1999L0045 — EN — 01.01.1999 — 000.001 — 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
concerningtheapproximationofthelaws,regulationsandadministrativeprovisionsoftheMember
Statesrelatingtotheclassification,packagingandlabellingofdangerouspreparations
(OJ L 200, 30.7.1999, p. 1)
Corrected by:
►C1Corrigendum, OJ L 6, 10.1.2002, p. 70 (1999/45/EC)
▼B
DIRECTIVE 1999/45/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of31May1999
concerning the approximation of the laws, regulations and admin-
istrative provisions of the Member States relating to the
classification,packagingandlabellingofdangerouspreparations
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN
UNION,
Having regard to the Treaty establishing the European Community, and
inparticular 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 administrativeprovisions 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 of clarity, berecast;
(2)Whereas, in spite of Community provisions, the rules applying tocertain dangerous preparations in the Member States exhibitconsiderable differences as regards classification, packaging andlabelling; whereas these differences constitute a barrier to trade,
create unequal competition conditions and directly affect the
functioning of the internal market; whereas it is thereforenecessary to remove this barrier to trade by approximating therelevant legislation existing in the Member States;
(3)Whereas measures for the approximationof the provision s of theMember 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
protectionas 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 in thecourse of their work or inthe pursuit of a hobby, protectionforconsumers and for the environment;
(4)Whereas containers containing certain categories of dangerous
preparations offered or sold to the general public must be fitted
with child-resistant fastenings and/or carry a tactile warning ofdanger; whereas certain preparations not falling within thesecategories of danger may nevertheless, owing to their composi-tion, present a danger for children; whereas the packaging of suchpreparations should therefore be equipped with child-resistant
fastenings;
(5)Whereas it is necessary to provide concentration limits expressed
as a volume/volume percentage in the case of preparationsmarketed ingaseous form;
(6)Whereas this Directive contains special labelling provisionsapplicable to certain preparations; whereas, to ensure an adequate1999L0045 — EN — 01.01.1999 — 000.001 — 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).
▼B
level of protection for man and the environment, special labelling
provisions must also be introduced for certain preparations which,although not dangerous within the meaning of this Directive, may
nevertheless present a danger to the user;
(7)Whereas on30 April 1992 the Coun cil adopted Directive 92/32/
EEC amending for the seventh time Directive 67/548/EEC on theapproximation of the laws, regulations and administrativeprovisions relating to the classification, packaging and labellingof dangerous substances(
1); whereas on27 April 1993 the
Commissionadopted 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 at Community
level on the classification and labelling of preparations to takeaccount of their effects on the environment and whereas it istherefore necessary to introduce a method for assessing thehazards of a given preparation for the environment either by a
calculation method, or by determining the ecotoxicological
properties by test methods under certain conditions;
(8)Whereas the number of animals used for experiments should bereduced to a minimum, in accordance with the provisions ofCouncil Directive 86/609/EEC of 24 November 1986 on theapproximation of laws, regulations and administrative provisionsof the Member States regarding the protection of animals used for
experimentalandotherscientificpurposes(
3);whereasArticle7(2)
of that Directive stipulates that an experiment shall not beperformed if another scientifically satisfactory method ofobtaining the results sought, not entailing the use of an animal,is reasonably and practically available; whereas, therefore, this
Directive makes use of the results of assessments of toxicological
and ecotoxicological properties only when these are alreadyknown and entails no obligation to conduct further experimentsonan imals;
(9)Whereas it is necessary to define what human experience mightbe considered for the evaluation of the health hazards of apreparation; whereas, if clinical studies may be accepted, it is
takenas giventhat such studies comply with the Helsin ki
Declaration 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 develop a specific method of classificationwhich takes in toaccount their particular chemical properties; whereas the
Commission, in consultation with Member States, will examine
this need and submit a proposal, if appropriate, before theimplementation date of this Directive;
(11)Whereas classification, packaging and labelling of plant protec-tionproducts covered by Coun cil Directive 78/631/EEC of26 June 1978 on the approximation of the laws of the Member
States relating to the classification, packaging and labelling of
dangerous preparations (pesticides)(
4) need to be revised taking
into account technical and scientific developments as well asregulatory developments following implementation of CouncilDirective 91/414/EEC of 15 July 1991 concerning the placing ofplant protection products on the market(
5);1999L0045 — EN — 01.01.1999 — 000.001 — 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.
(5) 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).
▼B
(12)Whereas Directive 91/414/EEC and Directive 98/8/EC of the
European Parliament and of the Council of 16 February 1998
concerning the placing of biocidal products on the market(1), in
contrast to the provisions applicable to chemical preparationscovered by this Directive, provide for anauthorisationprocedurefor each product onthe basis of a dossier presen ted by theapplicant and an assessment carried out by the competent
authority ineach Member State; whereas furthermore that
authorisation procedure includes a control relating specificallyto the classification, packaging and labelling of each productbefore it is placed onthe market; whereas it is appropriate, as partof a clear and transparent information process, to classify and
label plant protection products according to the provisions of this
Directive, and also to provide instructions for use in accordancewith the results of the evaluationcarried out inthe framework ofDirective 91/414/EEC and to ensure that the labelling satisfies thehigh level of protectionsought by both this Directive an dDirective 91/414/EEC; whereas, inaddition , a safety data sheet
has to be established for plant protectioon products in accordance
with this Directive;
(13)Whereas it is appropriate to provide, in relation to environmentallabelling, that specific exemptions or specific provisions may bedecided uponinspecific cases where it canbe demon strated that
the overall environmental impact of the product types in question
is lower than that of corresponding product types;
(14)Whereas, although munitions are not covered by this Directive,explosives marketed to produce anexplosive or pyrotechn ic effectmay, through their chemical composition, present dangers to
health; whereas it is therefore necessary as part of a transparent
information process to classify them and assign to them a safetydata sheet in accordance with the provisions of this Directive andalso to label them in accordance with the international rules usedfor 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 suchpreparations;
(16)Whereas the label constitutes a basic tool for users of the
dangerous preparations in so far as it provides them with the
initial essential concise information; whereas it neverthelessneeds to be supplemented by a two-fold system of more detailedinformation, consisting firstly of the safety data sheet, intendedfor professional users as defined by Commission Directive 91/
155/EEC of 5 March 1991 defining and laying down the detailed
arrangements for the system of specific information relating todangerous preparations in implementation of Article 10 ofDirective 88/379/EEC(
2) and secondly of the bodies appointed
by the Member States which are responsible for the provision ofinformation solely for medical purposes, both preventive and
curative;
(17)Whereas, onthe basis of in formationto be supplied by the
Member 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 Directive
on experience with the present overall approach to labelling of
dangerous preparations and in particular on its understanding andapplication by users, experience with publicity campaigns andeducational and training programmes; whereas, on the basis ofthis report, the Commissionwill, if appropriate, submit thenecessary proposals;1999L0045 — EN — 01.01.1999 — 000.001 — 4
(1) OJ L 123, 24.4.1998, p. 1.
(2) 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).
▼B
(18)Whereas it is necessary to require safety data sheets providing
proportionate information on the dangers to man and the
environment 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 submittedby Member States, will review Directive 91/155/EEC and submit
proposals, if appropriate, before the expiry of the date for
implementation of this Directive;
(19)Whereas, in the case of preparations classified as dangerouswithin the meaning of this Directive, it is appropriate to permit
Member States to allow certainderogation s with respect to
labelling where the packaging is too small, or otherwiseunsuitable for labelling, or where such small packaging or suchsmall quantities are involved that there is no reason to fear anydanger to man or the environment; whereas in such casesappropriate consideration should also be given to the approxima-
tion of the relevant provisions at Community level; whereas the
Commission will therefore examine the needs for harmonisationand, if appropriate, submit proposals;
(20)Whereas the confidentiality of certain substances contained in the
preparations should be guaranteed and whereas it is therefore
necessary to institute a system which allows the personresponsible for placing the preparation on the market to requestconfidentiality for such substances;
(21)Whereas the provisions of this Directive will have regard to the
commitment entered into by the Community and its Member
States, in accordance with the goals for sustainable developmentset under Agenda 21, Chapter 19, at the UNCED conference heldinJun e 1992 inRio de Jan eiro, to strive for the futureharmonisation of systems for the classification of dangerous
substances and preparations;
(22)Whereas the Commissionshould be giventhe powers n ecessary
to adapt all the Annexes to this Directive to technical progress;
(23)Whereas the adoptionof this Directive should n ot affect theobligations of the Member States concerning the deadlines fortransposition into national law and for application of theDirectives indicated in Annex VIII;
(24)Whereas the Directives indicated in Annex VIII should be
repealed, subject to certain conditions; whereas the conditions for
repealing the Directives indicated in Annex VIII should bespecified for Austria, Finland and Swedenin order to take accountof the present level of their legislation, in particular as regards theprotection of health and the protection of the environment,
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Objectivesandscope
1. This Directive aims at the approximationof the laws, regulation s
and administrative provisions of the Member States relating to:
— the classification, packaging and labelling of dangerous preparations,
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,
whensuch preparation s are placed onthe market of the Member States.2. This Directive shall apply to preparations which:
— contain at least one dangerous substance within the meaning of
Article 2,
and1999L0045 — EN — 01.01.1999 — 000.001 — 5
▼B
— 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
— inArticle 14
shall also apply to preparations which are not considered dangerous
within the meaning of Articles 5, 6 or 7 but may nevertheless present aspecific hazard.
