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

Substance name:	N,N-dimethylacetamide (DMAC)	
CAS number:	127-19-5	
EC number:	204-826-4	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: CMR

Disclaimer: The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency. 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 result of the 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	
26	2011/10/13	National Authority
RIVM
Netherlands	The Netherlands supports the proposal to include N,N-Dimethylacetamide (DMAC) in the candidate list of substances of very high concern. 	Thank you for providing your opinion.	
25	2011/10/13	Company
Spain	CEPSA Química agrees that its use as ink remover in corrector liquid requires to be phased out, and will be included as “advice against use” in relevant documentation. 

Regarding the use of DMAC as a carrier in pharmaceutical and vererinary products, CEPSA Química wishes to remind that according Regulation 1907/2008, (REACH), article 2.5.a exempts the uses as human and veterinary medicinal products from regulation, evaluation, authorisation and restriction. Although CEPSA shares the concern, wishes to remind that these products are regulated by other mechanisms.  

p. 55  Where it is said “These limits were set to prevent the development of respiratory irritation in workers and do not take account of reproductive toxicity” (Section 1.6.1.3), CEPSA Química advises about a possible misunderstanding. These IOEL were established using inhalatory irritation based that at these levels (20 ppm 15 min 10 ppm at 8 hours). When DMAC was tested in theses range for toxic for reproduction by inhalation, efects on reproduction weren’t observed. Therefore it gives more significance to the established IOEL
	 Thank you for your comment and the information provided.

 Please see our response to comment #22 at the same (General comments) section.	
23	2011/10/13	Industry or trade association
Portugal	APEQ comments concerning the ECHA public consultation for identification of new 20 substances, as SVHC.
Please see attached document Refª Technical Note 013/2011	Thank you for your comment.

The substance is toxic for reproduction, Repr. 1B according to Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1. As a consequence the substance fulfils Article 57(c) of Regulation (EC) 1907/2006 (REACH) and can be identified as a substance of very high concern following article 59 of the same regulation.

 Thank you for the submitted information.
 Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.

As regards the impact of an inclusion of DMAC in the Candidate List on industry while alternatives may not be available, please note that, provided the substance is identified as SVHC and included in Annex XIV, information such as on the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use, as well as information on the low level of risk associated to a use, can be provided as part of an application for authorisation. This information will be considered by RAC and SEAC in developing their opinions on the application and be taken into account in the decision on granting or not the authorisation (Art. 64 of REACH Regulation). Arguments brought forward may have an impact on the decision to grant an authorisation for the use applied for, the conditions applicable, and on the length of the time limited review period of the authorisation.	
			See also:
Comment 23 attachment (NT 2011_013 APEQ Position _ECHA (20 Substances List)List_DMCA.doc).doc		
22	2011/10/13	Company
Belgium	p 14-15: It is stated that produced fibres contain residual amounts of DMAc up to 3%. On the nex page however, it is clarified that residual quantities in consumer goods are negligible. It would be better if this statement is also added on p14.
p16, 59: DMSO is listed as an alternative for DMAc. But according to the physico-chemical properties, this is not the case in most processes. DMSO has a higher boiling and melting point which is not favourable during production of fibres.
p16,60: DMI as alternative. Also for DMI, physico chemical properties are not ideal to replace DMAc. There is very little data available on DMI. Structural relationships to DMPU would however indicate that DMI could also have reprotoxic properties. In biodegradation screenings, it was concluded that DMI is not biodegradable. For environmental reasons, DMI would not be a suitable alternative.
p18, 22: DMAc as solvent in ink erasers: It was agreed in the reach consortium that this would be a "use advise against".
p22: use in pharmaceuticals. Use of DMAc in pharmaceuticals is not within the scope of REACH. Concerns about this use should be handled under the appropriate regulations. If this use would only be authorized under REACH, imported pharmaceuticals could still contain this product. If required, other regulation would be more relevant in this case.	 Thank you for your comment and the information provided.

