The Directive 97/69/EC on the Classification, Packaging and Labelling of Dangerous Substances was formally adopted by the European Parliament and the Council on 1997 December 5. This was agreed by qualified majority vote, with only Germany voting against the Directive. Unilaterally, Germany has introduced a new piece of legislation, entitled Appendix V, No. 7, Ordinance on Dangerous Chemicals (Gefahrstoffverordnung), which contradicts some of the requirements of the above EU Directive.
Key elements of Directive 97/69/EC for sealing materials
The Directive includes reference to certain fibre materials, which have applications in sealing technology:
The classification of ceramic fibres as Carcinogenic Category 2 may result in tighter rules for worker protection. The classification of mineral wool fibres as Carcinogenic Category 3 is in accordance with the classification already in force on the basis of most national regulations in the EU Member States.
When supplied as raw materials (discreet substances), the material must be labelled according to the above requirements. When incorporated as a component with other materials into a final product or article, this does not require labelling.
The Material Safety Data Sheets (MSDS’s) of the producer or supplier of products containing classified substances must refer to the classification according to the Directive.
Types of exoneration criteria
Fibres may be exonerated if they fulfil one of the specified conditions of:
Key elements of Appendix V, No.7, Gefahrstoffverordnung for sealing materials
Directive 97/69/EC has not been transposed into German law and the fibre classification is the responsibility of the fibre producer. Instead, Germany has adopted a new piece of legislation to regulate worker protection and covering all mineral fibres with the exception of those which fulfil certain exoneration criteria. Most ceramic and some mineral wool fibres do not fulfil these exoneration criteria.
For sealing materials (such as gaskets) which contain these classified fibre materials, this legislation in Germany requires a notification of the handling of these products to the national authorities whenever there may be a possible release of respirable fibrous dust.
Implications for sealing materials
A variety of fibres have been used in the manufacture of sealing materials. As experience has grown, a number of medical conditions have been ascribed to fibre exposure. In particular, the adverse health effects of exposure to high airborne levels of asbestos have been well documented. Health effects vary markedly amongst fibre types, and a number of pieces of legislation have been introduced by the European Union and EU Member States accordingly.
Despite these concerns listed above, the manufacture of fibre-reinforced gasket materials results in the binding of the fibres within the elastomer matrix.
Under such circumstances, these materials present no health and safety hazard, and do not require labelling.
Under normal handling and use (such as cutting and water-jet cutting), it is unlikely that these products will give rise to significant levels of exposure to constituent materials.
However, under harsh mechanical treatment (such as abrasion, drilling, grinding, milling, sanding, sawing, turning), or if the product has become embrittled by high temperature service, higher levels of dust may be generated. Such maltreatment should be avoided unless additional safety precautions are applied.
Information
The ESA has registered a formal complaint with the European Commission against the unilateral legislation in Germany, on the grounds that this is contrary to the requirements of the EU Directive 97/69/EC and hence is a barrier to trade. The complaint was acknowledged on 1999 January 14 by the Secretariat-General of the European Commission as Complaint No. 98/5098, SG (98), A/18032.
Members of the ESA Flange Gaskets Division have agreed to issue Material Safety Data Sheets (MSDS’s) for gasket sheet materials for sale in Germany, and separate MSDS’s for gasket materials for sale in all other EU Member States, reflecting the differing requirements of the German and EU legislation.
In Germany, all Companies handling products where classified fibres may be released as respirable fibrous dust, must inform their local authority (an example form is indicated below):
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Firma ............................................................
Datum
................................Gefahrstoffverordnung, Anhang V, Nr. 7, "Künstliche Mineralfasern"
Anzeige gemäß Abschnitt 7.3
Hiermit zeigen wir den Umgang mit Produkten an, die klassifizierte, künstliche Mineralfasern enthalten und die möglicherweise zum Teil während der Verarbeitung freigesetzt werden können.
Betrieb: ……………………………………….. Abteilung: ………………………………….
Beschreibung der Arbeiten: ………………………………………..
Zeitdauer der Arbeiten: ………………… (gegebenenfalls ‚unbefristet‘ oder ‚bis auf weiteres ….‘.)
Zahl der Arbeitnehmer: …………
Voraussichtliche Expositionsdauer: ………………… (wöchentlich / monatlich / jährlich)
Entweder Angaben zum Umfang der Arbeiten : …………………… (z.B. Stückzahlen / m2 / Mengen)
Oder Hinweis: Es handelt sich um Arbeiten geringfügigen Umfangs nach TRGS 521, Teil 1.
Die Schutzmaßnahmen nach GefstoffV werden eingehalten.
Unterschriften .................................................................................................................................
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Translation of German notification form (for information only)
Company .....................................................
Date ..................................
Ordinance on Dangerous Chemicals, Appendix V, No. 7, "Man-made mineral fibres"
Notice according to section 7.3
Hereby we give notice of the use of products containing classified man-made mineral fibres that might be partially released during use.
Plant ……………………………………………. Department ………………………………..
Description of work: …………………………………………….
Duration of work: ………………… (if applicable, ‘for an unlimited period’, or ‘until further notice …’)
Number of employees: …………………
Prospective duration of exposure: ………………… (weekly / monthly / yearly)
Either, indication on the extent of work: ………………… (for example: units / m2 / quantities …)
or, indication: ‘The notice concerns work of minor extent according to TRGS 521, part 1.’
The protective measures according to the Ordinance on Dangerous Chemicals are observed.
Signatures .................................................................................
Information provided for guidance only. The ESA does not warrant, either expressly or by implication, the accuracy or completeness of the information, nor does the ESA assume any liability resulting from the reliance upon any detail contained herein. The information does not attempt to address compliance requirements of regulations specific to a particular industrial facility. Please consult your appropriate local, regional, state, national or federal authorities for precise compliance issues.