4. Without prejudice to Directive 91/414/EEC, the articles on
classification, packaging, labelling and safety data sheets of thisDirective shall 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 usedin direct physical contact
with the humanbody inso far as Commun ity measures lay downprovisions 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 anyadditive necessary to preserve the stability of the products and anyimpurity deriving from the process used, but excluding any solvent
which may be separated without affecting the stability of the
substance or changing its composition;
(b) ‘preparations’ means mixtures or solutions composed of two or more
substances;
(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 atleast three monomer units which are covalently bound to at least one1999L0045 — EN — 01.01.1999 — 000.001 — 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) OJL 262,27.9.1976, p. 169. Directive as last amended byDirective 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
Decision96/350/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).
▼B
other monomer unit or other reactant and consists of less than a
simple weight majority of molecules of the same molecular weight.Such molecules must be distributed over a range of molecular
weights whereindifferen ces inthe molecular weight are primarily
attributable to differences in the number of monomer units. In thecontext of this definition a ‘monomer unit’ means the reacted formof 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 deemed
to 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 controlled
conditions; it includes the determination of intrinsic properties,
performance and efficacy as well as scientific investigation relatedto product development;
(g) ‘process-orientated research and development’ means the further
development of a substance in the course of which pilot plant orproductiontrials are used to test the fields of applicationof 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
Directive:
(a) explosive substances and preparations: solid, liquid, pasty or
gelatinous substances and preparations which may also reactexothermically without atmospheric oxygenthereby quickly evol-ving gases, and which, under defined test conditions, detonate,quickly deflagrate or upon heating explode when partially confined;
(b) oxidising substances and preparations: substances and preparations
which give rise to a highly exothermic reactionincon tact withother substances, particularly flammable substances;
(c) extremely flammable substances and preparations: liquid substances
and preparations having an extremely low flash-point and a lowboiling-point and gaseous substances and preparations which areflammable in contact with air at ambient temperature and 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 without anyapplicationof en ergy, or
— solid substances and preparations which may readily catch fire
after brief contact with a source of ignition and which continueto burnor to be con sumed after removal of the source ofignition, or
— liquid substances and preparations having a very low flash-
point, or
— substances and preparations which, in contact with water or
damp air, evolve extremely flammable gases indan gerousquantities;
(e) flammable substances and preparations: liquid substances and
preparations having a low flash-point;
(f) very toxic substances and preparations: substances and preparations
which in very low quantities cause death or acute or chronic
damage to health when inhaled, swallowed or absorbed via the skin;
(g) toxic substances and preparations: substances and preparations
which in low quantities cause death or acute or chronic damage tohealth 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 wheninhaled, swallowed or absorbed via the skin;1999L0045 — EN — 01.01.1999 — 000.001 — 7
▼B
(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 repeatedcontact with the skin or mucous membrane, may cause inflamma-tion;
(k) sensitising substances and preparations: substances and preparations
which, if they are inhaled or if they penetrate the skin, are capableof eliciting a reaction of hypersensitisation such that on furtherexposure to the substance of preparation, characteristic adverseeffects are produced;
(l) carcinogenic substances and preparations: substances or prepara-
tions which, if they are inhaled or ingested or if they penetrate theskin, may induce cancer or increase its incidence;
(m) mutagenic substances and preparations: substances and preparations
which, if they are inhaled or ingested or if they penetrate the skin,may induce heritable genetic defects or increase their incidence;
(n) substances and preparations which are toxic for reproduction:
substances and preparations which, if they are inhaled oringested or
if they penetrate the skin, may produce, orincrease the incidence of,non-heritable adverse effects in the progeny and/or an impairmentof 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 theenvironment, would or could present an immediate or delayeddanger for one or more components of the environment.
Article 3
Determinationofdangerouspropertiesofpreparations
1. The evaluationof the hazards of a preparationshall 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
preparationas placed onthe market.
2. Where the determination of dangerous properties is carried out in
accordance with Articles 5, 6 and 7, all dangerous substances within themeaning 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,
shall be taken into consideration in accordance with the provisions laid
downinthe method used.
3. For preparations covered by this Directive, dangerous substances
as referred to inparagraph 2 which are classified as dan gerous onthe
basis of their health and/or environmental effects, whether they arepresent as impurities or additives, shall be taken into consideration whentheir concentrations are equal to, or greater than, those defined in thefollowing table unless lower values are given in Annex I to Directive 67/1999L0045 — EN — 01.01.1999 — 000.001 — 8
▼B
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 thisDirective.
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
Generalprinciplesofclassificationandlabelling
1. The classification of dangerous preparations according to the
degree and specific nature of the hazards involved shall be based on thedefinitions 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 down in
Annex VI to Directive 67/548/EEC, save where alternative criteriareferred to in Article 5, 6, 7 or 10 and the relevant Annexes of thisDirective are applied.
Article 5
Evaluation of the hazards deriving from physico-chemical proper-
ties
1. The hazards of a preparationderivin g from its physico-chemical
properties shall be assessed by determining, by means of the methods1999L0045 — EN — 01.01.1999 — 000.001 — 9
▼B
specified in Part A of Annex V to Directive 67/548/EEC, the physico-
chemical properties of the preparationn ecessary for appropriateclassification and labelling in accordance with the criteria laid down
in Annex VI to that Directive.
2. By way of derogationfrom paragraph 1:the determination of the explosive, oxidising, extremely flammable,
highly flammable, or flammable properties is not necessary providedthat:
— none of the constituents possesses such properties and that, on the
basis of the information available to the manufacturer, the
preparation 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 reassessment
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 certaincases for which the methods laid downinPart A of
Annex V to Directive 67/548/EEC are not appropriate, alternativecalculation methods are laid down in Part B of Annex I to this Directive.
4. Certainexemption s from the applicationof the methods laid down
in Part A of Annex V to Directive 67/548/EEC are referred to in Part Aof Annex I to this Directive.
5. The hazards deriving from the physico-chemical properties of a
preparationcovered by Directive 91/414/EEC shall be assessed by
determining the physico-chemical properties of the preparation neces-
sary for appropriate classificationinaccordan ce with the criteria set outin Annex VI to Directive 67/548/EEC. These properties shall bedetermined by means of the methods laid down in Part A of Annex V toDirective 67/548/EEC unless other internationally recognised methods
are acceptable in accordance with the provisions of Annexes II and III to
Directive 91/414/EEC.
Article 6
Evaluationofhealthhazards
1. The health hazards of a preparationshall be assessed by on e 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 properties shallbe determined by means of the methods laid down in Part B of
Annex V to Directive 67/548/EEC, unless, in the case of plant
protection products, other internationally recognised methods areacceptable in accordance with the provisions ofAnnexes II and III toDirective 91/414/EEC.
2. Without prejudice to the requirements of Directive 91/414/EEC,
only where it can be scientifically demonstrated by the person
responsible for placing the preparation on the market that the
toxicological properties of the preparation cannot correctly bedetermined by the method outlined in paragraph 1(a), or on the basisofexistingtestresultsonanimals,themethodsoutlinedinparagraph1(b)may be used, provided they are justified or specifically authorised underArticle 12 of Directive 86/609/EEC.