Comments and information submitted on Part II of the Annex XV report may, where relevant, be considered at later stages of the risk management process.

As regards the use in pharmaceuticals, please note that according to Art. 2 (5 a) of the REACH Regulation, the provisions of Titles VII (Authorisation) shall not apply to the extent that a substance is used “in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 

It is important to note that this exemption applies only to substances which are covered by the relevant authorisations for medicinal products, such as active substances for use as starting materials within the meaning of the medicinal products legislation. If the substance falls within this definition, e.g., because it is covered by a manufacturing authorisation, it is exempt from the authorisation requirement.
	
21	2011/10/13	Company
Germany	Update of previously submitted comments (submitted on 12.10.2011, Reference number: e512341c-8f30-41aa-958f-7a35969eb818).Please find our updated comments attached (split of non-confidential and confidentail information). Could you please delete the comments submitted yesterday and send us a confirmation?
	Your comments have been updated.

Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 21 attachment (Bullet points for Commenting DMAC - non-confidential.zip).zip		
19	2011/10/13	Member State
Sweden	The Swedish CA agrees that N,N-dimethylacetamide, 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 providing your opinion.	
18	2011/10/13	Company
Denmark	N/A	-	
17	2011/10/12	Member State
Belgium	Belgium supports the identification of N,N-dimethylacetamide (DMAC) as SVHC according to article 57 (c)	Thank you for providing your opinion.	
16	2011/10/12	Company
United States	See attachment below for general comments, use, and alternatives.  Note:  our comments are inserted in italics within the context of the Annex XV dossier section	 Please see our response in your comment at the Specific comments section.	
			See also:
Comment 16 attachment (DMAC_CLEAN-Final text 11Oct2011.doc).doc		
15	2011/10/12	International NGO
Health and Environment Alliance
Belgium	HEAL supports the nomination of DMAC to the candidate list based on the information in the Annex XIV dossier	Thank you for providing your opinion.	
14	2011/10/12	Company
DuPont (U.K.) Industrial Limited
United Kingdom	General Comment 1
Using the CMR categorization as the sole criterion for defining DMAc as an SVHC does not take into account the concentration levels that are recognized by CLP.  That concentration threshold should be a critical criterion to determine the level at which DMAc is identified an SVHC. 

General Comment 2
The dossier does not provide any information on DMAc properties relevant for environmental fate and transport considerations.  

We understand that Part I focuses on those properties relevant for SVHC identification according to REACH Article 37.  Part II, however, focuses primarily on DMAc uses and assumed release patterns.  The emphasis on release patterns, combined with missing information on DMAc’s environmental properties, could create the false perception of adverse health risks from uncontrolled releases of DMAc to the environment.

Since the Annex XV dossier is a public document, the information should be accurate and complete to avoid the misperception of adverse public and environmental health impacts.  Information on the environmental fate of DMAc is publicly available and used to address potential risks from exposure to DMAc (e.g., REACH, Canada).  These evaluations considered releases to the environment and concluded that adverse impact from environmental exposures is low.  In addition to controlled releases during industrial uses and negligible release from final products, DMAc is readily biodegradable and digestible by activated sludge in biological wastewater treatment plants.  DMAc’s low partition coefficient (log Kow = -0.77) means it is not expected to be environmentally persistent or bioaccumulate in the environment via the food chain.  Finally, DMAc is not classifiable as toxic to the environment under CLP.  

These substance properties of DMAc should be included in the Annex XV dossier because the dossier as it stands creates the perception of adverse impact from uncontrolled releases to the environment.

General Comment 3
We agree with the conclusion that worker exposure to DMAc is limited and very well controlled, and that “no consumer exposure to DMAC is anticipated.”  (Pages 15 and 55)

The Dossier conclusion on page 55, which reflects that downstream worker exposure during the various uses of DMAc is likely to be within the Indicative Occupational Exposure Limit Value (IOELV), is consistent with DuPont’s experience.  Conclusions about the lack of consumer exposure to DMAc are also supported by the health assessments conducted by the Canadian government and the OECD SIDS document.	Thank you for your comment and the information submitted.

