Regulation of Tagetes (erecta,minuta,patula) in the EU

Tagetes erecta (CAS 90131-43-4), Tagetes minuta (CAS 91770-75-1, 8016-84-0) and Tagetes patula (CAS 91722-29-1, 8016-84-0) extracts and oils are widely used fragrance ingredients of many fragrance compounds used in perfumery. Furthermore, it can be used “as such” in cosmetic products. The common name of these plants is Marigold, their extracts smell sweet-herbaceous with a powerful fruity-green undertone, reminiscent of green apple.

These ingredients have been evaluated by the Scientific Committee on Consumer Safety (SCCS) because of their phototoxic potential. After various information exchanges with the industry, the SCCS finalized its Scientific Opinion. On this basis, the European Commission along with the European Member States validated a series of risk management measures:

  • Tagetes erecta (flower extract and flower oil) will be prohibited in cosmetic products and added to Annex II of the European Cosmetics Regulation EC No 1223/2009.
  • Tagetes minuta and Tagetes patula (flower extract and flower oil) will be restricted asfollows and added to Annex III of the regulation:
    • Maximum 0.01 % in leave-on products
    • Maximum 0.1 % in rinse-off products
    • Prohibited in sunscreen products and products marketed for exposure to natural/artificial UV light
    • Purity criterion: Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0,35 %
    • In case both Tagetes minuta and Tagetes patula are used in the same product, the total combined content of Tagetes shall not exceed the maximum concentration limits outlined above.

This new amendment (EU No 2018/978) will get enforced 20 days after its publication in the Official Journal of the European Union, namely on Monday, July 30th, 2018. However, transition periods are granted:

  • From May 1st, 2019 (> 9 months from now) only cosmetic products that comply with this Regulation shall be placed on the Union market (namely, no further placing on the market of non-compliant products after this date).
  • From August 1st, 2021 (> 1 year from now) only cosmetic products that comply with this Regulation shall be made available on the Union market (namely, non-compliant products are withdrawn from the market by this date).

Caution: these ingredients are also used in fragrances and because fragrances are traditionally covered by the trade secret, you (and BIORIUS) may be unaware that your products contain Tagetes. Therefore, we strongly recommend that you inform your fragrance suppliers and ensure that your fragrances will continue to comply with the European Cosmetics Regulation after the end of the transition period.

Any questions?