ENTRY 11

The following substances unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC18 and provided that they do not contain constituents meeting the criteria as dangerous in accordance with Directive 67/548/EEC present in concentrations above the lowest of the applicable concentration limits set out in Directive 1999/45/EC19 or concentration limit set out in Annex I to Directive 67/548/EEC, unless conclusive scientific experimental data show that these constituents are not available throughout the life-cycle of the substance and those data have been ascertained to be adequate and reliable: Glass, ceramic frits. 

According to the scientific literature glass is the state of a substance rather than a substance as such. For legislative purposes, it can best be defined through its starting materials and production process, similar to many other UVCB substances. EINECS has several entries for glasses as follows: 

Glass, nonoxide, chemicals (EC: 295-731-7); glass, oxide, calcium magnesium potassium sodium phosphosilicate (EC: 305-415-3); glass, oxide, calcium magnesium sodium phosphosilicate (EC: 305-416-9); and glass, oxide, chemicals (EC: 266-046-0)20; 

According to available scientific information frits are a ground glass or glassy substance used for example in ceramic tiles and in pottery. 

EINECS lists frits under the following entry: 

Frits, chemicals (EC: 266-047-6). The glass and frits substances are very similar in composition and manufacturing process. Only those types of glass and ceramic frits are exempted which do not have any significant hazard properties: 

- Firstly, glass or ceramic frits are only to be exempted if they (as substances as such) do not meet the criteria for classification as dangerous according to Directive 67/548/EEC. There are two possibilities to assess this criterion: look at the glass or frit itself or look at the starting materials. 

- Secondly, they are not exempted if the substance contains constituents meeting the criteria as dangerous in accordance with Directive 67/548/EEC that are present in concentrations above the lowest of the applicable concentration limits set out in Directive 1999/45/EC or concentration limit set out in Annex I to Directive 67/548/EEC, unless conclusive scientific experimental data show that these constituents are not available throughout the life-cycle of the substance and those data have been ascertained to be adequate and reliable. In this case, industry has to look at the constituents after the production of the glass (constituents could be different than the starting materials) to see if they meet the criteria as dangerous in accordance with Directive 67/548/EEC and are present above the relevant concentration limit. If this is the case then they are not exempted unless the constituent is not available throughout the life-cycle of the substance21. 

It is the responsibility of manufacturers or importers to assess and document the conclusive scientific data to demonstrate their substance(s) fulfil these criteria. 

Man Made Vitreous Fibres (MMVF) included in Annex I to Directive 67/548/EEC are not covered by this exemption as they meet the criteria in Annex VI of that Directive. In addition, MMVF, which are not listed in Annex I to Directive 67/548/EEC, but that meet the criteria for classification as dangerous according to Annex VI of Directive 67/548/EEC are also not to be exempted. 

18 Directive 67/548/EEC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015. 

19 Directive 1999/45/EEC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015. 

20 Please note that the description following the heading in the EINECS listing of these substances is part of the substance entry and in most cases it is most decisive for substance identification.