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

Substance name:	Methoxy acetic acid [MAA]	
CAS number:	625-45-6	
EC number:	210-894-6	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Repr. 1B (Art. 57 (c)) and equivalent level of concern (Art. 57(f))

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. 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. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

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	
15	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the nomination and adoption of this chemical to the candidate list.	Thanks for this support.	
14	2012/10/18	European institution
European Chemicals Agency
Finland	Methoxy acetic acid (MAA; EC 210-894-6) is proposed to be identified as SVHC in accordance with: 
-	Art. 57 (c) as being toxic for reproduction
-	Art. 57 (f) as giving rise to an equivalent level of concern because of its endocrine disrupting properties and scientific evidence of probable serious effects to human health and the environment

Whereas it is evident that the conditions for SVHC identification set out in Article 57 (c) are met on the basis of the classification of the substance as toxic for reproduction (Repr. 1B) in Annex VI of the CLP Regulation, we consider discussion necessary as to whether additional identification as SVHC in accordance with Art. 57 (f) is appropriate. 
The data presented in the Annex XV report on the endocrine disrupting properties and in support of the equivalent level of concern case seem to indicate that the adverse effects elicited by the supposed endocrine disrupting mode of action of the substance all belong to the hazard class “reproductive toxicity”. Hence, the concern caused by the endocrine disrupting mode of action appears already to be covered by classification of the substance as toxic for reproduction (Repr. 1B) and the proposed SVHC identification on the basis of REACH Article 57 (c). No further SVHC identification on the basis of “equivalent concern” in accordance with Article 57 (f) appears to be necessary or possible.

Nevertheless, if the proposal to identify the substance in accordance with REACH Art. 57 (f) is maintained, we further would suggest to expand the justifications for the two following issues:
1.	Regarding the proposed identification of the substance as giving rise to an equivalent level of concern for the environment, it appears that this proposal is not supported by sufficient evidence to justify this concern. The sole statement “since numerous mammals are part of the environment a similar degree of concern applies also for the environment” does not provide enough such evidence. 
2.	Two in vivo studies used as important evidence to conclude on the endocrine disrupting properties of MAA have been performed with ethylene glycol monomethyl ether (EGME). Although it is stated that EGME is a metabolic precursor of MAA and that it is the latter substance that is eliciting the endocrine effects it does not seem to be sufficiently substantiated in the Annex XV report that this is indeed the case and that the effects observed were not caused by the parent compound EGME or any other possible transformation product. 

From considerations brought forward in Annex I to the Annex XV report it appears that you are concerned that the current generic limit for classification of a mixture containing MAA of 0.5% (0.3% from 2015 on) is not low enough to exclude risks to human health arising from uses of such mixtures. If this is the case we would suggest to consider submission of a proposal in the context of the CLP Regulation to lower the concentration limit for MAA in mixtures to a level deemed appropriate.
	We noted the comment that further discussion on the identification as SVHC in accordance with Art. 57 (f) in addition to Art 57 (c) was consider necessary. 

This proposal is in line with the recommendation resulting from the discussion and analysis in the project commissioned by the European Commission, DG Environment as presented in the report by Kortenkamp et al., 2011. 

Rationale for Art. 57 (f) in this proposal:
1)	All applicable Article 57 (a-f) properties should be identified
2)	Art. 57 (f) should be used to identify ED (Even if the effects are classifiable under CLP and can be identified in parallel under REACH Art. 57 (a-c)):
•	Additional concern due to the uncertainty in quantifying risk and setting the safe levels are not necessarily catered for by Art.57 (a-c) identification. 
•	The severity, irreversibility and/or long term character of effects are in this case equal to those identified under Art. 57 (c) for human hazard assessment. 
3)	Prediction of the “full added value” of Art. 57(f) in comparison to Art. 57(c) in the terms of risk management is at present not possible.
Specific provisions concerning the authorization process may later on apply for substances identified under Art. 57 (f) as having ED properties– c.f. REACH Article 138.7 (Commission review). Due to the uncertainty in setting safe levels, risk management decisions  for substances with ED properties in e.g. authorisation may not be based on the adequate control route (Art. 60.2) but instead require socio-economic analysis and the Art. 60.4 decision route.
4)	Identified “added value”
•	The lower mixture limit of 0.1% for authorization (instead of default classification limit(s) 0.5% / 0.3%) (Article 56.6)
•	Assessment of risk should reflects the uncertainties associated with ED mode of action, as the standard threshold approaches may underestimate the risk, potentially resulting in inadequate control of the risks
•	Environmental RA / RM due to ED properties not covered by Article 57(c)
•	Regulatory consistency in identification of all hazardous ED
•	Indirect consequences for authorisation of related substances (e.g. methoxyethanol metabolised to MAA)

