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

Substance name:	2-ethoxyethyl acetate	
CAS number:	111-15-9	
EC number:	203-839-2	

Reason of the submission of the Annex XV: CMR
Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table (RCOM) has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier. RCOM has not been agreed by the Member State Committee nor has the document been modified as a result of 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	
9	2011/04/07	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as toxic for reproduction 1 B.	Thank you for the support	
8	2011/04/07	Company
Belgium	Article 55 of the REACH regulation states that the purpose of authorisation is to control the risks from substances of very high concern and to replace them with suitable alternatives where this is technically and economically feasible.  It is clear from the evidence available that this process of replacement has already taken place.  There is no longer manufacture or import of the substance itself into Europe in commercial quantities.  It is also clear that there is a safe level of exposure to the substance that is without adverse effect.  We conclude that whilst this substance is a CMR, the negligible level of residual use do not make it a substance of high concern from a risk perspective.  We do not believe it would be a good use of ECHA and member state resources to spend further time on the substance (a conclusion also reached when the substance was evaluated under the Existing Substances Regulation) and believe a more effective and swifter approach to address any residual concerns would be for member states to work towards adopting the EU IOELV as soon as possible.	2-Ethoxyethyl acetate clearly fulfils the SVHC criteria laid down under article 57. This is the basis for the inclusion of the substance in the candidate list. 

The aim of the authorisation title under REACH is to substitute substances with SVHC properties. The identification of such substances does not depend on the degree of risk arising from the uses. 	
7	2011/04/06	Member State
Norway	The Norwegian CA supports that 2-ethoxyethyl acetate should be identified as a substance of very high concern and should be included in the Candidate list	Thank you for the support	
6	2011/04/06	Member State
Netherlands	The NL-CA supports the proposal to include 2-ethoxyethyl acetate in the candidate list of substances of very high concern.
It can be understood from Annex XV report that the main concern for worker, via inhalation and dermal exposure. We agree with this opinion. 
	Thank you for the support	
5	2011/04/06	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	2-EEA has not been registered by any company until the end of the first registration dead-line. No producer / importer will manufacture / import this CMR-substance above 1 ton per year. This suggests that 2-EEA is not important in the EU at the present time. (It should be noted that pre-registration resulted in a minimum amount of 10.000 t/a of this substance.) 
Also from a socio-economic point of view we support 2-EEA being identified as a substance of very high concern.
	Thank you for the support	
4	2011/04/05	Member State
Sweden	The Swedish CA agrees that 2-ethoxyethyl acetate, 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	
2	2011/03/29	Member State
Germany	The SVHC proposal for 2-ethoxyethyl acetate is supported by the German CA, because the substance meets the criteria of REACH Art. 7(c) based on its classification as toxic for reproduction.  	Thank you for the support	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of 2-ethoxyethyl acetate as a SVHC.	Thank you for the support	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
8	2011/04/07	Company
Belgium	DNEL DERIVATION (p22):  We agree with use of the SCOEL derived IOELV in place of a DNEL.  This indicates that there is an exposure level for this substance that can be deemed as safe.	Noted	
3	2011/04/04	Member State
Ireland	2-ethoxyethyl acetate 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	
2	2011/03/29	Member State
Germany	Identity of the substance and physical and chemical properties:

Concerning the substance identity in the IUCLID File only the CAS number is given for the impurity 2-ethoxyethanol. No IUPAC Name, molecular and structural information are given. Furthermore InChl codes of the most reference substances are missing. 

Page 8:
Explosion limits in air are an important safety characteristic and the data should be included in table 5 "Flammability". The explosion limits in air are:
Lower explosion limit (LEL): 1,2 vol%,
Upper explosion limit (UEL): 10,7 vol% 
and lower explosion limit (LEL): 65 g/cm³
upper explosion limit (UEL): 585 g/cm³.
(Reference: CHEMSAFE (2009): Database that contains safety characteristic data for fire and explosion prevention, evaluated and recommended by experts at BAM and PTB. CHEMSAFE is a joint project between BAM (Federal Institute for Materials Research and Testing, Berlin), PTB (Physikalisch-Technische Bundesanstalt, Braunschweig) and DECHEMA (Gesellschaft für Chemische Technik und Biotechnologie e.V., Frankfurt am Main)

Human health hazard assessment:

Section 3.1:
It should be mentioned here, that the OEL derived by Sweeney et al. (2001) which concerns workplace exposure, might not be protective for the general population and for consumers, because (I) it does not regard dermal exposure and because (II) the 95th percentile was used to calculate the uncertainty factor for intraspecies pharmacokinetic differences which might not fully regard sensitive subpopulations of the general population.	For the impurity “2-ethoxyethanolformate”, only the CAS number is given, as no other information could be find on this impurity. The list of impurities was taken from the RAR of 2-EEA (EU-RAR, 2008) (for the impurity 2-ethoxyethanol, more information is given in the IUCLID file). 

Thank you for the information on explosion limits. It will be included in the support document.  

It is noted.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	2-ethoxyethyl acetate is included in the Trade Union Priority List for REACH authorisation.
see http://www.etuc.org/a/6023
	Thank you for the information. 

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	2011/04/07	Company
Belgium	VOLUMES (p12): We note that no registrations were received for this substance and this agrees with our knowledge of the current uses of glycol ethers.  We urge caution in interpreting Classification and Labelling notifications as evidence of current significant use unless it can be confirmed that these have not been received from suppliers of laboratory chemicals making precautionary notifications.
USES (p14): The information on uses in France needs to be treated with caution.  The data collection period for the AFSSET report cited was 2000-2006.  However, since imports of ethoxyethyl acetate did not cease until 2002, and formulated products may have remained in supply chains beyond this point, uses and exposures gathered over this period will not reflect uses in 2011.
EXPOSURE (p21): The conclusion that there is a risk to workers (p23) seems to be primarily based on limited data from France (8 measurements from uses in screen printing).  However, as indicated above, these were taken over the period 2000-2006 when there was still imported substance on the market and almost certainly inks containing the substance still clearing supply chains.  We do not believe there remains any use in this application.  It should also be noted that whilst the quoted exposures are above the IOELV they are within the national limit for France cited in table 15.
INFORMATION ON ALTERNATIVES (p21):  Where substitution is technically or economically feasible, this has already been carried out as shown by the virtual disappearance of manufacture and use over the past two decades.	Thank you for these comments. 

Information on volumes, uses and exposure will be forwarded for discussion on prioritisation. 	
5	2011/04/06	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	p 18
Today 2-EEA is restricted to professional users. Because 2-EEA is toxic to reproduction there is urgent need to include this substance into the authorisation regime. The same is true for consumer products since low concentrations of 2-EEA are still legally present in every day goods.	We agree.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	2-ethoxyethyl acetate is among the substances or group of substances related with recognised occupational diseases(encephalopathies or polyneuropathies due to oganic solvent)
see Annex I from Commission Recommendation (19/09/2003) concerning the European schedule of occupational diseases C(2003)3297 final	Thank you for the information.	

Attachments

Comment number	Public attachment	Confidential attachment	
10	
Comment 10 attachment (20015-2011- ECHA_Gifas-ethoxyethyl acetate.pdf).pdf		
11	
Comment 11 attachment (20015-2011- ECHA_Gifas-ethoxyethyl acetate-draft 0.pdf).pdf