Comments on ECHA’s Draft 9th Recommendation for 2-methoxyethanol (EC number: 203-713-7) and references to responses

The present document compiles the comments received during the public consultation on the draft 9th recommendation for inclusion of substances in Annex XIV of REACH for 2-methoxyethanol (EC number: 203-713-7). The public consultation took place between 5 September 2018 and 5 December 2018.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at https://echa.europa.eu/documents/10162/13640/9th_recom_respdoc_methoxy_ethoxyethanol_en.pdf). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

PUBLIC VERSION

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3297
2018/11/26	GE Healthcare AS,
Company,
Norway	As a consequence of the inclusion of 2-methoxyethanol on the 9th draft recommendation of priority substances to be included in Annex XIV of the REACH Regulation that was published on September 5th, 2018, we would like to ensure that ECHA is familiar with certain critical uses of 2-methoxyethanol.

We encourage ECHA to exempt from the authorization requirement the vital use of 2-methoxyethanol as a solvent in the synthesis and purification of two Active
Pharmaceutical Ingredients in X-ray contrast agents. 2-methoxyethanol is not part of the final products. It is obvious that for this key solvent used in the production processes, solubility, reaction selectivity, crystallisation selectivity and recoverability are important parameters to obtain the required product quality and output to meet the demand from the market.

Use descriptors for our use of 2-methoxyethanol:
SU 9 - Manufacture of fine chemicals
PC 29 -  Pharmaceuticals
PROC 0 – Other (use for tank storage)
PROC 2 - Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
PROC 3 - Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment condition
PROC 8b - Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 15 - Use as laboratory reagent
PROC 28 - Manual maintenance (cleaning and repair) of machinery
ERC 6a - Use of intermediate

In agreement with signed Strictly Controlled Conditions in declaration on Application for Customers.

Used 2-methoxyethanol from our processes are recovered on site and re-used in the same processes. The recovery rate has gradually increased over several years. Hence, the purchased volume per unit X-ray contrast agents produced has decreased. (Further details in the Confidential Attachment)

2-methoxyethanol is handled under controlled conditions. It is controlled by a series of
rigorous systems and risk management measures, including technical barriers, electronic
control systems, procedures, monitoring programmes and training requirements. The Occupational Exposure Limit (OEL) for 2-methoxyethanol governs our handling of the substance in all aspects. Control measurements at all potential emission points (e.g. sampling points) are conducted regularly as part of the occupational health monitoring programme at the site.

Regarding emission, control programme is implemented at the site to ensure that we
are within the approved limits at all times. All waste water (including minor amounts from the laboratories and from cleaning of production areas etc.) is collected through a common pump station where sampling is carried out for emission control. This ensures that accidental emissions into the draining system cannot reach the sea. Secondary containment is in place for all tanks in the tank farm including all tanks containing 2-methoxyethanol or 2-methoxyethanol mixtures.

A Programme is ongoing on site to ensure sustainable compliance with the IED EU Directive by the due date of June 2020. The utilisation rate of 2-methoxyethanol is currently about 99.1 %; via recycling, energy production and destruction by certified third parties. In this Programme, the majority of the remaining 0.9% will be abated with biological treatment. The plan is to complete the programme by June 2020, which will ensure compliance with the IED Directive.
	A.1.1.5. New information and next steps towards the final recommendation
C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01. Exempt use as solvent in pharmaceuticals with reference to Directive 2010/75/EU
C.2.02. Exempt use as solvent in pharmaceuticals with reference to Directive 98/24/EC
C.2.03. Request to exempt use as process solvent under strictly controlled conditions	
		
Confidential attachment removed
		
3309
2018/12/03	Ineos NV,
Company,
Belgium	See attachment	A.1.1.5. New information and next steps towards the final recommendation
A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.6. Socio-economic benefits of continued use
A.2.01. Questioning the grouping of ethoxy- and methoxyethanol
A.2.02. Urge ECHA to perform an RMOA before progressing with the authorisation process
A.2.03. claim that no other uses than as intermediate or process solvent happen
C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01. Exempt use as solvent in pharmaceuticals with reference to Directive 2010/75/EU
C.2.02. Exempt use as solvent in pharmaceuticals with reference to Directive 98/24/EC
C.2.03. Request to exempt use as process solvent under strictly controlled conditions	
		Attachment: 3309_Response to proposal for authorisation listing EGME - Final.pdf
		