Whena toxicological property is established by the methods outlin ed in
paragraph 1(b) to obtain new data, the test shall be conducted in
compliance with the principles of good laboratory practice provided forinCoun cil Directive 87/18/EEC of 18 December 1986 onthe1999L0045 — EN — 01.01.1999 — 000.001 — 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).
▼B
harmonisation of laws, regulations and administrative provisions relating
to the application of the principles of good laboratory practice and theverification of their applications for tests on chemical substances(
1)a nd
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 beenestablished onthe basis of both the methods outlin ed in
paragraphs 1(a) and (b), the results from the methods outlined inparagraph 1(b) shall be used for classifying the preparation, except in thecase of carcinogenic, mutagenic or toxic effects for reproduction forwhich 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 inaccordance with the method outlined in paragraph 1(a).
3. Furthermore, where it canbe demon strated:
— 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 poisoninformation units or concerning occupational diseases, that toxico-
logical effects onmandiffer from those suggested by the application
of the methods outlined in paragraph 1, then the preparation shall beclassified according to its effects on man,
— that, owing to effects such as potentiation, a conventional assessment
would underestimate the toxicological hazard, those effects shall be
taken into account in classifying the preparation,
— that, owing to effects such as antagonism, a conventional assessment
would overestimate the toxicological hazard, those effects shall be
taken into account in classifying the preparation.
4. For preparations of a known composition, with the exception of
those covered by Directive 91/414/EEC, classified inaccordan ce withparagraph 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 thedangerous 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 within themeaning of the definitions set out in Article 2, are introduced by themanufacturer.
This new evaluation will apply unless there is valid scientific
justification for considering that a re-evaluation of the hazard will notresult in a change of classification.1999L0045 — EN — 01.01.1999 — 000.001 — 11
(1) OJ L 15, 17.1.1987, p. 29.
▼B
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 methods laid down inPart C of Annex V to Directive 67/548/EEC unless, in the case ofplant protection products, other internationally recognised methodsare acceptable in accordance with the provisions of Annexes II and
III to Directive 91/414/EEC. Without prejudice to the testing
requirements set out in Directive 91/414/EEC, the conditions forapplication of the test methods are described in Part C of Annex IIIto this Directive.
2. Where anecotoxicological property is established by on e of the
methods outlined in paragraph 1(b) to obtain new data, the test shall be
conducted in compliance with the principles of good laboratory practice
provided for in Directive 87/18/EEC and with the provisions ofDirective 86/609/EEC.
Where the environmental hazards have been assessed in compliance
with both the procedures mentioned above, the results of the methodsreferred to inparagraph 1(b) shall be used for classifyin g the
preparation.
3. For preparations of a known composition, with the exception of
those covered by Directive 91/414/EEC, classified inaccordan ce withthe method outlined in paragraph 1(b), a new evaluation of environ-mental hazard either by the method outlined in paragraph 1(a) or that
outlined 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 thedangerous 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 within the
meaning of the definitions set out in Article 2, are introduced by themanufacturer.
This new evaluation will apply unless there is valid scientific
justification for considering that a re-evaluation of the hazard will notresult in a change of classification.
Article 8
ObligationsanddutiesoftheMemberStates
1. Member States shall take all necessary measures to ensure that the
preparations covered by this Directive cannot be placed on the marketunless 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 of the1999L0045 — EN — 01.01.1999 — 000.001 — 12
▼B
preparation and any other pertinent information from any person
responsible 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 thedisposal 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 issued inaccordance 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
(authorities) 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 preparations
covered by Annex IV pursuant to Article 1(3) cannot be placed
on the market unless their packaging satisfies the followingrequirements:
— it shall be so designed and constructed that its contents
cannot escape; this requirement shall not apply where specialsafety devices are prescribed,
— the materials constituting the packaging and fastenings must
not be susceptible to adverse attack by the contents, or liableto 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 repeatedly
without the contents escaping;
1.2. containers which contain preparations within the meaning of
Article 1(2) and preparations covered by Annex IV pursuant to
Article 1(3) offered or sold to the general public do not have:
— either a shape and/or graphic decoration likely to attract or
arouse the active curiosity of childrenor to misleadconsumers, 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.
2. The packaging of preparations shall be deemed to satisfy the
requirements of paragraph 1.1, first, second and third indents, ifit complies with the requirements for carriage of dangerousgoods by rail, road, inland waterway, sea or air.1999L0045 — EN — 01.01.1999 — 000.001 — 13
▼B
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 packagingsatisfies all the requirements of this Article and the specific
provisions 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 marketunless the labelling on their packaging satisfies the
requirements of paragraphs 2.1 and 2.2 and the specific
provisions 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
onan y 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 placing thepreparationonthe market, whether it be the man ufacturer, theimporter 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 ,Xninaccordan ce with Article 6,
only the substances T+,T ,Xnpresent in concentrations 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 Bof Annex II to this Directive have to be taken 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 Directive have tobe taken into consideration;
2.3.3. the name of the substances which have given rise to the
classification of the preparation in one or more of the followingdanger categories:
— carcinogen category 1, 2 or 3,
— mutagencategory 1, 2 or 3,
— toxic for reproductioncategory 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.The chemical name shall be one of the designations listed in
Annex I to Directive 67/548/EEC or an internationallyrecognised chemical nomenclature if no corresponding designa-tion is yet listed in that Annex.1999L0045 — EN — 01.01.1999 — 000.001 — 14
▼B
2.3.4. As a consequence of the above provisions the name of any
substance which led to the classification of the preparation in thefollowing 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 the
major health hazards which have givenrise to the classificationand the choice of the corresponding phrases referring to the riskinvolved. In some cases, more than four chemical names may benecessary.
2.4.Thedangersymbol(s)andindication(s)ofdanger
The danger symbols, where specified in this Directive, and
indications of the dangers involved in the use of the preparation,
shall be in accordance with the wording of Annexes II and VI toDirective 67/548/EEC and shall be applied in accordance withthe evaluationof the hazards carried out inaccordan ce withAnnexes I, II and III to this Directive.
Where more than one danger symbol must be assigned to a
preparationthe obligationto 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 evaluationcarried out inaccordance 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 preparationfalls withinmore thanon e
danger category, those standard phrases shall cover all theprincipal hazards associated with the preparation. In some casesmore thansix R phrases may be n ecessary.
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 accordance
with the results of the hazard evaluationcarried out in
accordance 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 purposethe1999L0045 — EN — 01.01.1999 — 000.001 — 15
▼B
combined phrases listed in Annex IV to Directive 67/548/EEC
shall be regarded as single phrases. However, in some casesmore thansix S phrases may be n ecessary.
Where it is physically impossible to include the advice on the
label or package itself, the package shall be accompanied bysafety advice onthe 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 the generalpublic.
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 to certain provisions on
environmental labelling or specific provisions in relation to
environmental labelling may be determined in accordance withthe procedure referred to inArticle 20, where it canbedemonstrated that there would be a reduction in the environ-mental impact. These exemptions or specific provisions aredefined and laid down in Part A or B of Annex V.
4. If the contents of the package do not exceed 125 ml:
— inthe case of preparation s that are classified as highly
flammable, oxidising, irritant, with the exception of thoseassigned R41, or dangerous for the environment and assigned
the N symbol it shall not be necessary to indicate the
R phrases or the S phrases,
— inthe case of preparation s that are classified as flammable or
dangerousfortheenvironment andnotassignedtheNsymbolit shall be necessary to indicate the R phrases but 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 thisDirective.
Article 11
Implementationofthelabellingrequirements
1. Where the particulars required by Article 10 appear ona label, that
label shall be firmly affixed to one or more surfaces of the packaging sothat those particulars canbe read horizon tally whenthe package is setdown normally. The dimensions of the label are laid down in Annex VI
to Directive 67/548/EEC and the label is intended solely for provision of
the information required by this Directive and if necessary of anysupplementary health or safety information.
2. A label shall not be required when the particulars are clearly
shownonthe package itself, as specified inparagraph 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 spacing as
to be easily read.
Specific provisions regarding the presentation and format of this
information shall be laid down in Annex VI to Directive 67/548/EEC.
