COMMISSION DIRECTIVE 97/69/EC of 5 December 1997 adapting to technical progress for the 23rd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European 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 95/56/EC of the European Parliament and the Council (2), and in particular Article 28 thereof,

Whereas Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling in respect of each substance or group of substances;

Whereas laboratory studies have shown that certain man-made vitreous (silicate) fibres have carcinogenic effects; whereas epidemiological surveys have raised concern over the health effects of man-made vitreous (silicate) fibres;

Whereas the list of dangerous substances contained in Annex I to that Directive should therefore be adapted and enlarged, particularly to include certain man-made vitreous (silicate) fibres; whereas in consequence it is necessary to amend the Foreword to Annex I so as to include notes and particulars relating to the identification, classification and labelling of man-made vitreous (silicate) fibres;

Whereas in the current state of knowledge, it seems justified under certain circumstances to exclude some man-made vitreous (silicate) fibres from classification as a carcinogen; whereas this possibility should be reviewed in the light of scientific and technical developments, in particular in the area of carcinogenicity testing;

Whereas the abbreviation 'EEC` appears in certain provisions of Annexes I and VI to Directive 67/548/EEC;

Whereas Article G of the Treaty on European Union has replaced the term 'European Economic Community` with the term 'European Community`; whereas the abbreviation 'EEC` should therefore be replaced by the abbreviation 'EC` in the abovementioned provisions;

Whereas Directive 96/56/EC has amended Articles 21 and 23 of Directive 67/548/EEC accordingly and allows the placing on the market of dangerous substances whose labels bear an 'EEC number` and the words 'EEC label` until 31 December 2000;

Whereas the measures provided for in this Directive are in accordance 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,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 67/548/EEC is hereby amended as follows:

1. Annex I is amended as follows:

(a) The fifth paragraph of the chapter entitled 'Nomenclature` of the Foreword is replaced by the following text:

'Article 23 (2) (a) requires that for substances appearing in Annex I, the name of the substance to be used on the label should be one of the designations given in the Annex. For certain substances, additional information has been added in square brackets in order to help identify the substance. This additional information need not be included on the label.`;

(b) Note A in the Foreword is replaced by the following text:

'Note A:

The name of the substance must appear on the label in the form of one of the designations given in Annex I (see Article 23 (2) (a)).

In Annex I, use is sometimes made of a general description such as ". . . compounds" or ". . . salts". In this case, the manufacturer or any other person who markets such a substance is required to state on the label the correct name, due account being taken of the chapter "Nomenclature" of the Foreword:

Example: for BeCl2: beryllium chloride.`;

(c) The following Notes Q and R are added to the Foreword:

'Note Q:

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

- a short-term biopersistence test by inhalation has shown that the fibres longer than 20 矛m have a weighted half life less than 10 days, or

- a short-term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 矛m have a weighted half life less than 40 days, or

- an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity, or

- absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.

Note R:

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard errors greater than 6 矛m.`;

(d) The entries in the Annex to this Directive are added;

(e) All references to 'EEC number` are replaced by 'EC number`.

2. Annex VI is amended as follows:

(a) All reference to 'EEC number` are replaced by 'EC number`;

(b) All references to 'EEC label` are replaced by 'EC label`.

Article 2

During the period of five years after entry into force of this Directive, the Commission shall evaluate scientific developments and adopt measures to delete or amend Note Q.

Article 3

1. Not later than 16 December 1998, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

2. Notwithstanding Article 1, Member States shall permit the placing on the market of substances whose labels bear the words 'EEC number` or the words 'EEC label` until 31 December 2000.

Article 4

This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 5 December 1997.

For the Commission

Ritt BJERREGAARD

Member of the Commission

(1) OJ L 196, 16. 8. 1967, p. 1.

(2) OJ L 236, 18. 9. 1996, p. 35.

ANNEX

CAS No -

EC No -

No 650-016-00-2

Nota A

Nota Q

Nota R

ES: Lanas minerales, excepto aquellas indicadas espec铆ficamente en este anexo;

[Fibra v铆treas artificiales (silicatos) con una orientaci贸n aleatoria y cuyo contenido en 贸xidos alcalinos y 贸xidos alcalino-térreos (Na2O+K2O+CaO+MgO+BaO) sea superior al 18 % en peso]

DA: Mineraluld, undtagen s氓danne n忙vnt andetsteds i dette bilag;

[Syntetiske glasagtige (silikat) fibre uden bestemt orientering og med et indhold af alkaliske oxider og alkaliske jordarters oxider (Na2O+K2O+CaO+MgO+BaO) p氓 over 18 v忙gtprocent]

DE: Mineralwolle, soweit in diesem Anhang nicht gesondert aufgef眉hrt;

[K眉nstlich hergestellte ungerichtete glasige (Silikat-) Fasern mit einem Anteil an Alkali- und Erdalkalimetalloxiden (Na2O+ K2O+CaO+MgO+BaO) von 眉ber 18 Gewichtsprozent]

EL: 脧帽玫锚么脻貌 脽铆氓貌, 氓卯谩é帽茂玫矛脻铆霉铆 谩玫么镁铆 冒茂玫 锚谩么茂铆茂矛脺忙茂铆么谩é 贸氓 脺毛毛茂 贸ç矛氓脽茂 谩玫么茂媒 么茂玫 脨谩帽谩帽么脼矛谩么茂貌.

