COMMISSION DIRECTIVE of 29 July 1983 adapting to technical progress for the fifth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (83/467/EEC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 79/831/EEC (2), and in particular Article 19 thereof,
Whereas experience shows that it is necessary to adapt the list of dangerous substances in Annex I to Directive 67/548/EEC in the light of present scientific and technical knowledge, so as to enter further substances on the list, to explain certain criteria for the classification of these substances and to revise the classification and labelling of some of them;
Whereas Article 2 of Directive 67/548/EEC defines as dangerous inter alia explosive, oxidizing, extremely flammable, highly flammable, very toxic, toxic, harmful, corrosive and irritant substances and preparations according to general criteria ; whereas Article 16 lays down the symbols and indications of danger to be used for the labelling of such substances and preparations ; whereas these symbols and indications of danger are illustrated in Annex II of Directive 67/548/EEC ; whereas, to take into account the new categories of danger included in the Directive, Annex II must be amended;
Whereas Annexes III and IV to Directive 67/548/EEC define the indications of special risks (R phrases) and safety advice (S phrases) ; whereas, in view of the advances in knowledge, certain special risks can be better identified and certain safety advice better formulated ; whereas, under these circumstances, Annexes III and IV need to be amended;
Whereas Articles 5 and 8 (2) of Directive 67/548/EEC lay down provisions on the packaging and provisional labelling of dangerous substances not contained in Annex I thereof ; whereas these provisions must, in particular, be in accordance with the criteria laid down in part II (B) of Annex VI, which lays down the definition of corrosion criteria and irritation criteria, and part II (D), which contains a guide to the labelling of dangerous substances and the criteria for the choice of phrases indicating the special risks (R phrases) and the safety advice (S phrases) assigned to dangerous substances ; whereas in these circumstances Annex VI must be expanded;
Whereas the provisions of this Directive are in conformity with the opinion of the Committee on the adaptation to technical progress of the Directives for the elimination of technical barriers to trade in dangerous substances and preparations, (1) OJ No 196, 16.8.1967, p. 1. (2) OJ No L 259, 15.10.1979, p. 10.
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 67/548/EEC is hereby amended as follows: 1. The general remark in the preamble to Annex I (List of dangerous substances) is expanded as follows:
"More particularly in the case of salts (under any denomination such as mentioned in Annex I), these are considered in Annex I both in their anhydrous and their hydrated form unless expressly specified to the contrary."
2. The substance mentioned in Annex I to this Directive shall be added to Annex I (List of dangerous substances).
3. The following corrections are made to Annex I (List of dangerous substances): PIC FILE= "T
4. Annex I (List of dangerous substances) is amended as follows: PIC FILE= "T
5. Annex II is replaced by Annex II to this Directive.
6. Annex III (Nature of the special risks attaching to dangerous substances) is amended as follows: (1) The following phrases are added: R 41 Risiko for alvorlig øjenskade.
Gefahr ernster Augenschäden.
PIC FILE= "T
Risk of serious damage to eyes.
Risque de lésions oculaires graves.
Rischio di gravi lesioni oculari.
Gevaar voor ernstig oogletsel.
R 44 Eksplosionsfarlig ved opvarmning under indeslutning.
Explosionsgefahr bei Erhitzen unter Einschluß.
PIC FILE= "T
Risk of explosion if heated under confinement.
Risque d'explosion si chauffé en ambiance confinée.
Rischio di esplosione per riscaldamento in ambiente confinato.
Ontploffingsgevaar bij verwarming in afgesloten toestand.
R 45 Kan fremkalde kræft.
Kann Krebs erzeugen.
PIC FILE= "T
May cause cancer.
Peut causer le cancer.
Può provocare il cancro.
Kan kanker veroorzaken.
R 46 Kan forårsage arvelige genetiske skader.
Kann vererbbare Schäden verursachen.
PIC FILE= "T
May cause heritable genetic damage.
Peut causer des altérations génétiques héréditaires.
Può provocare alterazioni genetiche ereditarie.
Kan erfelijke genetische schade veroorzaken.
R 47 Kan medføre fosterskader.
Kann Mißbildungen verursachen.
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May cause birth defects.
Peut causer des malformations congénitales.
Può provocare malformazioni congenite.
Kan geboorteafwijkingen veroorzaken.
R 48 Alvorlig sundhedsfare ved længere tids påvirkning.
Gefahr ernster Gesundheitsschäden bei längerer Exposition.
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Danger of serious damage to health by prolonged exposure.
Risque d'effets graves pour la santé en cas d'exposition prolongée.
Pericolo di gravi danni per la salute in caso di esposizione prolungata.
Gevaar voor ernstige schade aan de gezondheid bij langdurige blootstelling.