5. Member States may make the placing on the market of
preparations covered by this Directive within their territories subjectto use of their official language or languages in respect of the labellingthereof.1999L0045 — EN — 01.01.1999 — 000.001 — 16
▼B
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 inaccordan ce withinternational rules on the transport of dangerous goods and the innerpackage or packages are labelled inaccordan ce with this Directive;
(b) inthe case of a sin gle package:
— if such a package is labelled in accordance with international
rules on the transport of dangerous goods and withArticle 10(2.1), (2.2), (2.3), (2.5) and (2.6); for preparationsclassified according to Article 7, the provisions ofArticle 10(2.4)
shall additionally apply with respect to the property 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 transport of
dangerous goods.
Article 12
Exemptionsfromthelabellingandpackagingrequirements
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. Forcertain dangerous preparations within the meaning ofArticle 5,
6 or 7 defined in Annex VII which, in the form in which they are placedon the market, do not present any physico-chemical risk, orrisk to healthor to the environment, Articles 9, 10 and 11 shall not apply.
3. Member States may also:
(a) permit the labelling required by Article 10 to be applied in some
other appropriate manner on packages which are either too small orotherwise unsuitable for labelling in accordance with Article 11(1)and (2);
(b) by way of derogation from Articles 10 and 11 permit the packaging
of dangerous preparations which are classified as harmful, extremely
flammable, highly flammable, flammable, irritant or oxidising to be
unlabelled or to be labelled in some other way, if they contain suchsmall quantities that there is no reason to fear any danger to personshandling such preparations or to other persons;
(c) by way of derogation from Articles 10 and 11, for preparations
classified according to Article 7, permit the packaging of dangerouspreparations to be unlabelled or labelled in some other way if they
contain such small quantities that there is no reason to fear any
dangers to the environment;
(d) by way of derogation from Articles 10 and 11 permit the packaging
of dangerous preparations which are not mentioned in (b) or (c)above to be labelled insome other appropriate way, if the packagesare too small for the labelling provided for in Articles 10 and 11 andthere 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 laiddowninthis Directive shall n ot be permitted.
4. If a Member State makes use of the options provided for in
paragraph 3, it shall forthwith inform the Commission and MemberStates thereof. Where it is appropriate, measures shall be decided uponin the framework of Annex V and in accordance with the provisions ofArticle 20.1999L0045 — EN — 01.01.1999 — 000.001 — 17
▼B
Article 13
Distanceselling
Any advertisement for a preparation within the meaning ofthis Directive
which enables a member of the general public to conclude a contract forpurchase without first having sight of the label for that preparation mustmake mention of the type or types of hazard indicated on the label. Thisrequirement is without prejudice to Directive 97/7/EC of the European
Parliament and of the Council of 20 May 1997 on the protection of
consumers in respect of distance contracts(
1).
Article 14
Safetydatasheet
1. The safety data sheet information is principally intended for use
by professional users and must enable them to take the necessary
measures as regards the protectionof health, safety an d 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
preparation within the meaning of Article 1(2) provides asafety data sheet;
(b) the person responsible for placing on the market a
preparationprovides onrequest of a profession al user asafety data sheet providing proportionate information forpreparations not classified as dangerous within the meaningof Articles 5, 6 and 7 but containing in an individual
concentration of ≥1 % by weight for non-gaseous
preparations and ≥0,2 % by volume for gaseous
preparations at least:
— one substance posing health or environmental hazards, or
— one substance for which there are Community workplace
exposure limits.
2.2. The safety data sheet and its supply must comply with the
provisions of Directive 91/155/EEC.
2.3. The necessary amendments required to adapt to technical
progress Directive 91/155/EEC shall be adopted inaccordan ce
with the procedure laid downinArticle 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 inArticle 22(1).
2.4. The safety data sheet may be supplied onpaper or electron ically,
provided that the addressee has the necessary means of receivingit.
Article 15
Confidentialityofchemicalnames
Where the person responsible for placing the preparation on the market
candemon strate that the disclosure onthe label or safety data sheet ofthe 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 inpoint 2.3.4 of Article 10, or
— harmful or harmful in combination with one or more of the
properties mentioned in point 2.3.4 of Article 10 presenting acutelethal effects alone1999L0045 — EN — 01.01.1999 — 000.001 — 18
(1) OJ L 144, 4.6.1997, p. 19.
▼B
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 alternative
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
preparationis to be first placed onthe 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 nevertheless requestfurther 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 confidentiality
shall notify the applicant of its decision. The person responsible forplacing the preparation on the market shall forward a copy of thisdecisionto 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 Commissionshall be treated inaccordan ce withArticle 19(4) of Directive 67/548/EEC.
Article 16
RightsofMemberStatesregardingsafetyofworkers
This Directive shall not affect the right of Member States to specify, in
compliance with the Treaty, the requirements they deem necessary toensure that workers are protected when using the dangerous preparationsin question, provided that this does not mean that the classification,packaging, and labelling of dangerous preparations are modified in away not provided for in this Directive.
Article 17
Bodiesresponsibleforreceivinginformationrelatingtohealth
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 onthe 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 theconfidentiality of the information received. Such information may onlybe used to meet any medical demand by formulating preventive andcurative measures, inparticular incase of emergen cy.
Member States shall ensure that the information is not used for other
purposes.
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 areresponsible.
Article 18
Freemovementclause
Without prejudice to the provisions set out in other Community
legislation, Member States may not prohibit, restrict or impede theplacing on the market of preparations because of their classification,packaging, labelling or safety data sheets if such preparations complywith the provisions laid down in this Directive.1999L0045 — EN — 01.01.1999 — 000.001 — 19
▼B
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 of this
Directive, it may provisionally prohibit the placing on the market of that
preparation or subject it to special conditions in its territory. It shallimmediately inform the Commission and the other Member States ofsuch action and give reasons for its decision.
2. Inthe case referred to inparagraph 1, the Commissionshall
consult the Member States as soon as possible.
3. The Commissionshall take a decisioninaccordan ce with the
procedure laid downinArticle 20.
Article 20
Adaptationtotechnicalprogress
Amendments required to adapt the Annexes to this Directive to technical
progress shall be adopted inaccordan ce with the procedure laid downin
Article 29(4)(a) of Directive 67/548/EEC.
The Commissionshall 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 itsopinion on the draft within a time limit which the chairman may lay
down according to the urgency of the matter. The opinion shall be
delivered by the majority laid downinArticle 205(2) of the Treaty inthecase of decisions which the Council is required to adopt on a proposalfrom the Commission. The votes of the representatives of the MemberStates within the committee shall be weighted in the manner set out inthat Article. The chairmanshall n ot vote.
The Commissionshall adopt the measures en visaged 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, withoutdelay, 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 States concerning thedeadlines for transposition into national law and for application of the
Directives indicated in Part B of Annex VIII.
2. The Directives listed in Part A of Annex VIII shall apply to
Austria, Finland and Sweden subject to provisions laid downin Part C ofthat 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 Commission thereof.1999L0045 — EN — 01.01.1999 — 000.001 — 20
▼B
2. Member States shall apply the laws, regulations and administrative
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. WhenMember States adopt such measures, they shall con taina
reference to this Directive or shall be accompanied by such reference atthe 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 — 01.01.1999 — 000.001 — 21
▼B
ANNEXI
METHODSFORTHEEVALUATIONOFPHYSICO-CHEMICALPROP-
ERTIESOFPREPARATIONSINACCORDANCEWITHARTICLE5
PART A
ExemptionstotestmethodsofAnnexV—PartAtoDirective67/548/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 — 01.01.1999 — 000.001 — 22
▼B
ANNEXII
METHODS FOR THE EVALUATION OF HEALTH HAZARDS 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 preparationare to be assessed inaccordan ce with
Article 6(1)(a) by the conventional method described in parts A and B of this
Annex using individual concentration limits.
(a) where the dangerous substances listed in Annex I to Directive 67/548/EEC
are assigned concentration limits necessary for the application of the method
of assessment described in part A of this Annex, these concentration limits
must be used;
(b) where the dangerous substances do not appear in Annex I to Directive 67/
548/EEC or appear there without the concentration limits necessary for the
application of the method of evaluation described in part A of this Annex, the
concentration limits must be assigned in accordance with the specifications in
part B of this Annex.
The procedure for classification is set out in Part A of this Annex.
The classification of the substance(s) and the resulting classification of the
preparationare 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
percentage and in conjunction with the classification of the substance.
Where they are not given in Annex I to Directive 67/548/EEC, the concentration
limits to be taken into account for the application of this conventional method are
those set out in Part B of this Annex.
