Closing event of the European Week for Safety and Health at Work 2003, Bilbao (Spain), 24. November 2003
Biosoluble Fibres
A Win-Win Strategy of Regulation and Product Innovation for
Quality of Work in Small and Medium Enterprises (SME)
Rolf Packroff, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, Dortmund (Germany)
Asbestos was known to be a potent human carcinogen as early as the 1930s. Ignoring this
fact in occupational safety and health regulation for further decades led to the current
asbestos disaster in the EU and worldwide [1]. It was not until the 1970s and 1980s that
regulatory initiatives on asbestos were started in several member states and at least at EU
level as a result of growing public concerns. The primary strategies for the "safe use" of
asbestos products consisted of labelling, OELs and workplace control measures. These
largely failed due to problems with performance and compliance and did not reduce
workplace asbestos fibre concentrations to a sufficiently low-risk level. Finally, several EU
member states and at least the EU decided to ban all asbestos products in 2005 [2]. The
systematic development of asbestos substitutes started in Germany in 1980 and was
completed in 1995 - faster than predicted by industry and without serious economic
consequences [3].
2
Pott and Stanton´s fibre principle (1972)
Fibre number x 107 in i. p.-test for 25 % tumour risk
10000
1000
100
10
1
B-01-0.9
B-09-2.0
MMVF-11
B-20-2.0
Basalt
0,1
Crocidolite
Carcinogenic
potency of a fibre
=
length
+
diameter
+
biopersistence
In 1972 POTT and STANTON published the first results on the factors determining the
carcinogenic activity of respirable fibres [4, 5]. The "fibre principle“ was born: dimension and
biopersistence are the main determinants of the carcinogenic activity of respirable fibres.
Asbestos and man-made-mineral fibres (MMMF) share the needle-like structure of the dust
particles. Public interest now focuses on mineral wool and other non-asbestos products. In
1980 the German Commission for the Investigation of Health Hazards of Chemical
Compounds in the Work Area (MAC Commission) shows that man-made mineral fibres with
a diameter below 1 micron are possible carcinogens [6]. Consequently, the image of many
MMMF products has changed from harmless to harmful.
In 1993 a comprehensive risk assessment of MMMF by a working group of German public
health, environment and OSH authorities led to a far-reaching all-clear signal for consumers
concerning built-in products. However, risk assessment predicts significant health risks for
workers if biopersistent fibres become airborne during working procedures [7].
In 1994 a scheme for the classification of respirable fibres was published by the German
hazardous substances committee (AGS) [8]. Based on the "fibre principle", it provides
criteria for critical fibre dimensions and biopersistence - and, in turn, "official" criteria for noncarcinogenic fibres. The classification scheme avoids technical terms like "glass wool" or
"stone wool" which were shown to have no direct scientific link to biopersistence.
3
The fibre principle offers industry two fundamental ways for developing safe fibre types.
However, the first, making the fibres thicker so as to be non-respirable, fails because the
products then also lose their good insulating properties. Biopersistence therefore became
the key for product innovation with safer fibre types. Biopersistence depends on the fibres'
chemical composition - and this could be changed. Investigations performed by BAYER in
the mid-80s led to the first experimental glass fibre which shows no significant carcinogenic
effects even in sensitive animal tests [9]. In the following years the "Bayer – fibre" serves as
a gold standard for successful product innovation in the MMMF industry.
In 1994, only a few weeks after the German classification scheme (TRGS 905) for fibrous
dust was published, a leading European producer launched the first biosoluble glass wool.
He used one of the TRGS 905 criteria "carcinogenicity index KI beyond 40" for advertising it
as "free of cancer risk". This product innovation served as a catalyst for the rest of the
European industry – in the following years all mineral wool producers changed to biosoluble
fibres. This success for occupational safety and health was safeguarded by legislation. An
amendment of the hazardous substances ordinance, which came into force in June 1998,
strengthens the duty to substitute biopersistent mineral wool by safer alternatives and
burdens their remaining use with strong workplace control measures. Beyond this, the TRGS
905 criteria for biosolubility acquired the status of a regulation [10].
Only one year later, in 1999, a focus activity of the German federal states confirms the
nationwide use of the new biosoluble generation of mineral wool. The German government
now notifies a ban on the production, use and placing on the market of biopersistent mineral
wool for building purposes at the European Commission. It aims at securing product safety
and safeguarding mineral wool producers against imports of biopersistent products. After 6
months of "stand-still" the ban came into force in June 2000 [11].
4
Producers of biosoluble mineral wool label their products with a seal of quality. A producers'
panel supervises the use of the seal and its conformity to the criteria of the hazardous
substances ordinance. Meanwhile all producers have voluntarily tested the intratracheal
biological half-life time for their new products in animal experiments. Beyond this, a product
list from industry is available from the worldwide web [12].
Biosoluble mineral wool requires only basic hygiene measures in the workplace according to
the meaning of article 5 of 98/24/EC (table 1). They aim at protecting users against
mechanical irritation from thick product fibres with diameters beyond 5 microns. As a rule,
there is no need for special control measures (acc. to art. 6 of 98/24/EC) to protect the
health of about 500,000 employees in Germany working with mineral wool.
Table 1: Basic hygiene measures for fibre products [13]
clean workplace, achieved by

