Position paper concerning the status of the raw materials, for the production of glass, as intermediates under the EU REACH Regulation May 2012 The following position paper explains the status of the raw materials, used for the production of glass by the European Glass Industry, with respect to the EU REACH Regulation (1907/2006/EC) of 18 December 20061. Summary Raw materials for glass manufacture are transported isolated intermediates 3 as they are ‘manufactured for’2, ‘consumed in’2, ‘transported between or supplied to other sites’3 and ‘transformed into another substance’2 having undergone further chemical reaction after mixing with other substances for glass manufacture. Isolated intermediates for use in the glass industry require full registration, but are not subject to authorisation requirements (Art. 2(8b)) even if they include SVHC substances. The glass industry The European Glass Industry is very diverse and covers a wide variety of different technologies and products, including container glass, flat glass, domestic glass (tableware, giftware, crystal glass, jewellery …), continuous filament glass fibre, insulation glass wool, optical fibres and special glass (glass for televisions and monitors, lighting glass (tubes and bulbs), optical glass, laboratory and technical glassware, ceramic glasses (cookware), X-Ray and nuclear radiation protection glasses…). European Glass Industries are represented by Glass Alliance Europe (www.glassallianceeurope.eu). 1 Regulation of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF) 2 “Intermediate” is defined in Article 3 (15) of REACH as “a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)” 3 “Transported isolated intermediate” is defined in Article 3 (15c) of REACH as “an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites” The nature of glass Glass is an inorganic material obtained from different inorganic raw materials, which react at high temperature. During this process, elements from the raw materials form a new random network, where different elements are linked together by oxygen bridges. The general chemical reaction for soda lime glass can be illustrated by the following simplified formula: a SiO2 [sand] + b Na2CO3 [soda] + c CaCO3 [lime] + d CaMg(CO3)2 [dolomite] + e Na2SO4 [sodium sulphate] +….. → x Si(m)Na(n)Ca(o) Mg(p)……O(s) [glass] + y CO2 ↑+ z SO2 ↑ + ….. In the case of borosilicate glass, silica and boron are network formers of the glass structure and the simplified formula is: a SiO2 [sand] + b Na2B4O7 [borax] + c Na2CO3 [soda] + d Al2O3 [alumina] + ….. → x Si(m)B(n)Na(o) Al(p)……. O(s) [glass] + y CO2 ↑ + ….. It should be stressed that all raw materials used in a glass formulation undergo similar physical (melting) and chemical (formation of the network) processes. During the chemical reaction to form glass, different crystalline substances (A, B, C, D, E, …) are transformed to a non-crystalline vitreous substance (X). In glass, the chemical elements are incorporated via strong new chemical bonds and become an integral part of the glass three-dimensional structure. The chemical-physical properties of the new substance glass (chemical resistance, mechanical resistance, transmittance, colour, etc.) are a function of the composition and the network formed. Different compositions lead to different glass chemical structures and consequently different chemical-physical properties of the final material. For example, the main function of boron in a borosilicate glass is to increase the mechanical and chemical resistance and thermal shock resistance of the glass. More information on the nature of glass can be found in the “further reading” listed at the end of the document. Glass is a substance under REACH Under REACH glass is classified as a UVCB substance (substance of unknown or variable composition, complex reaction products or biological materials). It is exempted from the registration requirement under REACH under certain conditions laid down in Annex V (11) REACH. Definition of intermediate The term “intermediate” is defined in Article 3 (15) of REACH as “a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)”. REACH distinguishes between “non-isolated” and “isolated” intermediates which are further divided into on-site non transported and transported intermediates (Article 3 (15a to 15 c) REACH). Isolated intermediates are substances which are destined to undergo further chemical reaction on their own or after mixing with other substances. Isolated intermediates may be manufactured at the same site where the reaction takes place (“on-site isolated intermediates”), or transported to that site from another site (“transported isolated intermediates”). Intermediate status of raw materials for glass production Raw materials that are used in the manufacture of glass meet the definition of intermediates inasmuch as they are transformed into a new substance, namely glass. They are transported isolated intermediates, since they are produced elsewhere and transformed at the glass manufacturers’ sites. This is consistent with the ECHA document on “Clarification of the concept of intermediates under REACH” . The CPIV position on the intermediate status of raw materials to produce glass is also in line with the outcome of a legal opinion obtained on that specific issue. The glass industry considers that for raw materials the use descriptor is the Environmental Release Category ERC6A: “Industrial use resulting in manufacture of another substance (use of intermediates).” Intermediates and registration REACH does not apply to non-isolated intermediates (Article 2 (1c) REACH). Isolated intermediates on the other hand are subject to registration but may benefit from reduced information requirements if they are manufactured and used under “strictly controlled conditions” (Article 2 (8a) and Art. 18 REACH). The glass industry requires that all raw materials subject to registration requirements are fully registered given that the industry cannot guarantee that strictly controlled conditions are met under all circumstances. Intermediates in the glass industry and authorisation - Conclusion Isolated intermediates are not subject to authorisation (Art. 2(8b) REACH and Title VII). Therefore, even if an intermediate is on the candidate list of substances of very high concern (SVHC) and is going to be prioritized, its use as an intermediate in the glass industry will not be subject to authorisation. * * * Nature of glass: further reading 1) J. Zarzycki: Glasses and the vitreous state – Cambridge University Press, 1991. 2) H. Scholze: Glass, nature, structure and properties – Springer Verlag, 1991. 3) J.E. Shelby: Introduction to glass science and technology – The Royal Society of Chemistry, 1997. 4) A. K. Varshneya: Fundamentals of Inorganic Glasses – Society of Glass technology, 2006.
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