Source: European Parliament
The ongoing discussion on the potential classification of ethanol to which the Honourable Members refer to is part of the evaluation of ethanol in view of its possible approval as an active substance for use in biocidal products[1]. Any decision taken in that regulatory context will, therefore, only concern uses of ethanol in biocidal products.
The Commission notes that, even if the hazard properties under discussion were to be confirmed, ethanol might still be approved for use in biocidal products, provided its use is safe for human and animal health, and the environment.
Ethanol is currently not subject to a harmonised classification, as carcinogen or reprotoxicant, according to Regulation (EC) No 1272/2008[2].
The Greek authorities plan to submit a dossier for harmonised classification in 2025. After a thorough assessment by the European Chemicals Agency, the Commission will decide on the appropriateness of classification, after consultation of the expert group.
Once a harmonised classification materialises, the Commission will carefully assess the regulatory consequences in other EU legislation, like Regulation (EC) 1907/2006[3] or Regulation (EC) No 1223/2009[4], and the needs and possibilities for derogations.
The Commission is aware of the versatile role of ethanol across a wide range of industries, including in the health sector. Any costs to be incurred by industry will depend upon the final classification and derogations that might be granted under EU legislation.
The Clean Industrial Deal[5] aims at accelerating decarbonisation, reindustrialisation and innovation. It will increase sustainable and resilient production in Europe, also by providing continuous support to innovation in sustainable and bio-sourced raw materials.
- [1] Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
- [2] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353 31.12.2008, p. 1-1355.
- [3] Regulation (EC) No 1907/2006 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, OJ L 396, 30.12.2006, p. 1-850.
- [4] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, OJ L 342, 22.12.2009, p. 59-209.
- [5] https://commission.europa.eu/topics/eu-competitiveness/clean-industrial-deal_en.