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

Substance name:	1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TGIC)	
CAS number:	2451-62-9	
EC number:	219-514-3	

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. In addition, ECHA is not responsible for the content of the responses prepared by Member States.

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	
9	2012/04/12	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as mutagen category 1B.	Thank you.	
7	2012/04/12	Member State
Ireland	Section 1.2 of the Annex XV Dossier states that the available registration dossier for this CAS number, 2451-62-9, relates to a mix of two isomers, with an α:β ratio of approx. 90:10 and it is proposed that this Annex XV dossier “should cover all possible combinations of isomers independent of their individual concentration in the substance.” It should be confirmed that this CAS number covers all combinations of isomers.	Thank you. We have extended this sentence to: “The currently available Registration Dossiers refer to a substance with the α : ß ration of ca. 90 : 10 but this dossier should cover all possible combinations of isomers independent of their individual concentration in the substance, covered by the CAS number 2451-62-9.”	
6	2012/04/11	Member State
Sweden	The Swedish CA agrees that TGIC (a combination of two isomers), being classified as Muta. 1B, meets the criteria according to Article 57(b) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you.	
5	2012/04/11	Company
Japan	These comments are made by a REACH Registrant of TGIC.
We note a range of Regulatory actions currently ongoing and planned in relation to TGIC: namely this “PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR CATEGORY 1A OR 1B, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN” as well as a Substance Evaluation as scheduled for 2013 by the Polish Competent Authority.
We note that the document for the “PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR CATEGORY 1A OR 1B, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN” contains multiple historical references to use and exposure of TGIC which we consider to be outdated and to significantly overestimate exposure (pages 18-19).
We therefore consider (given our comments on Section II) that to ensure efficiency of regulatory reviews and avoid duplication of regulatory actions, that this “PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR CATEGORY 1A OR 1B, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN” should not be taken forward until the Substance Evaluation is undertaken in 2013.  This would enable a more definitive and accurate assessment to be made on safety of TGIC.  We would also suggest that should a wide dispersive use still be suspected, that consideration be given to use of Restrictions as a means to control the risk without adversely harming a whole industry, where other uses are tightly controlled.
	Thank you for your comments.
We understand your concern on two independent Regulatory actions ongoing for TGIC mixture of isomers. However, we consider these two routes complimenting and NL CA will proceed with current action.

We agree that exposure data given in non-confidential part of the Annex XV dossier are old. 
However, measured data given in CSR for TGIC mixture of isomers is only 2-3 years more recent. In addition modelled exposure data (taking into account PPE) given in CSR for TGIC mixture of isomers indicates risk for several life cycle steps. All this information is included in the confidential part of Annex XV dossier.

If you have any additional exposure data, you are welcome to update the Registration Dossier. All new information will be taken into account during the prioritisation process.
We have taken notice of your preference for the Restriction route.	
4	2012/04/11	Member State
Germany	The German CA supports the identification of TGIC as SVHC.	Thank you.	
3	2012/04/11	Member State
Norway	The Norwegian CA supports that TGIC (1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione) should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you.	
2	2012/04/06	Member State
Belgium	Belgium supports the identification of TGIC as SVHC according to article 57 (b)	Thank you.	
1	2012/04/03	Member State
United Kingdom	These comments apply to both dossiers for TGIC, we are only posting them the once.	Noted.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
7	2012/04/12	Member State
Ireland	TGIC is classified as Muta. 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 (b) of REACH.	Thank you.	
1	2012/04/03	Member State
United Kingdom	We agree that both forms of TGIC meet the hazard criteria for inclusion on to the Candidate List and that subsequent addition to Annex XIV is appropriate.	Thank you.	

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	
8	2012/04/12	Company
Switzerland	PAG 14
TGIC  uses in European semiconductor  manufacturing sites 
We have identified a specific use, although involving limited quantities, this use may lead to customers communication requirements, due to presence in articles
Sector of use (SU) SU 3	Industrial manufacturing  SU 16	Manufacturing of computer, electronic and optical product, electrical equipment
Chemical product category (PC) 	PC 33 Semi-conductor
Process category (PROC)	PROC 14 Production of  articles by tableting, and extrusion, Article category (AC) AC 2 Electrical  and electronic articles 

Quantity imported in Europe in 2011 84 kg of resin containing TGIC @ 15%, therefore adding to  12.6 kg of TGIC , used for manufacturing an article, the so called semiconductor device
Maximum nominal concentration in finished semiconductor devices being used in Europe or exported from Europe 6 % of TGIC 
	Thank you for your comments. We will include this information in chapter on uses of the substance in supporting document.	
5	2012/04/11	Company
Japan	As part of the Registration process we have subsequently undertaken a Chemical Safety Assessment on TGIC in which safety of supported TGIC uses was demonstrated.
However, (as we consider exposure data as presented on pages 18-19 to be outdated), we acknowledge the necessity to obtain occupational exposure monitoring data relating to the applications of TGIC in the European Union.  As part of an industry grouping we are therefore to undertake such a monitoring exercise and report this to support the planned Substance Evaluation for 2013. 	Thank you for this information. We will add to the updated document, which will be used by ECHA for prioritisation process, the following remark:
“TGIC mixture of isomers (CAS nr 2451-62-9) is also submitted for Substance Evaluation as scheduled for 2013 by the Polish Competent Authority. The Industry has recognized that the available worker exposure data is outdated, and acknowledged the necessity to obtain occupational exposure monitoring data relating to the applications of TGIC in the European Union. Therefore the Industry will collect monitoring data and report this to support the planned Substance Evaluation for 2013.”
	
1	2012/04/03	Member State
United Kingdom	Non confidential document

Section 1.2 – the use of very old (1994/1998) information and data could be misleading as it is likely to be out of date. Processes and exposure s are likely to be have changed. More up to date information (<10years old) is preferred.	Thank you for your comment.
More recent exposure data is not available. This fact is also acknowledged by the industry. Industry acknowledges also the necessity to obtain recent occupational exposure monitoring data relating to the applications of TGIC in the European Union.  Monitoring data will be made available to support the planned Substance Evaluation for 2013. See also Industry response in previous comment (number 5).	
			Non confidential document
Section 2.1.1 – Similar comment to above. The relevance of the older data to current practices is questionable. It would have been helpful to have more background information on the measurement data presented in Table 5 (see Chapter R.14 of the IR and CSA guidance) to help judge the relevance of the data for current situations	Thank you for your comment. Please, see our response above.

We can not provide more background information on the measurement data presented in Table 5, as it is simply not available.
Monitoring data will be made available to support the planned Substance Evaluation for 2013. See also Industry response in previous comment (number 5). We have added this information to this paragraph.	
			Non confidential document
Section 2.1.2 – there appears to be some confusion relating to OELs and which regulatory body has set them and what the numerical value of any limit is. The registration dossier quoted seems to believe that the US ACGIH limit applies in the EU. 
	Thank you for your comment.
The reference to US ACGIH limit has been deleted, and explanations that given values are national guidelines and not a SCOEL agreed value have been added.	
			Non confidential document 
Section 4 risk related information – The relevance of comparing very old measured occupational exposure data to different OELs is questionable. It might have been better to compare any recent measured or modelled data to a DNEL. It is not surprising that the modelled data are much lower than the very old measured data.	Thank you for your comment. 
We agree that drawing conclusion for the recent situation based on old data is questionable. We have replaced this paragraph with the information that the industry is planning to supply recent monitoring data.