PART A
Procedureforevaluationofhealthhazards
The evaluationproceeds 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 appear in Annex I
to Directive 67/548/EEC or appear in it without concentration limits;1999L0045 — EN — 01.01.1999 — 000.001 — 23
▼B
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
concentration limits.
2.The following preparations shall be classified as toxic:
2.1. owing to their acute lethal effects and assigned the symbol ‘T’, the
indication 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 concentration limits;
2.1.2. preparations containing more than one substance classified as very toxic
or toxic in lower individual concentrations than the limits specified under
2.1.1(a) or (b) if:
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 concentrations
equal to or greater than:
(a) either the concentration specified in Annex I to Directive 67/548/
EEC for the substance or substances under consideration, or
(b) the concentration specified at point 2 in Part B of this Annex
(Table II and II A) where the substance or substances do not appear
in Annex I to Directive 67/548/EEC or appear in it without
concentration limits;1999L0045 — EN — 01.01.1999 — 000.001 — 24
▼B
2.3. owing to their long-term effects and assigned the symbol ‘T’, the
indication 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 concentration limits.
3.1.2. preparations containing more than one substance classified as very toxic,
toxic or harmful in lower individual concentrations than the limits
specified under 3.1.1(a) or (b) if:
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 weight
or by volume;
3.2. owing to their acute effects to the lungs if swallowed and assigned the
symbol ‘Xn’, 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 theconventional method according to the above paragraph 3.1 no account
shall be takenof the classificationof a substan ce as R65;
3.3. owing to their non-lethal irreversible effects after a single exposure and
assigned the symbol ‘X
n’, the indication of danger ‘harmful’ and the risk
phrase R40/route of exposure.
Preparations containing at least one dangerous substance classified as
very toxic, toxic or harmful that produces such effects inin dividual
concentrations equal to or greater than:
(a) either the concentration specified in Annex I to Directive 67/548/
EEC for the substance or substances under consideration, or
(b) the concentration specified at point 2 in Part B of this Annex
(Table II and II A) where the substance or substances do not appear
in Annex I to Directive 67/548/EEC or appear in it without
concentration limits;
3.4. owing to their long-term effects and assigned the symbol ‘Xn’, the
indication 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, or1999L0045 — EN — 01.01.1999 — 000.001 — 25
▼B
(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 corrosive
substance which is assigned phrase R35 in the preparation,
LC, R35= is the corrosive limit R35 specified for each corrosive
substance to which is assigned phrase R35, expressed as a
percentage by weight or by volume;
4.2. and assigned the symbol ‘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 individual
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 corrosive
substance to which is assigned phrase R35 in the
preparation,
PC, R34= is the percentage by weight or by volume of each corrosive
substance to which is assigned phrase R34 in the
preparation,
LC, R34= is the respective corrosive limit R34 specified for each
corrosive substance to which is assigned phrase R35 or
R34, expressed as a percentage by weight or by volume.
5.The following preparations are to be classified as irritants:
5.1. liable to cause serious eye damage and assigned the symbol ‘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, or1999L0045 — EN — 01.01.1999 — 000.001 — 26
▼B
(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
corrosive substance to which is assigned phrase R35 in
the preparation,
PC, R34= is the percentage by weight or by volume of each
corrosive substance to which is assigned phrase R34 in
the preparation,
PXi, R41= is the percentage by weight or by volume of each irritant
substance to which is assigned phrase R41 in the
preparation,
LXi, R41= is the respective irritant limit R41 specified for each
corrosive substance to which is assigned phrase R35 or
R34 or irritant substance to which is assigned phrase R41,
expressed as percentage by weight or by volume;
5.2. irritant to eyes and assigned the symbol ‘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
corrosive substance to which is assigned phrase R35 in
the preparation,
PC, R34= is the percentage by weight or by volume of each
corrosive substance to which is assigned phrase R34 in
the preparation,
PXi, R41= is the percentage by weight or by volume of each irritant
substance to which is assigned phrase R41 in the
preparation,
PXi, R36= is the percentage by weight or by volume of each irritant
substance to which is assigned phrase R36 in the
preparation,
LXi, R36= is the respective irritant limit R36 specified for each
corrosive substance to which is assigned phrase R35 or
R34 or irritant substance to which is assigned phrase R41,
or R36 expressed as percentage by weight or by volume;
5.3. irritant to skin and assigned the symbol ‘Xi’, the indication of danger
‘irritant’ and the risk phrase R38;1999L0045 — EN — 01.01.1999 — 000.001 — 27
▼B
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
corrosive substance to which is assigned phrase R35 inthe preparation,
P
C, R35= is the percentage by weight or by volume of each
corrosive substance to which is assigned phrase R34 in
the preparation,
PXi, R38= is the percentage by weight or by volume of each irritant
substance to which is assigned phrase R38 in the
preparation,
LXi, R38= is the respective irritant limit R38 specified for each
corrosive substance to which is assigned phrase R35 or
R34 or irritant substance to which is assigned phrase R38,
expressed as percentage by weight or by volume;
5.4. irritant to respiratory system and assigned the symbol ‘Xi’, the indication
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 notappear 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:
X
PXi;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
preparation,
LXi, R37= is the irritant limit R37 specified for each irritant
substance to which is assigned phrase R37, expressed as
percentage by weight or by volume;
5.4.3. gaseous preparations containing more than one of the substances
classified as irritant to which is assigned phrase R37 or as corrosive
and to which is assigned phrase R35 or R34 in lower individual
concentrations than the limits specified under 5.4.1(a) or (b) if:
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,1999L0045 — EN — 01.01.1999 — 000.001 — 28
▼B
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
individual concentrations equal to or greater than:
(a) either the concentration specified in Annex I to Directive 67/548/
EEC for the substance or substances under consideration, or
(b) the concentration specified at point 5 in Part B of this Annex
(Table V and V A) where the substance or substances do not appear
in Annex I to Directive 67/548/EEC or appear in it without
concentration limits;
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
concentration limits.
7.The following preparations are to be classified as carcinogenic:
7.1. those of category 1 or 2 which are assigned the symbol ‘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 not
appear in Annex I to Directive 67/548/EEC or appear in it without
concentration limits.
8.The following preparations are to be classified as mutagenic:
8.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the
phrase R46.
Preparations containing at least one substance producing such effects,
classified as mutagenic and to which is assigned phrase R46 which1999L0045 — EN — 01.01.1999 — 000.001 — 29
▼B
denotes mutagenic 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;
8.2. 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 mutagenic and to which is assigned phrase R40 which
denotes mutagenic substances in category 3, in individual concentrations
equal to or greater than:
(a) either the concentration specified in Annex I to Directive 67/548/
EEC for the substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Annex
(Table VI and VI A) where the substance or substances do not
appear in Annex I to Directive 67/548/EEC or appear in it without
concentration limits.
9.Thefollowingpreparationsaretobeclassifiedastoxicforreproduction:
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, inindividual 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, or
(b) the concentration specified at point 6 in Part B of this Annex
(Table VI and VI A) where the substance or substances do not
appear in Annex I to Directive 67/548/EEC or appear in it without
concentration limits;
9.4. those of category 3 which are assigned the symbol ‘X
n’ 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 R631999L0045 — EN — 01.01.1999 — 000.001 — 30
▼B
which denotes substances toxic for reproduction of category 3, in
individual concentrations equal to or greater than:
(a) either the concentration specified in Annex I to Directive 67/548/
EEC for the substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Annex (Table
VI and VI A) where the substance or substances do not appear in
Annex I to Directive 67/548/EEC or appear in it without
concentration limits.
PART B
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
classificationis also shown .
TableI
Classificationof the
substanceClassificationof 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,
— ingen eral, 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 preparations
in relation to the individual concentration of the gas(es) present whose
classificationis also shown .
TableIA
Classificationof the
substance
(gas)Classificationof 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 %1999L0045 — EN — 01.01.1999 — 000.001 — 31
▼B
Classificationof the
substance
(gas)Classificationof the gaseous preparation
T+TXn
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,
— ingen eral, 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, R40/route of exposure), the individual
concentration limits specified in Table II, expressed as a weight/weight
percentage, determine, when appropriate, the classification of the
preparation.
