases
according to the classification used,
— 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.
2.Non-lethal irreversible effects after a single exposure
2.1. Non-gaseous preparations
For substances that produce non-lethal irreversible effects after a single
exposure (R39/route of exposure, ►M1R68◄/route of exposure),
the individual concentration limits specified in Table II, expressed as a
weight/weight percentage, determine, when appropriate, the classifica-
tion of the preparation.
TableII
Classification of the
substanceClassification of the preparation
T+TXn
T+with R39/route of
exposureconcentration
≥10 %
R39(*) obligatory1%≤concentra-
tion < 10 %
R39(*) obligatory0,1 %≤concentra-
tion < 1 %
►M1R68◄(*)
obligatory
T with R39/route of
exposureconcentration
≥10 %
R39(*) obligatory1%≤concentration
<1 0%
►M1R68◄(*)
obligatory
Xnwith
►M1R68◄/route
of exposureconcentration ≥10%
►M1R68◄(*)
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. Gaseous preparations
For gases that produce non-lethal irreversible effects after a single
exposure (R39/route of exposure, ►M1R68◄/route of exposure),
the individual concentration limits specified in Table II A, expressed
as a volume/volume percentage, determine, when appropriate, the clas-
sification of the preparation.1999L0045 — EN — 11.09.2001 — 001.001 — 32
▼B
TableIIA
Classification of the
substance (gas)Classification of the gaseous preparation
T+TXn
T+with R39/route of
exposureconcentration
≥1%
R39(*) obligatory0,2 %≤concen-
tration < 1 %
R39(*) obligatory0,02 %≤concentra-
tion < 0,2 %
►M1R68◄(*)
obligatory
T with R39/route of
exposureconcentration
≥5%
R39(*) obligatory0,5 %≤concentra-
tion < 5 %
►M1R68◄(*)
obligatory
Xnwith
►M1R68◄/route
of exposureconcentration ≥5%
►M1R68◄(*)
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. Non-gaseous preparations
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, deter-
mine, when appropriate, the classification of the preparation.
TableIII
Classification of the substanceClassification of the preparation
TXn
T with R48/route of expo-
sureconcentration ≥10 %
R48(*) obligatory1%≤concentration < 10 %
R48(*) obligatory
Xnwith R48/route of expo-
sureconcentration ≥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. Gaseous preparations
For gases that produce severe effects after repeated or prolonged expo-
sure (R48/route of exposure), the individual concentration limits
specified in Table III A below, expressed as a volume/volume percen-
tage, determine, when appropriate, the classification of the preparation.
TableIIIA
Classification of the substance
(gas)Classification of the gaseous preparation
TXn
T with R48/route of expo-
sureconcentration ≥5%
R48(*) obligatory0,5 %≤concentration < 5 %
R48(*) obligatory
Xnwith R48/route of expo-
sureconcentration ≥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.1999L0045 — EN — 11.09.2001 — 001.001 — 33
▼B
4.Corrosive and irritant effects including serious damage to the eye
4.1. Non-gaseous preparations
For substances that produce corrosive effects (R34, R35) or irritant
effects (R36, R37, R38, R41), the individual concentration limits speci-
fied in Table IV, expressed as a weight/weight percentage, determine,
when appropriate, the classification of the preparation.
TableIV
Classification of
the substanceClassification of the preparation
C with R35 C with R34 Xiwith R41Xiwith R36, R37,
R38
C with R35 concentration
≥10 %
R35 obligatory5%≤
concentration
<1 0%
R34 obligatory5 % (*) 1 % ≤concen-
tration < 5 %
R36/38 obliga-
tory
C with R34 concentration
≥10 %
R34 obligatory10 % (*) 5 % ≤concen-
tration < 10 %
R36/38 obliga-
tory
Xiwith R41 concentration
≥10 %
R41 obligatory5%≤concen-
tration < 10 %
R36 obligatory
Xiwith R36,
R37, R38concentration
≥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 thepreparation contains corrosive substances with R35 or R34 below the concentration limits for a classi-fication of the preparation as corrosive, such substances can contribute to a classification of thepreparation as irritant with R41 or irritant with R36.
►
M1NB:Simple application of the conventional method to preparations containing substances classified
as corrosive or irritant may result in under-classification or over-classification of the hazard, ifother relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in
classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI to Direc-
tive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive. ◄
4.2. Gaseous preparations
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.
TableIVA
Classification of
the substance
(gas)Classification of the gaseous preparation
C with R35 C with R34 Xiwith R41Xiwith R36, R37,
R38
C with R35 concentration
≥1%
R35 obligatory0,2 %≤
concentration
<1%
R34 obligatory0,2 % (*) 0,02 % ≤
concentration
< 0,2 %
R36/37/38 obli-
gatory1999L0045 — EN — 11.09.2001 — 001.001 — 34
▼B
Classification of
the substance
(gas)Classification of the gaseous preparation
C with R35 C with R34 Xiwith R41Xiwith R36, R37,
R38
C with R34 concentration
≥5%
R34 obligatory5 % (*) 0,5 % ≤
concentration
<5%
R36/37/38 obli-
gatory
Xiwith R41 concentration
≥5%
R41 obligatory0,5 %≤
concentration
<5%
R36 obligatory
Xiwith R36,
R37, R38concentration
≥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 thepreparation contains corrosive substances with R35 or R34 below the concentration limits for a classi-fication of the preparation as corrosive, such substances can contribute to a classification of thepreparation as irritant with R41 or irritant with R36.
