COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC: PROPOSAL AND JUSTIFICATION

Substance name:	2-Ethoxyethanol	
CAS number:	110-80-5	
EC number:	203-804-1	

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 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. The table does not contain any confidential information.

General comments
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
13	2010-10-15	International NGO,
Health and Environment Alliance,
Belgium	We support the inclusion of  2-Ethoxyethanol on the candidate list on the basis of the information in the Annex XV dossier	Thank you for the support	
12	2010-10-14	National Authority,
RIVM,
Netherlands	NL supports the proposal to include 2-ethoxyethanol in the candidate list of substances of very high concern. 	Thank you for the support	
11	2010-10-14	National Authority,
Climate and pollution agency,
Norway	The Norwegian CA supports that 2- ethoxyethanol (CAS number 110-80-5) should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for the support	
10	2010-10-14	MS CA, UK	Although there appear to be industrial sectors where exposures exceed the recently established IOELV, it is too early to assess what impact this new legislation will have. It is also too early to assess the suitability of the operating conditions and risk management measures in the registrant’s exposure scenarios. Depending on the accessibility of information in registration dossiers to MS, we would suggest interrogation of the registration dossiers before any further regulatory action is considered. If MS cannot get sufficient information from registration dossiers then this substance should be considered for substance evaluation to confirm where 2-ethoxyethanol is used and the risk associated with these uses. 	EGEE clearly fulfils the SVHC criteria laid down under REACH article 57 and was prioritized by the EU-working group. It should therefore be included in the candidate list.
Although uses have declined, exposure of workers still takes place and was verified. Alternatives are available for a number of uses of EGEE. 
In our view, the objective of title VII of REACH is to substitute substances with SVHC properties, preferably by substances which are not SVHC. The identification of a substance with SVHC properties does not depend on the degree of risk associated with its uses. 
During the decision taking process under the authorisation additional data on the uses and exposure of the substance may become available from registration dossiers. These data should be used during the consultation and prioritization process.  
In case that there will be no registration for the substance, this fact will be taken into account in the Member States Committee on its proposal for inclusion of the substance into Annex XIV.     	
9	2010-10-14	International NGO,
WWF European Policy Office,
Belgium	WWF and CHEM Trust support the inclusion of 2-ethoxyethanol in the candidate list due to its reprotoxic properties.	Thank you for the support	
8	2010-10-13	International NGO,
International chemical secretariat,
Sweden	Full support regarding its identification as a SVHC.    	Thank you for the support	
5	2010-10-11	MS CA, Germany	The German CA agrees with the identification of 2-ethoxyethanol as SVHC. 	Thank you for the support	
4	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	We support placing of EGME on the candidate list and subsequently very soon in Annex XIV.	Thank you for the support	
3	2010-10-06	MS CA, Sweden	Sweden supports the proposal to identify 2-Ethoxyethanol as a substance of very high concern.	Thank you for the support	
2	2010-10-04	Company,
INEOS nv,
Belgium	INEOS nv was, to our knowledge, the last remaining manufacturer of 2-ethoxyethanol in the EU.  INEOS nv pre-registered the substance in order to allow it to phase out production in an orderly manner before 2010.  Production has now ceased and INEOS nv is not intending to proceed to a full registration of the substance.  To our knowledge there is no SIEF facilitator for the substance (to check!) and there has been no SIEF activity.  We know of no activity to prepare a registration dossier.  We therefore do not anticipate any registrations being submitted.  We therefore recommend that no further work is done on the dossier until after the 30/11/10 deadline and that the need to proceed further with the authorisation process should be reviewed after this date. 	EGEE clearly fulfils the SVHC criteria laid down under REACH article 57 and was prioritized by the EU-working group. It should therefore be included in the candidate list.
Although uses have declined, exposure of workers still takes place and was verified. Alternatives are available for a number of uses of EGEE. 
In our view, the objective of title VII of REACH is to substitute substances with SVHC properties, preferably by substances which are not SVHC. The identification of a substance with SVHC properties does not depend on the degree of risk associated with its uses. 
During the decision taking process under the authorisation additional data on the uses and exposure of the substance may become available from registration dossiers. These data should be used during the consultation and prioritization process.  
In case that there will be no registration for the substance, this fact will be taken into account in the Member States Committee on its proposal for inclusion of the substance into Annex XIV.     	
1	2010-09-04	Trade union,
European Trade Union Confederation,
Belgium	ETUC supports the inclusion of 2-ethoxyethanol in the Candidate List.	Thank you for the support	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
8	2010-10-13	International NGO,
International chemical secretariat,
Sweden	The classification is clearly justified due to its CMR properties and its wide dispersive use.	Thank you for the support	
6	2010-10-12	National Authority,
Health & Safety Authority,
Ireland	2-ethoxyethanol is classified as toxic for reproduction category 1B according to Regulation (EC) 1272/2008. Therefore, the Irish CA agrees that the substance meets the criteria as toxic for reproduction in accordance with Article 57 (c) of REACH.	Thank you for the support	
12	2010-10-14	National Authority,
RIVM,
Netherlands	In part 1 (Justification) information is provided on the substance (composition of the substance, classification and labelling, manufacture and use). However, an overall justification is not included, which would make part 1 more evident.	In the dossier the structure of the format is followed. From our point of view the sections “Proposal for identification” on p5 and chapter 6 of part I do give an overall justification.	
1	2010-09-04	Trade union,
European Trade Union Confederation,
Belgium	That substance is also included in the TU priority List for REACH Authorisation http://www.etuc.org/a/7479 	Thank you for the information.	

