European Directive 97/69/EC – Classification, Packaging
& Labelling of Dangerous Substances
| • | Within the EU all Member states are required to implement a
common framework for hazardous substance classification and labelling, based on
Directive 67/548/EC. A Working Group of the European commission DG Environment
(then DGXI) reviewed the position of man-made mineral vitreous [silicate] fibres
(MMVFs). The parent directive was then amended by directive 97/69/EC in November
1997. |
| • | Saffil fibre wools are polycrystalline, not vitreous, and so
were not assessed under this directive. |
| • | Since polycrystalline wools are not affected by this
directive there is no legal obligation to provide hazard warning labels on
Saffil products (unless a risk assessment indicates there is a need to
self-classify) and whether or not to apply voluntary labelling is therefore a
decision for individual companies. |
European Directive 2000/53/EC – End of Vehicle Life | • | The End of Life Vehicle Directive of 18
September 2000 requires manufacturers to seek alternatives where the use of
hazardous materials affects recovery and recycling capability. |
| • | The directive clearly defines “hazardous
material” as any substance which is considered dangerous under Directive
67/548/EC (97/69/EC). |
| • | Since Saffil polycrystalline wool products
are outside the scope of Directive 67/548/EC they are not affected by Directive
2000/53/EC. |
REACH
| • | Future updates of this document will include
information on REACH as the requirements become
clearer. |
IARC
| • | In 1988 IARC considered the carcinogenicity
of several groups of fibres. One grouping they defined consigned a range of
disparate fibre types (polycrystalline, refractory ceramic fibre referred to as
RCF and single crystal whiskers) into a single category they termed “ceramic
fibres”. The text of the resulting monogram clearly indicated that available
test data with Saffil polycrystalline fibres were negative, but according to the
IARC rules positive results with other types of fibre meant that the whole
grouping was considered as Category 2B (possible carcinogen). |
| • | IARC decisions are not binding for labelling
in Europe, but must be taken into account in the USA. |
Update on the German Regulatory Position
In the interests of free trade EU member states do not have the powers to
implement local regulations for hazard-classification and labelling of
substances and preparations. Nevertheless, each member state has the right to
enforce additional worker protection regulations. In Germany this has happened
to all mineral wools, classified or not, and includes the dust generated from
polycrystalline wools.
1. TRGS 905
| • | TRGS 905 provides technical guidance on
worker protection and can be regarded as a national supplement to annex 1 of EU
Directive 67/548 but is not limited to those substances listed in that annex.
Although the TRGSs are not laws they are technical rules/recommendations which
have a quasi-legal status. They are referred to in national law requiring
employees to comply with their recommendations |
| • | Manufacturers and importers of
polycrystalline wool products must therefore respect the provisions of TRGS 905
and implement measures to avoid excessive exposure to fibrous dust. |
| • | TRGS 905 contains a list of substances that
can release dusts which are classified as carcinogenic. This list includes dusts
generated from substances or preparations which may not have been classified by
the EU. The dusts are classified into categories K1, K2 or K3 which are broadly
equivalent to the European categories 1, 2 and 3. |
| • | Polycrystalline wools are not named
specifically but are included as one of the substances that could release
fibrous dust containing “other inorganic types of (airborne) WHO fibres”.
Consequently, in Germany, suppliers of polycrystalline wool products must give
information on their legal status if they release fibrous dust on handling and
they must also provide advice on handling and dust control measures. |
| • | In all Member States each manufacturer must
determine the extent and the form of any hazard information to be communicated
to the users and this is usually in the form of a statement on a label and in a
Safety Data Sheet. |
2. Discussions with German
authorities | • | In Germany the Working Group “Fibres and
Dusts” (Arbeitskreis Fasern und Stäube - AK F&S) of the Committee on
Hazardous Substances (Ausschuss für Gefahrstoffe, AGS, is responsible for
assessing the classification of polycrystalline fibre dust which finally may be
adopted by the AGS. The present assessment of polycrystalline fibrous dust as K3
(TRGS 905) is based on a proposal of the former Advisory Group on Toxicology,
which regarded this as an interim assessment pending the separation of a
suitable sample for animal testing. |
| • | Sections 2.3.2 through 2.3.4 of TRGS 905
gives the criteria for assessing the carcinogenicity of (specifically) vitreous
WHO fibres, in particular the KI index and standard numbers of fibres to
be injected into rats in intraperitoneal (IP) tests. These are not adapted to
the assessment of polycrystalline fibres, hence the need to agree with the AK
F&S on appropriate criteria for the IP testing of these materials and in
particular to agree on the meaning of the requirement that the fibrous dust in
the sample tested should be of similar sizes to those occurring in workplace
air. |
| • | Due to the small respirable fibre fraction
(see Note 1) in the samples of the commercial polycrystalline wools tested, the
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), who had
previously successfully isolated samples from many vitreous fibre types, could
not, in spite of adapting their method, produce a suitable sample. |
| • | Under ECFIA sponsorship, one member company
has developed a new method that might allow a more representative fibrous dust
sample to be isolated in sufficient quantities for intraperitoneal testing. This
method is being adjusted so that the dimensions of WHO fibres contained in the
isolated dust are as similar as possible to the WHO fibres found in workplace
air. The completion timeframe is difficult to assess but the work is being
progressed as quickly as possible. |
| • | Work to-date has shown that it might not be
possible to isolate a test sample from some polycrystalline products. This has
led to an agreement with the AK F&S that there is a need to establish
criteria that would define materials that could avoid the need for testing and
hazard classification. A separate project, sponsored by ECFIA, will involve
independent experts from several countries in an attempt to recommend candidate
fibre size-based exemption criteria. |
| • | Polycrystalline wool producers will
co-operate in a further ECFIA project to conduct more extensive dust
measurements in both manufacturing and customer premises. Both airborne fibrous
dust levels and fibre size distributions will be studied and related to the
processes releasing them. |
| • | ECFIA member companies with manufacturing or
sales responsibility for polycrystalline wools will keep you updated when there
are further developments. |
Note 1. WHO
fibres are defined by their size; they are counted on filters collecting all
airborne dust. All WHO fibres are not equally likely to enter and remain in the
lung. The probability of alveolar deposition varies from <1% for fibres close
to the 3 micron diameter up to about 40% for fibres of 0.5-1.0 microns diameter.
Total respirable fibrous dust is usually measured by using a size selective
sampler and weighing the amount collected.