use of low-dust generation work processes and appliances

use of pre-prepared products

careful handling of products and cut-off parts

regular cleaning of the workplace, or ventilation and air conditioning measures
working clothes, personal protective equipment, skin protection

loose fitting, closed working clothes

suitable gloves, if necessary

dust protection masks (P1-Filter or particle filtering FFP1) in cases of heavy dust generation
(should be generally made available on workers' request)

goggles for overhead work

use of suitable protective creams or lotions for sensitive skin

washing off dust at the end of working
For more details see
TRGS 500, www.baua.de/prax/ags/trgs500e.htm; COSHH Essentials (control strategy 1), www.coshh-essentials.org.uk
5
By contrast, working with "old" biopersistent mineral wool requires specific protection
measures according to art. 6 of the chemical agents directive 98/24/EC. They have been laid
down in detail in the technical rule TRGS 521 since 1996 and in the hazardous substances
ordinance since 1998 [10, 13]. Workers' exposure has to be minimised below the value of a
technical-based OEL of 250,000 fibres/m3 [14]. TRGS 521 helps find the adequate control
strategy without the need for expensive and time-consuming fibre measurements.
A list of typical tasks with mineral wool for building purposes and technical insulation is given
in the TRGS 521. Every task is correlated to one of three control strategies (quite similar to
the HSE's COSHH Essentials). The corresponding protection measures are listed and
described in detail. In case of full compliance, control strategies 1 and 2 ensure that the
technical OEL of 250,000 fibres / m3 for respirable fibres is adhered to. The extensive
measures of control strategy 3 are required for large reconstruction and demolition works.
The task-related concept of the TRGS 521 has been developed on the basis of present
results of fibre measurements. Its application supersedes regular workplace measurements
required by hazardous substances regulation - a significant cost saving for trades working
with "old" biopersistent mineral wool. Beyond this, the regular obligation for notification of
every task to the competent authority has been reduced to once only.
Such standardised working practices are also mentioned in the ILO code of practice on
"Safety in the use of mineral wool". They allow limited OSH resources in SME to be used
directly for worker protection measures rather than for expensive measurements. As an
example, the ILO Code provides a direct link to the TRGS 521 [15].
The employers' liability insurance association for the building trade in Germany supports the
practical implementation of the TRGS 521 by a booklet which has been revised several
times and mass-distributed during the last ten years [16]. In addition, the German federal
states committee for OSH (LASI) gives advice on waste disposal and on how to tender for
reconstruction and demolition works with biopersistent mineral wool [17].
Refractory ceramic fibres - high temperature glass fibres
Refractory ceramic fibres (RCF) are used in industrial furnaces and other high temperature
applications. Most RCF are made from aluminium silicates, partially in admixture with
zirconium oxide. The white coloured RCF products usually contain no binding agents and
have a high portion of thin fibres. This often leads to a more inferior generation of respirable
fibres and in higher workplace exposures during the open handling and processing of RCF
products compared to mineral wool. For a lot of typical tasks involving RCF products the
technical OEL of 250,000 respirable fibres / m3 cannot be adhered to at present [18].
Nevertheless, the exposures are clearly lower than those measured for equivalent asbestos
products in former times [19].
6
Since 1997 vitreous RCF are classified as carcinogenic, cat. 2 under annex I of directive
67/548/EEC [20]. In 2002 the carcinogenic properties of RCF were confirmed by IARC [21].
The carcinogenic potency of respirable RCF fibres is similar to that of asbestos fibres [22].
There is a significant health risk for workers if RCF products are handled and processed in
open systems [7, 15]. Therefore exposure to respirable fibres has to be reduced to the
lowest technical feasible level through the use of closed systems, local exhaust ventilation,
