14 REGULATIONS
SCCS/1608/19 Hydroxypropyl p-phenylenediamine and its dihydrochloride salt Hydroxypropyl p-phenylenediamine and its dihydrochloride salt are intended to be used in oxidative hair colouring products. The Scientific Committee on Consumer Safety was asked to consider if hydroxypropyl p-phenylenediamine and its dihydrochloride salt are safe when used in oxidative hair colouring products up to a maximum on head concentration of 2%. The Scientific Committee on Consumer Safety concluded that it not safe when used in oxidative hair colouring products due to potential genotoxicity. The Scientific Committee on Consumer Safety also stated that it has mild to moderate eye irritation potential and is a skin sensitiser.
SCCS/1609/19 Methylimidazoliumpropyl p-Phenylenediamine HCl The Scientific Committee on Consumer Safety was asked to consider if methylimidazoliumpropyl p-phenylenediamine HCl is safe when used in oxidative hair colouring products up to a maximum concentration of 2%. The Scientific Committee on Consumer Safety concluded that methylimidazoliumpropyl p-phenylenediamine HCl is safe to be used in oxidative hair colouring products up to a maximum on head concentration of 2%. The Scientific Committee on Consumer Safety also noted that methylimidazoliumpropyl p- phenylenediamine HCl is a strong skin sensitiser.
SCCS/1610/19 Tetrabromophenol Blue The Scientific Committee on Consumer Safety was asked to consider the safety of tetrabromophenol blue as an oxidative and non-oxidative hair colouring ingredient. They concluded that it would be safe to use in these applications at a maximum concentration of 0.2%.
SCCS/1612/19 Dihydroxyacetone The Scientific Committee on Consumer Safety reviewed the safety of dihydroxyacetone as a hair colouring ingredient. They concluded that it was safe as a non-oxidative leave-on hair colouring ingredient at a maximum concentration of 6.25%. They also concluded that dihydroxyacetone at a maximum concentration of 6.25% was safe to be used in conjunction with self tanning lotion and face cream containing up to 10% dihydroxyacetone.
SCCS/1598/18 1,2,4-trihydroxybenzene The Scientific Committee on Consumer Safety was asked to look at the safety of 1,2,4-trihydroxybenzene when used as an auto oxidative hair dye in permanent hair
PERSONAL CARE EUROPE
to exposure of the consumer’s lungs by inhalation the Scientific Committee on Consumer Safety assessment will be for titanium dioxide in the non nano form. The Scientific Committee on Consumer Safety will consider whether they consider the use of titanium dioxide safe as a colorant; as a UV filter up to a maximum concentration of 25%; and as an ingredient in all other cosmetic products. If it is the Scientific Committee on Consumer Safety’s opinion that the use of titanium dioxide up to a maximum concentration of 25% is not safe they have been asked to consider what the safe level would be. The Scientific Committee on Consumer Safety has until August 2020 to consider the safety of titanium dioxide.
dye formulations, not requiring the action of peroxide with a maximum concentration of 2.5% or 0.7%. On the basis of the data available to the Scientific Committee on Consumer Safety they concluded that they did not consider 1,2,4-trihydroxybenzene safe for use as an auto oxidative hair dye in permanent hair dye formulations at concentrations of 2.5% or 0.7% due to potential genotoxicity. The data submitted to the Scientific Committee on Consumer Safety indicates that the consumer would be exposed to unreacted 1,2,4- trihydroxybenzene and (semi)quinones during the use of a 1,2,4-trihydroxybenzene dye formulation. According to the Scientific Committee on Consumer Safety opinion the data submitted did not consider that the systemic availability of 1,2,4- trihydroxybenzene may lead to intracellular generation of hydrogen peroxide or potential genotoxicity via DNA adduct formation by 1,2,4-trihydroxybenzene or (semi)quinones.
Titanium Dioxide Regulation (EC) No 1272/2008 (CLP) is being amended by Commission Delegated Regulation (EU) 2020/217 (14th ATP). Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 µm will be classified as CMR 2 by inhalation. The classification comes in to force on 9 September 2021. In January 2020 Cosmetics Europe
submitted a dossier to support the safety of titanium dioxide. The European Commission has asked the Scientific Committee on Consumer Safety to carry out a safety assessment on titanium dioxide.1
As titanium dioxide in nano form cannot be used in products which may lead
Conclusion This article has looked at how Regulation (EC) No 1223/2009 has been amended in 2019. It has also looked at the decisions of the Scientific Committee on Consumer Safety and how these opinions may lead to the regulation being amended in the future. For the exact wording it is recommended that the commission regulations and Scientific Committee on Consumer Safety opinions are referred to.
PC
References 1 SCCS/1580/16 final version of 7 March 2017
and corrigendum of 22 June 2018
2 Scientific Committee on Consumer Safety (SCCS) Opinion on Ethylzingerone – ‘Hydroxyethoxyphenyl Butanone’ (HEPB) – (Cosmetics Europe No P98), SCCS/1582/16
3 Scientific Committee on Consumer Safety (SCCS) Opinion on Ethylzingerone – ‘Hydroxyethoxyphenyl Butanone’ (HEPB) – Cosmetics Europe No P98 – CAS No 569646- 79-3 Submission II (eye irritation), SCCS/1604/18
4 Commission Regulation (EU) 2019/1966 + Corrigendum + Corrigendum (II)
5 Regulation (EU) 2017/776 6 SCCS/1587/17 Final opinion on Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S7) – Submission I
7 SCCS/1525/14 Scientific Committee on Consumer Safety SCCS Opinion on the safety of aluminium in cosmetic products
8 SCCS/1512/13 and SCCS/1593/2018. 9 Committee for Risk Assessment RAC Opinion proposing harmonised classification and labelling at EU level of pyrithione zinc; (T-4)- bis[1-(hydroxyl-.kappa.O) pyridine-2(1H)- thionato-.kappa.S]zinc
https://echa.europa.eu/documents/10162/640 5ddd0-2429-9e13-31bd-4e0752fe7430
10 Scientific Committee on Consumer Safety (SCCS) Request for a scientific opinion on Titanium dioxide (TiO2) (CAS/EC numbers 13463-67-7 / 236-675-5, 1317-70-0 / 215-280- 1, 1317-80-2 / 215-282-2) used in cosmetic products
June 2020
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