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

Substance name:	[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26)	
CAS number:	2580-56-5	
EC number:	219-943-6	

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

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. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions.

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	
10	2012/04/12	International NGO
ClientEarth
Belgium	ClientEarth supports the inclusion of C.I. Basic Blue 26 in the candidate list.	Thank you for providing your opinion.	
9	2012/04/12	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of  the substance [4-[[4-anilino-1-naphthyl][4-
(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride
(C.I. Basic Blue 26) containing Michler’s ketone or Michler’s base ≥ 0.1% in the candidate list as it meets the criteria for classification as carcinogen in accordance with Article 57 (a) of REACH. 	Thank you for providing your opinion.	
7	2012/04/11	Member State
Sweden	The Swedish CA agrees that C. I. Basic Blue 26, containing ≥ 0.1 % of either Michler’s base or Michler’s ketone, then 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.
Although substances containing other CMR substances above the respective classification limits can be identified as SVHC substances, we question the practicality of this approach. Potentially, an endless number of non-homogenous substances may then be identified as SVHC, creating a huge work load if an Annex XV dossier is to be compiled in all cases. Substance identification might also be a problem; the CAS number will cover lots of different substances depending on the minor constituents/additives/impurities, which in addition are considered as confidential information.  	Thank you for your comment.

On your point regarding “different substances” with the same CAS number but different impurity levels, please note that, according to ECHA’s Guidance for identification and naming of substances under REACH, for the sameness of mono-constituent substances the “≥ 80%” rule applies. On that basis, C.I. Basic Blue 26 with Michler’s ketone ≥ 0.1 % and C.I. Basic Blue 26  with Michler’s ketone < 0.1 % are considered as the same substances as they contain the main constituent in a concentration ≥ 80%.

Therefore, the substance proposed to be identified as SVHC is C.I. Basic Blue 26, with the condition that it contains Michler’s ketone (or Michler’s base) ≥ 0.1 %.

We take note of your concerns about the practicality of our approach taken for the identification of C.I. Basic Blue 26, with the condition that it contains Michler’s ketone (or Michler’s base) ≥0.1 %. However, as you agree in your comment, this has no implications with regard to the formal correctness of the approach applied by us.	
6	2012/04/11	Member State
Germany	The German CA supports the identification of Basic Blue 26 as SVHC.	Thank you for providing your opinion.	
5	2012/04/11	Member State
Norway	The Norwegian CA supports that C.I. Basic Blue 26 should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for providing your opinion.	
4	2012/04/10	Industry or trade association
European Writing Instruments Manufacturer's Association
Greece	p4: The authors state in their respective „Annex XV dossier“ that not Basic Blue 26 itself meets the criteria for Art. 57 of the REACH regulation. The occurrence of Michler’s ketone or Michler’s base > 0.1 % are responsible for a subsequent classification of the colorant including its technical based contaminations.

In fact, EWIMA supports the current investigations on Michler’s ketone and Michler’s base in order to identify whether they meet the criteria for SVHC. 

An identification of Basic Blue 26 as SVHC is not justified based on the following reasons:

·	Based on the assumption, that Michler’s ketone / Michler’s base would be considered as SVHC, formulation of mixtures with higher Michler’s Ketone content may not lead to information requirements for SVHC compared to mixtures with lower Michler’s ketone content. 
A theoretical mixture of the colourant without Michler’s ketone / Michler’s base (10 %), Michler’s Ketone used as single substance (0.09%) and other ingredients (89.91 %) would not lead to information requirements regarding SVHC. 
A mixture of 10% colourant including 0.5 % Michler’s Ketone and other ingredients (90 %) would lead to information requirements regarding SVHC although the Michler’s Ketone concentration would be 0.05 % in the final mixture. 
Colorant qualities with small Michler’s Ketone / Michler’s base concentration slightly above 0.1 % would have to fulfil the same requirements as the single substances Michler’s Ketone or Michler’s base without considering a dilution effect. 	Thank you for your comment.

ECHA would firstly like to clarify that C.I. Basic Blue 26 containing Michler’s ketone or Michler’s base impurity is considered as a substance and not as a mixture, according to the definitions in Art. 3(1) and (2) REACH.