On General Comment 1:
As a substance, but not a mixture, may be included in the Candidate List, we consider not relevant to mention therein the concentration limit applying for mixtures. Nevertheless, in case DMAC is identified as SVHC the Art. 31(1) requirements for safety data sheets (and, in case of further inclusion in Annex XIV, also the authorisation requirement) indeed do not apply for mixtures containing DMAC below the concentration limit.

On General Comment 2:
The Annex XV Dossier presents some information and discussion on environmental releases, but does not assess or discuss associated risks. Information on environmental fate and risk for man via the environment is indeed important, but to be mainly considered (provided the substance is identified as SVHC) at later stages of the risk management process.

On General Comment 3 and attachment:
Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
12	2011/10/12	Company
Switzerland	Please see below for Specific Comments on Part II (Information on use, exposure, alternatives and risks).	 Please see response to your comment at the Specific comments section.	
			See also:
Comment 12 attachment (general comments dmac.pdf).pdf		
11	2011/10/12	Industry or trade association
EDANA a.i.s.b.l.
Belgium	EDANA, the international association representing the nonwovens and related industries, has taken note of the Annex XV dossier to propose N,N-dimethylacetamide (DMAC) as a substance of very high concern, submitted by ECHA on behalf of the Commission.  Although we agree with many aspects of the dossier, we would like to provide feedback on some specific elements on behalf of our members.	 Thank you for your comment.	
10	2011/10/12	National Authority
Allgemeine Unfallversicherungs-anstalt, Austria	We support N,N-Dimethylacetamide (DMAC) entering the authorisation process. This will help and accelerate forcing this substance to be used under controlled conditions that allow safer use.	 Thank you for providing your opinion.	
9	2011/10/12	Company
Germany	The following laboratory use should be exempted from the authorisation because there is very low exposure to consumers and the environment. Industrial and professional personnel, which are well trained, are using the substance for analytical purposes. The disposal of the substance is also controlled.	Thank you for your comment.

Please note that information on uses that should be exempted from the authorisation requirement are relevant at a later stage of the risk management process, and only in case the substance is identified as SVHC and later included, by ECHA, in a recommendation for inclusion into Annex XIV.

The use you mention may fall under the exemption of the use of substances in scientific research and development from the authorisation requirement in accordance with Art. 56(3). We would suggest that you examine whether the mentioned use of the substance can be regarded as SRD in accordance with the definition set out in Article 3(23). Article 3(23) defines SRD as “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year”. 
It is noted that
•	SRD activities can cover analysis for monitoring or quality controls purposes;
•	Therefore, in principle a substance may be exempt from authorisation if used, on its own or in a mixture, in analysis for monitoring and quality control purposes, for instance, in order to monitor the presence or concentration of that substance or other substances;
•	Nevertheless, this exemption only applies to the extent that the relevant operator uses that substance under controlled conditions and in a volume less than 1 tonne per year.
•	Only substances used directly for research or analytical purpose, whether on their own, in mixture, or in conjunction with analytical equipments, can benefit from the SRD exemption. This excludes from the exemption any substances forming an integral part of an analytical device.  
If you conclude that your laboratory uses of the mentioned substances fulfil the above points, the uses can benefit from the exemption of SRD from authorisation as set out in Article 56(3) and no authorisation would be required to continue the use after the sunset date (to be defined in case of inclusion in Annex XIV).
	