3316
2018/12/04	Clariant Produkte (Deutschland) GmbH,
Company,
Germany	please see attachment	A.1.1.5. New information and next steps towards the final recommendation
A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.6. Socio-economic benefits of continued use
A.2.01. Questioning the grouping of ethoxy- and methoxyethanol
A.2.02. Urge ECHA to perform an RMOA before progressing with the authorisation process
A.2.03. claim that no other uses than as intermediate or process solvent happen
C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01. Exempt use as solvent in pharmaceuticals with reference to Directive 2010/75/EU
C.2.02. Exempt use as solvent in pharmaceuticals with reference to Directive 98/24/EC
C.2.03. Request to exempt use as process solvent under strictly controlled conditions	
		Attachment: 3316_Response to proposal for authorisation listing EGME_final 12-2018_CLA.pdf
		
3326
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	The substance 2-Methoxyethanol (also known as Ethylene glycol monomethyl ether (EGME) and Methyl Cellosolve) CAS 109-86-4 was identified as an SVHC and added to the REACH Candidate List on 15th Dec 2010 due to its Toxic for reproduction (Article 57C) properties and is currently in the 9th recommendation to be added to Annex XIV.
2-Methoxyethanol is an organic solvent and is typically used as a solvent in paints, printer inks, quick drying varnishes, dyes, enamels, nail polishes, wood stain, resins and as a solvent for cellulose acetate. It is frequently used as a solvent in primers applied to a surface prior to bonding with a Room Temperature Vulcanisation (RTV) silicone rubber adhesive to aid adhesion. It also has important aerospace uses as an additive in aircraft de-icing solutions and as a jet-fuel de-icer.
	A.1.1.5. New information and next steps towards the final recommendation

A.1.5.5. Availability of suitable alternatives	
				
3349
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of 2-methoxyethanol for inclusion in Annex XIV.	Thank you for your opinion.	
				
3365
2018/12/05	Norway,
Member State	The Norwegian CA supports the prioritisation of 2-methoxyethanol for inclusion in Annex XIV.
In general, the Norwegian CA supports grouping of substances of very high concern to avoid substitution with substances with similar properties within the same use categories.
	A.1.4.1. Relevant further considerations
Thank you for your opinion.	
				
3367
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of 2-methoxyethanol for inclusion in Annex XIV.	Thank you for your opinion.	
				
3390
2018/12/05	Hovione FarmaCiencia SA,
Company,
Portugal	We disagree with the principle of treating 2-methoxyethanol and 2-ethoxyethanol as a category and believe that each needs to be addressed individually.  The remaining uses of these substances are in applications where substitution is difficult and it is not likely that one can be substituted for the other.

We do not believe that authorisation is the most appropriate solution to address the few remaining uses of 2-methoxyethanol.  To our knowledge, a regulatory management options analysis (RMOA) has not been carried out for this substance.  We believe that ECHA should perform such an analysis to determine what the actual risks are from the remaining current (as opposed to historic) uses of this substance and to identify what are the most effective management options to address risks identified.  This should include all regulatory options available, including restriction and community wide exposure limits and not just authorisation.  The RMOA should also consider the effectiveness of existing voluntary industry measures to control the use and exposure to this substance.
We know from our supplier of the substance that the remaining current uses of the substance and volumes are quite different from the historic ones, and we know that he committed to update this information in the registration dossier soon.
The substance was prioritized for inclusion in Annex XIV with a Total score of 18 mainly due to the score on the Volume (score 12) with lower scores on Inherent properties (score 1) and Wide dispersiveness of uses (score 5). We think there is margin for other options to control and reduce the risk of use of this substance in the EU, namely with a review of the DNEL/OEL alongside the existing industry voluntary measures and regulatory measures or a restriction on use in conjunction with a revised DNEL/OEL.