Thanks for specific suggestions for justification. 

We noted the comment on the justification regarding the identification of the substance as giving rise to an equivalent level of concern for the environment. No changes were introduced at this stage as this could be considered as incorporation of evidence that was not available in the public consultation).

We noted the comment on the toxicological relation between metabolic precursor EGME and active metabolite MAA. This relation has been established and reported (e.g ECETOC, 2005). In the revised SD it has been further substantiated and referenced in the section concerning ED properties (previously provided in Annex I, toxicokinetics).

We noted the comment with the suggestion of the CLP proposal for the future consideration.	
13	2012/10/18	Member State
Norway	The Norwegian CA supports the Swedish proposal that Methoxyacetic acid (MAA) should be added to the candidate list as a SVHC according to REACH article 57 (c) and article 57(f). There is a harmonized classification for MAA for reproductive toxicity with Repr 1B, H360FD according to Regulation (EC) No. 1272/2008 (CLP) and Repr Cat. 2; R60 and Repr Cat. 2; R61 according to Directive 67/548/EEC (DSD).  This classification is in accordance with REACH Article 57(c) requirements. MAA is the first substance which is proposed as an SVHC due to its endocrine disrupting effects for humans. We consider that the information submitted by Sweden clearly shows the endocrine disrupting properties of MAA for humans and is considered in accordance with REACH Article 57(f) requirements. 	Thanks for this support.	
12	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Methoxy acetic acid as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thanks for this support.	
11	2012/10/17	National NGO
CHEM Trust
United Kingdom	CHEM trust supports the inclusion of these substances in the REACH candidate list according to 57 c) and f). 	Thanks for this support.	
10	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Methoxy acetic acid as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thanks for this support.	
9	2012/10/16	Company
Netherlands	As described on page 32, the methoxyacetic acid (MAA) SVHC proposal by the Swedish competent authorities seems to be intended to achieve two goals:
A.	To reduce the concentration limit of MAA for consumer products from 0.5 % to 0.1 % through the identification of this substance as an endocrine disruptor
B.	To see this as the first step for a subsequent authorisation requirement for MAA
Based on the information used in the Annex XV dossier, we consider that a SVHC proposal based on endocrine disruption and possible authorisation is a disproportionate risk management option for controlling potential risks to human health or the environment, and hence should be rejected.  We reach this conclusion for the reasons given in detail below but these can be summarised as: 1) Insufficient justification to identify MAA as a substance of very high concern because of its endocrine disrupting properties; and 2) No evidence of the existence of uses that would be subject to authorisation.	The comment has been noted.	
8	2012/10/16	Member State
United Kingdom	Overall, we can support identification of MAA as an SVHC according to Art 57(c) but not in accordance with Art 57(f). We are also of the opinion that more robust information on the non-intermediate uses of MAA should be obtained to substantiate the risks that are implied in the dossier. 

