(9)The substance Formaldehyde is currently listed in entry 13 of Annex III to Regulation (EC) No 1223/2009 as allowed in nail hardening products in a concentration of up to 5 % in ready for use preparation. It is also currently listed in entry 5 of Annex V to Regulation (EC) No 1223/2009 as allowed in oral products in a concentration of up to 0,1 % and in other products in a concentration of up to 0,2 %. Formaldehyde has been classified as a CMR substance of category 1B by Commission Regulation (EU) No 605/2014note. The classification became applicable on 1 January 2016. In accordance with the second subparagraph of Article 15(2) of Regulation (EC) No 1223/2009, substances classified as CMR substances of category 1A or 1B may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances, certain conditions are fulfilled, including the conditions that no suitable alternative substances are available, that an application is made for a particular use of the product category with a known exposure and that the substance has been evaluated and found safe by the SCCS. On 7 November 2014, the SCCS concluded in its opinionnote that ‘nail hardeners with a maximum concentration of about 2,2 % free formaldehyde can be used safely to harden or strengthen nails’. However, since it has not been established that there are no suitable alternative substances available for the purpose of hardening nails, Formaldehyde should be deleted from the list of restricted substances in Annex III to Regulation (EC) No 1223/2009. Since no application was made for other uses of Formaldehyde, the substance should be deleted from the list of preservatives allowed in cosmetic products in Annex V to that Regulation. Formaldehyde should also be added to the list of substances prohibited in cosmetic products in Annex II to Regulation (EC) No 1223/2009.