This substance is used by our company as a solvent in the synthesis of an active pharmaceutical ingredient that is used in a proprietary life-saving drug that was approved by several Health Authorities in several countries (in the EU and outside the EU) and there is no alternative supplier/manufacturer for this API. The inclusion of 2-methoxyethanol in the Annex XIV could cause a serious fall of its production and difficult availability which could lead to a big risk in the manufacturing of active pharmaceutical ingredients causing potential disruption of medicinal products vital for the human health.
	A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.2.01. Questioning the grouping of ethoxy- and methoxyethanol
A.2.02. Urge ECHA to perform an RMOA before progressing with the authorisation process
B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3406
2018/12/05	AeroSpace and Defence Industries Association of Europe (ASD),
Industry or trade association,
Belgium		A.1.1.5. New information and next steps towards the final recommendation
A.1.5.5. Availability of suitable alternatives
B.1.2.2. Lack of alternatives, socio-economic aspects	
		Attachment: 3406_ASD input_on_2-Methoxyethanol and 2-Ethoxyethanol.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3297
2018/11/26	GE Healthcare AS,
Company,
Norway	A huge effort has been undertaken to identify substitutes for 2-methoxyethanol. However, after several years of development work it was finally concluded that it was not possible to find one single replacement for 2-methoxyethanol fulfilling all the criteria even if different solvents were selected for each of the process steps. It was however possible to use different solvent combinations to fulfil most of the criteria, but a significant amount of work remains before replacements can be implemented.

Major redesign of the production facilities is required to accommodate to the replacements. This will take time and require large investments for two products. A very challenging transition phase between old and new processes, with likely stops (possibly several months) of production at the time of transition due to final construction and validation work. This has major impact on the ability to meet product demand of Active Pharmaceutical Ingredients. Change of solvents and the associated changes in process conditions and purification methods will require pre-approvals from the medicinal authorities in all countries the products are sold in (more than 150 countries), which for many countries takes several years.

We estimate a realistic timeline for a replacement project to be 6 years. However, countries that have not approved the solvent change at the sunset date will not get any product as soon as the stock of old material has been consumed, i.e. they might face general healthcare impact.
	B.1.2.2. Lack of alternatives, socio-economic aspects	
		
Confidential attachment removed
		
3326
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	As with any product used in the aerospace and defence industries the time to fully qualify and industrialise an alternative, if any identified, is a very lengthy process. For such safety critical aerospace uses such as aircraft and jet-fuel de-icing the qualification time will be even longer	B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3390
2018/12/05	Hovione FarmaCiencia SA,
Company,
Portugal	Assuming that this substance might be included in the Annex XIV we have a strong need for very long review periods (>12 years) to guarantee the supply of the life-saving drug.	B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3399
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	The aerospace sector relies on surveys and encourages affected downstream users to collaborate in authorisation consortia (by joining or contributing) and voluntarily provide relevant data to third party consultants that aggregate the available data.  In the short 18 to 24 month timeframe after substance listing on Annex XIV and the Last Application Date, there is not always sufficient time to encourage enough supply chain actors to develop an accurate and comprehensive application.	B.1.1.3. ECHA's proposal for latest application dates

B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)	

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3297
2018/11/26	GE Healthcare AS,
Company,
Norway	It is our primary opinion that the current legislative status for 2-methoxyethanol should remain in place and consequently there is no need to add 2-methoxyethanol to the Authorisation list (Annex XIV). GE Healthcare handles 2-methoxyethanol in a safe and sustainable way and based on information from our suppliers has reason to believe that this also is the case for the other users in Europe.