►
M1NB:Simple application of the conventional method to preparations containing substances classified
as corrosive or irritant may result in under-classification or over-classification of the hazard, ifother relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, inclassifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI to Direc-
tive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive. ◄
5.Sensitising effects
5.1. Non-gaseous preparations
Preparations that produce such effects are classified as sensitising and
assigned:
— the symbol Xnand phrase R42 if this effect can be produced by
inhalation,
— the symbol Xiand 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 classifica-
tion of the preparation.
TableV
Classification of the substanceClassification of the preparation
Sensitising with R42 Sensitising with R43
Sensitising with R42 concentration ≥1%
R42 obligatory
Sensitising with R43 concentration ≥1%
R43 obligatory
5.2. Gaseous preparations
Gaseous preparations that produce such effects are classified as sensi-
tising and assigned:
— the symbol Xnand phrase R42 if this effect can be produced by
inhalation,
— the symbol Xiand 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.1999L0045 — EN — 11.09.2001 — 001.001 — 35
▼B
TableVA
Classification of the substance
(gas)Classification of the gaseous preparation
Sensitising with R42 Sensitising with R43
Sensitising with R42 concentration ≥0,2 %
R42 obligatory
Sensitising with R43 concentration ≥0,2 %
R43 obligatory
6.Carcinogenic/mutagenic/toxic effects for reproduction
6.1. Non-gaseous preparations
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 classifica-
tion of the preparation. The following symbol and risk phrases are assigned:
Carcinogenic categories 1 and 2: T; R45 or R49
Carcinogenic category 3: Xn; R40
Mutagenic categories 1 and 2: T; R46Mutagenic category 3: X
n;►M1R68◄
Toxic for reproduction fertility categories 1 and 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61Toxic for reproduction fertility category 3: X
n; R62
Toxic for reproduction development category 3: Xn; R63
TableVI
Classification of the substanceClassification of the preparation
Categories 1 and 2 Category 3
carcinogenic substances of category 1
or 2 with R45 or R49concentration ≥0,1 %
carcinogenic
R45, R49 obligatory as
appropriate
carcinogenic substances of category 3
with R40concentration ≥1%
carcinogenic
R40 obligatory
mutagenic substances of category 1 or
2 with R46concentration ≥0,1 %
mutagenic
R46 obligatory
mutagenic substances of category 3
with►M1R68◄concentration ≥1%
mutagenic
►M1R68◄obliga-
tory
substances ‘toxic for reproduction’ of
category 1 or 2 with R60 (fertility)concentration ≥0,5 %
toxic for reproduction
(fertility)
R60 obligatory
substances ‘toxic for reproduction’ of
category 3 with R62 (fertility)concentration ≥5%
toxic for reproduction
(fertility)
R62 obligatory
substances ‘toxic for reproduction’ of
category 1 or 2 with R61 (develop-
ment)concentration ≥0,5 %
toxic for reproduction
(development)
R61 obligatory1999L0045 — EN — 11.09.2001 — 001.001 — 36
▼B
Classification of the substanceClassification of the preparation
Categories 1 and 2 Category 3
substances ‘toxic for reproduction’ of
category 3 with R63 (Development)concentration ≥5%
toxic for reproduction
(development)
R63 obligatory
6.2. Gaseous preparations
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: Xn; R40
Mutagenic categories 1 and 2: T; R46
Mutagenic category 3: Xn;►M1R68◄
Toxic for reproduction fertility categories 1 and 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61
Toxic for reproduction fertility category 3: Xn; R62
Toxic for reproduction development category 3: Xn; R63
TableVIA
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 R49concentration ≥0,1 %
carcinogenic
R45, R49 obligatory as
appropriate
carcinogenic substances of category 3
with R40concentration ≥1%
carcinogenic
R40 obligatory
mutagenic substances of category 1 or
2 with R46concentration ≥0,1 %
mutagenic
R46 obligatory
mutagenic substances of category 3
with►M1R68◄concentration ≥1%
mutagenic
►M1R68◄obliga-
tory
substances ‘toxic for reproduction’ of
category 1 or 2 with R60 (fertility)concentration ≥0,2 %
toxic for reproduction
(fertility)
R60 obligatory
substances ‘toxic for reproduction’ of
category 3 with R62 (fertility)concentration ≥1%
toxic for reproduction
(fertility)
R62 obligatory
substances ‘toxic for reproduction’ of
category 1 or 2 with R61 (develop-
ment)concentration ≥0,2 %
toxic for reproduction
(development)
R61 obligatory1999L0045 — EN — 11.09.2001 — 001.001 — 37
▼B
Classification of the substance
(gas)Classification of the gaseous preparation
Categories 1 and 2 Category 3
substances ‘toxic for reproduction’ of
category 3 with R63 (development)concentration ≥1%
toxic for reproduction
(development)
R63 obligatory1999L0045 — EN — 11.09.2001 — 001.001 — 38
▼B
ANNEX III
METHODS FORTHE EVALUATION OF THE ENVIR ONMENTAL
HAZARDSOFPREPARATIONSINACCORDANCEWITHARTICLE7
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 specifica-
tion 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 fortheevaluationofenvironmentalhazards
(a)Aquatic environment
I. Conventional method for the evaluation of hazards to the
aquatic environment
The conventional method for the evaluation of hazards to the aquatic
environment ►C1takes into account all the hazards that a preparation
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 ‘N’, the indication of danger ‘dangerous for
the environment’ and the risk phrases R50 and R53 (R50-53):
1.1. preparations containing one or more substances classified as