As regards the mixtures described in your comment, please note that a formulator of the second of the mixtures which you describe (i.e. a mixture of 10% colourant including 0.5 % Michler’s Ketone and other ingredients (90 %)) would not be required to provide the recipient with a safety data sheet (SDS), as the specific mixture does not meet the criteria for classification as dangerous (Michler’s ketone is present at 0.05%, i.e. below the generic concentration limit of 0.1% applying for the classification of the mixture).	
3	2012/04/06	Member State
Belgium	Belgium supports the identification of C.I. Basic Blue 26, where it contains Michler’s ketone or/and Michler’s ≥ 0.1% (wt/wt), as SVHC according to article 57 (a)	Thank you for providing your opinion.	
2	2012/04/03	Industry or trade association
Verband der Chemischen Industrie e.V. (VCI)
Germany	Modification of Substance Name required 
Comment is related to
•	4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride  (C.I. Basic Violet 3)
•	[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26)  
•	α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol  (C.I. Solvent Blue 4)
•	4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol

In the press release informing about the current consultation on potential SVHC substances ECHA lists the substances names and justifications in a table. ECHA states in a footnote to the field “proposed SVHC property” for the substances listed above: “The substance does only fulfil the criteria of REACH Art. 57 (a) if it contains Michler's ketone (EC Number: 202-027-5) or Michler's base (EC Number: 202-959-2) in a concentration ≥ 0.1% (weight / weight).”
This statement clarifies that it is not the intention to bring the respective pure substance as such into the authorisation procedure. The entry into the candidate list shall only be effective if ≥ 0.1% (weight / weight) of Michler’s base or Michler’s ketone is present as an impurity of this substance, according to ECHA’s statement and Annex XV reports.
Therefore, the substance name in the candidate list needs to reflect this mandatory precondition by adding the requirement “if contaminated by Michler's ketone (EC Number: 202-027-5) or Michler's base (EC Number: 202-959-2) in a concentration ≥ 0.1% (weight / weight)” in the field “Substance name”. A footnote solely to the “proposed SVHC property” entry is not sufficient. 
In the table on ECHA’s consultation webpage this necessary precondition is completely lacking.
An entry of the pure substance’s name in the candidate list would unjustifiably and wrongly cause the impression of the substance itself being an SVHC substance.	Thank you for your comment and your suggestion.

As you have correctly noted in your comment, the presence of Michler’s ketone (MK) or Michler’s base (MB) in concentrations ≥ 0.1% is the precondition for the identification of the 4 substances as SVHC. Therefore, ECHA agrees with your consideration that this precondition needs to be clearly reflected in the candidate list. 

Based on the above, the candidate list entry would be (example C.I. Basic Blue 26):
“[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26)  [with ≥ 0.1%  Michler's ketone (EC Number: 202-027-5) or Michler's base (EC Number: 202-959-2)]”

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
8	2012/04/11	Member State
Ireland	[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) containing Michler’s ketone or Michler’s base at ≥ 0.1% 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. 

As per footnote 2 in the Annex XV dossier, it is important that the proposed entry in the candidate list for this substance specifically identifies that it relates to the situation where Michler’s ketone and/or Michler’s base is present at ≥ 0.1%.	Thank you for providing your opinion.

Please see the response to comment #2 in the “General comments” section of this RCOM)
	
1	2012/03/30	Member State
United Kingdom	This substance meets the criteria in Art 57a only where it contains >= 0.1% Michler’s ketone or >= 0.1% Michler’s base. This needs to be clearly stated in the candidate list entry	Please see the response to comment #2 in the “General comments” section of this RCOM)

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
Germany	p. 14: The substance is listed in the Swiss Consumer Goods Ordinance (SR 817.023.21) of the Federal Department of Home Affairs of 23. November 2005
Annex 6: List of permissible substances for use in manufacturing of packaging inks, and requirements on these substances, II. List of dyes and pigments, Part B: non-evaluated substances.
Substances listed in Part B (as of 1. May 2011) may be used provided that the migration into food is non-detectable (<0,01 mg/kg, including analytical tolerance)
http://www.bag.admin.ch/themen/lebensmittel/04867/10015/index.html?lang=de

No exposure scenario is given for this substance which is in contrast to the detailed exposure modelling performed in the companion SVHC dossier for C.I. Basic Violet 3 (CAS Nr. 548-62-9). Given the use of Basic Blue 26 in consumer products a description of exposure scenarios also for this dossier would be valuable.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.

