Regulation 2018/978 of 9 July 2018, published in Official Journal of the European Union on 12 July, amends Annexes II (banned substances) and III (restricted substances) of Cosmetics Regulation 1223/2009, to insert the extracts and essential oils of Tagetes erecta, Tagestes minuta and Tagetes patula. This provision will apply from 1st May 2019.
The whereas of Regulation 2018/978
Tagetes erecta, Tagetes minuta and Tagetes patula extracts and oils are widely used fragrance ingredients of many fragrance compounds used in perfumery. The Scientific Committee on Consumer Products (SCCP), subsequently replaced by the Scientific Committee on Consumer Safety (SCCS), concluded in its opinion of 21 June 2005 that Tagetes erecta, Tagetes minuta and Tagetes patula extracts and oils should not be used in cosmetic products as no safe limits had been demonstrated.
Following the submission in August 2013 of an update dossier on the safety assessment of Tagetes minuta and Tagetes patula extracts and oils, the SCCS adopted a revised opinion on 25 March 2015. In that opinion, as corrected on 13 December 2017, the SCCS concluded that for Tagetes minuta and Tagetes patula extracts and oils in leave-on products (except sunscreen products and products marketed for exposure to natural/artificial UV light), a maximum concentration in ready to use preparation of 0.01% is safe, provided that the alpha terthienyl (terthiophene) content of those extracts and oils does not exceed 0.35%. The SCCS thus concluded that Tagetes minuta and Tagetes patula extracts and oils should not be used as ingredients in sunscreen products and in …
