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Announcements by ECHA on the use of Zinc oxide and clarification 

for downstream users of Cromium VI Compounds

 

Dear Members,

 

The European Chemical Agency (ECHA) recently  published following regulation/information in respect of  the use of Zinc Oxide in cosmetic products  and clarification for downstream users of Chromium VI Compounds. The copy of the said regulation is attached for your ready reference.

 

The European Commission adopted a regulation No 2017/1413  of 3 August 2017, amending Annex IV to Regulation (EC) No 1223/2009 on cosmetic products. The decision to amend the regulation is based on the opinion of Scientific Committee on Consumer Safety (SCCS) which considered that in view of the lung inflammation induced by zinc oxide particles after inhalation, the use of zinc oxide in cosmetic products that may result in exposure of the consumer's lungs to zinc oxide by inhalation was of concern. Hence the use of zinc oxide as a colorant, in its uncoated non-nano form, in cosmetic products should be restricted to those applications which may not lead to exposure of the end-user's lungs by inhalation.

         
From 24 February 2018, only cosmetic products which comply with this Regulation shall be placed on the Union market. This Regulation shall be binding in its entirety and directly applicable in all Member States. The relevant EU  regulation is attached for information.

 

2. Clarification by ECHA for downstream users of Chromium VI Compounds after Sunset date of 21 September 2017

 

The European Chemical Agency (ECHA) through a Q & A published in its website has clarified that downstream users can continue using Chromium VI compounds after the sunset of the substance which is on 21 September 2017 even if the Commission has not decided to grant or not to grant an authorisation. This continuation is possible, if a company up their supply chain, has applied for an authorisation for their use before the latest application date for this substance, which was 21 March 2016.

As long as the authorisation is pending, the downstream users do not need to do anything extra. Once the Commission has made its decision, and if an authorisation is granted, downstream users will need to notify their use to ECHA. If the Commission has made the decision of granting an authorisation users  must notify the use to ECHA three months from the first delivery of the substance. The notification needs to refer to the specific authorisation number indicated in the label of the product and the safety data sheet they receive from your supplier, which corresponds to your use. For the companies which need more information, they can contact via: ECHA: application-authorisation@echa.europa.eu.

 

All members are requested to please take a note of it.

 

Thanking You,

 

Yours faithfully

 

Prafulla Walhe
Deputy Director

 

Commission Regulation No. 1413