7	2011/10/11	Company
Netherlands	Our comments on N,N-Dimethylacetamide, or DMAC, have to be seen with in connection with the previous input by the European Federation of the Pharmaceutical Industry  (FPIA) on the related consultation for  NMP.  Both, DMAC and NMP are particularly useful solvents frequently used in the chemical synthesis of Active Pharmaceutical Ingredients and associated intermediates.  Existing regulation under the Solvent Emissions Directive means that use of DMAC within pharmaceutical manufacturing is restricted to those applications where there is no feasible alternative.  A lack of alternative solvents without the same hazards as DMAC means that placing DMAC on the SHVC Candidate List and potential prioritisation for inclusion in Annex XIV would, in certain circumstances, push the pharmaceutical industry towards using alternatives that may present a higher risk to both worker health and the environment than DMAC.  

The facts presented below lead us to the conclusion that it would be inappropriate for DMAC (same as previously submitted by EFPIA for NMP) to be considered for inclusion in Annex XIV.  In the context of pharmaceutical manufacturing, the proposal is based purely on hazard, with no account of any exposure scenario that allows translation to the risk presented by DMAC.  Whilst we do not, and cannot, disagree with the current classification of DMAC, we would strongly argue that to propose DMAC for prioritization for inclusion into annex XIV is to ignore the relative risks associated with DMAC and some of its obvious alternatives (DMF and NMP). 

The regulation of pharmaceutical manufacturing under the Solvent Emissions Directive currently provides a more effective regulatory framework than the SVHC proposal for DMAC: use of NMP, DMF and DMAc are collectively ruled out unless there is no feasible alternative.  Where no feasible alternative exists, the legislation allows for their use if risks are adequately controlled, and, unlike this proposal, would tend to steer one towards use of NMP if possible, as it presents the lowest risk.  Inclusion of DMAC and NMP in the SVHC candidate list and potential prioritisation for inclusion in Annex XIV, would push the pharmaceutical manufacturing industry, in circumstances where an alternative was not feasible, towards using the higher risk solvents DMAc and DMF.  This would appear illogical and consequently EFPIA disagrees with the proposal.

Our detailed comments below are largely relevant to the following sections of the explanatory dossier accompanying the consultation:
-	Section 2.3 - Use #2 ‘Pharmaceuticals’
-	Section 3.1.4  Occupational releases and exposure- Use #2 – Use as a solvent and intermediate in production of pharmaceuticals
-	Section 4 .8 conclusion on alternatives	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
6	2011/10/11	Member State
Germany	The German CA supports the identification of the substance as a possible SVHC.
We appreciate the detailed and exhaustive illustration of the existing data on the substance.	Thank you for providing your opinion.	
5	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of N,N-dimethylacetamide (DMAC)as SVHC.	Thank you for providing your opinion.	
4	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for providing your opinion.	
3	2011/10/07	Company
United Kingdom	none	-	
2	2011/10/07	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 category 1B.	Thank you for providing your opinion.	
1	2011/10/06	Member State
Norway	The Norwegian CA supports that N,N-dimethylacetamide (DMAC) should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for providing your opinion.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
27	2011/10/13	Member State
Ireland	DMAC 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. We note that a specific concentration limit (Repr. 1B; H360D: C ≥ 5 %) applies for DMAC, which should be carried forward to the candidate list entry for this substance.	Thank you for your comment.

As substances are included in the Candidate List (C.L.) and not mixtures, we consider it not appropriate to list concentration limits applying to mixtures (containing that substance) in the C.L. Such limits specify under what conditions mixtures containing a substance have to be classified and  which  requirements for safety data sheets according to Art. 31(1) of REACH apply in case the contained substance is a SVHC. 	
18	2011/10/13	Company
Denmark	N/A	-	
14	2011/10/12	Company
DuPont (U.K.) Industrial Limited
United Kingdom	Classification and Labelling/Other

Using the CMR categorization as the sole criterion for defining DMAc as an SVHC does not take into account the concentration levels that are recognized by CLP.  That concentration threshold should be a critical criterion to determine the level at which DMAc is identified an SVHC.  In addition, lack of guidance on analytical methods and article definition creates uncertainty on supplier obligations pursuant to REACH Articles 7(2) and 33. (Section 6, Page 13)

As DMAc is listed in Annex VI of CLP on Harmonised Classification and Labelling (CLP), it fulfils the requirements of Article 57(1)(c) REACH .  The reproductive toxicity classification is subject to specific concentration limits of 5% for mixtures.  The need to take concentration limits into account finds support in other provisions of REACH and CLP.  For example, Article 56(6)(b) REACH exempts uses for substances from authorisation when present in mixtures below the concentration limits for classification, as specified in Annex VI of CLP.  

