EEC Directive 67/548 of 27 June 1967 (Dangerous Substances Directive) and its subsequent 31 adaptations to technical progress, in particular Directive 97/69EC of 5 December 1997 EC relating to classification of man-made vitreous (silicate) fibres).

EU carcinogenicity classification

EC Regulation No 1272/2008 of the European Parliament and the Council of 16 December 2008 (CLP) on classification, labelling and packaging of substances and mixtures, as amended from time to time is replacing the Dangerous Substances Directive; it came into effect on 1 June 2007, its classification and labelling obligations, however, will come into effect as from 1 December 2010.

The harmonized classification and labelling system of the Dangerous Substances Directive has been translated into a new system without changes in the classification; the labels, pictogrammes, signal words, hazard communication and precautionary statements have been changed to those of the adopted UN Globally Harmonized System (GHS).

Alumino-Silicate Glass Wool (ASW)

ASW also known as refractory ceramic fibres (RCF) have been classified as a carcinogen category 2 - “Substances that should be regarded as if they are carcinogenic to human” under the Dangerous Substances Directive.

Translated under CLP Regulation into a carcinogen category 1B “Known or presumed human carcinogen; presumed to have carcinogenic potential for humans, classification is largely based on animal evidence”.

They have been listed under the EU index number 650-017-00-8 in Annex I of the Dangerous Substances Directive and under Annex VI part 3 table 3.1 of CLP, which specifies the information required on the labels.

Obligations exist for ASW/RCF substances and for preparations if they contain 0.1 wt. % of the substance.

Hazard statement code: H350i "may cause cancer by inhalation"

Alkaline-Earth Silicate Glass Wool (AES)

AES wools have been exempted from classification after scientific assessment. They fulfil the Exoneration Criteria of Nota Q of the European Dangerous Substances Directive based on biopersistance tests or long-term animal studies. (See Annex 1 of the Dangerous Substance Directive and Annex VI part 3 table 3.1 of CLP, reference group EU index number 65060160002.)

Polycrystalline Wool

PCW are not classified.* The above legal provisions do not apply to PCW.

In Germany under TRGS 905 providing technical guidance on worker protection; supplementing or extending Annex 1 of EU Directive 67/548, fibrous dusts emanating from the handling of polycrystalline wools are classified as Category K3: „ ... cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment ... ” Although the TRGSs are not laws they are technical rules/recommendations that have a quasi-legal status.