(2) In the German language the term "explosionsfähig" is replaced by the term "explosionsgefährlich" in phrases R 1, R 2, R 4 and R 16 ; the term "leicht explosionsfähig" is replaced by the term "besonders explosionsgefährlich" in phrase 3. The term "hochgiftige" is replaced by the term "sehr giftige" in phrase R 32.
7. Annex IV (Safety advice concerning dangerous chemical substances) is amended as follows: (1) The following phrases are deleted:
S 10 : Keep contents wet.
S 11 : Avoid contact with air.
S 31 : Keep away from explosive materials.
(2) The following phrases are added: S 46 Ved indtagelse, kontakt omgående læge og vis denne beholder eller etiket.
Bei Verschlucken sofort ärztlichen Rat einholen und Verpackung oder Etikett vorzeigen.
PIC FILE= "T
If swallowed, seek medical advice immediately and show this container or label.
En cas d'ingest on consulter immédiatement un médecin et lui montrer l'emballage ou l'étiquette.
In caso d'ingestione consultare immediatamente il medico e mostrargli il contenitore o l'etichetta.
In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.
S 47 Må ikke opbevares ved temperaturer på over ... °C (angives af fabrikanten).
Nicht bei Temperaturen über ... °C aufbewahren (vom Hersteller anzugeben).
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Keep at temperature not exceeding ... °C (to be specified by the manufacturer).
Conserver à une température ne dépassant pas ... °C (à préciser par le fabricant).
Conservare a temperatura non superiore a ... °C (da precisare da parte del fabbricante).
Bewaren bij een temperatuur beneden ... °C (aan te geven door de fabrikant).
S 48 Holdes befugtet med ... (passende middel angives af fabrikanten).
Feucht halten mit ... (geeignetes Mittel vom Hersteller anzugeben).
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Keep wetted with ... (appropriate material to be specified by the manufacturer).
Maintenir humide avec ... (moyen approprié à préciser par le fabricant).
Mantenere umido con ... (mezzo appropriato da precisare da parte del fabbricante).
Inhoud vochtig houden met ... (middel aan te geven door de fabrikant).
S 49 Må kun opbevares i den originale emballage.
Nur im Originalbehälter aufbewahren.
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Keep only in the original container.
Conserver uniquement dans le récipient d'origine.
Conservare soltanto nel recipiente originale.
Uitsluitend in de oorspronkelijke verpakking bewaren.
S 50 Må ikke blandes med ... (angives af fabrikanten),
Nicht mischen mit ... (vom Hersteller anzugeben).
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Do not mix with ... (to be specified by the manufacturer).
Ne pas mélanger avec ... (à spécifier par le fabricant).
Non mescolare con ... (da specificare da parte del fabbricante).
Niet vermengen met ... (aan te geven door de fabrikant).
S 51 Må kun bruges på steder med god ventilation.
Nur in gut gelüfteten Bereichen verwenden.
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Use only in well ventilated areas.
Utiliser seulement dans des zones bien ventilées.
Usare soltanto in luogo ben ventilato.
Uitsluitend op goed geventileerde plaatsen gebruiken.
S 52 Bør ikke anvendes til større flader i beboelses- eller opholdsrum
Nicht großflächig für Wohn- und Aufenthaltsräume zu verwenden.
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Not recommended for interior use on large surface areas.
Ne pas utiliser sur de grandes surfaces dans les locaux habités.
Non utilizzare su grandi superfici in locali abitati.
Niet voor gebruik op grote oppervlakken in woon- en verblijfruimtes.
(3) The following combinations are added to the combinations of S-phrases: S 3/14 Opbevares køligt og adskilt fra ... (uforligelige stoffer angives af fabrikanten).
An einem kühlen, von ... entfernten Ort aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muß, sind vom Hersteller anzugeben).
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Keep in a cool place away from ... (incompatible materials to be indicated by the manufacturer).
Conserver dans un endroit frais à l'écart des ... (matières incompatibles à indiquer par le fabricant).
Conservare in luogo fresco lontano da ... (materiali incompatibili da precisare da parte del fabbricante).
Bewaren op een koele plaats verwijderd van ... (stoffen, waarmee contact vermeden dient te worden, aan te geven door de fabrikant).
S 3/9/14 Opbevares køligt, godt ventileret og adskilt fra ... (uforligelige stoffer angives af fabrikanten).
An einem kühlen, gut gelüfteten Ort, entfernt von ... aufbewahren (die Sroffe, mit denen Kontakt vermieden werden muß, sind vom Hersteller anzugeben).
PIC FILE= "T
Keep in a cool, well ventilated place away from ... (incompatible materials to be indicated by the manufacturer).
Conserver dans un endroit frais et bien ventilé à l'écart des ... (matières incompatibles à indiquer par le fabricant).
Conservare in luogo fresco e ben ventilato lontano da ... (materiali incompatibili da precisare da parte del fabbricante).