The 5% threshold concentration for reproductive toxicity characteristics of DMAc assigned during the harmonised classification process represents the latest scientific knowledge.  This information was further reviewed during the REACH registration process, and no additional information was identified to support a change to that threshold designation.  Thus, the 5% concentration value has been upheld under REACH as an appropriate threshold for DMAc, and infers there is no reprotoxic potential below that level.  This information should be considered during the SVHC identification process, especially for requirements pursuant to REACH Article 33, which requires communication of safe use information if the concentration is above 0.1% w/w.

Additionally, there is at present no consistent method or guidance for testing substance content in articles.  This, combined with the difference in interpretation of article definition, makes it difficult for article producers or importers to estimate the DMAc volume in articles for the purpose of notification requirements pursuant to REACH Article 7(2).	Thank you for your comment. 

Please see our response to your comment at the General comments section. Furthermore, please note that the concentration limit of 0.1% weight by weight for requirements pursuant to REACH Articles 33 and 7(2) are affixed and not dependent on SCLs set in Annex VI of the CLP.	
11	2011/10/12	Industry or trade association
EDANA a.i.s.b.l.
Belgium	None.  To our knowledge the information on substance identity and hazard is correct.	Thank you for your comment.	
7	2011/10/11	Company
Netherlands	none	-	
5	2011/10/10	Trade union
European Trade Union Confederation
Belgium	N,N-dimethylacetamide (DMAC)is included in the Trade Union Priority List for REACH authorisation.
see http://www.etuc.org/a/6023	 Thank you for this information.	
3	2011/10/07	Company
United Kingdom	none	-	

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	
28	2011/10/13	Industry or trade association
AIA
United States	238 company proprietary specs and 16 industry specs: ASTM, SAE  and military specs require its use.  There are no alternatives available.	 Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.

 Please note that in the attachment you refer to an “attached table address the accuracy and completeness of information regarding the use of N,N –dimethylacetamide (DMAC)”, which was not submitted together with your comment.   
	
			See also:
Comment 28 attachment (October 13 ConsultationDMAC.docx).docx		
25	2011/10/13	Company
Spain	Pp 57-62  Comments on proposed alternatives  
Only 1-methyl-2-pyrrolidone (NMP) and 1-ethylpyrrolidin-2-one (NEP) could be considered as general substitute based merely on their physico chemical properties, but their toxicological profile does not provide any reasonable profit to the worker’s health. NMP is classified as Toxic for Reproduction and it is expected that NEP will be classified in short term. 

Dimethyl Sulfoxide (DMSO) cannot be considered as substitute for all DMAC uses. As an example, DMSO is not suitable in fiber manufacture; its higher boiling point is above its decomposition temperature, and the presence of these impurities decreases the fibre perfomance. DMSO cannot be considered as alternative for DMAC in fibre manufacture.  

Regarding its use as solvent in chemical synthesis, DMSO and DMAC do not share the same Hansen parameters, therefore and considering above, it cannot be considered as a general alternative as a solvent in manufacture of chemicals, and substitution might need to be studied case per case. But it is expected that, where  DMAC is replaceable, it would be already changed, for example as a consequence of connected regulations to protect the environment and workers, (inter alia Directive 2010/75/EU, on Industrial Emission, Directive 98/24/EC on protection of of the health and safety of workers from the risks related to chemical agents at work…)

DMSO could be considered as alternative for Paint Strippers in some consumer and profesional uses, but taking into account that DMSO is more penetrating in gloves and skin, and can produce a garlic smell as a consequence of its metabolism. 