INFORMATION ON USE, EXPOSURE, ALTERNATIVE AND RISKS ON ANNEX XV SVHC

Substance name:	2-Ethoxyethanol	
CAS number:	110-80-5	
EC number:	203-804-1	

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 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. The table does not contain any confidential information.

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
14	2010-10-28	MSCA, France
	1.	Uses

The commitment of FIPEC members (French Federation of paints, inks, colors, glues and adhesives industries, FIPEC Convention - February 2004) completes the commitment of glycol ethers producers (OSPA Convention) and actions taken for several years to remove any use of glycol ethers classified as toxic to reproduction Class 2 into consumer products.
According to a French survey conducted by FIPEC in 2001 from members of all sectors, glycol ethers EGME and its acetate EGMEA, EGEE and its acetate EGEEA are no longer used in the manufacture of paints, varnishes, inks, colors, glues and adhesives. This doesn’t prevent their use in other sectors.

2.	Sectors of use and activities 

The list of relevant activities and industrial sectors where glycol ethers may be still used as solvent is as follows:
- surface protection by electrophoresis,
- painting of new vehicles, 
- car repair (body builders and painters),
- aircraft paint,
- screen printing (paper, cardboard, plastics),
- pad (watches, accessories for automobiles),
- offset,
- printing and coating of tin sheets (coil coating),
- coating of cans for food or other
- manufacture of paints and varnishes,
- paint structural steel in their manufacture,
- painting buildings,
- manufacture of printed circuit boards,
- dyeing and varnishing furniture,
- painting on plastics (hubcaps),
- hairdressers,
- housekeeping and maintenance,
- car washing,
- machining.
Uses of glycol ethers can also be considered as wide-dispersive. It is not know if EGEE and EGME are still used in for such activities. 

3.	Substitution and grouping approach. 

According to FIPEC a significant substitution occurs of glycol ethers of the E series (including EGEE and EGME) by non classified as CMR glycol ethers of the P-series (2PG1ME - 2PG1MEA, PGEE, etc.). To be noted that 1PG2ME 1PG2MEA are β isomers that are present as co-products (impurity) in the respective 2PG1ME and 2PG1MEA, at constant levels and stable in time, below the threshold of 0.5% threshold set by the regulation. Pure, these isomers are classified as toxic to reproduction category 2. 
The annex XV report didn’t state or study the potential substitution of EGEE and EGME in industrial solvents with other glycol ethers, which may also be identified as SVHC according their CMR classification, in a grouping approach. Amongst them their direct acetate salts EGEEA – CAS 111-15-9 and EGMEA - CAS 110-49-6 are very often reported in surveys of glycol ethers. 
According to FIPEC, substitutes of glycol ethers classified as toxic for reproduction category 2 such as EGDME (1-2 dimethoxyethane / ethylene glycol dimethylether - CAS 110-71-4), DEGDME (bis(2-methoxyethyl)ether, CAS 111-96-6) and TEGDME (1,2 bis(2 methoxyethoxy)ethane, CAS 112-49-2) have never been used in the formulations of products from members of FIPEC (sectors of paints, inks, colors, glues and adhesives). 
Other French surveys report the use of other glycol ethers in various sectors and activities but do not specify clearly their ability to substitute EGEE and EGME. 
	Thank you for this additional information. It will be forwarded for discussion on prioritisation and exemption of uses for the preparation of the entry in Annex XIV.

