The three forbidden Tagetes

Regulation (EU) 2018/978 of 9 July 2018 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products has prohibited the use of Tagetes erecta flower extract, Tagetes erecta flower oil and of Tagetes minuta, patula extracts and flower oils in cosmetic products.

While the Cosmetics Regulation (EC) 1223/2009 did not deal with the restriction or prohibition of these substances, precisely due to their extensive use in fragrance compounds as ingredients in perfumery, the Scientific Committee on Consumer Safety (SCCS) pointed out the harm they could pose.

Thus, the restriction came as a consequence to several SCCS opinions during time. The first one, from June 2005, concluded that Tagetes erecta, Tagetes minuta and Tagetes patula extracts and oils should not be used in cosmetic products since no safe limits had been established, thereby implying a potential human health risk. A revised opinion followed in March 2015, as corrected later in 2017, saying that Tagetes minuta and Tagetes patula extracts and oils should not be used as ingredients in sunscreen products and in products marketed for exposure to natural/artificial UV light. Finally, in a comment made on October 2016 to its opinion of March 2015, the SCCS noted that for rins-off products a concentration in ready to use preparation of up to 0,1% should be determined.

Therefore, the overall conclusion is exposed in the fifth recital Regulation (EU) 2018/978, which says that: “There is a potential risk to human health arising from the use of Tagetes minuta and Tagetes patula flower extracts and flower oils in cosmetic products in a concentration exceeding 0,01 % in leave-on products and 0,1 % in rinse-off products and from the use of those extracts and oils in a leave-on or rinse-off product where the content of alpha terthienyl (terthiophene) in the extracts or oils exceeds 0,35 %. There is also a potential risk to human health arising from the use of Tagetes minuta and Tagetes patula flower extracts and flower oils in any concentration in sunscreen products and products marketed for exposure to natural/artificial UV light. Those substances should therefore be added in the list of restricted substances in Annex III to .

Article 2 of the same Regulation sets the timeline of its application, so that from May 1, 2019 cosmetic products containing that substance shall not be placed on the Union market and from August 1, 2019 cosmetic products containing that substance shall not be made available on the Union market.

Consequently, the usage level of Tagetes erecta flower extract and Tagetes erecta flower in cosmetic products should start to decrease little by little, avoiding regulatory issues for the cosmetic manufacturers.

Should you wish to have more information, Obelis remains at your disposition. With 30 years of regulatory experience, it will be our pleasure to help and advise you on regulatory updates for the EU market, SCCS opinions and cosmetic ingredients in the EU. If you would like to know more on cosmetics products regulatory compliance, please contact us.

Bianca Sofian

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