atomised water spray and industrial vacuum cleaners. The TRGS 521 recommends a
general use of respiratory protection (at least FFP2), even if exposures are below the
German OEL. If the OEL is exceeded, higher levels of respiratory protection (FFP3, TM2P or
TH3P) and protective clothing (type 5) are stipulated. Works with RCF have to be notified to
the competent authority of the federal state and the employers' liability insurance
association. Annex 5 of TRGS 521 gives detailed information on the design of work with
RCF products [13].
Substitution is the most important OSH control strategy for carcinogenic agents! In 1997 a
market evaluation, initiated by BAuA, showed that a broad range of lower-risk products for
RCF applications below 1100 oC was already available [23]. This evaluation was performed
in response to public discussion of the use of RCF in domestic appliances such as cookers
and microwave ovens, which immediately leads to substitution efforts on the part of the
household appliances industry [24]. Although the total production quantity of RCF rose from
42,000 tonnes in 1994 to 50,000 tonnes in 2000, the share for domestic appliances declined
from 20 to 0.3 percent over the same period [25]. Today the substitution process can be
regarded as largely completed - as in the case of mineral wool.
Beyond this, even in the main field of application of RCF, the high temperature insulation of
industrial furnaces, substitutes have recently been developed. They should preserve the
7
technical advantages of RCF compared to refractory light stones or concretes: i.e.
lightweight, all-purpose and energy-saving furnaces. Fibres are the best material for this but
desired temperature resistance and undesired biopersistence largely run in parallel.
Nevertheless the efforts of the RCF industry have resulted in a new product line: hightemperature glass fibres (HTGF).
OSH product innovation:
high-temperature glass fibres (HTGF)
i.tr. half-life period / application temperature
HTGF market share (%)
RCF
300
50
65
biosoluble
mineral wool
100
HTGF
?
0
1.000
T (oC)
2003
40
(industry
estimate)
1999
days
HTGF manufacturers have sought expert advice from the German OSH and environmental
authorities at the early stages of the new product developments. Aiming at a reliable legal
basis for placing products on the market in Germany, they voluntarily commission animal
experiments for biosolubility. Meanwhile HTGF are commercialised with classification
temperatures up to 1260 oC. Some of them fulfil the criteria of the German hazardous
substances regulation for biosoluble fibres by having an intratracheal half-life period below
40 days. However, industry has not yet been successful in developing an all-purpose HTGF
to replace RCF. Present research activities now concentrate on biosoluble HTGF with
classification temperatures above 1300 oC. In addition, they should also be resistant to short
periods of higher application temperatures. Industry expects a market share of about 45 %
of the overall high-temperature fibre production for HTGF in 2003. In 2001 the HTGF share
amounted to 32 % compared to 23 % in 1999.
The launch of HTGF on the German market has been supported by legal requirements and
technical rules. In June 2000 HTGF with a classification temperature above 1000 oC and an
intratracheal biological half-life period below 65 days were excluded from the general ban on
biopersistent mineral wool (half-life period below 40 days) - at the request of the HTGF
producing industries [11]. HTGF is a mineral wool but not a substitute for the biopersistent
stone and glass wool formerly used in building trade. Instead, it substitutes vitreous RCF
with a biological half-life period of about 300 days [26]. This easing of restrictions should
extend the range of substitutes for RCF products.
8
Bearing in mind that inherently safe products such as those which have been achieved for
low-temperature insulation wool are not yet available for high-temperature applications,
HTGF with half-life periods between 40 and 65 days may not be used in the workplace
without adequate control measures. A technical-based OEL of 500,000 respirable fibres / m3
has to be adhered to [14].
A new technical rule TRGS 619 was published in October 2002. It gives recommendations
on substitutes for RCF - in consideration of HTGF and their specific technical properties [27].