[脭氓梅铆ç么脻貌 玫谩毛镁盲氓é貌 (冒玫帽é么é锚脻貌) 脽铆氓貌 脺么谩锚么茂玫 冒帽茂贸谩铆谩么茂毛é贸矛茂媒 矛氓 冒氓帽é氓锚么é锚眉么ç么谩 贸氓 茂卯氓脽盲é谩 谩毛锚谩毛脽霉铆 锚谩é 谩毛锚谩毛é锚镁铆 茫谩é镁铆 (Na2O+K2O+CaO+MgO+BaO) 谩铆镁么氓帽ç 么茂玫 18 % 锚谩么脺 芒脺帽茂貌].

EN: Mineral wool, with the exception of those specified elsewhere in this Annex;

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

FR: Laines minérales, 脿 l'exception de celles nommément désignées dans cette annexe;

[Fibres (de silicates) vitreuses artificielles 脿 orientation aléatoire, dont le pourcentage pondéral d'oxydes alcalins et d'oxydes alcalino-terreux (Na2O+K2O+CaO+MgO+BaO) est supérieur 脿 18 %]

IT: Lane minerali, escluse quelle espressamente indicate in questo allegato;

[Fibre artificiali vetrose (silicati), che presentano un'orientazione casuale e un tenore di ossidi alcalini e ossidi alcalino-terrosi (Na2O+K2O+CaO+MgO+BaO) superiore al 18 % in peso]

NL: Minerale vezels, met uitzondering van in deze bijlage met name genoemde;

[Kunstmatige (silicaat)glasvezels met een willekeurige ori毛ntatie en een gehalte aan alkali- en aardalkali-oxiden (Na2O+ K2O+CaO+MgO+BaO) van meer dan 18 gewichtspercenten]

PT: L茫 mineral, com excepç茫o das expressamente referidas no presente anexo;

[Fibras de vidro (silicatos) sintéticas com orientaç茫o aleat贸ria e um teor ponderal de 贸xidos de elementos alcalinos e alcalino-terrosos (Na2O+K2O+CaO+MgO+BaO) superior a 18 %]

FI: Mineraalikuidut, paitsi muualla t盲ss盲 liitteess盲 mainitut;

[Keinotekoiset s盲盲nn枚tt枚m盲sti suuntautuneet lasimaiset (silikaatti) kuidut, joiden alkalioksidija maa-alkaalioksidipitoisuus (Na2O+K2O+CaO+MgO+BaO) on yli 18 painoprosenttia]

SV: Mineralull, f枚rutom det p氓 andra st盲llen i bilagan n盲mnda;

[Syntetiska glasaktiga (silikat) fibrer slumpvis ordnade vars totala inneh氓ll av oxider av alkalimetaller och alkaliska jordartsmetaller (Na2O+K2O+CaO+MgO+BaO), 枚verstiger 18 viktprocent]

Clasificaci贸n, Klassificering, Einstufung, 脭谩卯é铆眉矛ç贸ç, Classification, Classification, Classificazione, Indeling, Classificaç茫o, Luokitus, Klassificering

Carc. Cat. 3; R40 Xi; R38Etiquetado, Etikettering, Kennzeichnung, 脜冒é贸脼矛谩铆贸ç, Labelling, 脡tiquetage, Etichettatura, Kenmerken, Rotulagem, Merkinn盲t, M盲rkning

Xn

>REFERENCE TO A GRAPHIC>

R: 38-40

S: (2-)36/37

L铆mites de concentraci贸n, Koncentrationsgr忙nser, Konzentrationsgrenzwerte, 录帽é谩 贸玫茫锚脻铆么帽霉贸ç貌, Concentration Limits, Limites de concentration, Limiti di concentrazione, Concentratiegrenzen, Limites de concentraç茫o, Pitoisuusrajat, Koncentrationsgr盲nser

CAS No -

EC No -

No 650-017-00-8

Nota A

Nota R

ES: Fibras cer谩micas refractarias; fibras para usos especiales, excepto aquellas expresamente citadas en este anexo;

[Fibras v铆treas artificiales (silicatos) con una orientaci贸n aleatoria y cuyo contenido en 贸xidos alcalinos y 贸xidos alcalino-térreos (Na2O+K2O+CaO+MgO+BaO) sea inferior o igual al 18 % en peso]

DA: Keramiske fibre; special fibre, undtagen s氓danne n忙vnt andetsteds i dette bilag;

[Syntetiske glasagtige (silikat) fibre uden bestemt orientering og med et indhold af alkaliske oxider og alkaliske jordarters oxider (Na2O+K2O+CaO+MgO+BaO) p氓 18 v忙gtprocent og derunder]

DE: Keramische Mineralfasern; Fasern f眉r spezielle Anwendungen, soweit in diesem Anhang nicht gesondert aufgef眉hrt;

