On 25 September 2023, the European Chemicals Agency (ECHA) launched consultations on Germany’s proposal for the harmonised classification and labelling of ethylenediaminetetramethylene phosphonic acid (EDTMP) and three of its salts, in particular sodium and potassium, as carcinogens category 1B. They are open until 24 November 2023.
The ECHA has opened four separate consultations. They concern [Ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid (No.CAS: 1429-50-1; No.EC: 215-851-5) and three of its salts, two of which have INCI names:
• [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt (No.CAS: 22036-77-7; No.EC: 244-742-5; INCI: Sodium EDTMP)
• [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, potassium salt (No.CAS: 34274-30-1; No.EC: 251-910-1; INCI: Potassium EDTMP).
These two chelating agents are not currently regulated by Cosmetics Regulation 1223/2009, nor are they listed in Annex VI of CLP Regulation 1272/2008.
The proposal by Germany
Germany proposes to classify the two substance as follows.
Hazard class and Category codes, Hazard statement codes
• Carc. 1B, H350 - May cause cancer
Pictogram, Signal word code
• GHS08
• Dgr (Danger)
Specific Concentrations Limits, M-factors
• Carc. 1B ; H350: C ≥ 1%
The consultations are open until 24 November 2023.
If these classifications become effective, these ingredients will be listed as CMRs whose use, unless exempted, is prohibited in cosmetic products in Europe.
Sources
• Harmonised classification and labelling consultations - [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt, ECHA, 25 September 2023
• CLH report - Proposal for Harmonised Classification and Labelling - [Ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt, BAuA, Federal Institute for Occupational Safety and Health, Germany, …