dangerous to the environment and to which is assigned phrases
R50-53 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;
1.2. preparations containing more than one substance classified as
dangerous for the environment and to which is assigned phrases
R50-53 in lower individual concentrations than the limits specified
under I.1.1(a) or (b) if:
XPN;R50—53
LN;R50—53/C18/C19
/C2111999L0045 — EN — 11.09.2001 — 001.001 — 39
▼B
where:
PN, R50—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R50-53 in the preparation,
LN, R50—53= is the limit R50-53 for each substance dangerous
for the environment to which is assigned the
phrases R50-53, expressed as percentage by
weight
2. and assigned the symbol ‘N’, the indication of danger ‘dangerous for
the environment’ and the risk phrases R51 and R53 (R51-53) unless
the preparation is already classified according to I.1 above;
2.1. preparations containing one or more than one substance classified as
dangerous to the environment and to which is assigned phrases R50-
53 or R51-53 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
R50-53 or R51-53 in lower individual concentrations than the limits
specified under I.2. (a) or (b) if:
XPN;R50—53
LN;R51—53/C18/C19
þPN;R51—53
LN;R51—53/C18/C19 /C18/C19
/C211
where:
PN, R50—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R50-53 in the preparation,
PN, R51—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R51-53 in the preparation,
LN, R51—53= is the respective limit R51-53 for each substance
dangerous for the environment to which is
assigned phrases R50-53 or R51-53, expressed as
percentage by weight
3. and assigned the risk phrases R52 and R53 (R52-53) 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-
53 or R51-53 or R52-53 in individual concentrations equal to orgreater 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
R51-53 or R50-53 or R52-53 in lower individual concentrations
than the limits specified under I.3.1(a) or (b) if:
X
PN;R50—53
LR52—53/C18/C19
þPN;R51—53
LR52—53/C18/C19
þPR52—53
LR52—53/C18/C19 /C18/C19
/C211
where:
PN, R50—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R50-53 in the preparation,1999L0045 — EN — 11.09.2001 — 001.001 — 40
▼B
PN, R51—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R51-53 in the preparation,
PR52—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R52-53 in the preparation,
LR52—53= is the respective limit R52-53 for each substance
dangerous for the environment to which is
assigned phrases R50-53 or R51-53 or R52-53,
expressed as percentage by weight;
4. and assigned the symbol ‘N’, the indication of danger ‘dangerous for
the environment’ 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:
XPN;R50
LN;R50/C18/C19
/C211
where:
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 clas-
sified 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 R50-53 if:
XPN;R50
LN;R50/C18/C19
þPN;R50—53
LN;R50/C18/C19 /C18/C19
/C211
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—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrases R50-53 in the preparation,
LN, R50= is the perspective limit R50 for each substance
dangerous for the environment to which is
assigned phrases R50 or R50-53, 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, or1999L0045 — EN — 11.09.2001 — 001.001 — 41
▼B
(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;
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:
XPR52
LR52/C18/C19
/C211
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:
XPR53
LR53/C18/C19
/C211
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 clas-
sified 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 environ-
ment and to which is assigned phrases R50-53 or R51-53 or R52-53
if:
XPR53
LR53/C18/C19
þPN;R50—53
LR53/C18/C19
þPN;R51—53
LR53/C18/C19
þPR52—53
LR53/C18/C19 /C18/C19
/C211
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—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrase R50-53 in the preparation,
PN, R51—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrase R51-53 in the preparation,1999L0045 — EN — 11.09.2001 — 001.001 — 42
▼B
PR52—53= is the percentage by weight of each substance
dangerous for the environment to which is
assigned phrase R52-53 in the preparation,
LR53= is the respective limit R53 for each substance
dangerous for the environment to which is
assigned phrase R53 or R50-53 or R51-53 or
R52-53, expressed as percentage by weight.
(b)Non-aquatic environment
(1) OZONE LAYER
I. Conventional method for the evaluation of preparations
dangerous for the ozone layer
The following preparations are to classified as dangerous for the
environment:
1. and assigned the symbol ‘N’, the indication of danger
‘dangerous for the environment’ and the risk phrase R59;
1.1. preparations containing one or more substances classified as
dangerous to the environment and to which is assigned the
symbol ‘N’ 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 considera-
tion, 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 concentra-
tion 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 considera-
tion, 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 concentra-
tion limits;
(2) TERRESTRIAL ENVIRONMENT
I. Evaluation of preparations dangerous for the terrestrial
environment
Classification of preparations using the risk phrases below will follow
after the detailed criteria for use of the phrases have been incorpo-
rated in Annex VI to Directive 67/548/EEC.
R54 Toxic to flora
R55 Toxic to fauna
R56 Toxic to soil organismsR57 Toxic to beesR58 May cause long-term adverse effects in the environment.
