Date: 2018-07-12Category: Not ApplicableState: Union GovernmentCountry: Europe
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.)
Executive Summary:
Commission Regulation (EU) 2018/978 amends Annexes II and III to Regulation (EC) No 1223/2009 concerning cosmetic products. It addresses potential health risks associated with Tagetes extracts and oils, specifically Tagetes erecta, Tagetes minuta, and Tagetes patula. The regulation prohibits or restricts the use of these substances in cosmetic products. Key deadlines for compliance are May 1, 2019, and August 1, 2019.
Key Points / Main Content:
* **Prohibition of Tagetes erecta:**
* Tagetes erecta flower extract and oil are prohibited in cosmetic products.
* These substances are added to the list of prohibited substances in Annex II of Regulation (EC) No 1223/2009.
* **Restriction of Tagetes minuta and Tagetes patula:**
* Tagetes minuta and Tagetes patula extracts and oils are restricted in cosmetic products based on concentration and product type.
* For leave-on products (excluding sunscreen and products marketed for UV exposure), the maximum concentration is 0.01%, with an alpha-terthienyl/terthiophene content not exceeding 0.35%.
* For rinse-off products, the maximum concentration is 0.1%, with an alpha-terthienyl/terthiophene content not exceeding 0.35%.
* These substances are prohibited in sunscreen products and products marketed for exposure to natural/artificial UV light.
* These substances are added to the list of restricted substances in Annex III of Regulation (EC) No 1223/2009.
* In case of combined use of Tagetes minuta and Tagetes patula, the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column g of Annex III.
* **Compliance Deadlines:**
* From May 1, 2019, non-compliant cosmetic products shall not be placed on the Union market.
* From August 1, 2019, non-compliant cosmetic products shall not be made available on the Union market.
* **Amendments to Annexes II and III:**
* Annexes II and III to Regulation (EC) No 1223/2009 are amended as specified in the Annex to this Regulation.
Impact Analysis:
* **Cosmetic Product Manufacturers:**
* Impact: Manufacturers must reformulate products to comply with the new prohibitions and restrictions on Tagetes extracts and oils.
* Action Required: Review product formulations, reformulate as necessary, and ensure compliance by the deadlines of May 1, 2019, and August 1, 2019.
* **Suppliers of Cosmetic Ingredients:**
* Impact: Suppliers of Tagetes extracts and oils need to ensure their products meet the new restrictions, including concentration limits and alpha-terthienyl/terthiophene content.
* Action Required: Provide updated specifications and safety data to manufacturers to facilitate compliance.
* **Distributors/Retailers of Cosmetic Products:**
* Impact: Distributors and retailers must ensure that products they place on or make available to the Union market comply with the new regulations.
* Action Required: Review product inventories and remove or replace non-compliant products by the deadlines of May 1, 2019, and August 1, 2019.
* **European Commission/Member States:**
* Impact: Responsible for the enforcement of the regulation and monitoring compliance.
* Action Required: Implement measures to ensure compliance with the regulation, including market surveillance and enforcement actions.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1223/2009: A regulation of the European Parliament and of the Council on cosmetic products.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union.
Scientific Committee on Consumer Safety (SCCS): A committee that provides opinions on health and safety risks of non-food consumer products (e.g., cosmetic products and their ingredients) for the European Commission.
Tagetes erecta: A species of flowering plant, extracts and oils of which are addressed in this regulation regarding their use in cosmetic products.
Tagetes minuta: A species of flowering plant, extracts and oils of which are addressed in this regulation regarding their use in cosmetic products.
Tagetes patula: A species of flowering plant, extracts and oils of which are addressed in this regulation regarding their use in cosmetic products.
12.7.2018 EN Official Journal of the European Union L 176/3
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009
on cosmetic products (1), and in particular Article 31(1) thereof,
Whereas:
(1) 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 (2)
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.