TableII
Classificationof the
substanceClassificationof the preparation
T+TXn
T+with R39/route of
exposureconcentration
≥10 %
R39(*) obligatory1%≤concentra-
tion< 10 %
R39(*) obligatory0,1 %≤concentra-
tion< 1 %
R40(*) obligatory
T with R39/route of
exposureconcentration
≥10 %
R39(*) obligatory1%≤concentration
<1 0%
R40(*) obligatory
Xnwith R40/route of
exposureconcentration ≥10%
R40(*) obligatory
(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases
listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) areto be used.
2.2. Gaseous preparations
For gases that produce non-lethal irreversible effects after a single
exposure (R39/route of exposure, R40/route of exposure), the individual
concentration limits specified in Table II A, expressed as a volume/
volume percentage, determine, when appropriate, the classification of the
preparation.
TableIIA
Classificationof the
substance (gas)Classificationof 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 %
R40(*) obligatory
T with R39/route of
exposureconcentration ≥5%
R39(*) obligatory0,5 %≤concentra-
tion< 5 %
R40(*) obligatory
Xnwith R40/route of
exposureconcentration ≥5%
R40(*) obligatory1999L0045 — EN — 01.01.1999 — 000.001 — 32
▼B
(*) 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 inTable III, expressed as a weight/weight percen tage,
determine, when appropriate, the classification of the preparation.
TableIII
Classificationof the substan ceClassificationof the preparation
TXn
T with R48/route of exposure concentration ≥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) areto be used.
3.2. Gaseous preparations
For gases that produce severe effects after repeated or prolonged
exposure (R48/route of exposure), the individual concentration limits
specified inTable III A below, expressed as a volume/volume
percentage, determine, when appropriate, the classification of the
preparation.
TableIIIA
Classificationof the substan ce
(gas)Classificationof the gaseous preparation
TXn
T with R48/route of exposure concentration ≥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) areto be used.
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
specified inTable IV, expressed as a weight/weight percen tage,
determine, when appropriate, the classification of the preparation.1999L0045 — EN — 01.01.1999 — 000.001 — 33
▼B
TableIV
Classificationof
the substanceClassificationof 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 the
preparation contains corrosive substances with R35 or R34 below the concentration limits for a
classificationof the preparationas corrosive, such substan ces cancon tribute to a classificationof thepreparation as irritant with R41 or irritant with R36.
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 classificationof the preparation .
TableIVA
Classificationof
the substance
(gas)Classificationof 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-
gatory
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
appropriate1999L0045 — EN — 01.01.1999 — 000.001 — 34
▼B
(*) 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
classificationof the preparationas corrosive, such substan ces cancon tribute to a classificationof the
preparation as irritant with R41 or irritant with R36.
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-
tionof the preparation .
TableV
Classificationof the substan ceClassificationof 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
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 A below,
expressed as a volume/volume percentage, determine, when appropriate,
the classificationof the preparation .
TableVA
Classificationof the substan ce
(gas)Classificationof 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 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; R461999L0045 — EN — 01.01.1999 — 000.001 — 35
▼B
Mutagenic category 3: Xn; R40
Toxic for reproductionfertility categories 1 an d 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61
Toxic for reproductionfertility category 3: Xn; R62
Toxic for reproductiondevelopmen t category 3: Xn; R63
TableVI
Classificationof the substan ceClassificationof 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 R40concentration ≥1%
mutagenic
R40 obligatory
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 obligatory
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
inTable VI A, expressed as a volume/volume percen tage, shalldetermine, 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: X
n; R40
Mutagenic categories 1 and 2: T; R46
Mutagenic category 3: Xn; R40
Toxic for reproductionfertility categories 1 an d 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61
Toxic for reproductionfertility category 3: Xn; R621999L0045 — EN — 01.01.1999 — 000.001 — 36
▼B
Toxic for reproductiondevelopmen t category 3: Xn; R63
TableVIA
Classificationof the substan ce
(gas)Classificationof 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 R40concentration ≥1%
mutagenic
R40 obligatory
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 obligatory
substances ‘toxic for reproduction’ of
category 3 with R63 (development)concentration ≥1%
toxic for reproduction
(development)
R63 obligatory1999L0045 — EN — 01.01.1999 — 000.001 — 37
▼B
ANNEXIII
METHODS FOR THE EVALUATION OF THE ENVIRONMENTAL
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 specification in
Part B of this Annex.
Part C gives the test methods for the evaluationof the hazards for the aquatic
environment.
PART A
Procedurefortheevaluationofenvironmentalhazards
(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 — 01.01.1999 — 000.001 — 38
▼B
where:
PN, R50—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrases R50-53 inthe 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 preparationis already classified accordin g 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 inthe preparation ,
PN, R51—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrases R51-53 inthe 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 percen-
tage by weight
3. and assigned the risk phrases R52 and R53 (R52-53) unless the
preparationis already classified accordin g 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 or
greater than:
(a) either the concentration specified in Annex I to Directive 67/548/
EEC for the substance or substances under consideration, or
(b) the concentration specified in Part B of this Annex (Table 1)
where the substance or substances do not appear in Annex I to
Directive 67/548/EEC or appear in it without concentration
limits;
3.2. preparations containing more than one of the substances classified as
dangerous for the environment and to which is assigned phrases R51-
53 or R50-53 or R52-53 in lower individual concentrations than the
limits specified under I.3.1(a) or (b) if:
XPN;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 inthe preparation ,
PN, R51—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrases R51-53 inthe preparation ,1999L0045 — EN — 01.01.1999 — 000.001 — 39
▼B
PR52—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrases R52-53 inthe 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
classified as dangerous for the environment and to which is assigned
phrase R50 not meeting the criteria under I.4.1 or I.4.2 and containing
one or more than one substance classified as dangerous for the
environment and to which is assigned phrases R50-53 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 inthe preparation ,
PN, R50—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrases R50-53 inthe 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, or
(b) the concentration specified in Part B of this Annex (Table 3)
where the substance or substances do not appear in Annex I to
Directive 67/548/EEC or appear in it without concentration
limits;1999L0045 — EN — 01.01.1999 — 000.001 — 40
▼B
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 inindividual 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 underI.6.1(a) or (b) if:
X
PR53
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
classified as dangerous for the environment and to which is assigned
phrase R53 not meeting the criteria under I.6.2 and containing one or
more than one substance classified as dangerous for the environment
and to which is assigned phrases R50-53 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 inthe preparation ,
PN, R50—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrase R50-53 inthe preparation ,
PN, R51—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrase R51-53 inthe preparation ,
PR52—53= is the percentage by weight of each substance
dangerous for the environment to which is assigned
phrase R52-53 inthe preparation ,
LR53= is the respective limit R53 for each substance
dangerous for the environment to which is assigned1999L0045 — EN — 01.01.1999 — 000.001 — 41
▼B
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 consideration,
or
(b) the concentration specified in Part B of this Annex (Table 5)
where the substance or substances do not appear in Annex I
to Directive 67/548/EEC or appear in it without concentration
limits;
2. and assigned the risk phrase R59:
2.1. preparations containing one or more substances classified as
dangerous to the environment and to which is assigned R59 in
individual concentrations equal to or greater than:
(a) either the concentration specified in Annex I to Directive 67/
548/EEC for the substance or substances under consideration,
or
(b) the concentration specified in Part B of this Annex (Table 5)
where the substance or substances do not appear in Annex I
to Directive 67/548/EEC or appear in it without concentration
limits;
(2) TERRESTRIAL ENVIRONMENT
I. Evaluationof preparation s dan gerous for the terrestrial
environment
Classification of preparations using the risk phrases below will follow
after the detailed criteria for use of the phrases have beenin corporated
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 classification
is also shown.
Table1
Acute aquatic toxicity and long-term adverse effects
Classificationof the
substanceClassificationof the preparation
N, R50—53 N, R51—53 R52—53
N, R50—53 Cn≥25 % 2,5 % ≤Cn< 25 % 0,25 % ≤Cn< 2,5 %1999L0045 — EN — 01.01.1999 — 000.001 — 42
▼B
Classificationof the
substanceClassificationof the preparation
N, R50—53 N, R51—53 R52—53
N, R51—53 Cn≥25 % 2,5 % ≤Cn<2 5%
R52—53 Cn≥25 %
Table2
Acute aquatic toxicity
Classificationof the substan ceClassificationof the preparation
N, R50
N, R50 Cn≥25 %
N, R50—53 Cn≥25 %
Table3
Aquatic toxicity
Classificationof the substan ceClassificationof the preparationR52
R52
R52 Cn≥25 %
Table4
Long-term adverse effects
Classificationof the substan ceClassificationof the preparationR53
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
percentage, 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
Classificationof the substan ceClassificationof preparation
N, R59
N with R59 C ≥0,1 %
Classificationof the substan ceClassificationof preparation
R59
R59 C ≥0,1 %1999L0045 — EN — 01.01.1999 — 000.001 — 43
▼B
PART C
Testmethodsfortheevaluationofthehazardsfortheaquaticenvironment
Normally, the classificationof a preparationis made onthe basis of the
conventional method. However, for the determination of the acute aquatic
toxicity, there may be cases for which it is appropriate to carry out tests onthepreparation.