As regards the development of exposure scenarios, we note that, although such scenarios were developed for Basic Violet 3, such a task is normally not to be performed in detail in the context of SVHC identification.	
4	2012/04/10	Industry or trade association
European Writing Instruments Manufacturer's Association
Greece	p 12 Colorant qualities with Michler’s Ketone concentrations < 0.1 % are marketed under the same CAS number as colorant qualities with Michler’s ketone concentrations > 0.1 %. The lacking possibility of differentiation between the qualitities would not only lead to an administrative burden to the manufacturers but also to additional analytical costs. It is likely that customers would like to see analytical evidence of the Michler‘s ketone concentration in the final mixture although this is not justified due to legal requirements.	Thank you for your comment.

On your point regarding “different quality of substances with the same CAS number see our response to comment #7 in the “General comments” section of this RCOM,

Further, note that pursuant to Article 10 of Regulation (EC) No 1272/2008 (CLP-Regulation), the presence of a substance (i.e. Michler’s ketone or Michler’s base) in another substance (i.e. C.I. Basic Blue 26) in a concentration at or above a threshold (here: ≥ 0.1%) leads to the classification of that other substance as hazardous. In accordance with Art. 4(4) CLP, where a substance is classified as hazardous, suppliers shall ensure that the substance is labelled and packaged in accordance with the criteria set down in the CLP Regulation. The label shall include details permitting the identification of the substance (Art. 18(1) CLP). 	
1	2012/03/30	Member State
United Kingdom	Page 15. Releases from uses. Oral exposure is also relevant for consumers. Children may mouth/ingest paper products. Also paper towel wipes (and other paper products such as napkins) may be to be used to wrap or carry food (e.g. slices of cake) bringing food into direct and potentially prolonged contact with the paper product.

Page 15. Releases from uses. It would be useful to have further details of the processes where this substance is used, and the measures that are used to limit human exposure. This will help the reader form an opinion about the likelihood of exposure during use. 

The most likely substitute for Basic Blue 26 containing >=0.1% Michler’s ketone/base seems to be the same substance with less than 0.1% of these impurities (which would not be subject to authorisation because its hazard classification does not meet the Article 57 criteria). By analogy with Basic Violet 3, it is not clear that this substitution will have much impact on human exposure to the impurities of concern. Imported articles which contain Basic Blue 26 with >= 0.1% Michler’s ketone/base will not be affected. Thus it is not clear that imposing this regulatory measure will have much impact on human exposure to Michler’s ketone/base. 	Thank you for your comment. 

In case the substance is identified as SVHC and later included, by ECHA, in a recommendation for inclusion into Annex XIV, a background document for this substance will be published by ECHA, summarising mainly 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.

On your comment requesting more detailed information on processes, RMM, and releases, please note that all the relevant information made available by the responding companies has been included in the A.XV report, part of it, due to its confidential nature, however in the confidential annex not available to the public.

Import of articles containing Basic Blue 26 with Michler’s ketone or Michler’s base ≥0.1% is indeed not directly affected by the authorisation requirement (in case the substance is later included in Annex XIV) and a restriction process has to be applied if there is a need to restrict such import. 

After the sunset date defined in Annex XIV for a given substance, ECHA has an obligation under Article 69(2) to consider whether the substance in articles poses a risk and, if yes, prepare an Annex XV restriction dossier. 

As regards the impact - of inclusion of the substance in the Candidate List - on human exposure to Michler’s ketone/base, we note that inclusion in the Candidate List would be expected to lead to a reduction in the uses of BB26 with MK or MB > 0.1% (due to increased awareness), thereby reducing the risks for workers involved in the formulation of inks or the use of inks for applications such as paper dyeing. In case of inclusion into Annex XIV, provided that it is not possible to determine a threshold for the carcinogenic effects of MK/MB, such uses could be authorised only where no suitable alternatives exist and the socioeconomic benefits of continuing the use would outweigh the risks.