Neither 1,3-dimethylimidazolidin-2-one (DMI) is a suitable alternative. It is produced by a propietary process, which triggers to a lower disponibility and higher expenses. Based on its structure, DMI is toxic for reproduction; and not biodegradable; consequently it is not a suitable alternative since it can drive a major concern than DMAC. 

Wet spinning cannot be used to manufacture high performance fiber because it does not produce suitable polymer (less strength and higher thickness). DMAC content in fibers can be reduced intensifying drying processes in dry spinning	
Thank you for your comment and the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
24	2011/10/13	Company
DINOX Handels-GmbH
Germany	Page 14, 30: The sentence "The fibers produced contain residual amounts of DMAC of up to 3 %, which is released by the subsequent processing steps." in the summary of page 14 is on its own misleading. The information from page 30 of the dossier "The residual contet of DMAC in the final textile product is reported to be below detection limit."  should be added to this summary, to give detailed information.

Page 16, 66: "DMSO is specifically marketed as alternative to DMAC."  To our knowledge, DMSO is not a general alternative to DMAC, because due to its intrinsic properties it cannot replace DMAC for all uses.

Page 19, 45, 55: "...These limits were set to prevent the development of respiratory irritation in workers and do not take account of reproductive toxicity.(Scientific Commnittee on Occupational Exposure Limits, 1994)" is not correct. The original text states: "...if these limits are kept and not exceeded, no reproductive effects are expected to occur." The effect on the respiratory system will start at much lower levels than the reprotoxicity effects, therefore the given IOELVs for the respiratory system will eliminate the possibility of reprotoxic effects automatically.

Page 21-23, 25, 30, 42: The production volumes mentioned in the dossier regarding acrylic fibers seem to be too high.

According to our knowledge, these figures should be much lower.
The total DMAC which is used for all fibers is estimated to be approx. 2.500 t. Therefore the use for fiber production is considerably lower than 25-30% which are mentioned in the dossier.

Page 22, 32, 44, 50: The use "excipient (carrier ingredient) in human and veterinary pharmaceutcals." should not be included in this dossier, because this is to be discussed in the pharmaceuticals regulations. Adressing the matter iin the pharmaceutcal regulation will have more effect.

Page 54, 55, 24-30: No DMAC is brought into the environment by waste disposal due to authorized waste processing systems.
DMAC in fiber              < 0,1 % is possible
Converters                 lower than above
Clothing manufacturers     lower than above
Consumer                   below detection limit

Page 59: Alternative DMSO
Due to different reasons, we consider DMSO not as a general substitute for DMAC:
a) In the fiber production it is not suitable, as intrinsic properties will cause problems with the operational conditions (melting point), will cause concern to due decomposition products, that will form when the fiber is dried by heat evaporation (boiling point), which are hard to wash off and it causes garlic odour, which is not acceptable for the fibers. Furthermore, there is no to only negligible consumer exposure via fibers.
b) It is assumed, that DMSO is already used whereever possible due to the regulations being of advantage for DMSO.
c) DMSO could be a substitute for paint strippers and solvent cleansers.

Page 60: Alternative DMI
We see two reasons for not considering DMI as a suitable substitute for DMAC. 
The first is due to no experimental data being available while the structural similarity alerts the concern for reproduction toxicology, especially for the fertility and maybe even developmental effects. The second reason is the missing biodegradability of DMI. With 90 % of the DMAC release is via the fiber industry, this will raise the persistence issue.

Page 58: Alternatives DMF and NMP
In our opinion, this substances should not be in the dossier as possible substitutes for DMAC, as they are both CMR 1 a/b-classified and therefore not suitable substitutes.

