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

Substance name:	1,2-bis(2-methoxyethoxy)ethane (TEGDME; triglyme)	
CAS number:	112-49-2	
EC number:	203-977-3	

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	
11	2012/04/12	International NGO
ClientEarth
Belgium	ClientEarth believes that all CMRs for which there is a likelihood of exposure to humans, including workers and the environment, must be phased out immediately. There is no doubt that all known CMRs are substances of very high concern and should be included in the candidate list.	Thank you for the support	
10	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 toxic to reproduction category 1 B. 	Thank you for the support	
8	2012/04/12	Member State
Austria	The Austrian Competent Authority supports the proposal to include 1,2-bis(2-methoxyethoxy)ethane (triglyme) in the candidate list of substances of very high concern. The substance is classified as Repr. 1B and meets the criteria according to Article 57(c) in REACH. Triglyme has the same toxic metabolite (2-methoxyacetic acid) as other glycol ethers already on the candidate list. As other glymes (like diglyme – already included in the candidate list) triglyme has aprotic properties and is used as special solvent. The inclusion of triglyme into the candidate list ensures that any possible substitution of diglyme with triglyme is avoided.	Thank you for the support	
7	2012/04/12	Member State
Finland	The Finnish CA agrees that TEGDME meets the criteria as SVHC according to article 57(c). We have only editorial suggestions. The substance is classified as a Repr 1B (H360 Df) according to CLP Regulation. The letter f and hazard statement: suspected of damaging fertility is missing from pages 7 and 12. TEGDME is included in Annex XVII (appendix 6) and is covered by entry 30 of the REACH Regulation. The classification limit for mixtures containing TEGDME is 0.5 % according to the Directive 1999/45/EC and from 1 June 2015 it will be 0.3 % according to CLP. 	Thank you for the support. 
Thank you for the comment. Regarding the C&L, only the C&L driving the SVHC identification was included in p. 7 and 12.  	
5	2012/04/11	Company

Germany	1,2-bis(2-methoxyethoxy)ethane (Triglyme) has highly desirable properties as a polar aprotic solvent (e.g. sufficient solubility of many inorganic reagents, enhanced reactions due to the solvent polarity, water miscibility, high boiling point, etc.). It is therefore frequently used in the chemical synthesis of Active Pharmaceutical Ingredients (API´s), associated intermediates and in the synthesis of fine chemicals. The lack of reactive functional groups makes it inert towards a broad range of reactants (e. g. Grignard reagents, organo-lithium compounds). Under this aspect Triglyme is superior to other aprotic polar solvents. Alternative feasible solvents with comparable properties have not been found so far.
Furthermore, Triglyme is used as part of absorption liquids in the industrial cleaning of waste gases (gas scrubber, e.g. absorption of sulphur dioxide from flue gas). It is an excellent absorbent for AGR (acid gas removal) or desulphurization processes, mercaptane absorption and VOC abatement.

Worker exposure: The great majority of uses of Triglyme are industrial and are in industries where control of exposure and contamination is well-understood and practiced. Good industrial hygiene and air quality are essential in these industries and we are not aware of any applications where there is a need for direct contact with Triglyme. Risks associated with the use of Triglyme are therefore adequately controlled.

Consumer exposure: Based on the OSPA Charter on Glycolethers inappropriate end-use applications are not supported by the OSPA member companies. To enforce this, member companies request annual declarations from all customers that Triglyme will not be used for products placed on the market for sale to the general public (e.g. household & consumer products, cosmetics etc.). The return of the completed and signed declaration form is a pre-requisite for the future supply of Triglyme. Consequently, the REACH registration dossier does not include use scenarios for consumer applications as these are not supported (e.g. use as component of brake fluids is not supported).
In addition to that Triglyme is listed in Annex XVII of REACH regulation (entry 30). According to this restriction Triglyme shall not be used in substances and preparations placed on the market for sale to the general public above the concentration limit of 0.3%.
Therefore, we conclude that the Annex XV dossier overestimates the use of Triglyme by the general public.  To the best of our knowledge all registrants have registered Triglyme for uses limited to industrial processes or uses by professional workers only.

