48 REGULATIONS
Extract and Tagetes Erecta Flower Oil and restricts the use of Tagetes Minuta Flower Extract, Tagetes Minuta Flower Oil, Tagetes Patula Flower Extract and Tagetes Patula Flower Oil to 0.01% in leave- on products and 0.1% in rinse-off products. For Tagetes Minuta Flower Extract, Tagetes Minuta Flower Oil, Tagetes Patula Flower Extract and Tagetes Patula Flower Oil the alpha Terthienyl (Terthiophen) content must not exceed 0.35% and they must not be used in sunscreen products or products marketed for exposure to natural or artificial UV light. The total combined concentration of Tagetes Minuta and Tagetes Patula must not exceed 0.01% in leave-on products and 0.1% in rinse-off products. Tagetes Erecta Flower Extract and Tagetes Erecta Flower Oil have been added to annex II (entry 1383). Tagetes Minuta Flower Extract, Tagetes Minuta Flower Oil, Tagetes Patula Flower Extract and Tagetes Patula Flower Oil have been added to annex III (entries 308 and 309). From 1 May 2019 products placed on
the European Union market must comply with this amendment to the regulation and by 1 August 2019 products that do not comply with the regulation must not be available on the market. Tagetes Erecta Flower Extract, Tagetes Erecta Flower Oil, Tagetes Minuta Flower Extract and Tagetes Minuta Flower Oil are used as fragrance ingredients in perfumes.
Commission Regulation (EU) 2018/1847
Commission Regulation (EU) 2018/1847 amends the maximum permitted concentration for the preservative o- Phenylphenol (annex V, entry 7) to 0.2% in rinse–off products and 0.15% in leave–on products. The regulation also prohibits the use of MEA o-Phenylphenate, Potassium o- Phenylphenate and Sodium o- Phenylphenate as preservatives due to their greater skin penetration. From 17 June 2019 cosmetic products placed on the market must comply with this regulation and by 17 September 2019 cosmetic products not complying with this regulation must not be available on the European Union market.
Commission Regulation (EU) 2018/35
Commission Regulation (EU) 2018/35 is an amendment to the Regulation (EC) No 1907/2006 (REACH). It restricts the use of Cyclotetrasiloxane and Cyclopentasiloxane to a maximum concentration of 0.1% by weight in rinse-off products on environmental grounds. Cyclotetrasiloxane is considered to be a persistent, bioaccumulative and toxic (PBT) substance and a very persistent very bioaccumulative (vPvB) substance and Cyclopentasiloxane is
PERSONAL CARE NORTH AMERICA 2018, Panel meeting date: March 5-6, 2018
2 Amended Safety Assessment of Malic Acid and Sodium Malate as Used in Cosmetics, Final amended report, Release date: June 6, 2018, Panel meeting date: March 5-6, 2018
3 Amended Safety Assessment of Mentha piperita (Peppermint)-Derived Ingredients as Used in Cosmetics, Final amended report, Release date: June 7, 2018, Panel meeting date: March 5-6, 2018
4 Safety Assessment of Alkyl Sultaines as Used in Cosmetics, Final report, Release date: June 6, 2018, Panel meeting date: March 5-6, 2018
5 Safety Assessment of Hamamelis virginiana (Witch Hazel)-Derived Ingredients as Used in Cosmetics, Final report, Release date June 7, 2018, Panel meeting date 5-6 March 2018
considered to be a very persistent very bioaccumulative (vPvB) substance. The 0.1% maximum concentration does not apply to leave–on products that are in prolonged contact with the skin, hair or mucous membranes as Cyclotetrasiloxane and Cyclopentasiloxane are able to evaporate over time and any residues washed off are not considered to be a major risk to the environment. Rinse-off cosmetic products containing 0.1% by weight or greater of Cyclotetrasiloxane or Cyclopentasiloxane must not be placed on the European Union market after 31 January 2020.
The Scientific Committee on Consumer Safety opinion for Cyclopentasiloxane (SCCS/1549/15) should also be considered for products containing Cyclotetrasiloxane and Cyclopentasiloxane. Cyclotetrasiloxane is an impurity found in Cyclopentasiloxane and is classified as toxic to reproduction category 2 by Regulation (EC) No 1272/2008. The Scientific Committee on Consumer Safety concluded that the level of Cyclotetrasiloxane impurity in Cyclopentasiloxane should be kept to as low as possible. The Scientific Committee on Consumer Safety opinion did not cover the use of Cyclopentasiloxane in oral care products or its effect on the environment.
Conclusion
This article has tried to summarise the opinions of the Cosmetic Ingredient Review expert panel and amendments to the European Cosmetic Regulation (EC) No 1223/2009. The Cosmetic Ingredient Review expert panel opinions and the European Cosmetic Regulation are important sources of information for determining the safety of ingredients used in cosmetic products.
PC
References 1 Safety Assessment of Alkane Diols as Used in Cosmetics, Final report, Release date: June 13,
6 Safety Assessment of Zinc Salts as Used in Cosmetics, Final report, Release date: September 12, 2018, Panel meeting date: March 5-6, 2018
7 Safety Assessment of Triphenyl Phosphate as Used in Cosmetics, Final report, Release date: September 18, 2018, Panel meeting date: June 4-5, 2018
8 Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients as Used in Cosmetics, Final report, Release date: September 20, 2018, Panel meeting date: June 4 – 5, 2018
9 Amended Safety Assessment of Dialkyl Dimer Dilinoleates as Used in Cosmetics, Final amended report, Release date: October 17, 2018, Panel meeting date: September 24-25, 2018
10 Safety Assessment of Ginkgo biloba -Derived Ingredients as Used in Cosmetics, Final report, Release date: October 12, 2018, Panel meeting date: September 24-25, 2018
11 Safety Assessment of Hydrogen Peroxide as Used in Cosmetics, Final report, Release date: October 16, 2018, Panel meeting date: September 24-25, 2018
12 Safety Assessment of Polyfluorinated Polymers as Used in Cosmetics, Final report, Release date: October 16, 2018, Panel meeting date: September 24-25, 2018.
13 Safety Assessment of Polyol Phosphates as Used in Cosmetics, Final report, Release date: October 18, 2018, Panel meeting date: September 24-25, 2018
14 Amended Safety Assessment of Acrylates Copolymers as Used in Cosmetics, Release date: January 23, 2019, Panel Meeting Date: December 3-4, 2018
15 Safety Assessment of Hydroxyethyl Urea as used in Cosmetics, Final report, Release date: January 23, 2019, Panel meeting date: December 3-4, 2018
16 Safety Assessment of Vinylpyrrolidone Polymers as Used in Cosmetics, Final report, Release date: January 23, 2019, Panel date: December 3-4, 2018
17 Safety Assessment of Methylxanthines as Used in Cosmetics, Final report, Release date: January 25, 2019
May 2019
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