Comments on ECHA’s Draft 9th Recommendation for 4,4-bis(dimethylamino)-4-(methylamino)trityl alcohol with Michlers ketone or Michlers base above 0.1% (EC number: 209-218-2) and references to responses

The present document compiles the comments received during the public consultation on the draft 9th recommendation for inclusion of substances in Annex XIV of REACH for 4,4-bis(dimethylamino)-4-(methylamino)trityl alcohol with Michlers ketone or Michlers base above 0.1% (EC number: 209-218-2). The public consultation took place between 5 September 2018 and 5 December 2018.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at https://echa.europa.eu/documents/10162/13640/9th_recom_respdoc_trityl_alcohol_en.pdf). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

PUBLIC VERSION

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3314
2018/12/04	Sustainability Support Services (Europe) AB,
Company,
Sweden	The reply is attached	A.1.1.3. Prioritisation approach applied
A.1.3.2. Assignment of WDU score based on use types and their associated volumes
A.1.3.3. Refinement of WDU score based on article service-life
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.01. Claim that content of Michler’s ketone in ink is <0.1%
A.2.02. Noting that substance does not accumulate in body
A.2.04. Disagreement with WDU score claiming that PROF <10t/y
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation	
		Attachment: 3314_SV8 comments.pdf
		
3315
2018/12/04	K. Patel Chemo Pharma Pvt. Ltd.,
Company,
India	please see the attachment	A.1.1.3. Prioritisation approach applied
A.1.3.2. Assignment of WDU score based on use types and their associated volumes
A.1.3.3. Refinement of WDU score based on article service-life
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.01. Claim that content of Michler’s ketone in ink is <0.1%
A.2.02. Noting that substance does not accumulate in body
A.2.04. Disagreement with WDU score claiming that PROF <10t/y
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation	
		Attachment: 3315_20181204170302.pdf
		
3335
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of Michler’s ketone (4,4'-bis(dimethylamino)benzophenone for inclusion in Annex XIV.	Thank you for your opinion.	
				
3358
2018/12/05	Norway,
Member State	The Norwegian CA supports the prioritisation of 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2) for inclusion in Annex XIV.
In general, the Norwegian CA supports grouping of substances of very high concern to avoid substitution with substances with similar properties within the same use categories.	Thank you for your opinion.	
				
3381
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of Michler’s ketone (4,4'-bis(dimethylamino)benzophenone for inclusion in Annex XIV.	Thank you for your opinion.	
				
3394
2018/12/05	Dokumental GmbH & Co KG Schreibfarben,
Company,
Germany	Dokumental GmbH & Co. KG Schreibfarben as an importer would like to take the opportunity to comment on this proposal within the public consultation phase.
Taking into consideration the priority scores on the 9th draft list for recommendation of Priority Substances for inclusion in Annex XIV of REACH, it is Dokumental’s opinion that the total score of 19 assigned to trityl alcohol is too high and should be lowered based on the argumentation below.
Dokumental uses trityl alcohol in the formulation of inks for ballpoint pens and permanent markers. The registered uses by Dokumental of trityl alcohol with Michler’s Ketone (MK) ≥ 0.1% includes only uses at industrial sites (formulation of inks and their use in the production of ballpoint pens and permanent markers). No professional uses occur. According to the lead registrant, industrial use is by far the most relevant and professional uses are limited to ≤ 10 t trityl alcohol/y. The content of MK in Dokumental’s trityl alcohol does not exceed 0.5% and the content of Michler’s Base (MB) is below 0.05%. This is assured by analytical monitoring of the purchased trityl alcohol.  Since only a maximum of 10% of the dye is used for the formulation of the ink, the MK content in the ink is always below 0.1%. Further, the ink is well encapsulated in the writing instruments preventing direct contact by consumers.
According to the lead registrant, the tonnage of trityl alcohol used in printed articles is ≤ 10 t/y.  Moreover, Dokumental’s downstream users are not using the ink for printing articles.
In our opinion the assigned score for "Wide dispersiveness of uses (WDU)" of 12 is not justified. Since industrial use is the most relevant and the professional use accounts for ≤ 10 t/y a score of 7 instead of 10 should be applied. Moreover, no additional score for the use in printed articles should be applied as the tonnage related to this use is ≤ 10 t/y.
Further, Dokumental has made every effort to ensure worker safety. The industrial use is done in a closed system and stringent risk management measures are in place. The air is cleaned by exhaust air scrubbers and no waste water containing the substance is produced. Thus, exposure of the worker and the environment is negligible. Workplace measurements have proven that no measurable worker exposure to the dust of the substance occurs. Moreover, a medical surveillance program has been in place at Dokumental since many years. No adverse effect to human health has been noted so far.
In summary, the score for "Wide dispersiveness of uses (WDU)" should be lowered from 12 to 7 resulting in a total score of 14 instead of the currently proposed total score of 19.	A.1.1.3. Prioritisation approach applied
A.1.3.2. Assignment of WDU score based on use types and their associated volumes
A.1.3.3. Refinement of WDU score based on article service-life
A.1.5.4. Control of risks
A.2.01. Claim that content of Michler’s ketone in ink is <0.1%
A.2.03. Claim that company-specific use conditions need to be considered
A.2.04. Disagreement with WDU score claiming that PROF <10t/y
A.2.05. Disagreement with WDU score refinement for article service life due to claim that related tonnage is ≤ 10t/y	

II - Transitional arrangements. Comments on the proposed dates
No comments received.

III - Comments on uses that should be exempted from authorisation, including reasons for that
No comments received.