(2) 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 (3). In that opinion, as
corrected on 13 December 2017 (4), 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
products marketed for exposure to natural/artificial UV light.
(3) In a comment of 6 October 2016 (5) to its opinion of 25 March 2015, the SCCS indicated that for Tagetes
minuta and Tagetes patula extracts and oils in rinse-off products, a maximum concentration in ready to use
preparation of 0,1 % should be set.
(4) In light of the opinion of the SCCP of 21 June 2005 there is a potential risk to human health arising from the
use of Tagetes erecta flower extract and Tagetes erecta flower oil in cosmetic products. Those substances should
therefore be prohibited in cosmetic products and added in the list of prohibited substances in Annex II to
Regulation (EC) No 1223/2009.
(5) In light of the opinion of the SCCP of 21 June 2005, the revised opinion of the SCCS of 25 March 2015, as
corrected on 13 December 2017, and the comment of the SCCS of 6 October 2016, 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 Regulation (EC) No 1223/2009.
(6) It is appropriate to provide for reasonable periods of time in order for the industry to adapt to the new
prohibitions and restrictions. The complex and lengthy procedure for fragrance reformulation should be reflected
in a longer than usual duration of the time periods given to the industry for adjustments of products.
(1) OJ L 342, 22.12.2009, p. 59.
(2) SCCP/0869/05; https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_025d.pdf;
(3) SCCS/1551/15; https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_172.pdf
(4) SCCS/1551/15; https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_172.pdf
(5) Minutes of the SCCS Plenary of 6 October 2016; https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_
safety/docs/sccs2016_mi_plenary_02_en.pdfL 176/4 EN Official Journal of the European Union 12.7.2018
(7) Annexes II and III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.
(8) The measure provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Cosmetic Products,
HAS ADOPTED THIS REGULATION:
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 July 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX
Annexes II and III are amended as follows:
(1) in Annex II, in the table, the following entry is added:
Substance identification
Ref No.
Chemical name/INN CAS number EC number
a b c d
‘x Tagetes erecta flower extract(*) 90131-43-4 290-353-9
Tagetes erecta flower oil(**) 90131-43-4 290-353-9/-
(*) 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.
(**) 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) in Annex III, in the table, the following entries are added:
Wording of
conditions of
Substance Identification Restrictions
use and
Reference warnings
number
Name of Common Maximum concen
Product type, Body
Chemical name/INN Ingredients CAS number EC number tration in ready for Other
parts
Glossary use preparation
a b c d e f g h i
‘x Tagetes minuta Tagetes minuta 91770-75-1; 294-862-7; (a) Leave-on (a) 0,01 % For (a) and (b): Alpha terthienyl
flower extract(*) flower extract products (terthiophen) content in the extract/oil
91770-75-1/ 294-862-7
≤ 0,35 %.
Tagetes minuta Tagetes minuta 8016-84-0
flower oil(**) flower oil (b) Rinse-off (b) 0,1 % For (a): Not to be used in sunscreen
products 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 ex
ceed the maximum concentration lim
its set out in column (g).
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176/5Wording of
conditions of
Substance Identification Restrictions
use and
Reference warnings
number
Name of Common Maximum concen
Product type, Body
Chemical name/INN Ingredients CAS number EC number tration in ready for Other
parts
Glossary use preparation
a b c d e f g h i
x Tagetes patula Tagetes patula 91722-29-1; 294-431-3; (a) Leave-on (a) 0,01 % For (a) and (b): Alpha terthienyl
flower extract(***) flower extract products (terthiophen) content in the extract/oil
91722-29-1/ 294-431-3/-
≤ 0,35 %.
Tagetes patula Tagetes patula 8016-84-0
(b) Rinse-off (b) 0,1 %
flower oil(****) flower oil For (a): Not to be used in sunscreen
products
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 ex
ceed the maximum concentration lim
its set out in column (g).
(*) 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.
(**) 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.
(***) 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.
(****) 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.’
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