PART B
Concentrationlimitstobeusedfortheevaluationofenvironmentalhazards
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 classifica-
tion is also shown.1999L0045 — EN — 11.09.2001 — 001.001 — 43
▼B
Table1
Acute aquatic toxicity and long-term adverse effects
Classification of the
substanceClassification of the preparation
N, R50—53 N, R51—53 R52—53
N, R50—53 Cn≥25 % 2,5 % ≤Cn< 25 % 0,25 % ≤Cn< 2,5 %
N, R51—53 Cn≥25 % 2,5 % ≤Cn<2 5%
R52—53 Cn≥25 %
Table2
Acute aquatic toxicity
Classification of the substanceClassification of the preparation
N, R50
N, R50 Cn≥25 %
N, R50—53 Cn≥25 %
Table3
Aquatic toxicity
Classification of the substanceClassification of the preparation R52
R52
R52 Cn≥25 %
Table4
Long-term adverse effects
Classification of the substanceClassification of the preparation R53
R53
R53 Cn≥25 %
N, R50—53 Cn≥25 %
N, R51—53 Cn≥25 %
R52—53 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 percen-
tage, determine the classification of the preparation in relation to the
individual concentration of the substance(s) present whose classification is
also shown.
Table5
Dangerous for the ozone layer
Classification of the substanceClassification of preparation
N, R59
N with R59 C ≥0,1 %1999L0045 — EN — 11.09.2001 — 001.001 — 44
▼B
Classification of the substanceClassification of preparation
R59
R59 C ≥0,1 %
PART C
TestmethodsfortheevaluationofthehazardsfortheaquaticenvironmentNormally, the classification of a preparation is made on the basis of the conven-
tional 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 prepara-
tion.
The result of these tests on the preparation may only modify the classification
concerning acute aquatic toxicity which would have been obtained by the appli-
cation 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.1999L0045 — EN — 11.09.2001 — 001.001 — 45
▼B
ANNEX IV
SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARA-
TIONSOFFEREDORSOLDTOTHEGENERALPUBLIC
PART A
Containerstobefittedwithchild-resistantfastenings
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 Direc-
tive, are to fitted with child-resistant fastenings.
2. Containers of whatever capacity containing preparations presenting an aspira-
tion 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,
NoIdentification of the substance
Concentration limit
CAS-Reg No Name Einecs No
1 67-56-1 Methanol 2006596 ≥3%
2 75-09-2 Dichloromethane 2008389 ≥1%
which are offered or sold to the general public are to be fitted with child-
resistant fastenings.
PART B
Containerstobefittedwithatactile warningofdanger
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 extre-
mely flammable or highly flammable.1999L0045 — EN — 11.09.2001 — 001.001 — 46
▼B
ANNEX V
SPECIAL PROVISIONS CONCERNING THE LABELLING OF
CERTAINPREPARATIONS
A.For preparations classified as dangerouswithin the meaning of Articles
5,6and7
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 Direc-
tive 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 infor-
mation 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 this phrase
as set out in Annex III to Directive 67/548/EEC, when the concentra-
tion of this substance present in the preparation is equal to or higher
than 1 %, unless different values are set in Annex I to Directive 67/
548/EEC.
4.Preparations containing a substance assigned phrase R64: May cause
harm to breastfed babies
When a preparation contains at least one substance assigned phrase
R64, the label of the preparation must carry the wording of this phrase
as set out in Annex III to Directive 67/548/EEC, when the concentra-
tion 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
ofArticles5,6and7
1.Preparations containing lead
1.1. Paint and varnishes
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: ‘Contains lead. Should not
be used on surfaces liable to be chewed or sucked by children.’
In the case of packages the contents of which are less than 125 millili-
tres, the particulars may be as follows: ‘Warning! Contains lead’.
2.Preparations containing cyanoacrylates
2.1. Adhesives
The immediate packaging of adhesives based on cyanoacrylate must
bear the following inscriptions:
‘CyanoacrylateDangerBonds skin and eyes in secondsKeepout of the
reach of children’.
Appropriate advice on safety must accompany the package.1999L0045 — EN — 11.09.2001 — 001.001 — 47
▼B
3.Preparations containing isocyanates
The package labels of preparations containing isocyanates (as mono-
mers, oligomers, prepolymers, etc., or as mixtures thereof) must bear
the following inscriptions:
‘Contains isocyanates.See information supplied by the manufacturer.’
4.Preparations containing epoxy constituents withan average molecular
weight≤700
The package labels of preparations containing epoxy constituents with
an average molecular weight ≤700 must bear the following inscrip-
tions:
‘Contains epoxy constituents.See information supplied by the manufac-
turer.’
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: ‘Warning! Do
not use together with other products. May release dangerous gases
(chlorine).’
6.Preparations containing cadmium (alloys) and intended to be used for
brazing or soldering
The packaging of the abovementioned preparations must bear the
following inscription printed in clearly legible and indelible characters:
‘Warning! Contains cadmium.Dangerous fumes are formed during
use.See information supplied by the manufacturer.Comply with the
safety instructions.’
7.Preparations available as aerosols
Without prejudice to the provisions of this Directive, preparations avail-
able as aerosols are also subject to the labelling provisions inaccordance with points 2.2 and 2.3 of the Annex to Directive 75/324/
EEC as last amended by Directive 94/1/EC.
8.Preparations containing substances not yet tested completely
Where a preparation contains at least one substance which, in accor-
dance with Article 13.3 of Directive 67/548/EEC, bears the inscription
►
C1‘Caution — substance not yet fully tested’ ◄, the label of the
preparation must bear the inscription ‘Warning — this preparation
contains a substance not yet tested completely’ if this substance is
present in a concentration ≥1% .