Page 58: Alternative NEP
This product is expected to be classified CMR 1 a/b at a not so far point in time and is therefore not suitable as a substitute.

Page 58: Alternatives Acetone and Acetonitrile
The flammability of Acetone and Acetonitrile is enabling the use of this substance for large scale processes, therefore these substanes are not suitable as substitutes.

Page 62: Alternative processes - Wet spinning
For high performance fibers the alternative of wet spinning is not suitable due to the loss of strength and thickness of the fiber.

Generally wet spinning is not really an alterantive for DMAC, as this process is using DMAC as well. However, by intensifying the drying process of the raw yarn directly after spinning, either in time or temperature, the DMAC content could be reduced at the start. As raw yarn is being produced by well equipped manufacturers, this would lead to a reduction of the environmental release at the source, that would be efficient.

Page 62: Alternative process - wet spinning
Our sister company, the biggest acrylic fiber producer in the world, situated in Turkey, has declared that they are willing to improve their wet spinning process by increasing the washing time in order to have a bigger cleaning effect of DMAC without reducing the speed of production and by doing so, the final fibers will have a DMAC content much lower than 0,1 %. These fibers are also being imported into the EU.

Additional:
The consortium will start an update of the dossier for DMAC in order to make sure, that the use of DMAC in ink erasers will be taken as "a used advised against". 	 Thank you for your comment and the information submitted.