As a consequence, the interdiction of use of Triglyme in industrial processes would limit the number of chemical reactions and would make the manufacturing of some active ingredients for pharmaceutical applications virtually impossible. Introduction of alternatives require extensive redevelopment of processes and associated authorization from health authorities.
In addition, tailor made solutions for many specific waste gas problems would become unavailable.

We suggest to exclude uses of Triglyme as synthesis solvent in organic chemistry and as component of gas absorption fluids in case of inclusion of Triglyme in Annex XIV or to evaluate the alternative of the restriction procedure for this substance for the uses identified as dangerous for workers and consumers. 	Thank you for these comments. 

Information on uses, exposure and alternatives will be forwarded for discussion on prioritisation.	
4	2012/04/11	Member State
Sweden	The Swedish CA agrees that TEGDME, being classified as Repr. 1B, meets the criteria according to Article 57(c) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for the support	
3	2012/04/11	Member State
Germany	The German CA supports the identification of TEGDME as SVHC.

All glycol ethers which are classified as Repr 1B should be put on the candidate list in order to prevent their possible use as substitutes for glycol ethers already identified as SVHC (see Risk Management ad hoc meeting Berlin 23/24 Feb 2012, presentation “Considerations for identification and prioritisation of SVHC candidates”).	Thank you for the support	
2	2012/04/11	Member State
Norway	The Norwegian CA supports that 1,2-bis(2-methoxyethoxy)ethane should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for the support	
1	2012/03/30	Member State
United Kingdom	It is difficult to come to a view on the need for further regulatory action or prioritisation for Annex XIV based on the level of information provided in the dossier.	Noted. Information on use, exposure and alternatives received during the public consultation will be taken into account for the prioritisation step.

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
11	2012/04/12	International NGO
ClientEarth
Belgium	Since the substance has a harmonised classification as Repr. 1B, H360D, the justification part is not needed but a reference to the entry in Annex VI of the CLP Regulation would have been sufficient.  	Basically it’s correct, but the added information should help during the prioritisation step.	
6	2012/04/11	Member State
Ireland	1,2-bis(2-methoxyethoxy)ethane (TEGDME) is classified as Repr. 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 (c) of REACH.	Thank you for the support	
4	2012/04/11	Member State
Sweden	Page 7. Please note that the hazard code is H360Df.	Thank you for the comment. Regarding the C&L, only the C&L driving the SVHC identification was included in p. 7 and 12.  	
1	2012/03/30	Member State
United Kingdom	We agree that TEGDME meets the hazard criteria for inclusion on to the Candidate List.	Thank you for the support	

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	
11	2012/04/12	International NGO
ClientEarth
Belgium	The dossier give no chance to understand the tonnage in which this substance is placed on the market as it refers to a confidential Annex. Tonnage information must be provided in order to understand that the relevant substances have been prioritised. 	Tonnage information was not in the public annex XV dossier due to confidential reason.	
1	2012/03/30	Member State
United Kingdom	Section 1 – It would be helpful if there was more contextual information with the data provided on consumer exposure to enable assessment of its relevance to the  EU population.

1.3.2.1 – Little information is provided on current workplace risk management measures and why they not be providing adequate control. This information would be helpful in the prioritisation stage of the process.

Although a summary of the worker exposure data from the CSA’s have been provided in the confidential annex, insufficient detail has been included to allow evaluation of its relevance. 

Section 2 – Little information is provided on alternatives, their applicability and the risks.

Section 3 – Very little information is provided on the overall level and scale of risks to human health, both for workers and consumers to help with prioritisation of this substance for Annex XIV.

Section 3.2 – No risk characterisation is provided for either workers or consumers. This would be helpful to demonstrate the scale of the risks.	We agree on the fact that more information would be helpful. 

We rely on the public consultation to get more information on use, exposure and alternatives.