9.Preparations not classified as sensitising but containing at least one
sensitising substance
The packaging of preparations containing at least one substance classi-
fied as sensitising and being present in a concentration equal to or
greater than 0,1 % or in a concentration equal to or greater than that
specified under a specific note for the substance in Annex I to Directive
67/548/EEC must bear the inscription: ‘Contains (name of sensitising
substance). May produce an allergic reaction.’
10.Liquid preparations containing halogenated hydrocarbons
For liquid preparations which show no flashpoint or a flashpoint higher
than 55 ºC and contain a halogenated hydrocarbon and more than 5 %
flammable or highly flammable substances, the packaging must bear the
following inscription as appropriate: ‘Can become highly flammable in
use’ or ‘Can become flammable in use’.
11.Preparations containing a substance assigned phrase R67: vapours may
cause drowsiness and dizziness
When a preparation contains one or more substances assigned the
phrase R67, the label of the preparation must carry the wording of this
phrase as set out in Annex III to Directive 67/548/EEC, when the total1999L0045 — EN — 11.09.2001 — 001.001 — 48
▼M1
▼M1
concentration of these substances present in the preparation is equal to
or higher than 15 %, unless:
— the preparation is already classified with phrases R20, R23, R26,
R68/20, R39/23 or R39/26,
— or the preparation is in a package not exceeding 125 ml.
12.Cements and cement preparations
The packaging of cements and cement preparations containing more
than 0,0002 % soluble chromium (VI) of the total dry weight of the
cement must bear the inscription: ‘Contains chromium (VI). May
produce an allergic reaction’ unless the preparation is already classified
and labelled as a sensitiser with phrase R43.
C.ForpreparationsnotclassifiedwithinthemeaningofArticles5,6and7
butcontainingatleastonedangeroussubstance
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: ‘Safety data sheet available
for professional user on request’.1999L0045 — EN — 11.09.2001 — 001.001 — 49
▼B
▼B
ANNEX VI
CONFIDENTIALITY FORTHE CHEMICAL IDENTITY OF A
SUBSTANCE
PART A
Informationtobecommunicatedintherequestforconfidentiality
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:
— the same dangerous constituents present in the same concentration
range,
— the same classification and labelling,
— the same expected uses.
A single alternative denomination must be used to mask the chemical iden-
tity 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 ‘Composition/information on ingredients’ 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 infor-
mation about the substance to ensure risk-free handling.
D. In making the request to use an alternative designation the person respon-
sible 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.
Requestforconfidentiality
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 estab-
lished 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 NoChemical name according to international
nomenclature and classification (Annex I
to Council Directive 67/548/EEC or
provisional classification)Alternative desig-
nation
(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 pertinentinformation available on the properties of the substance.
3. Justification for confidentiality (probability — 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□ NO□1999L0045 — EN — 11.09.2001 — 001.001 — 50
▼B
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 Direc-
tive 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
Lexiconguideforestablishingthealternative designations(generic names)
1.Introductorynote
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:
— 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),
— organic substances whose properties are identified by having a common
functional groupas their chief characteristics.
The family name is derived from the functional groupname.
These families are identified by the conventional number found in Annex I
(601—650).
Sub-families bringing together substances with a common specific character
have been added in certain cases.
2.Establishingthegenericname
General principles
For the purposes of establishing the generic name, the following general
approach, involving two successive stages, is adopted:
(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.1999L0045 — EN — 11.09.2001 — 001.001 — 51
▼B
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.Divisionofsubstancesintofamilies andsub-families
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
001 Hydrogen compounds
Hydrides
002 Helium compounds003 Lithium compounds004 Beryllium compounds
005 Boron compounds
Boranes
Borates
006 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 Oxygen compounds
009 Fluorine compounds
Inorganic fluorides
010 Neon compounds
011 Sodium compounds
012 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
Perchlorates1999L0045 — EN — 11.09.2001 — 001.001 — 52
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
018 Argon compounds
019 Potassium compounds
020 Calcium compounds021 Scandium compounds
022 Titanium compounds
023 Vanadium compounds024 Chromium compounds
Chromium VI compounds
025 Manganese compounds026 Iron compounds
027 Cobalt compounds
028 Nickel compounds029 Copper compounds
030 Zinc compounds
Organometallic zinc derivatives
031 Gallium compounds
032 Germanium compounds
033 Arsenic compounds034 Selenium compounds
035 Bromine compounds
036 Krypton compounds037 Rubidium compounds