Currently, HTGF industries request more flexible regulations for placing on the market RCF
alternatives which do not fulfil the strict legal requirements for biosolubility but are
characterised by significantly lower intratracheal half-life periods than RCF. An amendment
of the relevant German regulation is expected in 2003.
RCF are not included in the German ban on biopersistent mineral wool from June 2000. This
causes confusion because RCF are classified as carcinogenic cat. 2 in the EU, something
which is not the case for mineral wool. Although an EU restriction from June 2001 is in force
in connection with placing RCF on the market for use by the general public, this only applies
to loose, pure RCF fibres and preparations with more than 0.1 percent by weight of RCF
[28]. The directive excludes articles containing RCF. Most RCF products in domestic
applications are therefore not covered yet.
The European Economic and Social Committee (ESC) has pointed to this discrepancy in its
opinion on the above-mentioned EEC directive. Moreover, the ESC "wonders whether the
term ´general public´ could not be defined more precisely, with a specific mention of
consumers and small craft industries in particular" [29].
The German federal environmental agency (UBA) and BAuA organised a hearing on RCF in
domestic applications in December 2001. Producers, operators, OSH and environmental
authorities confirmed the far-reaching substitution of RCF in household appliances and
heating engineering. In the case of fire protection appliances the industry aims at a 60
percent degree of RCF substitution in 2002 - at a total quantity of 50 tonnes of RCF per year
in Germany. In vehicle construction RCF are currently used for friction materials, catalysts
and engine insulation - with ongoing activities for testing alternative materials like HTGF.
Due to new technologies, RCF are meanwhile dispensable in air-bags. The advanced
substitution process would open the possibility for a restriction comparable to biopersistent
mineral wool by legislation or by voluntary agreement with industry. Deliberations in this
regard are ongoing.
New quality of work by safe-to-apply products
Small and medium enterprises (SME) often have difficulties ensuring the safety and health of
their employees by means of technical and organisational protection measures. In Germany
the annual report on safety and health at work still shows more than 40,000 suspicious
notifications and about 4,000 new pensions granted due to chemical-related diseases [30].
Inherently safe products which offer the prospect of OSH without extensive and expensive
control measures are the key to solving this dilemma [31]. The above mentioned biosoluble
9
mineral wool is an example of this. The new generation of stone and glass wool can be
handled by workers, the self-employed and do-it-yourselfers without any cancer risk if a
good standard of workplace hygiene is maintained.
safe, healthy and competetive
working environment
co-operation
+ networks
good practice
solutions
New quality of work
with
Safe-to-apply products
purchased with tailor-made
control strategies
or
inherently safe
Products bearing some residual health risks, e.g. HTGF with half-time periods above 40
days, can be purchased as safe-to-use products with tailor-made control strategies. An
example of this are low-dust HTGF modules with detailed, user-friendly safety instructions.
Such an anticipated generic workplace risk assessment makes it easier for SME to comply
with OSH obligations.
Designing, developing and promoting safe-to-apply chemical products is one main focus of
the German social partners' initiative "New Quality of Work" (INQA) [32]. Aiming at a safe,
healthy and competitive working environment in terms of the European strategy for OSH,
INQA promotes new types of co-operation and implementation, the construction of networks
and the promulgation of "good practice" solutions [33].
The example of biosoluble fibres highlights how communication with mutual
understanding of all involved parties and sensitive legislation can promote a
framework in which innovation, entrepreneurship and health protection can flourish
together.
10
Literature
[1]
D. Gee, M. Greenberg: Asbestos: from ´magic´ to malevolent mineral, in: Late lessons
from early warnings: the precautionary principle 1896 - 2000, Office for Official
Publications of the European Communities, 2002