The result of these tests onthe preparationmay on ly modify the classification
concerning acute aquatic toxicity which would have been obtained by the
application of the conventional method.
If such tests are chosen by the person responsible for the placing on the market, it
must be ensured that the quality criteria of the test methods in Part C of Annex V
to Directive 67/548/EEC have beencomplied with.
Furthermore, the tests are to be carried out onall three species incon formity 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 — 01.01.1999 — 000.001 — 44
▼B
ANNEXIV
SPECIAL PROVISIONS FOR CONTAINERSCONTAININGPREPARA-
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 10and under the conditions laid down in Article 6 of this Directive, are
to fitted with child-resistant fastenings.
2. Containers of whatever capacity containing preparations presenting an
aspirationhazard (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
Containerstobefittedwithatactilewarningofdanger
Containers of whatever capacity, containing preparations offered or sold to the
general public and labelled as very toxic, toxic, corrosive, harmful, extremely
flammable or highly flammable in accordance with Article 10 and under the
conditions laid down in Articles 5 and 6 of this Directive, are to carry a tactile
warning of danger.
This provision does not apply to aerosols classified and labelled only as
extremely flammable or highly flammable.1999L0045 — EN — 01.01.1999 — 000.001 — 45
▼B
ANNEXV
SPECIALPROVISIONSCONCERNINGTHELABELLINGOFCERTAIN
PREPARATIONS
A.ForpreparationsclassifiedasdangerouswithinthemeaningofArticles5,
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
Directive 67/548/EEC.
1.2. Whensuch preparation s are classified as very toxic (T+), toxic (T) or
corrosive (C) and where it is physically impossible to give such
information on the package itself, packages containing such preparations
must be accompanied by precise and easily understandable instructions
for use including, where appropriate, instructions for the destruction of
the empty package.
2.Preparations intended for use by spraying
The package label containing such preparations must compulsorily bear
the safety advice S23 accompanied by safety advice S38 or S51 assigned
to it in accordance with the criteria laid down in Annex VI to Directive
67/548/EEC.
3.Preparations containing a substance assigned phrase R33: Danger of
cumulative effects
When a preparation contains at least one substance assigned the phrase
R33, the label of the preparationmust carry the wordin g of this phrase as
set out in Annex III to Directive 67/548/EEC, when the concentration of
this substance present in the preparation is equal to or higher than 1 %,
unless different values are set in Annex I to Directive 67/548/EEC.
4.Preparations containing a substance assigned phrase R64: May cause
harm to breastfed babies
When a preparation contains at least one substance assigned phrase R64,
the label of the preparationmust carry the wordin g of this phrase as set
out in Annex III to Directive 67/548/EEC, when the concentration of this
substance present in the preparation is equal to or higher than 1 %, unless
different values are set in Annex I to Directive 67/548/EEC.
B.Forpreparationsirrespectiveoftheirclassificationwithinthemeaningof
Articles5,6and7
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 onsurfaces liable to be chewed or sucked by children .’
In the case of packages the contents of which are less than 125 millilitres,
the particulars may be as follows: ‘Warning! Contains lead’.
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 secondsKeep out of the
reach of children’.
Appropriate advice onsafety must accompan y the package.1999L0045 — EN — 01.01.1999 — 000.001 — 46
▼B
3.Preparations containing isocyanates
The package labels of preparations containing isocyanates (as monomers,
oligomers, prepolymers, etc., or as mixtures thereof) must bear the
following inscriptions:
‘Contains isocyanates.See information supplied by the manufacturer.’
4.Preparations containing epoxy constituents with an average molecular
weight≤700
The package labels of preparations containing epoxy constituents with an
average molecular weight ≤700 must bear the following inscriptions:
‘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
available as aerosols are also subject to the labelling provisions in
accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/
EEC as last amended by Directive 94/1/EC.
8.Preparations containing substances not yet tested completely
Where a preparation contains at least one substance which, in accordance
with Article 13.3 of Directive 67/548/EEC, bears the inscription
►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
classified as sensitising and being present in a concentration equal to
or greater than 0,1 % or in a concentration equal to or greater than that
specified under a specific note for the substance in Annex I to Directive
67/548/EEC must bear the inscription: ‘Contains (name of sensitising
substance). May produce an allergic reaction.’
10.Liquid preparations containing halogenated hydrocarbons
For liquid preparations which show no flashpoint or a flashpoint higher
than 55 ºC and contain a halogenated hydrocarbon and more than 5 %
flammable or highly flammable substances, the packaging must bear thefollowing inscription as appropriate: ‘Can become highly flammable in
use’ or ‘Canbecome flammable inuse’.
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 — 01.01.1999 — 000.001 — 47
▼B
ANNEXVI
CONFIDENTIALITY FOR THE 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.
Asingle alternative denomination must be used to mask the chemical identity
of the same substance in the preparations concerned. Furthermore, the request
for confidentiality must contain all information indicated in the following
request, without forgetting the name or the trade name of each preparation.
C. The alternative designation used on the label must be the same as that given
under heading 2 ‘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
information about the substance to ensure risk-free handling.
D. In making the request to use an alternative designation the person responsible
for placing on the market must take into account the need to provide enough
information for necessary health and safety precautions to be taken in the
workplace and to ensure that risks from handling the preparation can be
minimised.
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
established in the Community who is responsible for placing the preparation
onthe market (man ufacturer, 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□
If no, specify the designation(s) or commercial name(s) used in the different
Member States:
Austria:1999L0045 — EN — 01.01.1999 — 000.001 — 48
▼B
Belgium:
Denmark:
Germany:Greece:Finland:France:Spain:
Sweden:
Ireland:Italy:Luxembourg:Netherlands:
Portugal:
United Kingdom:
6. Composition of the preparation(s) defined in point 2 of the Annex to
Directive 91/155/EEC as last amended by Directive 93/112/EEC.
7. Classification of the preparation(s) according to Article 6 of this Directive.8. Labelling of the preparation(s) according to Article 10 of this Directive.9. Intended uses for the preparation(s).10. Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by
Directive 93/112/EEC.
PART B
Lexiconguideforestablishingthealternativedesignations(genericnames)
1.Introductorynote
The lexiconguide is based onthe procedure for the classificationof
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 commonchemical elemen t 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 group as their chief characteristics.
The family name is derived from the functional group name.
These families are identified by the conventional number found in Annex I
(601—650).
Sub-families bringing together substances with a common specific character
have beenadded incertaincases.
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.