038 Strontium compounds
039 Yttrium compounds040 Zirconium compounds
041 Niobium compounds
042 Molybdenum compounds043 Technetium compounds044 Ruthenium compounds
045 Rhodium compounds
046 Palladium compounds047 Silver compounds
048 Cadmium compounds1999L0045 — EN — 11.09.2001 — 001.001 — 53
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
049 Indium compounds
050 Tin compounds
Organometallic tin derivatives
051 Antimony compounds052 Tellurium compounds053 Iodine compounds
054 Xenon compounds
055 Caesium compounds056 Barium compounds057 Lanthanum compounds
058 Cerium compounds
059 Praseodymium compounds060 Neodymium compounds061 Promethium compounds
062 Samarium compounds
063 Europium compounds064 Gandolinium compounds065 Terbium compounds066 Dysprosium compounds
067 Holmium compounds
068 Erbium compounds069 Thulium compounds070 Ytterbium compounds
071 Lutetium compounds
072 Hafnium compounds073 Tantalum compounds074 Tungsten compounds
075 Rhenium compounds
076 Osmium compounds077 Iridium compounds078 Platinum compounds
079 Gold compounds
080 Mercury compounds1999L0045 — EN — 11.09.2001 — 001.001 — 54
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
Organometallic mercury derivatives
081 Thallium compounds082 Lead compounds
Organometallic lead derivatives
083 Bismuth compounds084 Polonium compounds
085 Astate compounds
086 Radon compounds087 Francium compounds088 Radium compounds
089 Actinium compounds
090 Thorium compounds091 Protactinium compounds092 Uranium compounds
093 Neptunium compounds
094 Plutonium compounds095 Americium compounds096 Curium compounds097 Berkelium compounds
098 Californium compounds
099 Einsteinium compounds100 Fermium compounds101 Mendelevium compounds
102 Nobelium compounds
103 Lawrencium compounds601 Hydrocarbons
Aliphatic hydrocarbons
Aromatic hydrocarbons
Alicyclic hydrocarbons
Polycyclic aromatic hydrocarbons (PAH)
602 Halogenated hydrocarbons (*)
Halogenated aliphatic hydrocarbons (*)
Halogenated aromatic hydrocarbons (*)
Halogenated alicyclic hydrocarbons (*)
603 Alcohols and derivatives
Aliphatic alcohols
Aromatic alcohols
Alicyclic alcohols
Alcanolamines
Epoxy derivatives1999L0045 — EN — 11.09.2001 — 001.001 — 55
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
Ethers
Glycolethers
Glycols and polyols
604 Phenols and derivatives
Halogenated phenol derivatives (*)
605 Aldehydes and derivatives
Aliphatic aldehydes
Aromatic aldehydes
Alicyclic aldehydes
Aliphatic acetals
Aromatic acetals
Alicyclic acetals
606 Ketones and derivatives
Aliphatic ketones
Aromatic ketones (*)
Alicyclic ketones
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
608 Nitriles and derivatives609 Nitro compounds610 Chlornitrated compounds
611 Azoxy and azo compounds
612 Amine compounds
Aliphatic amines and derivatives
Alicyclic amines and derivatives
Aromatic amines and derivatives
Aniline and derivatives
Benzidine and derivatives
613 Heterocyclic bases and derivatives
Benzimidazole and derivatives
Imidazol and derivatives
Pyrethrinoids
Quinoline and derivatives1999L0045 — EN — 11.09.2001 — 001.001 — 56
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
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 Organic peroxides
647 Enzymes
648 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 basesDistillate phenols
Distillates
Distillates (coal), liquid solvent extraction, primary
Distillates (coal), solvent extraction, hydrocracked
Distillates (coal), solvent extraction, hydrocracked hydroge-
nated middle
Distillates (coal), solvent extraction, hydrocracked middle
Extract residues (coal), low temperature coal tar alkaline
Fresh oil
Fuels, diesel, coal solvent extraction, hydrocracked, hydro-
genated
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 redistillate1999L0045 — EN — 11.09.2001 — 001.001 — 57
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
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 oilWash 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 — unspecified
Straight-run kerosine
Kerosine — unspecified
Cracked gas oil
Gas oil — unspecified
Heavy fuel oil
Grease
Unrefined or mildly refined base oil
Base oil — 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.
(*) Specify according to the family corresponding to halogen.
(*) Quinones included.
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 estab-
lished 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:
— 1,4 dihydroxybenzen
family 604: phenols and derivatives
generic name: phenol derivatives
— butanol
family 603: alcohols and derivatives
sub-family: aliphatic alcoholsgeneric name: aliphatic alcohol
— 2-Isopropoxyethanol
family 603: alcohols and derivatives
sub-family: glycolethersgeneric name: glycolether1999L0045 — EN — 11.09.2001 — 001.001 — 58
▼B
— 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 :
— chlorobenzene
family 602: halogenated hydrocarbons
sub-family: halogenated aromatic hydrocarbonsfamily 017: chlorine compounds
generic name: chlorinated aromatic hydrocarbon
— 2,3,6-trichlorophenylacetic acid
family 607: organic acids
sub-family: halogenated aromatic acids
family 017: chlorine compounds
generic name: chlorinated aromatic acid
— 1-chloro-1-nitropropane
family 610: chloronitrated derivatives
family 601: hydrocarbons
sub-family: aliphatic hydrocarbonsgeneric name: chlorinated aliphatic hydrocarbon
— tetrapropyl dithiopyrophosphate
family 015: phosphorus compounds
sub-family: phosphoric estersfamily 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 ‘organic’ or ‘inorganic’.