[K眉nstlich hergestellte ungerichtete glasige (Silikat-) Fasern mit einem Anteil an Alkali- und Erdalkalimetalloxiden (Na2O+ K2O+CaO+MgO+BaO) von weniger oder gleich 18 Gewichtsprozent]

EL: 脛é谩è毛谩贸么é锚脻貌 锚氓帽谩矛é锚脻貌 脽铆氓貌 7 脽铆氓貌 茫é谩 氓é盲é锚茂媒貌 贸锚茂冒茂媒貌 氓卯谩é帽茂玫矛脻铆霉铆 谩玫么镁铆 冒茂玫 锚谩么茂铆茂矛脺忙茂铆么谩é 贸氓 脺毛毛茂 贸ç矛氓脽茂 谩玫么茂媒 么茂玫 脨谩帽谩帽么脼矛谩么茂貌 7

[脭氓梅铆ç么脻貌 玫谩毛镁盲氓é貌 (冒玫帽é么é锚脻貌) 脽铆氓貌 脺么谩锚么茂玫 冒帽茂贸谩铆谩么茂毛é贸矛茂媒 矛氓 冒氓帽é氓锚么é锚眉么ç么谩 贸氓 茂卯氓脽盲é谩 谩毛锚谩毛脽霉铆 锚谩é 谩毛锚谩毛é锚镁铆 茫谩é镁铆 (Na2O+K2O+CaO+MgO+BaO) 锚谩么镁么氓帽ç 脼 脽贸ç 么茂玫 18 % 锚谩么脺 芒脺帽茂貌].

EN: Refractory Ceramic Fibres; Special Purpose Fibres, with the exception of those specified elsewhere in this Annex;

[Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+ MgO+BaO) content less or equal to 18 % by weight]

FR: Fibres céramiques réfractaires; fibres 脿 usage spécial, 脿 l'exception de celles nommément désignées dans cette annexe;

[Fibres (de silicates) vitreuses artificielles 脿 orientation aléatoire, dont le pourcentage pondéral d'oxydes alcalins et d'oxydes alcalino-terreux (Na2O+K2O+CaO+MgO+BaO) est inférieur ou égal 脿 18 %]

IT: Fibre ceramiche refrattarie; fibre per scopi speciali, escluse quelle espressamente indicate in questo allegato;

[Fibre artificiali vetrose (silicati), che presentano un'orientazione casuale e un tenore di ossidi alcalini e ossidi alcalino-terrosi (Na2O+K2O+CaO+MgO+BaO) pari o inferiore al 18 % in peso]

NL: Keramische minerale vezels; vezels voor speciale toepassingen, met uitzondering van in deze bijlage met name genoemde;

[Kunstmatige (silicaat)glasvezels met een willekeurige ori毛ntatie en een gehalte aan alkali- en aardalkali-oxiden (Na2O+K2O+ CaO+MgO+BaO) van ten hoogste 18 gewichtspercenten]

PT: Fibras cer芒micas refract谩rias; fibras para usos espec铆ficos, com excepç茫o das expressamente referidas no presente anexo;

[Fibras de vidro (silicatos) sintéticas com orientaç茫o aleat贸ria e um teor ponderal de 贸xidos de elementos alcalinos e alcalino-terrosos (Na2O+K2O+CaO+MgO+BaO) n茫o superior a 18 %]

FI: Keraamiset kuidut; kuidut erityistarkoituksiin, paitsi muualla t盲ss盲 liitteess盲 mainitut;

[Keinotekoiset s盲盲nn枚tt枚m盲sti suuntautuneet lasimaiset (silikaatti) kuidut, joiden alkalioksidija maa-alkalioksidipitoisuus (Na2O+K2O+CaO+MgO+BaO) on enint盲盲n 18 painoprosenttia]

SV: Keramiska fibrer; specialfibrer f枚rutom det p氓 andra st盲llen i bilagan n盲mnda;

[Syntetiska glasaktiga (silikat) fibrer slumpvis ordnade vars totala inneh氓ll av oxider av alkalimetaller och alkaliska jordartsmetaller (Na2O+K2O+CaO+MgO+BaO), 盲r lika med eller understiger 18 viktprocent]

Clasificaci贸n, Klassificering, Einstufung, 脭谩卯é铆眉矛ç贸ç, Classification, Classification, Classificazione, Indeling, Classificaç茫o, Luokitus, Klassificering

Carc. Cat. 2; R49 Xi; R38Etiquetado, Etikettering, Kennzeichnung, 脜冒é贸脼矛谩铆贸ç, Labelling, 脡tiquetage, Etichettatura, Kenmerken, Rotulagem, Merkinn盲t, M盲rkning

T

>REFERENCE TO A GRAPHIC>

R: 49-38

S: 53-45

L铆mites de concentraci贸n, Koncentrationsgr忙nser, Konzentrationsgrenzwerte, 录帽é谩 贸玫茫锚脻铆么帽霉贸ç貌, Concentration Limits, Limites de concentration, Limiti di concentrazione, Concentratiegrenzen, Limites de concentraç茫o, Pitoisuusrajat, Koncentrationsgr盲nser