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.1999L0045 — EN — 01.01.1999 — 000.001 — 49
▼B
3.Divisionofsubstancesintofamiliesandsub-families
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
001 Hydrogencompoun ds
Hydrides
002 Helium compounds
003 Lithium compounds004 Beryllium compounds005 Boroncompoun ds
Boranes
Borates
006 Carboncompoun ds
Carbamates
Inorganic carbon compounds
Salts of hydrogencyan ide
Urea and derivatives
007 Nitrogencompoun ds
Quaternary ammonium compounds
Acid nitrogen compounds
Nitrates
Nitrites
008 Oxygencompoun ds009 Fluorine compounds
Inorganic fluorides
010 Neoncompoun ds011 Sodium compounds012 Magnesium compounds
Organometallic magnesium derivatives
013 Aluminium compounds
Organometallic aluminium derivatives
014 Siliconcompoun ds
Silicones
Silicates
015 Phosphorus compounds
Acid phosphorus compounds
Phosphonium compounds
Phosphoric esters
Phosphates
Phosphites
Phosphoramides and derivatives
016 Sulphur compounds
Acid sulphur compounds
Mercaptans
Sulphates
Sulphites
017 Chlorine compounds
Chlorates
Perchlorates
018 Argoncompoun ds019 Potassium compounds1999L0045 — EN — 01.01.1999 — 000.001 — 50
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
020 Calcium compounds
021 Scandium compounds
022 Titanium compounds
023 Vanadium compounds024 Chromium compounds
Chromium VI compounds
025 Manganese compounds026 Ironcompoun ds
027 Cobalt compounds
028 Nickel compounds
029 Copper compounds
030 Zinc compounds
Organometallic zinc derivatives
031 Gallium compounds
032 Germanium compounds033 Arsenic compounds
034 Selenium compounds
035 Bromine compounds
036 Kryptoncompoun ds
037 Rubidium compounds038 Strontium compounds
039 Yttrium compounds
040 Zirconium compounds041 Niobium compounds
042 Molybdenum compounds
043 Technetium compounds044 Ruthenium compounds
045 Rhodium compounds
046 Palladium compounds047 Silver compounds
048 Cadmium compounds
049 Indium compounds050 Tincompoun ds
Organometallic tin derivatives1999L0045 — EN — 01.01.1999 — 000.001 — 51
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
051 Antimony compounds
052 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 compounds
Organometallic mercury derivatives
081 Thallium compounds
082 Lead compounds1999L0045 — EN — 01.01.1999 — 000.001 — 52
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
Organometallic lead derivatives
083 Bismuth compounds084 Polonium compounds
085 Astate compounds
086 Radoncompoun ds087 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 derivatives
Ethers
Glycolethers
Glycols and polyols
604 Phenols and derivatives1999L0045 — EN — 01.01.1999 — 000.001 — 53
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
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 compounds
610 Chlornitrated compounds
611 Azoxy and azo compounds612 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 derivatives
Triazine and derivatives
Triazole and derivatives
614 Glycosides and alkaloids
Alkaloid and derivatives1999L0045 — EN — 01.01.1999 — 000.001 — 54
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
Glycosides and derivatives
615 Cyanates and isocyanates
Cyanates
Isocyanates
616 Amides and derivatives
Acetamide and derivatives
Anilides
617 Organic peroxides
647 Enzymes648 Complex coal derivatives
Acid extract
Alkaline extract
Anthracene oil
Anthracene oil extract residue
Anthracene oil fraction
Carbolic oil
Carbolic oil extract residue
Coal liquids, liquid solvent extraction
Coal liquids, liquid solvent extraction solvents
Coal oil
Coal tar
Coal tar extract
Coal tar solids residue
Coke (coal tar) low temperature, high temperature pitch
Coke (coal tar), high temperature pitch
Coke (coal tar), mixed coal high temperature pitch
Crude benzole
Crude phenols
Crude tar bases
Distillate bases
Distillate phenols
Distillates
Distillates (coal), liquid solvent extraction, primary
Distillates (coal), solvent extraction, hydrocracked
Distillates (coal), solvent extraction, hydrocracked hydro-
genated 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 redistillate
Pitch residue
Pitch residue, heat treated
Pitch residue, oxidised
Pyrolysis products
Redistillates1999L0045 — EN — 01.01.1999 — 000.001 — 55
▼B
Family No
Annex I to Directive 67/548/EECFamilies
Sub-families
Residues (coal), liquid solvent extractions
Tar browncoal
Tar browncoal, low temperature
Tar oil, high boiling
Tar oil, intermediate boiling
Wash oil
Wash oil extract residue
Wash oil redistillate
649 Complex oil derivatives
Crude oil
Petroleum gas
Low boiling point naphtha
Low boiling point modified naphtha
Low boiling point cat-cracked naphtha
Low boiling point cat-reformed naphtha
Low boiling point thermally cracked naphtha
Low boiling point hydrogen treated naphtha
Low boiling point naphtha — unspecified
Straight-runkerosin e
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.Practicalapplication:
After having conducted a search to see if the substance belongs to one or
more families or sub-families on the list, the generic name can be established
inthe followin g 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: glycolethers
generic name: glycolether
— methacrylate
family 607: organic acids and derivatives
sub-family: acrylates1999L0045 — EN — 01.01.1999 — 000.001 — 56
▼B
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 hydrocarbons
family 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 compoundsgeneric name: chlorinated aromatic acid
— 1-chloro-1-nitropropane
family 610: chloronitrated derivatives
family 601: hydrocarbonssub-family: aliphatic hydrocarbons
generic name: chlorinated aliphatic hydrocarbon
— tetrapropyl dithiopyrophosphate
family 015: phosphorus compounds
sub-family: phosphoric esters
family 016: sulphur compounds
generic name: thiophosphoric ester
NB:In the case of certain elements, notably metals, the name of the family
or sub-family may be indicated by the words ‘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 — 01.01.1999 — 000.001 — 57
▼B
ANNEXVII
PREPARATIONSCOVEREDBYARTICLE12(2)
Preparations as specified by paragraph 9.3 of Annex VI to Directive 67/548/EEC.1999L0045 — EN — 01.01.1999 — 000.001 — 58
▼B
ANNEXVIII
PART A
DirectivesrepealedinaccordancewithArticle21
— Directive 78/631/EEC onthe approximationof the laws of the Member States
relating to the classification, packaging and labelling of dangerous
preparations (pesticides)
— Directive 88/379/EEC onthe approximationof 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
DeadlinesfortranspositionandforapplicationinaccordancewithArticle22
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 199189/178/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 1991
93/18/EEC (OJ L 104, 29.4.1993, p. 46) 1 July 1994 1 July 1994
90/35/EEC (OJ L 19, 24.1.1990, p. 14) 1 August 1992 1 November 199291/442/EEC (OJ L 238, 27.8.1991, p. 25) 1 August 1992 1 November 199296/65/EC (OJ L 265, 18.10.1996, p. 15) 31 May 1998 31 May 1998
PART C
Special provisions for Austria, Finland and Sweden concerning the
applicationofthefollowingDirectivesinaccordancewithArticle21
1. Austria, Finland and Sweden do not transpose or apply Council Directive 78/
631/EEC of 26 June 1978 on the approximation of the laws of the Member
States relating to the classification, packaging and labelling of dangerous
preparations (pesticides), as last amended by Council Directive 92/32/EEC of
30 April 1992.
2. Austria is to apply Council Directive 88/379/EEC of 7 June 1988 on the
approximation of laws, regulations and administrative provisions relating to
the classification, packaging and labelling of dangerous preparations, as last
amended by Directive 96/65/EC of 11 October 1996 under the following
conditions:
The following provisions of Directive 88/379/EEC will not apply to Austria
(a) Article 13in conjunction with Articles 3 and 7 with respect to preparations
containing substances listed in Appendix 1;
(b) Article 13 in conjunction with Article 7 with respect to labelling
respecting the Austrian provisions on:
— safety advice for waste disposal,
— pictogram for waste disposal until two years after the entry into force
of this Directive,
— safety advice for countermeasures in case of accidents;1999L0045 — EN — 01.01.1999 — 000.001 — 59
▼B
(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 13in conjunction with Articles 3 and 7 with respect to preparations
— 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 — 01.01.1999 — 000.001 — 60
▼B
Appendix 1
SubstancesreferredtoinAnnexVIII,PartC,paragraph2(Austria)
Name of the substanceIndex number in Annex I to
Directive 67/548/EEC
Linuron 006-021-00-1
Trichlorosilan014-001-00-9
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
Nitrofen609-040-00-9
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
Diuron006-015-00-9
Fenbutanin oxide 050-017-00-2
1-Butanol, 2-Butanol, iso-Butanol 603-004-00-61999L0045 — EN — 01.01.1999 — 000.001 — 61
▼B
Appendix 2
SubstancesreferredtoinAnnexVIII,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 — 01.01.1999 — 000.001 — 62
▼B
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 — 01.01.1999 — 000.001 — 63
▼B
ANNEXIX
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 — 01.01.1999 — 000.001 — 64
▼B
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 — 01.01.1999 — 000.001 — 65
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)Annex II.A.4 Article 3.5(d)▼B1999L0045 — EN — 01.01.1999 — 000.001 — 66
This Directive 88/379/EEC 90/35/EEC 91/442/EEC 93/18/EEC
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 — 01.01.1999 — 000.001 — 67
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 — 01.01.1999 — 000.001 — 68
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 — 01.01.1999 — 000.001 — 69
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 — 01.01.1999 — 000.001 — 70