SAFEGUARDS | Cosmetics, Personal Care & Household NO. 073/17
Considering SCCS opinions SCCS1572/16  and SCCS1563/15  , European Commission decided to amend to Regulation accordingly on cosmetic hair dyes and eyelash dyes.
Following the SCCS opinion SCCS/1553/15  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  and SCCS1563/15 , 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 .
|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)-
|Annex III (#’9a)||Chemical name/INN||1,4-Benzenediamine, 2-methyl-
|Name of Common Ingredients Glossary||Toluene-2,5-Diamine
Toluene-2,5-Diamine Sulfate (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|
|Annex III (#’200)||Chemical name/INN/XAN||2,4,5,6-Tetraamino-pyrimidine sulphate|
|Name of Common Ingredients Glossary||Tetraamino-
|Annex III (#’206)||Chemical name/INN/XAN||3-(2-Hydroxyethyl)- p-phenylenediammonium sulphate|
|Name of Common Ingredients Glossary||Hydroxyethyl-p- Phenylenediamine Sulfate|
|Annex III (#’211)||Chemical name/INN/XAN||2-Aminopyridin-3-ol|
|Name of Common Ingredients Glossary||2-Amino-3- Hydroxypyridine|
|Annex III (#’243)||Chemical name/INN/XAN||1,3-Benzenediol, 2- methyl|
|Name of Common Ingredients Glossary||2-Methylresorcinol|
|Annex III (#’272)||Chemical name/INN/XAN||4-Aminophenol|
|Name of Common Ingredients Glossary||p-Aminophenol|
|Annex III (#’298)||Chemical name/INN/XAN||Di[2-[4-[(E)-2-
|Name of Common Ingredients Glossary||HC Red No 17|
|Annex III (#299)||Chemical name/INN/XAN||Di[2-[4-[(E)-2-[2,4,5-trimethoxyphenyl] vinyl]pyridinin-1-ium]butanoyl]
|Name of Common Ingredients Glossary||HC Yellow No 17|
|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|
|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|
|Annex III (#302)||Chemical name/INN/XAN||2-[(3-Aminopyrazolo[1,5-a]
|Name of Common Ingredients Glossary||Hydroxyethoxy Aminopyrazolopyridine HCl|
|Annex III (#303)||Chemical name/INN/XAN||Phenol, 3-amino-2,6-dimethyl|
|Name of Common Ingredients Glossary||3-Amino-2,6-
|Annex III (#304)||Chemical name/INN/XAN||2-Naphthalenaminium
|Name of Common Ingredients Glossary||Basic Brown 17|
|Annex III (#305)||Chemical name/INN/XAN||3-Amino-7-(dimethylamino)-
|Name of Common Ingredients Glossary||Basic Blue 124|
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.
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