[2]
Directive 1999/77/EC, EC official journal, L 2007, 6.8.1999
[3]
S. Körber: Staatliche Steuerung und gesellschaftliche Selbstregulierung in der
Chemikalienkontrolle", Schriftenreihe der BAuA, Fb 810, Wirtschaftsverlag NW,
Bremerhaven, 1998
[4]
F. Pott, K. H.Friedrichs: Tumoren der Ratte nach i.p.-Injektion faserförmiger Stäube,
Naturwissenschaften 59, 318 (1972)
[5]
M. F. Stanton, C. Wrench: Mechanisms of mesothelioma induction with asbestos and
fibrous glass, J. Nat. Cancer Inst. 48,797-821 (1972)
[6]
Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe: MAK- und BATWerte-Liste 1980, Verlag Chemie, Weinheim
[7]
Bundesgesundheitsamt, Bundesanstalt für Arbeitsschutz, Umweltbundesamt:
Krebsgefährdung durch künstliche Mineralfasern am Arbeitsplatz und in der Umwelt,
in: M. Fischer: Krebsgefährdung durch künstliche Mineralfasern, bga Schriften 4/94,
MMV Medizin Verlag, München, 1994
[8]
Technische Regel für Gefahrstoffe TRGS 905, BArbBl. 6/1994
[9]
F. Pott et al.: Kanzerogenität von Glasfasern mit unterschiedlicher Beständigkeit, Zbl
Hyg 189, 563-566 (1990)
[10] 3. Verordnung zur Änderung der Gefahrstoffverordnung, Bundesgesetzblatt I Nr. 35,
1286 – 87 (1998)
[11] Verordnung zur Änderung chemikalienrechtlicher Verordnungen, Bundesgesetzblatt I
Nr. 24, 747 – 49 (2000)
[12] www.mineralwolle.de
[13] Technische Regel für Gefahrstoffe TRGS 521, BArbBl. 5 / 2002
[14] Technische Regel für Gefahrstoffe TRGS 900, BArbBl. 4 / 1999
[15] International Labour Office (ILO): Code of practice on safety in the use of synthetic
vitreous fibre insulation wools (glass wool, rock wool, slag wool), Genf, 2001
[16] Berufsgenossenschaften der Bauwirtschaft (Hrsg.): Handlungsanleitung "Umgang mit
Mineralwolle-Dämmstoffen (Glaswolle, Steinwolle)", 2002
[17] Länderausschuss für Arbeitsschutz und Sicherheitstechnik: Leitfaden "Künstliche
Mineralfasern", LV 17, 1999
[18] Technische Regel für Gefahrstoffe TRGS 901 Nr. 41, BArbBl. 4 / 1999
[19] Hauptverband der gewerblichen Berufsgenossenschaften: Faserjahre, BK-Report
1/94, St. Augustin, 1994
[20] Directive 97/69/EC, EC offical journal, L343/19, 13.12.97
11
[21] International Agency For Research on Cancer (WHO): IARC Monographs "Man- Made
Vitreous Fibres", Vol. 81, IARC, Lyon (F), 2002
[22] Begründung zur TRGS 905 "Anorganische Fasern", BArbBl. 10 / 1995 u. 5 / 1998
[23] Keramikfaserprodukte: Ersatzstoffe, Ersatzverfahren, Schutzmaßnahmen, Schriftenreihe der BAuA, GA 52, Wirtschaftsverlag NW, Bremerhaven, 1997
[24] Umweltbundesamt, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin: Technische
Maßnahmen zur Verminderung der Risiken durch Künstliche Mineralfasern (KMF)
sowie Anforderungen an mögliche Alternativen, UBA Texte 36/97, Berlin, 1997
[25] A. Kahl-Mentschel: Ist-Stand-Untersuchung zum betrieblichen Akzeptanzverhalten
beim Einsatz von Alkali Earth Silicate Fibres, Hans - Böckler - Stiftung, publication in
progress
[26] B. Bellmann, H. Muhle: Biobeständigkeit verschiedener Mineralfasertypen in der
Rattenlunge nach intratrachealer Applikation, Schriftenreihe der Bundesanstalt für
Arbeitsschutz, Fb 711, NW Verlag, Bremerhaven, 1995
[27] Technische Regel für Gefahrstoffe TRGS 619: Ersatzstoffe für Keramikfasern im
Ofen- und Feuerfestbau, Bundesarbeitsblatt 10 / 2002
[28] Directive 2001/41/EC, EC Official Journal, L 194, 18.7.2001
[29] Economic and Social Committee: Opinion of the Economic and Social Committee on
the ‘Proposal for a European Parliament andCouncil Directive amending for the 21st
time Council Directive 76/769/EEC relating to restrictions on the marketing and use of
certain dangerous substances and preparations (substances classified as carcinogens,
mutagens or substances toxic to reproduction - c/m/r), EC Official Journal, 2000/C
140/01, 18.5.2000
[30] Bericht der Bundesregierung: Sicherheit und Gesundheit bei der Arbeit 2001, Bundesanzeiger Verlagsgesellschaft mbH, Bonn, 2003
[31] R. Arndt, M. Henn, R. Packroff: Entwicklung und Verwendung von chemischen
Produkten und Verfahren mit geringem Gesundheitsrisiko, Sicherheitsingenieur,
7 /2003, C. Haefner Verlag, Heidelberg
[32] www.inqa.de
[33] Communication from the Commission of the European Communities: Adapting to
change in work and society: a new Community strategy on health and safety at work
2002–2006, COM(2002) 118 final, 11.3.2002
(http://europe.osha.eu.int/systems/strategies/future/com2002_en.pdf)