The need for grouping of potential substitutes of EGEE and EGME like other glycol ethers, which may also be identified as SVHC according their CMR classification is acknowledged. It should be noted that the Belgium CA is currently working on an RMO analysis, possibly followed by an Annex XV Dossier for the acetate salt EGEEA – CAS 111-15-9. 
	
8	2010-10-13	International NGO,
International chemical secretariat,
Sweden	Its wide dispersive use should be considered and render the substance priority in further prioritizations.  Uses: nitrocellulose, lacquers and dopes; cleaning agents, epoxy coatings, in varnish removers, cleansing solutions, dye baths; finishing leather with water pigments and dye solutions, printing inks and duplicating fluids, hydraulic fluid, Airplane fuel. Source: HSDB; OEHHA	Information on uses, exposure and release will be forwarded for discussion on prioritisation and exemption of uses for the preparation 	
5	2010-10-11	MS CA, Germany	Page 22: The German OEL has been changed recently to 7.6 mg/m3  
Page 27, Table 19 Firstly, we are not sure whether the values listed in table 19 are really meant to represent the LOD. Compared to exposure measurements given from France or other countries (e.g. a median value of 0.5 mg/m3) a LOD (or more precisely a LOQ) of 6.7 mg/m3 seems quite high and quite near to the German OEL of 7.6 mg/m3. Secondly, we would like to focus on the first row where 70 measurements are related to 95 workplaces. These values should be checked.  

Page 41: The report relates to the RAR draft 2008. Although the calculation of the critical exposure level (given in Table 28) was quite similar to the DNEL derivation, the DNEL should be mentioned and possible differences should be outlined.	Thank you for the information. 
The values listed in Table 19 refer to the LOQ and not by mistake to the LOD. 
Secondly, you are right, this was a mistake: 95 measurements relate to 70 workplaces. The same happened in the second row.

For the purpose of this dossier we believe that it is sufficient to refer to the critical exposure level.	
4	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	P39 There are still workplace measurements that lie above the critical exposure level of 3.6 mg/m3 for inhalation. Furthermore the limit of detection is still high. If there is hardly a way of measuring a critical exposure the precautionary principle is even more possible. Therefore the ongoing substitution of EGEE shall be accelerated by the authorisation process.	We agree.	
12	2010-10-14	National Authority,
RIVM,
Netherlands	The proposal contains calculations showing that the 0.5% limit as used for classification of mixtures and for authorisation (article 56.6b) is not protective for workers and consumers in case the critical exposure level for developmental toxicity (EU RAR, 0.72 mg/m3) is used as reference value. However, when the IOELV of 8 mg/m3 as derived by the SCOEL is used as reference value, the 0.5% limit would result in a safe situation (NL calculations). The reason for this difference is that the inhalation DNEL figure is lower than the IOELV (due to a different derivation method). According to the REACH guidance, Appendix R8-13, an IOELV may also be used,  nstead of developing a DNEL.	The IOELV of 8 mg/m3 (SCOEL, 2007) is based on a NOAEC of 190 mg/m3 from a developmental study in rats (Doe, 1984). 
The same study was the basis for the ciritcal exposure level of 0.72 mg/m3 derived within the European Draft RAR (2008), however, based on effects seen at 190 mg/m3 a NOAEC of 39 mg/m3 was used to derive this value. 
Within the REACH guidance document Chapter R.8 the recommendation to use IOELVs is not mandatory.	
1	2010-09-04	Trade union,
European Trade Union Confederation,
Belgium	That substance is causative agent for recognized occupational diseases in the EU, see: 1) Commission Recommendation 2003/670/EC of 19 September 2003 concerning the European schedule of occupational diseases: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003H0670:EN:HTML   The substances listed in Annex I are causative agents for diseases which have been scientifically recognised as being occupational in origin, which are liable for compensation and which must be the subject of preventive measures in all MS.     2) "Information notices on occupational diseases: a guide to diagnosis"  http://www.beroepsziekten.nl/sites/default/files/documents/Information-Notices-2009.pdf   This document contains additional information on entries listed on Annex I of the European Schedule of Occupational diseases.  	Thank you for the information.