An alternative approach would be to propose the use of a restriction measure to limit use of the substance to only those applications where the substance is handled or used under strictly controlled conditions.
	A.1.5.1. Potential other regulatory actions
A.1.5.4. Control of risks
C.2.01. Exempt use as solvent in pharmaceuticals with reference to Directive 2010/75/EU
C.2.02. Exempt use as solvent in pharmaceuticals with reference to Directive 98/24/EC
C.2.03. Request to exempt use as process solvent under strictly controlled conditions	
		
Confidential attachment removed
		
3326
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	See above.	C.1.3. Aspects not justifying an exemption from authorisation	
				
3390
2018/12/05	Hovione FarmaCiencia SA,
Company,
Portugal	2-Methoxyethanol is used by our company as a solvent in the synthesis of an active pharmaceutical ingredient (API) under controlled conditions. The API was approved by several health authorities and is used in a proprietary life-saving drug (medicinal product) in several countries (in the EU and outside the EU) and there is no alternative supplier/manufacturer for this API.
Medicinal products are subjected to a very exigent authorization procedure, which requires that the production process, raw materials used and their specifications are described in a dossier that was inspected and certified according to GMP and is very difficult to change after the approval has been granted.
The development, testing and the approval of medicinal products takes many years and is a very expensive process. It is because of that a PPORD can be extended for more 10 years (up to 15 years) according to REACH Regulation (Article 9 (7)) in the case of substances to be used exclusively in the development of medicinal products.

According to REACH Article 58 (2) “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled”.  In addition to the Directive on the protection of the health and safety of workers from the risks related to chemical agents at work (98/24/EC), which control exposure at work and define occupational exposure limit values, and the Directive on industrial emissions (2010/75/EU), which lays down rules designed to prevent or, where that is not practicable, to reduce emissions (into air, water, etc.), in order to achieve a high level of protection of the environment taken as a whole, the following regulations stipulated specifically for the manufacture of active pharmaceutical ingredients have to be observed:
•  Directive 2001/83/EC relating to medicinal products for human use and its implementation in national law through the Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients, ICH12 Q7 (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients), which specifically regulate and control the manufacturing process under the aspect of GMP.
•  ICH Q3C (Guideline for Residual Solvents) which defines maximum limits for solvent residues in active pharmaceutical ingredients (including for 2-methoxyethanol).
We think that in our case also there is an overlap of EU regulations and an exemption from the authorization requirement should be considered.

We believe that also there is scope to consider the use as process chemical/solvent exempt from authorisation.  There is existing binding EU wide legislation in the form of an IOELV for 2-methoxyethanol (introduced in 3rd ILV directive 2009/161).  This controls the risk of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV and therefore addresses the second bullet in section 3.3.1 of the ECHA consultation document.  We propose that this IOELV is reviewed as an alternative to authorization. It can be changed to a binding OELV and it can be reduced until 0,1 ppm (time-weighted average exposure limit 8h). A REACH Restriction to address the actual risks identified may also be considered as an alternative to the Authorization process.

In line with the OSPA Glycolether Charter, we sign each year a declaration to confirm that any exposures from use will be within regulatory occupational exposure standards (0,1 ppm, time-weighted average exposure limit 8h). The same stringently controlled use conditions for use as a process chemical are expected as for use as an intermediate. As part of the declaration, we confirm that substitutes are not viable for our application.
We believe that both ECHA and the commission should consider the effectiveness of these measures in a RMOA and based on the results of this, determine whether new regulatory measures would make any material difference in the uses and the risks arising from these uses, both in the context of current prevailing and possibly tightened future exposure limits.
Uses as an intermediate under strictly controlled conditions are exempted from authorisation.  We believe it would be both proportionate and consistent if industrial use as a process solvent under such similar stringently controlled conditions was exempted from further regulatory control based on the evidence of the effectiveness of existing measures.
	A.2.02. Urge ECHA to perform an RMOA before progressing with the authorisation process
C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01. Exempt use as solvent in pharmaceuticals with reference to Directive 2010/75/EU
C.2.02. Exempt use as solvent in pharmaceuticals with reference to Directive 98/24/EC
C.2.03. Request to exempt use as process solvent under strictly controlled conditions