Given the low tonnages that are used in applications that are in scope for authorisation, it may be better to consider a targeted restriction for uses that create an unacceptable risk. If restrictions are to be considered, the assumptions used to generate modelled exposure estimates will need to be justified and the uncertainties discussed in detail. 	Thanks for this support.
Your further comments have been noted.	
7	2012/10/16	National NGO
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thanks for this support.	
6	2012/10/16	Member State
Belgium	The BE MSCA supports the proposal to identify this substance as SVHC as the proposals are all based on article 57 (c) of the REACH Regulation.). Moreover, Methoxy acetic acid has been proposed to be identified as a SVHC based on its endocrine disrupting properties, what is also supported by the BE MSCA.	Thanks for this support.	
5	2012/10/12	Member State
Germany	DE notices that – in contrast to the RMO document – an Annex XV-SVHC document has been submitted by SE not only according to REACH Art 57 (c ) (CMR / Repr. 1B), but also according to REACH Art 57 (f ) (equivalent level of concern because of endocrine-disrupting activities).

The German CA supports the proposed identification of Methoxyacetic acid (CAS No. 625-45-6) as a Substance of Very High Concern according to Article 57(c).
We are currently still evaluating the possibility of identifying the substance as SVHC according to Article 57(f) (ED for human health).	The comment on RMO has been noted. For the update of RMO please see presentation RIME-2.

Thanks for this support.	
4	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC. 	Thanks for this support.	
3	2012/09/26	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.	Thanks for this support.	
1	2012/09/19	International NGO
ChemSec
Sweden	We support the inclusion of MAA in the candidate list. We also support the idea to flag additional problematic properties such as endocrine disruption in this case in order to be able in later regulatory stages take proper decisions and actions building on this flagged property.	Thanks for this support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
16	2012/10/18	Member State
Ireland	No comment. 	The comment has been noted, thank you.	
			CONFIDENTIAL attachment removed. 		
13	2012/10/18	Member State
Norway	The data presented in the Annex XV report on MAA clearly identify that MMA can interfere with the endocrine system. The development of criteria for the identification of endocrine disrupters is ongoing in EU for the inclusion in REACH, in the pesticide regulation and biocide regulation. Since the EU criteria is not established  yet, references is given in the SVHC proposal to the OECD Guidance document on standardized test guidelines for evaluating chemicals for endocrine disruption. This approach is supported. In vitro assays performed on MAA provide mechanistic data that support an endocrine mode of action. Both estrogenic and androgenic activity was reported. Furthermore, in vivo assays clearly show that MAA alters estrogen and androgen receptor expression, as well as induce adverse effects on endocrine-relevant endpoints including effects on endocrine-relevant endpoints such as fertility impairment and developmental toxicity. Endocrine disrupting effects of MAA were reported in all five levels in the OECD Conceptual Framework for the Testing and Assessment of Endocrine Disrupting Chemicals. 	Thanks for this support.	
11	2012/10/17	National NGO
CHEM Trust
United Kingdom	The endocrine disrupting properties of this substance are well described in the dossier. We also welcome the nomination based on both articles 57 c) and f) .	Thanks for this support.	
9	2012/10/16	Company
Netherlands	As noted in the proposal, MAA has a harmonised classification under Regulation (EC) No. 1272/2008 (CLP) as toxic for reproduction (1B).  This corresponds to a classification under Directive 67/548/EEC (DSD) as toxic to reproduction, category 2.  The proposal is that MAA is identified as a substance of very high concern because of its endocrine disrupting properties and scientific evidence of probable serious effects to human health and the environment, which give rise to equivalent level of concern according to Article 57 (f) of Regulation (EC) 1907/2006 (REACH).
According to the guidance for the preparation of an Annex XV dossier on the identification of a SVHC, specific criteria should be included in the dossier given the nature of the “complexity of the possible mechanisms and effects of endocrine active substances”.  The claim of endocrine disrupting properties for MAA is based on a discussion of the possible mechanisms of the observed reproductive toxicity in mammalian species based on reproductive and developmental toxicity tests with MAA and the metabolic precursor of MAA, ethylene glycol monomethyl ether (EGME).  The data presented do not clearly demonstrate that MAA displays specific endocrine-disrupting properties that lead to the effects on reproductive and developmental toxicity in mammalian species.
Specifically, the guidance document indicates that the following factors should be considered when evaluating the available data.  Reponses to each with respect to the dossier are included.
1.	The balance of positive and negative responses observed in both in vitro and in vivo assays.

