COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	4,4-bis(dimethylamino)benzophenone (Michler’s ketone)	
CAS number:	90-94-8	
EC number:	202-027-5	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: 

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the webform. It was in the “interested parties” own responsibility to ensure that no confidential information was included in the comments. The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
7	2012/04/12	International NGO
ClientEarth
Belgium	ClientEarth strongly supports the inclusion of trityl alcohol in the candidate list. As the substitutes identified in the dossier are CMRs as well, they should be included in the canidate list as soon as possible in order to avoid that companies substitute an SVHC with a substance of equivalent concern.	Thank you for providing your opinion.

As regards your comment on substitutes with CMR properties, we assume that this refers to Michler’s base, which has also been proposed to be identified as SVHC.

In case you instead refer to other dyes which, according to the literature, are manufactured via Michler’s ketone, we would like to note that, apart from the dyes proposed as SVHC in the last round. there is no other dye in the EU market notified for classification and labelling or registered with Michler’s ketone at or above 0.1% 	
5	2012/04/11	Member State
Sweden	The Swedish CA agrees that Michler’s ketone, being classified as Carc. 1B, meets the criteria according to Article 57(a) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for providing your opinion.
	
4	2012/04/11	Member State
Germany	The German CA suppports the identification of Michler's Ketone as SVHC.	Thank you for providing your opinion.
	
3	2012/04/11	Member State
Norway	The Norwegian CA supports that Michler's ketone should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for providing your opinion.
	
2	2012/04/06	Member State
Belgium	Belgium supports the identification of 4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) as SVHC according to article 57 (a)	Thank you for providing your opinion.
	
1	2012/03/30	Member State
United Kingdom	It is not clear that Annex XIV is the most appropriate risk management measure for Michler’s ketone. Based on the information in the Annex XV dossier the tonnages that are in scope are low. It may be entering the EU as an impurity in imported dyes or articles that have been coloured with those dyes. However, the specific listing of this substance in the EuIPA exclusion list for printing inks and related products suggests that industry is voluntarily trying to minimise the levels of this impurity. Based on the information in the Annex XV dossier it is not clear what additional benefits Annex XIV will bring. It would be useful to consider this before Michler’s ketone is included in a prioritisation exercise.  	Thank you for the submitted information. This information may, where relevant, be considered at later stages of the risk management process. 

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
6	2012/04/11	Member State
Ireland	Michler’s ketone is classified as Carc. 1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) of REACH.	Thank you for providing your opinion.
	
1	2012/03/30	Member State
United Kingdom	The substance is classified as Carc 1B therefore it meets Art 57a. 

Page 4. Should the statement under “Registration dossiers for this substance” refer to Michler’s ketone instead of Michler’s base?
	Thank you for providing your opinion, and for your correction, which was considered when developing the support document for the inclusion of the substance in the Candidate List.

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
6	2012/04/11	Member State
Ireland	While we agree that Michler’s ketone meets the criteria for identification as an SVHC in accordance with Article 57(a), from the information provided in Part II of Annex XV SVHC dossier, the regulatory benefit of including this substance on the candidate list at this time is not clear: no registration dossier has yet been submitted for Michler’s ketone, there is no indication the substance is currently on the market, it appears to only be present as an impurity in other dyes and the uses identified may be outside the scope of Authorisation (intermediate in the manufacture of dyes and pigments, intermediate in the production of hydrochloric salt and chemical reagent in R&D).	Thank you for your comment. We note that inclusion of Michler’s ketone in the Candidate List could increase awareness and pose notification and communication requirements for producers/importers and suppliers of articles containing Michler’s ketone (MK) above 0.1%, regardless of the exact origin of MK (e.g. as impurity of a certain dye or due to other processes). Nevertheless, monitoring studies at least in (recycled) paper have so far always indicated maximum concentrations lower than 0.1%.	
4	2012/04/11	Member State
Germany	p.15: 
Michler’s Keton is a known contaminant in recovered paper, if recovered paper is used for food contact applications its transfer into food must not be detectable (detection limit 0.01 mg/kg) according to the following provisions: 

-	Council of Europe
Resolution RESAP (2002) 1 on paper and board materials and articles intended to come into contact with foodstuffs, Technical Document No. 3 - Paper and board materials and articles, made from recycled fibres, intended to come into contact with foodstuffs
http://www.coe.int/t/e/social_cohesion/soc-sp/public_health/food_contact/PS%20E%20PAPER%20AND%20BOARD%20Version%203.pdf
-	BfR Recommendation XXXVI on Paper and board for food contact, Preconditions for the use of recycled fibres as raw materials for the production of paper
http://bfr.zadi.de/kse/faces/resources/pdf/360-english.pdf
	Thank you for the submitted information. This information may, where relevant, be considered at later stages of the risk management process.	
1	2012/03/30	Member State
United Kingdom	Page 13. A minor point. Although the dyes may be present on the outside of food packaging materials, there is the possibility for incidental contact with food when it is removed from the packaging, thus the statement that “there would be no direct contact with food” could be clarified.  

Page 14. Routes of exposure – I disagree with the view that the inhalation route is less relevant than the oral or dermal routes. Although the compound has low volatility, workers may be exposed via inhalation of dust during the manufacture of the substance and its use. 

Page 16. The alternatives assessment could also consider whether the specific dyes manufactured from Michler’s ketone, base or hydrol are essential or whether alternative dyes could be used. I recognise that the use of alternative dyes may limit the colour palette available to industry.
	Thank you for your comment. 

In case the substance is included at a later stage, by ECHA, in a recommendation for inclusion into Annex XIV, a background document for this substance will be published by ECHA, summarising mainly types of information such as those included in Parts I & II of the Annex XV report. Therein, information received during this public consultation will accordingly also be taken into account, where relevant.