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

Substance name: 2-methoxyethyl acetate	
CAS number: 203-772-9
EC number: 110-49-6

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Toxic for reproduction (Article 57c)

Disclaimer: Comments provided during public consultation are made available as submitted by the commenting parties. It was 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.

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, submitter type, country)	Comment	Responses	
5274
2019/04/18	Health and Environment Alliance (HEAL),
International NGO,
Belgium		Thank you for your support.	
		Attachment: 5274_HEAL-comments-2-MEA.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5272
2019/04/12	European Environmental Bureau,
International NGO,
Belgium	EEB supports the proposal to identify 2-methoxy ethyl acetate as SVHC according to Article 57c of the REACH regulation based on its harmonised classification as Toxic for reproduction category 1B (May damage fertility. May damage the unborn child). The substance is not registered under REACH, however it is notified under CLP and included in the SinList of Chemsec, which lists uses giving rise to widespread exposure. 2-methoxyethyl acetate should be added to the Candidate List to prevent it being used as substitute of other glycol ethers that are already identified as SVHC and included in the Candidate List.
	Thank you for your support.	
				
5274
2019/04/18	Health and Environment Alliance (HEAL),
International NGO,
Belgium	HEAL strongly supports the identification of 2-Methoxyethyl acetate as an SVHC. 2-MEA has already been identified as a 1B reprotoxic substance, fulfilling the criterion of Article 57(c).  This is unequivocal evidence for SVHC identification.  Moreover, two metabolites of 2-MEA, methoxyacetic acid and 2-methoxyethanol, are also categorised as reprotoxic 1B.	Thank you for your support.	
		See the corresponding embedded attachment in table 1 of Part I: 5274_HEAL-comments-2-MEA.pdf		
5277
2019/04/24	Glycol Ethers REACH consortium,
Industry or trade association,
Belgium	We do not disagree with the proposed addition of this substance to the candidate list based on the fact that it is metabolised to methoxyethanol and then methoxyacetic acid, both of which are listed SVHCs.  Our comments are related to the grouping approach proposed.
The comments made in the section “Identity and composition of structurally related substances (used in a grouping or read-across approach)” are potentially misleading and incorrect.  Whilst structural similarities clearly exist within the list of cited substances, this is not sufficient to infer similar metabolites (a fact that is acknowledged).  The glycol ethers (with a terminal hydroxyl group) are primarily metabolised through oxidation of the hydroxyl group to form the derivative alkoxyacetic acid. There is data available in the registration dossiers for the substances 2-(2-methoxyethoxy)ethanol (DEGME, EC 203-906-6), 2-(2-(2-methoxyethoxy)ethoxy)ethanol  (TEGME, EC 203-962-1) and 3,6,9,12-tetraoxotridecan-1-ol (TetraEGME, EC 245-883-5) to show that neither these glycol ethers, nor their derivative alkoxyacetic acids, exhibit any reproductive toxicity characteristic.  In contrast, the glymes metabolise significantly through cleavage of the ether linkage (via dealkylase), which in the case of the methyl glymes produces methoxyethanol and hence methoxyacetic acid.  It is the presence of this metabolite that gives rise to the reproductive toxicity of these substances.  Both DEGME and TEGME produce very small amounts of methoxyacetic acid during metabolism via this cleavage mechanism; in the case of DEGME ~1.1% of the dose and for TEGME ~0.5% of the dose.  Whilst there is no data for TetraEGME, the trend suggests even lower levels of MAA would be produced.  The metabolism data explains the slight and limited developmental effects seen with DEGME around and above the limit dose and the lack of developmental effects seen with TEGME in guideline and GLP studies in both rats and rabbits.  Robust study summaries of the developmental and reproductive toxicity studies are included in the relevant REACH registration dossiers.
We do not therefore think it is appropriate to include either TEGME or TetraEGME in the grouping table as the available data does not show them to share the same properties as the other substances listed.  At least it should be clarified that the joint REACH registrations for these substances indicate no classification and that no CMR classifications have been notified to the CL inventory.
Similarly, whilst we acknowledge that a classification proposal for DEGME has been submitted, this has not yet been put out for public consultation and certainly has not yet been agreed, so the official harmonised classification remains at category 2, which is the classification the consortium supports.	Thank you for your support to identify 2-methoxyethyl acetate as SVHC.