A thorough evaluation and discussion of both positive and negative data have not been presented.  This makes evaluation of the relevance of the presented studies more difficult in light of the limited presentation of only data showing “positive” effects.

2.	The nature and range of the biological effects observed in assays intended to identify and characterize hazards.

The data that are presented do not clearly support a potential endocrine mode of action for the adverse effects on reproduction that have been observed in experimental animals.  Inferences are made that, because effects are observed on oestrogen and androgen receptor levels in reproductive tissues and/or in vitro test systems, the effects on reproduction and development are due to those changes.  However, there is not a clear correlation between the effects observed in the in vitro and in vivo mechanistic studies and the effects observed on reproduction and development.  For example, in developmental toxicity studies, EGME, a MAA precursor, causes increased embryo/foetal mortality, decreased foetal weights, increased skeletal and soft tissue abnormalities, and cardiovascular malformations; however, these effects are not consistent with the effects on the endocrine system that are reported within the dossier.  The limited number of mechanistic studies is not sufficient to draw a conclusion of endocrine disruption as the mode of action for the reproductive and developmental effects caused by MAA.  In addition, the exposure scenarios that are used in the in vivo mechanistic studies (i.e., intraperitoneal injection) are not relevant routes for human exposure, and both the in vitro test concentrations and in vivo dose levels are typically very high.  As such, these studies are not sufficient to draw conclusions regarding the mechanism for the reproductive and developmental effects observed in the in vivo tests with MAA and/or EGME.

3.	The shape of the dose response curves when available.

As mentioned previously, the in vivo studies presented were not performed using a relevant route of exposure, and the doses employed in both the in vitro and in vivo assays represent very high exposure levels under abnormal dosing scenarios (i.e., intraperitoneal injection for the in vivo studies) that do not reflect potential exposure scenarios.  Doses that were employed in the in vivo mechanistic studies presented in the dossier were typically 1/3 to ½ of the oral LD50 value, and far in excess of levels that induced reproductive or developmental toxicity by the oral route of administration.  Given that dosing in the mechanistic studies was by the intraperitoneal route of exposure, the doses employed in the in vivo mechanistic studies are excessive and would be expected to induce overt toxicity that would confound interpretation of true endocrine-mediated effects.  In addition, mechanistic data presented do not illustrate a relationship between dose in the mechanistic studies and effects observed in the in vivo reproduction studies.

4.	The presence or absence of responses in multiple taxa.

Data supporting effects in other taxa are not presented, and inferences to possible effects on non-mammalian species are made based on the data from mammalian species
The assessment of endocrine disrupting properties giving rise to equivalent level of concern according to Article 57(f) is proposed in the absence of agreed criteria for completing such assessment.  Several Member States and ECETOC have been proposing various assessment concepts as a contribution to the development of objective and science based criteria to identify substances of regulatory concern in this context.  Weight of evidence approaches and how to address factors such as adversity, specificity and potency are among the scientific aspects currently being considered by a Commission expert group.
KEMI’s finding to support the proposal of a similar degree of concern for the environment is based on the concern from the data on toxicity to mammalian species but does not include an assessment of population relevance, specificity, and potency.  The environmental hazard assessment is marked as not relevant for the dossier and data on environmental fate and effects are absent.
The discussion about the uncertainty associated with assessing safe exposure levels and that it is not clear whether threshold levels can be established for endocrine disruptors is a general statement that should not be relevant for the identification of a specific substance as an endocrine disruptor.  This matter and the related provisions concerning the authorisation process are subject to review by the Commission who, pursuant to Article 138(7) of REACH, is currently reviewing whether to extend the scope of Article 60(3) to substances having endocrine disrupting properties.
Hence we conclude that the current classification of MAA as a reproductive toxicant adequately describes the hazard associated with this substance and that there is no justification for the additional identification of MAA as a SVHC based on endocrine disrupting properties.	We noted the comment. Please find responses below:

1) We do not agree. The intention was that the overview on all identified effects related to ED was presented. As an example the cases of “uncertain relevance” were also discussed.

