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

Substance name:	2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)	
CAS number:	3864-99-1	
EC number:	223-383-8	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: vPvB (Art. 57 (e))

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

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

General comments on the SVHC proposal
No.	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
7	2013/04/18	International NGO
Health and Environment Alliance
Belgium	HEAL supports this substance being adopted as an SVHC	Thank you for your support.	
4	2013/04/18	Member State
United Kingdom	Please refer to our comments on UV-320	See there.	

Specific comments on the justification
No.	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2013/05/03	Member State Finland	We agree that these substances provide grounds for environmental concern due to their persistence (P), potential to bioaccumulate (B) and their toxicity. However, we are uncertain whether the information presented in the proposal regarding P and vB provides a sufficiently robust basis for their selection as SVHCs (PBT/vPvB).   

The conclusion P is based on monitoring data and read-across simulation test data on two substances (a phenolic benzotriazole (EC 407-000-3) and the benzotriazole structure). Care should be taken when using monitoring data as proof for persistence, because environmental concentrations depend on many factors such as releases and distribution, and because the detection of substances is defined by the sensitivity of the available analytical methods. Preferably some information on concentration trends is needed in order to be able to draw conclusions from monitoring data on persistence. The mere detection of a substance is not, as such, a sufficient basis to conclude P/vP. 

A simulation test with at least one of the substances should be obtained to provide a reliable environmental degradation half-life, together with clearer information about the fate of the metabolites. In addition, reliable physico-chemical data on key parameters (logKow,water solubility, adsorption/desorption co-efficients) are needed to back-up the weight-of-evidence judgement. In conclusion, it would be useful to obtain more information e.g., via substance evaluation to justify the proposal.

The Finnish CA considers that after inclusion of substances identified based on article 57 (e) in the candidate list it still needs to be further considered which risk management measures would be the most appropriate. The coverage of existing measures shall be taken into account.	Thank you for your comments. We regret that the presented weight of evidence was not enough to convince you. The assessment of the persistence of the four substances in question is based on a chain of arguments:
The substances fulfil the screening criteria for persistence, but simulation tests are lacking. Due to their high adsorption potential for soil and sediment they mostly will not be available for degradation. The monitoring studies support these findings. Of special relevance are the studies on the Pawtuxet River showing that even decades after production of the substances ceased considerable concentrations can be found, e.g., in lower sediment layers.
We also simulated a possible degradation pathway. This information is important to evaluate the relevance of the Read Across on the simulation studies of EC 407-000-3 and 1H-benzotriazole, which have vP-properties.
In summary we assess the remaining uncertainty on the persistence properties to be well understood and comparably small. Therefore we believe a water/sediment degradation study would not give additional information necessary to come to a regulatory conclusion. The delay due to the Substance Evaluation procedure would not be justified, especially considering the goals of the SVHC-roadmap 2020.
Please note that our assessment is in line with the assessment done by the registrant of UV-328. In this dossier a degradation simulation study was waived, since the available data were enough to assess that UV-328 has P and vP-properties.
In response to your comment on reliable physico-chemical data we agree that in general such data would be beneficial. In this case, however, due to the very low water solubilities of the substances in combination with their very high lipophily, ranges are the best what can be expected and therefore additional QSAR-calculations can be necessary. In regard to experimental physic-chemical data please also note the updated information on UV-328.

With regard to your comment on the best RMO-measure for 57 (e) substances we refer to our assessment in the RMO-analysis, which concluded the need for substitution via authorisation.	
8	2013/04/18	Industry or trade association
ASD
Belgium	None	Thank you for your comments. The question of available alternatives will become important if there will be an authorisation requirement.	
			See also:
Comment 8 attachment (ASD Letter.docx).docx		
5	2013/04/18	Member State
Norway	The Norwegian CA supports that 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol, (UV 327), CAS Number: 3864-99-1 should be identified as a substance of very high concern and should be included in the Candidate List based on the evidence that UV 327 is a vPvB substance in accordance with Annex XIII of REACH, thereby fulfilling the criteria in Articles (e). The fact that the four phenolic benzotriazoles were found in a variety of compartments and biota showing a wide spread occurrence confirms their properties of high concern. 	Thank you for your support.	
4	2013/04/18	Member State
United Kingdom	Please refer to our comments on UV-320	See there.	
3	2013/04/18	International NGO
ChemSec
Sweden	We fully support the identification of the substance as an SVHC
	Thank you for your support.	
2	2013/04/17	National NGO
CHEM Trust
United Kingdom	CHEM Trust supports the inclusion of this substance in the REACH candidate list according to article 57 e) due to its vPvB properties. 
We also welcome the fact that four structurally very similar UV filters have been proposed for nomination at the same time based on a well-documented read-across and Weight-of-Evidence-approach.	Thank you for your support and the feedback on our assessment strategy.	
1	2013/04/16	Member State
Belgium	*vP criteria
Belgium agrees that the substance fulfils the criteria for P and vP based on on a weight of evidence approach (not ready biodegradable, persistence in soil after cessation of production in a manufacturing plant, read-across…).

*vB criteria
Belgium agrees that UV-327 fulfills the criteria for vB. BCF values higher than 5000 were found in two bioconcentration studies. In addition, high BAF values were also reported. 

Overall conclusion: Belgium supports the proposal to identify UV-327  as SVHC, based on article 57(e) of the REACH Regulation (vPvB)	Thank you for your support and the detailed explanation for it.	

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

Specific comments on use, exposure, alternatives and risks
No.	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
8	2013/04/18	Industry or trade association
ASD
Belgium	Alternatives none quoted in dossier

We do not know if these substances have viable alternatives at this time, however the presence of UV stabilisers in the paint products that we use provide a critical role in the longevity of the external paint layer. Removal of such substances would have a significant effect on our products with a potential for re-qualification being required.	Thank you for your comments. The question of available alternatives will become important if there will be an authorisation requirement.	
			See also:
Comment 8 attachment (ASD Letter.docx).docx		
6	2013/04/18	Other contributor
Alliance for Cancer Prevention
United Kingdom	We support this substance being added to the SVHC candidate list, because of its endocrine disrupting properties. We are concerned about occupational exposures and also exposures in the home and workplace. Along with the issue of breakdown in waste water.	We are sorry, but this comment was probably intended to be given on another SVHC-dossier. Our proposal for SVHC-identification of UV-327 is not based on endocrine disrupting properties.	
5	2013/04/18	Member State
Norway	Information on use, exposure, alternatives and risks
We would like to call attention to the fact that according to the Annex VI of the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND THE COUNCIL of November 2009 the four phenolic benzotriazoles (UV 327, 320, 328 and 350) are not allowed as UV filters in cosmetic products intended for sale in the EEA. Moreover the compounds are not listed in the Commission's extensive database of cosmetic ingredients, see link http://ec.europa.eu/consumers/cosmetics/cosing/. However they might possibly be used as additives in some plastic packaging of cosmetic products. 

Of the four phenolic benzotriazoles proposed as SVHC only UV 327 is registered in the list of approved food additives in the REGULATION (EU) No 10/2011 on plastic materials and articles intended to come into contact with food of 14 January 2011 with a specific migration limit of 30 [mg/kg], see also link http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF	Thank you for the additional information. It will be respected for the decision on the most appropriate risk management option.	
4	2013/04/18	Member State
United Kingdom	Please refer to our comments on UV-320	See there.	

Attachment

Comment number	Public attachment	
8	
Comment 8 attachment (ASD Letter.docx).docx