Examples :
— dimercury chloride
family 080: mercury compounds
generic name: inorganic mercury compound
— barium acetate
family 056: barium compounds
generic name: organic barium compound
— ethyl nitrite
family 007: nitrogen compounds
sub-family: nitrites
generic name: organic nitrite
— 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).1999L0045 — EN — 11.09.2001 — 001.001 — 59
▼B
ANNEX VII
PREPARATIONSCOVEREDBYARTICLE12(2)
Preparations as specified by paragraph 9.3 of Annex VI to Directive 67/548/
EEC.1999L0045 — EN — 11.09.2001 — 001.001 — 60
▼B
ANNEX VIII
PART A
Directives repealed inaccordancewithArticle 21
— 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)
— 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:
— Directive 89/178/EEC
— Directive 90/492/EEC
— Directive 93/18/EEC— Directive 96/65/EC
— 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
— 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) 1 January 1981 1 January 1981
88/379/EEC (OJ L 187, 16.7.1988, p. 14) 7 June 1991 7 June 1991
89/178/EEC (OJ L 64, 8.3.1989, p. 18) 1 December 1990 1 June 199190/492/EEC (OJ L 275, 5.10.1990, p. 35) 1 June 1991 8 June 199193/18/EEC (OJ L 104, 29.4.1993, p. 46) 1 July 1994 1 July 199490/35/EEC (OJ L 19, 24.1.1990, p. 14) 1 August 1992 1 November 1992
91/442/EEC (OJ L 238, 27.8.1991, p. 25) 1 August 1992 1 November 1992
96/65/EC (OJ L 265, 18.10.1996, p. 15) 31 May 1998 31 May 1998
PART C
SpecialprovisionsforAustria,FinlandandSwedenconcerningtheapplica-
tionofthefollowingDirectivesinaccordancewithArticle21
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 lastamended 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 prepara-
tions containing substances listed in Appendix 1;
(b) Article 13 in conjunction with Article 7 with respect to labelling
respecting the Austrian provisions on:
— safety advice for waste disposal,
— pictogram for waste disposal until two years after the entry into force
of this Directive,1999L0045 — EN — 11.09.2001 — 001.001 — 61
▼B
— 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 prepara-
tions
— containing substances listed in Appendix 2,
— 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,
— 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,
— which are not classified as dangerous according to the ‘måttligt
skadliga’ (Swedish: ‘moderately harmful’) criteria of Directive 88/
379/EEC.
(b) Article 13 in conjunction with Articles 3 and 7 with respect to
— 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,
— labelling of preparations classified as carcinogenic, category 3, with a
special R-phrase instead of R-phrase 40.1999L0045 — EN — 11.09.2001 — 001.001 — 62
▼B
Appendix 1
Substancesreferred toinAnnexVIII,PartC,paragraph2(Austria)
Name of the substanceIndex number in Annex I to
Directive 67/548/EEC
Linuron 006-021-00-1
Trichlorosilan 014-001-00-9
Phosphorus trichloride 015-007-00-4
Phosphorus pentachloride 015-008-00-X
Phosphorus oxychloride 015-009-00-5
Sodium polysulphides 016-010-00-3
Disulphur dichloride 016-012-00-4
Thionyl chloride 016-015-00-0
Calcium hypochlorite 017-012-00-7
Potassium hydroxide 019-002-00-8
2-Dimethylaminoethanol 603-047-00-0
2-Diethylaminoethanol 603-048-00-6
Diethanolamine 603-071-00-1
N-Methyl-2-ethanolamine 603-080-00-0
2-Ethylhexan-1,3-diol 603-087-00-9
Isophorone 606-012-00-8
6-Methyl-1,3-dithiolo(4,5-b)chinoxalin-2-one 606-036-00-9
Acetic anhydride 607-008-00-9
Methyl formate 607-014-00-1Ethyl formate 607-015-00-7
Acrylic acid 607-061-00-8
Chloroacetyl chloride 607-080-00-1
Nitrofen 609-040-00-9
Quintozen; Pentachloronitrobenzol 609-043-00-5
Dichlofluanid 616-006-00-7
Cumene hydroperoxide 617-002-00-8
Monocrotophos 015-072-00-9
Edifenphos 015-121-00-4
Triazophos 015-140-00-8
Methanol 603-001-00-X
Trifenmorph; 4-Tritylmorpholin 613-052-00-X
Diuron 006-015-00-9
Fenbutanin oxide 050-017-00-2
1-Butanol, 2-Butanol, iso-Butanol 603-004-00-61999L0045 — EN — 11.09.2001 — 001.001 — 63
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Appendix 2
Substancesreferred toinAnnexVIII,PartC,paragraph3(Sweden)
Name of the substanceIndex number in Annex I to
Directive 67/548/EEC
Acetone 606-001-00-8
Butanone 606-002-00-3Amyl formate 607-018-00-3Ethyl acetate 607-022-00-5n-Butylacetate 607-025-00-1sec-Butylacetate 607-026-00-7tert-Butylacetate 607-026-00-7iso-Butylacetate 607-026-00-7Butylformate 607-017-00-8Cyclohexane 601-017-00-11,4-Dimethylcyclohexane 601-019-00-2
Diethyl ether 603-022-00-4