2) The inferred mechanistic link between an ED MOA and the adverse effects on reproduction is supported by e.g. the reference describing the link between MAA-induced changes in stage-specific expression of AR in Sertoli cell and apoptosis of spermatocytes in rats (Tirado et al., 2003). No study clarifying the specific correlation between the presented MAA ED and the developmental effects has been identified. Considering the reported molecular mechanisms of MAA action (e.g. inhibition of histone deacetylase and MAPK signalling, ER and AR receptor modulation) multiply mechanistic pathways are likely to play a role involving directly or indirectly endocrine system. However those links are not well investigated. 

We agree that route of administration used in some studies (i.e., intraperitoneal injection) are not relevant routes for human exposure. However as described in the dossier (section 4.1) studies on toxicokinetics with oral and inhalatory exposure to MAA (or EGME) show systemic distribution. It is therefore considered that mechanistic studies with i.p. route are relevant to establish MOA.

3) The information on the dose response curves for the mechanistic studies was very limited or not available. However this limitation was not considered critical for this proposal. 

4) We understand that current justification for the environment is considered not sufficient (see also response to ECHA’s comment).

8	2012/10/16	Member State
United Kingdom	Human health hazard assessment

1)	Pg 6 - Please describe scenario A of the OECD GD 150.
2)	Pg 7 – It is unclear to us why with MAA meeting the criteria in Art 57(c), it is also proposed to consider Art 57(f), especially when there are no agreed criteria in the EU to identify endocrine disrupters (EDs). Do you consider the postulated ED effects of MAA more serious than its reproductive toxicity effects? Since the ED effects of MAA are the underlying mechanism of action of the reproductive toxicity effects, are you not considering the same effects twice?
3)	 Pg 7 – It is stated that it is not clear whether threshold levels can be established for all hormone-mediated adverse effects of EDs. We would like to point out that the evidence in support of this statement is very weak and widely contested. In our opinion, important regulatory decisions should not be based on unsound science. We also find that there is a contradiction between this statement and the risk assessment approach taken in Annex I where a DNEL has been derived for MAA.
4)	Pg 10 – section 4.1 – What is the TEDX List of Potential EDs? Who produces this list? And how?
5)	Pg 11 – section 4.1 – The mechanistic ED in vitro and in vivo studies have not been described in sufficient detail in the dossier for us to judge whether they are reliable and relevant. We note that they all are non-validated tests which use non-standardised techniques/methods.
6)	Table 8 – In vitro OECD Level 2 studies – Excluding the studies already being considered of uncertain relevance by the submitter, there remain 4 studies which have all investigated a variety of different parameters. These studies have shown very marginal responses (despite MAA being a very potent reproductive toxicant) or effects of unclear significance (e.g. how inhibition of HDAC indicates that expression of ER or AR is affected?).
7)	Table 8 – In vivo OECD Level 3 studies – These studies have also investigated a variety of different parameters in different tissues under different conditions, such that consistency and repeatability cannot be assessed. No details on the magnitude of the effects have been provided and in one case, the response did not reach statistical significance.
8)	Overall, on the basis of the evidence presented in the dossier, there are some indications of an ED MOA; however, when taking into account the variety of parameters investigated, the lack of consistency, the marginal degree of response observed and the use of non-standardised methodologies and non-validated tests, we consider that the evidence in support of an endocrine disruptive potential of MAA is inconclusive.
	Thank you for specific comments, please find responses:

1) Explanatory footnote was added:
“Scenarios (A-R) - each scenario is representing a different combination of assay results, existing in vitro data, and existing in vivo data. Scenario A describes the case when the level of suspicion about endocrine disrupting action is high.”

2) For the clarification of rationale of identification as SVHC under Art. 57 (f) in this proposal, please see the response to ECHA’s comment. Additionally, in response to the consideration of effects twice, reference can be made to the analogical situations foreseen for substance(s) identified under Art. 57 (a) and Art. 57 (b); or Art. 57 (d) with T - toxic for reproduction and Art. 57 (c); or Art. 57 (d) with T- cancerogenic and Art. 57 (a). 