Thank you for your comments regarding the grouping. We have deleted this text section in Part I of the report. 
However, in Part II of the Annex XV report a related discussion can be found under subheading 11.1 Substances with similar hazard and use profiles on the Candidate List.	
				
5287
2019/04/26	CHEM Trust Europe,
National NGO,
Germany	CHEM Trust supports the inclusion of 2-methoxyethyl acetate in the REACH candidate list owing to its classification as reproductive toxicant 1B which fulfills the criterion of article 57 c).	Thank you for your support.	
				
5299
2019/04/29	Netherlands,
Member State	Given the structural similarities with other glycol ethers, as well as identical metabolic products, the entry of 2-methoxyethyl acetate in the Candidate List is supported to prevent regrettable substitution.	Thank you for your support.	
				
5313
2019/04/29	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of 2-methoxyethylacetat as an SVHC based on it being classified as toxic to reproduction 1B.	Thank you for your 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, submitter type, country)	Comment	Responses	
5274
2019/04/18	Health and Environment Alliance (HEAL),
International NGO,
Belgium	This compound is not registered in the EU, nor is there any evidence of production from the US EPA's Chemical Data Reporting system.  While it appears to be little used in Europe, the Asia-Pacific Chemical Inventory Search System reports it as being on the “Inventory of Existing Chemical Substances Produced or Imported in China”,  as well appearing on the registration lists of New Zealand, Taiwan, Korea, the Philippines, Canada, and Australia.  2-MEA appears for sale in large volumes on Chinese chemical industry websites.  Therefore, despite not being registered in the EU, there is potential for 2-MEA to be used in imported products.  Formal identification of 2-MEA as an SVHC -- the explicit criteria, which it clearly fills -- will send a clear market signal to manufacturers worldwide.	Thank you for your comment and information provided. 	
		See the corresponding embedded attachment in table 1 of Part I: 5274_HEAL-comments-2-MEA.pdf		
5277
2019/04/24	Glycol Ethers REACH consortium,
Industry or trade association,
Belgium	This substance is not registered under REACH and therefore it must be imported in volumes below 1tpa.  We are not aware of any manufacture of this product in the EU in volumes below 1tpa.  As it is not registered under REACH and, due to its classification, we do not believe it is likely to be used as a viable substitute for other SVHC glycol ethers, not least because there are other, lower toxicity solvents from the P series glycol ethers available as alternatives.  It is not a technically feasible alternative solvent for the glymes due to its poor hydrolytic stability (susceptibility to hydrolysis).  We therefore believe it should be a low priority for any further work.	Thank you for your comments and  the information provided. 

5278
2019/04/24	Germany,
Member State	There are a number of AfAs for Diglyme including AoAs. In order to predict whether 2-MEA will be relevant as a substitute for Diglyme in the future it might be beneficial to screen the AoAs for the relevance of 2-MEA. This might enable the SE CA to better judge its market relevance and possible prioritisation for Annex XIV.

With regard to the substitution of 2-MEA the DE CA would like to refer to the German Technical rule TRGS609 for hazardous substances which provides recommendations on substitutes, substitution processes and restrictions on the use of methyl and ethyl glycol and their acetates. https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/TRGS-609.html (in German)

Information on uses:
p.13 the German CA has no information on current uses of 2-MEA in Germany	Thank you for your comment and information provided.	
				
5287
2019/04/26	CHEM Trust Europe,
National NGO,
Germany	We welcome the approach of the dossier submitter to group 10 glycol ethers based on structural similarity and potential to form the metabolites methoxyacetic acid and/or 2-methoxyethanol (EGME). Some of these substance group members are already on the Candidate list. Moreover, bis(2-methoxyethyl)ether (diglyme) is already in Annex XIV and 2-(2-methoxyethoxy) ethanol is restricted.

2-methoxyethyl acetate might have similar uses (even if currently not registered) and regrettable substitution should be prevented. We therefore support the proposal to use a grouping approach for all glycol ethers for the inclusion in Annex XIV following the addition of 2-methoxyethyl acetate to the REACH candidate list.
	Thank you for your support.