Rajat Narang

Posts Tagged ‘Annex III


In September 2016, European Commission confirmed that Carcinogenic, Mutagenic or Reprotoxic [CMR] substances are not automatically banned for their use in cosmetic products, if they have a mandatory classification as under the CLP Regulation.

The announcement stated Category 1 & 2 CMR substances are prohibited for use in cosmetics with exemptions. Category 2 CMRs could be used if deemed safe by SCCS. Category 1 CMRs could be used too if SCCS considred them safe.

Many member states, even after announcement deemed substances as banned in cosmetics and argued on several points.

Now, as notified to WTO on 29 June 2017 and reported by Chemical Watch on 3 July 2017, it is stated that the changes would be made through a Commission Regulation.

In Cosmetics, a number of Carcinogenic, Mutagenic or Reprotoxic (CMR) substances are being banned or restricted by the European Commission.

The changes would be made through Commission Regulation to 9 substances and Annexes would be amended.

Annex II

Six CMRs to the list of banned substances in Annex II are:


It is marked as Preservative and is currently under Annex VI/31


Chloroacetamide is a preservative and  used in hair, bath, body and hand cleansing and personal products.


Dichloromethane, also called Methylene chlorideis a volatile chemical produced and imported into the United States, with use estimated at over 260 million pounds per year. It is mostly used in adhesive, pharmaceutical, paint and coating industry.


Formaldehyde is mainly used in Nail hardening products. It is considered Carcinogenic Type 2 and is currently placed under Annex III/13.

Perboric Acid & Sodium Perborates

Sodium Perborate is mainly used in oral care and for oxidising. It is considred Carcinogenic CMR 1B and is currently under Annex III/1a and III/12.

Borates, Tetraborates & Octaborates 

Boric acid, Borates & tetraborates are currently under Annex III/1a except substance 1184 in Annex II. It is considred as CMR 1B.

Annex III

Three CMR substances escaped the ban as SCCS (Sceientic Commitee for Consumer Safety) considered them safe under certain conditions.

TPO [Trimethylbenzoyl diphenylphosphine oxide]

It is a skin conditioning agent and a organic compound. Maximum Concentration to be restricted to 5% only for Professional use in artificial nail systems


Furfural is a Organic compound and used as solvent. Maximum concentration to be restricted to 0.001%

PHMB [Polyaminopropyl biguanide]

PHMB is used as a preservative. The maximum concentration to be restricted to 0.1%, except in sprayable formulations.

The amendments of Regulation will enter into force after 20 days when published in the Official Journal.

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