3) DNELs have been derived following the standard “threshold-based” approach. It was further pointed out “(...) the mode of action is associated with endocrine disrupting properties that cause additional uncertainty in the derivation of safe levels using the standard threshold approaches for risk assessment” (section 9 in Annex XV dossier). In line with this information, in the revised SD document following paragraph has been included in the section 8.3. “It needs to be noted that the mode of action of MAA is associated with endocrine disrupting properties that cause additional uncertainty in the derivation of safe levels that has not been accounted for in this DNELs derivation”.

4) Following information has been included in the revised SD footnote “TEDX (The Endocrine Disruption Exchange, Inc.) is the organization that focuses primarily on the human health and environmental problems caused by low-dose and/or ambient exposure to chemicals that interfere with development and function, called endocrine disruptors. The TEDX List of Potential Endocrine Disruptors is a database of chemicals with the potential to affect the endocrine system. Every chemical on the TEDX List has one or more verified citations to published, accessible, primary scientific research demonstrating effects on the endocrine system. To date (October 13, 2011) there are approximately 870 endocrine disruptors on the TEDX List”.

5) We note that different details level in this respect will be required by different readers. As the studies are publicly available and access to all published methodological details exist, we aimed to balance the degree of details presented in the report. No changes were introduced. 

6) And 7) Considering the complexity of the endocrine systems modulation it is not surprising that the varieties of parameters have been the scope of different investigations.

With the reference to the comment on the magnitude of effects in the mechanistic studies, in general no strait forward correlation between “magnitude” of mechanistic responses and “magnitude” of (adverse) effect has established for those assays. In this respect e.g. 2-4 fold potentiation of AR activation in vitro (Tirado et al., 2003) or increased AR expression coincident with apoptotic spermatocytes in vivo (Tirado et al., 2004), gives mechanistic explanation. Additionally some methodological aspects need to be considered for e.g. histological techniques (should one aim at strictly quantitative analysis). 

Furthermore it is at present not possible to draw conclusion on consistency of specific effects between different studies because of diversity of parameters being investigated.

8) We noted this comment. 	
1	2012/09/19	International NGO
ChemSec
Sweden	MAA is a classified CMR and has convincing evidence with regard to its endocrine disrupting properties. It should hence be included in the candidate list both regarding its CMR and EDC properties.	Thanks for this 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	
13	2012/10/18	Member State
Norway	Information from the Nordic SPIN database is included in the Annex XV dossier in table 9. Numbers for tonnage level and products for MAA are included in the table for Norway for year 2008 and 2009, however, we have some more information regarding the registered tonnage level of MAA and number of products in Norway from 2007, 2010 and 2011, see table below. 
Year	Tonnage MAA	Number of products
2007	3.3	        2
2010	0.8	        12
2011	0.7	        11	Thank you for this information. It will be taken into account later in the process.	
9	2012/10/16	Company
Netherlands	The Swedish CA fails to prove that MAA has any significant intended use for which the risk should be controlled through the authorisation process:  The REACH registration information shows that, although MAA is produced in large quantities, no intended uses outside the use as an intermediate under strictly controlled conditions (which is exempt for authorisation), have been registered.  Therefore, there are no registered uses that would be subject to authorisation.
Furthermore, KEMI has conducted risk assessments for supposed uses based on its own assumptions rather than referring to the data available in the registration database.  The validity of these risk assessments is open to major doubt. For example, the Annex XV dossier refers to uses identified in patent databases (Section 7.2.3), including a patent application dating back to 1960.  The presence of a safety data sheet for a product gives no indication of actual concentrations of substances within the ranges specified and does not mean that the product concerned is currently placed on the EU market.  Since potential authorisation could have significant consequences on the supply chain, any information used to support the Annex XV dossier should be based on recent and actual information, such as that provided in registration dossiers or responses to recent questionnaires if they were used.  It is not possible for companies or sector groups to provide accurate information on hypothetical uses if such uses do not exist.

As there is no evidence of intended uses of MAA that would be subject to authorisation, identification of this substance as a SVHC is therefore inappropriate.	The comment has been noted. 

