12 July 2018, the Official Journal of the European Union issues a directive (EU) 2018/978, amending the Annex II and Annex III of the Regulation (EC) 1223/2009 on cosmetics products. This directive shall enter into force on the twentieth day following that of its publication in the OJ（i.e. 1 August 2018）.
From 1 May 2019 cosmetic products containing one or more of the substances prohibited by this Regulation and cosmetic products containing one or more of the substances restricted by this Regulation and not complying with the restrictions laid down in this Regulation shall not be placed on the Union market.
From 1 August 2019 cosmetic products containing one or more of the substances prohibited by this Regulation and cosmetic products containing one or more of the substances restricted by this Regulation and not complying with the restrictions laid down in this Regulation shall not be made available on the Union market.
(1) In Annex II, in the table, the following entry is added:
Ref No. | Substance identification | ||
Chemical name/INN | CAS number | EC number | |
a | b | c | d |
1383 | Tagetes erecta flower extract | 90131-43-4 | 290-353-9 |
Tagetes erecta flower oil | 90131-43-4 | 290-353-9/- | |
(2) In Annex III, in the table, the following entries are added:
Ref No. | Substance identification | Restrictions | |||||
Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | |
a | b | c | d | e | f | g | h |
308 | Tagetes minuta flower extract Tagetes minuta flower oil | Tagetes minuta flower extract Tagetes minuta flower oil | 91770-75-1; 91770-75-1/8016-84-0 | 294-862-7; 294-862-7 | (a) Leave-on products | (a) 0.01 % | For (a) and (b): Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0,35 %. For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. For (a) and (b): In case of combined use with Tagetes patula (entry 309), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (g). |
(b) Rinse-off products | (b) 0.1 % | ||||||
309 | Tagetes patula flower extract Tagetes patula flower oil | Tagetes patula flower extract Tagetes patula flower oil | 91722-29-1; 91722-29-1/8016-84-0 | 294-431-3; 294-431-3/- | (a) Leave-on products | (a) 0.01 % | For (a) and (b): Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0,35 %. For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. For (a) and (b): In case of combined use with Tagetes minuta (entry 308), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (g). |
(b) Rinse-off products | (b) 0.1 % | ||||||
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