SAFEGUARDS | Cosmetics, Personal Care & Household NO. 073/17

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Considering SCCS opinions SCCS1572/16 [1] and SCCS1563/15 [2] , European Commission decided to amend to Regulation accordingly on cosmetic hair dyes and eyelash dyes.

Following the SCCS opinion SCCS/1553/15 [3] adopted on March 25, 2015 which concluded – oxidative hair dye substances Toluene-2,5-Diamine, p-Aminophenol, 2-Methylresorcinol, Tetraaminopyrimidine Sulfate, Hydroxyethyl-p-Phenylenediamine Sulfate and 2-Amino-3-Hydroxypyridine can be safely used by professionals in products intended for colouring eyelashes, European Commission decided to amend to Regulation accordingly. However, in order to avoid any risk connected with the self-application of products intended for colouring eyelashes by consumers, they should be allowed for professional use only, and therefore, the product shall associate with appropriate warnings.

Considering SCCS opinions SCCS1572/16 [4] and SCCS1563/15 [5], separate reference numbers are created for substances N,N'-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine and 2,6-Dihydroxyethylaminotoluene, which are currently regulated under generic entries 8 and 9 of Annex III.

The regulation (EU) 2017/237 amending Annex III to Regulation (EC) 1223/2009 is published on 10 February 2017, and it shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union (March 2, 2017).

Requirements of following substances are amended or added into the Regulation (EC) 1223/2009. For other details such as applicable condition, restriction limit, restricted application area and product types, wording of conditions of use and warnings, please refer to the Official Journal [6].

Regulation (EC) 1223/2009 Substance Identification
Annex III (#’8c) Chemical name/INN Ethanol, 2,2′-[(2-nitro-1,4-phenylene)diimino] bis-(9CI)
Name of Common Ingredients Glossary N,N′-Bis(2-Hydroxyethyl)-
CAS number 84041-77-0
EC number 281-856-4
Annex III (#’9a) Chemical name/INN 1,4-Benzenediamine, 2-methyl-
2,5-Diaminotoluene sulphate
Name of Common Ingredients Glossary Toluene-2,5-Diamine
Toluene-2,5-Diamine Sulfate (1)
CAS number 95-70-5
EC number 202-442-1
Annex III (#’9b) Chemical name/INN/XAN 1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene
Name of Common Ingredients Glossary 2,6-Dihydroxyethyl-aminotoluene
CAS number 149330-25-6
EC number 443-210-1
Annex III (#’200) Chemical name/INN/XAN 2,4,5,6-Tetraamino-pyrimidine sulphate
Name of Common Ingredients Glossary Tetraamino-
pyrimidine Sulfate
CAS number 5392-28-9
EC number 226-393-0
Annex III (#’206) Chemical name/INN/XAN 3-(2-Hydroxyethyl)- p-phenylenediammonium sulphate
Name of Common Ingredients Glossary Hydroxyethyl-p- Phenylenediamine Sulfate
CAS number 93841-25-9
EC number 298-995-1
Annex III (#’211) Chemical name/INN/XAN 2-Aminopyridin-3-ol
Name of Common Ingredients Glossary 2-Amino-3- Hydroxypyridine
CAS number 16867-03-1
EC number 240-886-8
Annex III (#’243) Chemical name/INN/XAN 1,3-Benzenediol, 2- methyl
Name of Common Ingredients Glossary 2-Methylresorcinol
CAS number 608-25-3
EC number 210-155-8
Annex III (#’272) Chemical name/INN/XAN 4-Aminophenol
Name of Common Ingredients Glossary p-Aminophenol
CAS number 123-30-8
EC number 204-616-2
Annex III (#’298) Chemical name/INN/XAN Di[2-[4-[(E)-2-
vinyl]pyridin-1-ium] butanoyl]aminoethyl]
di-sulfanyl dichloride
Name of Common Ingredients Glossary HC Red No 17
CAS number 1449471-67-3
EC number -
Annex III (#299) Chemical name/INN/XAN Di[2-[4-[(E)-2-[2,4,5-trimethoxyphenyl] vinyl]pyridinin-1-ium]butanoyl]
aminoethyl]disulfanyl dichloride
Name of Common Ingredients Glossary HC Yellow No 17
CAS number 1450801-55-4
EC number
Annex III (#300) Chemical name/INN/XAN 1H-Pyrazole-4,5-diamine, 1-hexyl-, sulfate (2:1)
Name of Common Ingredients Glossary 1-Hexyl 4,5-Diamino Pyrazole Sulfate
CAS number 1361000-03-4
EC number
Annex III (#301) Chemical name/INN/XAN 4-Hydroxy-2,5,6-triaminopyrimidine sulfate
Name of Common Ingredients Glossary 2,5,6-Triamino-4-Pyrimidinol Sulfate
CAS number 1603-02-7
EC number 216-500-9
Annex III (#302) Chemical name/INN/XAN 2-[(3-Aminopyrazolo[1,5-a]
pyridin-2-yl)oxy]ethanol hydrochloride
Name of Common Ingredients Glossary Hydroxyethoxy Aminopyrazolopyridine HCl
CAS number 1079221-49-0
EC number 695-745-7
Annex III (#303) Chemical name/INN/XAN Phenol, 3-amino-2,6-dimethyl
Name of Common Ingredients Glossary 3-Amino-2,6-
CAS number 6994-64-5
EC number 230-268-6
Annex III (#304) Chemical name/INN/XAN 2-Naphthalenaminium
-7-hydroxy-N,N,N-trimethyl-, chloride
Name of Common Ingredients Glossary Basic Brown 17
CAS number 68391-32-2
EC number 269-944-0
Annex III (#305) Chemical name/INN/XAN 3-Amino-7-(dimethylamino)-
2-methoxyphenoxazin-5-ium chloride
Name of Common Ingredients Glossary Basic Blue 124
CAS number 67846-56-4
EC number 267-370-5

SGS solution:

It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

Reference Sources:

  • Commission Regulation (EU) 2017/237 [7]
  • SCCS Opinion SCCS/1535/15 [8]
  • SCCS Opinion SCCS/1572/16 [9]

For enquiries, please contact:

Queenie TSE
onsumer and Retail
Cosmetics, Personal Care and Household (CPCH)
Senior Technical Service Executive
t: +852 2765 3672 (ext 1672)

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