Non-intermediate use has been confirmed in the informal industry consultation – questioner performed in 2012 

The substance is meeting the REACH criteria for identification as SVHC.	
8	2012/10/16	Member State
United Kingdom	Section 7.4, exposure estimation. To understand the exposure calculations it would be useful to have information on the reasons for selecting each input for the exposure modelling. Are these estimates considered to represent a realistic or worst case situation?

Scenario 1 – Release of methoxyacetic acid from a solid (rubber disk) air freshener. Is the applied amount of 4 grams intended to represent the amount of product that is expected to be released from the rubber disk over the course of 1 day or over the lifetime of the product? Is there any information from the manufacturer on the weight of methoxyacetic acid typically in the product and the expected lifetime for the product?

Scenario 2 – Exposure to methoxyacetic acid from use of a bathroom disinfectant product. Please can you state which models within ConsExpo were used to calculate inhalation and dermal exposures. We question whether it is realistic to assume 400 g of product is applied per event. How has the mass transfer rate of 0.292 m/min been determined? How has it been determined that 19 g will be applied to the skin? 

Scenario 3 – Professional removal of concrete. Although a high RCR was obtained, this is based on the assumption that the product contains up to 1% MMA. The concentration in the product is likely to be lower than this (CLP would require products containing >= 0.5% to be labelled as Repr 1B). It would be useful to determine more precisely the concentration of MMA in this product to clarify the risks to the user.  	Thank you for specific comments.
Please find below responses:

Scenario 1 – The 4 grams represents the amount of product per 1 day and per room volume 58 m3 that release the substance (estimation based on publicly available information concerning the use of products and default model values – representing worse case assumptions). Concentration of MAA 0.5% corresponding to the current regulatory limits was used. Considered as worse case assumptions.

Information on specific, typical MAA concentration in the product was provided by the manufacturer as confidential information. 

Scenario 2 – Estimation was based on the ConsExpo defaults for product databases: “cleaning and washing”, product categories “All-purpose cleaners”, default products: “liquid cleaner”, scenario: “application”. Specifically: Inhalation model: Exposure to vapour: evaporation. Dermal model: Direct dermal contact with product: instant applications. Considered as worse case assumptions.

Scenario 3 – The concentration limit of 1% was the basis for calculation due to the limitation of choices in the exposure model (ECETOC TRA, TRAM version 3).   The reported concentration of MAA is < 0.5%. 
The calculated RCR overestimate the risk of uses with concentration < 0.5% at least by the factor of 2.	
5	2012/10/12	Member State
Germany	P. 38 This substance is only registered as intermediate. Consequently, the registrant has not been obliged to supply a CSR with DNELs etc. 
The German CA questions the practice in this dossier of estimating such toxicological data by the submitting CA, mainly based on data of another substance, and then using this data to derive own DNELs, which in turn are used to estimate risks in scenarios that are partly hypothetical. In addition, several countries in the EU (including Sweden) have established OELs for the substance. These OELs can be regarded better surrogates for the DNEL than extrapolation of data from other substances.
The validity of the risk evaluations in the annex XV dossier is not clear. 	This comment was noted.
Part of the information provided seems unclear. To our best knowledge Sweden has not derived OELs for MAA. Only two nationally established limits have been identified: German occupational exposure limits list: DFG 5 ppm or 19 mg/m3; and Switzerland list 1 ppm / 3.7 mg/m3. 
National OELs can not, as a default, be used in place of workers DNELs. The documentation for those OELs have not been made publicly available therefore no comparative analysis between setting of those OELs and derivation of DNELs was performed. Furthermore OELs can not be used instead of consumer DNELs. 	
1	2012/09/19	International NGO
ChemSec
Sweden	This substance has several other uses than as indicated in the registration dossier:
Potential Applications and/or uses: Used in the manufacturing of plant protecting agents and pharmaceuticals. Can also be used as plasticizer and coloring agent, as auxiliary agent in the textile industry, and also as a flotation adjuvant.	Thank you for this information.
It is a limitation that references to the source(s) of information have not been provided.