Commission 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 (Text with EEA relevance.)

• CELEX: Regulation (EU) 2018/978
• Articles: 4

Article 1

Annexes II and III to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2

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.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Annexes II and III are amended as follows:

(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

‘x

Tagetes erecta flower extract  ( *1 )

90131-43-4

290-353-9

Tagetes erecta flower oil  ( *2 )

90131-43-4

290-353-9/-

(2)

in Annex III, in the table, the following entries are added:

Reference number

Substance Identification

Restrictions

Wording of conditions of use and warnings

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

i

‘x

Tagetes minuta flower extract  ( *3 )

Tagetes minuta flower oil  ( *4 )

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 x), 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 %

x

Tagetes patula flower extract  ( *5 )

Tagetes patula flower oil  ( *6 )

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 x), 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 %

( *1 )   From 1 May 2019 cosmetic products containing that substance shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance shall not be made available on the Union market.

( *2 )   From 1 May 2019 cosmetic products containing that substance shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance shall not be made available on the Union market.’

( *3 )   From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.

( *4 )   From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.

( *5 )   From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.

( *6 )   From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.’