COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

14 November 2011

COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:

Aluminosilicate Refractory Ceramic Fibres (RCF)

CAS number:

-

EC number:

-

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: CMR

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal

Number

Date

Submitted by (name, Organisation/

MSCA)

Comment

Response

41

2011/10/13

Member StateUnited Kingdom

We understand the motive for adding further Refractory Ceramic Fibres (RCF) to the Candidate List. However, we are not sure that the proposal provides the necessary clarification to allow us to take these materials forward (e.g., to look at prioritisation for authorisation).

Whilst the substance identities of these new entries does represent an improvement over the ones used for previous RCF entries, that improvement only serves to expand slightly on a very restrictive definition. It is still not clear what the actual identity of the substances being proposed is. Nor is it clear how that relates to the RCFs that are currently on the market; to those that have been registered; or to the description used in Annex VI of Regulation 1272/2008.

It appears that a UVCB approach has been used, but there does not appear to be a satisfactory description of the substances formed. The identity of the fibres is still being described in terms of their oxide content. The reality is that the fibres are reaction products of their starting materials. Furthermore, as currently described, the proposed new entries entry could cover any silicon oxide/aluminium oxide-based RCF or any silicon oxide/aluminium oxide combined with zirconium oxide-based RCF. However, would it not be possible for manufacturers to add additional oxides to the mixture and thereby bypass the authorisation? For example, it may be possible to add oxides of zinc, magnesium, calcium, boron, titanium or gallium (or combinations thereof) in small amounts without seriously altering the nature of the RCF. Would such 'alternative' RCF be covered by the SVHC definition?

Perhaps a more appropriate approach would have been to use the entry for index number 650-017-00-8 (which allows for the presence of other metal oxides)- i.e., use the description 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.

If this latter approach is taken, then the two current entries and the two proposed entries could be consolidated into a single entry that both regulators and industry could understand.

The entry in Annex VI of the CLP Regulation refers to a group of refractory fibres, which are not specified in detail. Compared to this DE submitted Annex XV dossiers of well defined and specified fibres, which are a subset of the general Annex VI entry. Since the evaluation will be done for these two fibres, DE prefers not to use the general entry of Annex VI of the CLP Regulation.

Regarding the chemical composition (main constituents) there are two refractory fibres on the market:

aluminosilicate refractory ceramic fibres

zirconia aluminosilicate refractory ceramic fibres

The fibres are particular substances, so called UVCB substances which are not only defined by the chemical composition (silicon dioxide, aluminium trioxide and zirconium dioxide) but by additional parameters like the index number in Annex VI of the CLP Regulation (including the maximal range of alkaline oxides and alkaline earth oxides), the geometry of the fibres, the production process etc..

The hazardous effects of these fibres are primarily caused by the three dimensional structure (fibre) and not by the chemical composition ((zirconium) aluminosilicate). Nevertheless a prerequisite for the hazardous effects of the fibres is a (earth) alkaline oxide content of lower than 18%.

Following the Guidance for identification and naming of substances under REACH UVCB substances are described by parameters other than or additional to the chemical composition.

That means in the case of (zirconia) aluminosilicate fibres that there are mainly two identity criteria:

chemical composition: the main constituents, formally described as oxides, are silicon dioxide, aluminium trioxide and zirconium dioxide.

three dimensional structure: fibre

If the fibres contain other oxides e.g. of zinc, magnesium, calcium, boron, titanium or gallium with minor contents i.e. as impurities, nevertheless these fibres are covered by the aluminosilicate refractory ceramic fibres and zirconia aluminosilicate refractory ceramic fibres.

A description of these fibres by only the index no. which covers a very broad range of any kind of fibres would be insufficient because there is more information about the chemical composition of the fibres.

40

2011/10/13

International NGOHealth and Environment AllianceBelgium

HEAL supports the placement of this substance on the candidate list based on the Annex XV dossier.

Thank you for the supporting comment.

39

2011/10/13

Industry or trade associationThe Federation of Finnish Technology IndustriesFinland

Based on the insufficient quality of the Annex XV reports, the scientifically founded doubts on the current classification of RCF and the non-substitutable and exclusively professional uses of RCF, both Annex XV reports on RCF should be withdrawn and RCF should not placed on the REACH candidate list on Authorisation.

Regarding the chemical composition (main constituents) there are two refractory fibres on the market:

aluminosilicate refractory ceramic fibres

zirconia aluminosilicate refractory ceramic fibres

The fibres are particular substances, so called UVCB substances which are not only defined by the chemical composition (silicon dioxide, aluminium trioxide and zirconium dioxide) but by additional parameters like the index number in Annex VI of the CLP Regulation (including the maximal range of alkaline oxides and alkaline earth oxides), the geometry of the fibres, the production process etc..

The hazardous effects of these fibres are primarily caused by the three dimensional structure (fibre) and not by the chemical composition ((zirconium) aluminosilicate). Nevertheless a prerequisite for the hazardous effects of the fibres is a (earth) alkaline oxide content of lower than 18%.

Following the Guidance for identification and naming of substances under REACH UVCB substances are described by parameters other than or additional to the chemical composition.

That means in the case of (zirconia) aluminosilicate fibres that there are mainly two identity criteria:

chemical composition: the main constituents, formally described as oxides, are silicon dioxide, aluminium trioxide and zirconium dioxide.

three dimensional structure: fibre

If the fibres contain other oxides e.g. of zinc, magnesium, calcium, boron, titanium or gallium with minor contents i.e. as impurities, nevertheless these fibres are covered by the aluminosilicate refractory ceramic fibres and zirconia aluminosilicate refractory ceramic fibres.

A description of these fibres by only the index no. which covers a very broad range of any kind of fibres would be insufficient because there is more information about the chemical composition of the fibres.

See also:

Comment 39 attachment (SVHC_comments_RCF_.doc).doc

Copy of the affixed letter

ECHA has invited interested parties to comment on the latest proposal to identify Refractory Ceramic Fibres (Zr-RCF and RCF) as Substances of Very High Concern (SVHCs). The Federation of Finnish Technology Industries sees that both Annex XV reports on RCF are withdrawn and RCF are not placed on the REACH candidate list.

The substances described in the two dossiers are also described by a single CAS number (142844-00-6) and a single EU number (604-314-4). Thus, these two substances should not treated separately by submitting two separate dossiers.

According to the report, the largest single use of RCF is for furnace linings and related applications, accounting for approximately 67 % of consumption. Other uses are for example high temperature insulation, metal treatment, fire protection and appliances. For downstream users RCF have many necessary characteristics. RCF have long life-length, high temperature resistance and accurate temperature adjustment. At the moment, RCFs are not substitutable. For example, because of the good insulation properties, RCF is energy-effective. Also, the maintenance work would increase if RCF would be authorised.

Refractory Ceramic Fibres (RCF) are currently classified as a carcinogen 2 (Directive 67/548) transferred to carcinogens 1b (the CLP Regulation). This classification was established in 1997. It is based on experiment