Ethyl methyl ether 603-020-00-3Amyl acetate 607-130-00-2Ethyl lactate 607-129-00-7Amyl propionate 607-131-00-82,4-Dimethylpentan-3-one 606-028-00-5Di-n-propylether 603-045-00-XDi-n-propyl ketone 606-027-00-XEthyl propionate 607-028-00-8Heptane 601-008-00-2Hexane (mixture of isomers) containing less
than 5 % n-hexane601-007-00-7
Isopropyl acetate 607-024-00-6
Isopropyl alcohol 603-003-00-04-Methoxy-4-methylpentane-2-one 606-023-00-8Methyl acetate 607-021-00-XMethyl cyclohexane 601-018-00-75-Methylhexane-2-one 606-026-00-4
Methyllactate 607-092-00-7
4-Methylpentan-2-one 606-004-00-4Methyl propionate 607-027-00-2Octane 601-009-00-8Pentane 601-006-00-1Pentan-3-one 606-006-00-5Propan-1-ol 603-003-00-0Propyl acetate 607-024-00-6Propyl formate 607-016-00-2Propyl propionate 607-030-00-9Sodium bisulphite = polysulphite 016-010-00-3
Toluene-2,4-diisocyanate 615-006-00-4
Toluene-2,6-diisocyanate 615-006-00-4Cadmiumfluoride 048-006-00-21,2-Epoxy-3(tolyloxy)-propane 603-056-00-XDiphenylmethane-2,2 ′-diisocyanate 615-005-00-91999L0045 — EN — 11.09.2001 — 001.001 — 64
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Name of the substanceIndex number in Annex I to
Directive 67/548/EEC
Diphenylmethane-2,4 ′-diisocyanate 615-005-00-9
Diphenylmethane-4,4 ′-diisocyanate 615-005-00-9
Hydroquinone 604-005-00-4
Hydroxypropyl acrylate 607-108-00-2
Turpentine 650-002-00-6Butyl methyl ketone (2-Hexanone) 606-030-00-6
Hexane 601-007-00-7
Vanadium pentoxide 023-001-00-8
Sodium nitrate
Zinc oxide1999L0045 — EN — 11.09.2001 — 001.001 — 65
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ANNEX IX
CORRELATIONTABLE
This Directive 88/379/EEC
Article 1 Article 1
1.1 1.1
1.2 1.2
1.3
1.4
1.5 1.3
Article 2 Article 2Article 3 Article 3.6Article 4 Article 3.1
Article 4
Article 5 Article 3.2
5.1 3.2
5.1, third indent 3.2, paragraph 3(b)5.2—5.3
5.4
Article 6 Article 3.3
6.1 3.3, paragraphs (a) and (b)
6.2
6.3 3.3, paragraphs 3 and 4
6.4 3.4
6.5 3.5, paragraphs 1 to 3
Article 7Article 8 Article 5
8.1 5.1
8.2 5.2
8.3 5.3
8.4
Article 9 Article 6
9.1 6.1(a)
9.2 6.1(b)
9.3 6.2 and 6.3, second paragraph
Article 10 Article 7
10.1.1—1.2
10.2 7.1
10.2.3. 7.1(c)
10.2.4. 7.1(d)
10.2.5. 7.4
Article 11 Article 8
Article 12 Article 9
Article 131999L0045 — EN — 11.09.2001 — 001.001 — 66
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This Directive 88/379/EEC
Article 14 Article 10
Article 15 Article 7Article 16 Article 11
Article 17 Article 12
Article 18 Article 13Article 19 Article 14Article 20 Article 15
Article 21
Article 22 Article 16Article 23 Article 16(3)Article 24 Article 171999L0045 — EN — 11.09.2001 — 001.001 — 67
CORRELATIONTABLE
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—3)Annex I introduction
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 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)▼B1999L0045 — EN — 11.09.2001 — 001.001 — 68
This Directive 88/379/EEC 90/35/EEC 91/442/EEC 93/18/EEC
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)
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.6Annex 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.6Annex II.A.7.2 Article 3.5(k)Annex II.A.8.1 Article 3.5(l), (m)▼B1999L0045 — EN — 11.09.2001 — 001.001 — 69
This Directive 88/379/EEC 90/35/EEC 91/442/EEC 93/18/EEC
Annex II.A.8.2 Article 3.5(n)
Article 3.5(o), (p)
Annex II.A.9.1—9.4
Annex II.B. introduction Annex I. introduction
Annex II.B.1 Annex I.1
Annex II.B.1.1 Annex I.1.1
Annex II.B.1.2 Annex I.1.2
Annex II.B.2 Annex I.2
Annex II.B.2.1 Annex I.2.1
Annex II.B.2.2 Annex I.2.2
Annex II.B.3 Annex I.3
Annex II.B.3.1 Annex I.3.1
Annex II.B.3.2 Annex I.3.2
Annex II.B.4 Annex I.4
Annex II.B.4.1 Annex I.4.1
Annex II.B.4.2 Annex I.4.2
Annex II.B.5 Annex I.5
Annex II.B.5.1 Annex I.5.1
Annex II.B.5.2 Annex I.5.2
Annex II.B.6 Annex I.6▼B1999L0045 — EN — 11.09.2001 — 001.001 — 70
This Directive 88/379/EEC 90/35/EEC 91/442/EEC 93/18/EEC
Annex II.B.6.1 Annex I.6.1
Annex II.B.6.2 Annex I.6.2
Annex III.A
Annex III.B
Annex III.CAnnex IV.B Articles 1 and 2Annex IV.A.1 Article 1(1)
Annex IV.A.2 Article 2; Annex (a)
Annex IV.A.3 Article 1; Annex (b)Annex V.A.1 Annex II.A.1
Annex V.A.2 Annex II.A.2
Annex V.A.3 Annex II.A.3
Annex V.A.4 Annex II.A.4
Annex V.B.1 Annex II.B.1
Annex V.B.2 Annex II.B.2
Annex V.B.3 Annex II.B.3
Annex V.B.4 Annex II.B.4
Annex V.B.5 Annex II.B.5
Annex V.B.6 Annex II.B.6
Annex V.B.7 Article 3.2(3)(b)▼B1999L0045 — EN — 11.09.2001 — 001.001 — 71
This Directive 88/379/EEC 90/35/EEC 91/442/EEC 93/18/EEC
Annex V.B.8 Article 3.5(4)
Annex V.CAnnex VI
Annex VII
Annex VIIIAnnex IX▼B1999L0045 — EN — 11.09.2001 — 001.001 — 72