Bewaren op een koele, goed geventileerde plaats verwijderd van ... (stoffen, waarmee contact vermeden dient te worden, aan te geven door de fabrikant).
S 3/9/49 Må kun opbevares i originalemballagen på et køligt, godt ventileret sted.
Nur im Originalbehälter an einem kühlen, gut gelüfteten Ort aufbewahren.
PIC FILE= "T
Keep only in the original container in a cool well ventilated place.
Conserver uniquement dans le récipient d'origine dans un endroit frais et bien ventilé.
Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato.
Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats.
S 3/9/14/49 Må kun opbevares i originalemballagen på et køligt, godt ventileret sted og adskilt fra ... (uforligelige stoffer angives af fabrikanten).
Nur im Originalbehälter an einem kühlen, gut gelüfteten Ort, entfernt von ... aufbewahren (die Stoffe, mit denen Kontakt vermieden werden muß, sind vom Hersteller anzugeben).
PIC FILE= "T
Keep only in the original container in a cool well ventilated place away from ... (incompatible materials to be indicated by the manufacturer).
Conserver uniquement dans le récipient d'origine dans un endroit frais et bien ventilé à l'écart de ... (matières incompatibles à indiquer par le fabricant).
Conservare soltanto nel contenitore originale in luogo fresco e ben ventilato lontano da ... (materiali incompatibili da precisare da parte del fabbricante).
Uitsluitend in de oorspronkelijke verpakking bewaren op een koele, goed geventileerde plaats verwijderd van ... (stoffen, waarmee contact vermeden dient te worden, aan te geven door de fabrikant).
S 47/49 Må kun opbevares i originalemballagen ved en temperatur på ikke over ... °C (angives af fabrikanten).
Nur im Originalbehälter bei einer Temperatur von nicht über ... °C (vom Hersteller anzugeben) aufbewahren.
PIC FILE= "T
Keep only in the original container at temperature not exceeding ... °C (to be specified by the manufacturer).
Conserver uniquement dans le récipient d'origine à température ne dépassant pas ... °C (à préciser par le fabricant).
Conservare soltanto nel contenitore originale a temperatura non superiore a ... °C (da precisare da parte del fabbricante).
Uitsluitend in de oorspronkelijke verpakking bewaren bij een temperatuur beneden ... °C (aan te geven door de fabrikant).
8. Part II (B) of Annex VI is replaced by the following:
"B. Save where otherwise provided in separate Directives on dangerous preparations, substances and preparations shall be classified as corrosive or as irritant according to the following criteria: (a) Corrosion criteria
A substance or a preparation is considered to be corrosive if, when it is applied to healthy intact animal skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin irritation cited in Annex V or during an equivalent method or if the result can be predicted, for example from strongly acid or alkaline reactions.
(b) Irritation criteria
A substance or a preparation is considered to be irritant if it causes inflammation of the skin or ocular lesions corresponding to the evaluation of the parameters given below: 1. Inflammation of the skin (i) Inflammation of the skin which persists for at least 24 hours after an exposure period of up to four hours and corresponds to the following values determined on the rabbit according to the cutaneous irritation test method cited in Annex V: - the mean value of the scores for either erythema and eschar formation or oedema formation, calculated over all the animals tested, is two or more,
- or, in the case where the Annex V test has been completed using three animals, either erythema and eschar formation or oedema formation equivalent to a mean value of two or more calculated for each animal separately has been observed in two or more animals.
In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating the respective mean values.
(ii) If practical experience shows the substances and preparations to be capable of inducing a sensitization reaction in a substantial number of persons by skin contact, or on the basis of a positive response in experimental animals.
In the case of the test method for skin sensitization detailed in Annex V or in the case of other adjuvant-type test methods a response in at least 30 % of the animals is considered positive. For any other test method a response in at least 15 % of the animals is considered positive.
2. Ocular lesion
Ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours and correspond to the following values determined on the rabbit according to the eye irritation test method cited in Annex V: - the mean value of the scores for each type of lesion, calculated over all the animals tested, is one of the following: PIC FILE= "T
- or, in the case where the Annex V test has been completed using three animals, either cornea opacity, iris lesion, redness of conjunctive or oedema of conjunctive (chemosis) equivalent to a mean value such as is quoted above, but calculated for each animal separately, has been observed in two or more animals.
In both cases all scores at each of the reading times (24, 48 and 72 hours) and for an effect should be used in calculating the respective means values."
9. Part II (D) of Annex VI is replaced by Annex III to this Directive.
Article 2
Member States shall adopt and publish before 1 January 1985 the measures needed to comply with this Directive and shall immediately inform the Commission thereof.
They shall apply these measures by 1 January 1986 at the latest.
Article 3
This Directive is addressed to the Member States.
Done at Brussels, 29 July 1983.