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
20	2011/10/13	Industry or trade association
Portugal	Page 21, 23, 25, 30, 42 related to the DMAC volume used in fibres
1. - GENERAL CONSIDERATIONS
1.1 - THE COMPANY
FISIPE is a producer of acrylic fibres using DMAC in the process.
In the case of fibres for textile use, the DMAC levels are very low. In the particular case of fibre of FISIPE, these values are residual. The average values of 2010 of DMAC content on the fibre are below 0.10% in the more common fibres and in some types of fibres the values are 0.05%.
FISIPE has developed special fibres. FISIPE is a producer of Precursor for Oxidized and Carbon Fibres, these fibres are among the products that are considered strategic in EU and are integrated in the list of critical products for Space and Defence Technologies.
There is a marked dependence on the carbon fibre produced in the USA and Japan.
Fisipe is a partner in a project called EUCARBON, financed by 7th Framework Program of EU.
EUCARBON project got an approval from the EU, because:
“The projects are expected, first and foremost, to reduce the dependence on critical technologies and capabilities from outside Europe for future space applications, as identified in the EC-ESA-EDA Critical Space Technologies for European Strategic Non-Dependence - List of Urgent Actions 2010/2011.”
1.2 - PRODUCT CERTIFICATION AND THE MARKET
The customers are demanding that the fibres produced by FISIPE have Oeko-Tex standard 100 certification. This certification ensures that the fibres do not contain substances that might affect safety and health. The certification of FISIPE fibres is Class IV certification, which means that the fibre can be used in baby clothing.
Textile products obtained with acrylic fibre has a very low DMAC concentration - almost undetectable.
1.3 - GOOD PRACTICES
DMAC is used in industrial applications where there is a set of good practices implemented that ensure the safety and health of the workers.
FISIPE is covered by the IPPC Directive (Integrated Pollution Prevention and Control). From this Directive arises the necessity of the company have an Environmental License issued by National Authority.
The operation of the facility is subject to the use of techniques identified as BAT (Best Available Techniques).
 These techniques were adopted by the European Commission as BREFs.
 The applicable BREFs are:
- Reference Document on Best Available Techniques in the Large Volume Organic Chemical Industry - BREF LVOC;
- Reference Document on Best Available Techniques in Common Waste Water and Waste gas treatment / Management Systems in Chemical Sector - BREF CWW;
- Reference Document on Best Available Techniques in Emissions from storage - BREF ESB;
- Reference Document on Best Available Techniques to Industrial Cooling Systems - BREF CV;
- Reference Document on the General principles of Monitoring - BREF Mon;
- Reference Document on Best Available Techniques in the Production of Polymers - BREF POL:
The company has mechanisms to monitor the process of preparation and review of BREFs to ensure the adoption of BAT on the facilities. According to the Environmental License BREFs are periodically re-examined to identify any BATs in these documents and with potential for implementation at the facility.
2. - SPECIFIC CONSIDERATIONS
Page 21, 23, 25, 30, 42 related to the DMAC volume used in fibres
2.1. - ABOUT PRODUCTION VOLUMES OF ACRYLIC FIBRE
Annex XV Dossier refers some values for acrylic fibres production: 
- Figure 1, page21;
- Table 2.1, page 23;
- Item 2.2.2.1, page25;
- Item 2.2.7, page 30;
- Item 2.9, page 42;
These values are not correct. In accordance with CIRFS data, the EU27 acrylic production where DMAC is involved is only about 180 kton. The trade balance (export/import) is about 110 kton positive, resulting in a volume converted in EU27 being about 70 kton only. And the DMAC use for fibre production is much lower than the 25-30% of the total EU DMAC consumption as mentioned in the dossier. The total DMAC use for all fibres is at about 2900 ton.
2.2. - DMAC MASS BALANCE
Page 24 to 30, 54, 55,
Annex XV Dossier refers some values for DMAC mass balance: 
- Item 2.2.4, page 28
- Item 3.2, table 3.7, page 54 and 55.
These values are not correct. CIRFS. Estimate, for 2010, diferent values:
1. Emissions to the air	650 ton;
2. Emissions to water treatment	350 ton;
3. Losses as waste 	950 ton;
4. Used in the process	500 ton;
5. Residue in the fibre	450 ton;
 Total 	2900 ton
2.3 - ABOUT EFFECTS ON HUMAN HEATH AND ENVIRONMENT
The Annex XV Dossier does not give relevance to the document "OECD, 2001, N, N dimehylacetamide (DMAC) CAS Nº: 127-19-5, SIDS Initial Assessment Report for 13th SIAM, Bern, Switzerland, 6-9 November 2001".
Although the study was conducted 10 years ago, we do not know each other. The study takes into account the effects in the workplace and on the environment. We emphasize the study states:
- “From all these data DMAC doesn’t result acutely toxic to aquatic organisms.” Item 3.1, page 13;
- “DMAC is not irritant to skin when applied undiluted to rabbits in 100, 250, 500 mg/dose group to the clipped skin.” Item 4.2, page 16;
- “DMAC is not sensitising on guinea pig.” Item 4.2, page 16;
- “No adverse effects on fertility, litter size or number, resorptions, fetal weight or malformation visible externally. No signs of toxicity in males other than increase of absolute and relative liver weight at 120 and 400 ppm. No adverse effects on testes weight or histopathology. (Wang G.M. et al. 1989)In a sperm abnormality test male mice were exposed to 20 and 700 ppm for 7hours/day for 5 days/w for 6 weeks. They were not mated and sperm was analysed 5 weeks after the end of exposure. No differences in frequency of sperm abnormalities between exposed groups and controls (Fairhurst et al., 1992).” Item 4.4, page 17;
- “DMAC was non mutagenic in a transgenic mouse mutation assay on liver tissue were it was used as control substance while studying the mutagenicity of adolezesin.” Item 4.5, page 20;
- “A frequency of lethals of 0.57 % was detected. This was due to three lethals derived all from a single male, so that this high frequency was not interpreted as indicative of mutagenic response (Mc Gregor, 1981). Item 4.5, page 21;
- “Data of Log Pow and BCF indicate a low bioaccumulation potential in aquatic species. DMAC shows low toxicity to fish, daphnia and bacteria. It shows high toxicity to earthworms, but due to its high mobility and biodegradability it is not expected to accumulate in soil nor to reach dangerous concentrations. 
The Danish EPA QSAR Estimation system predicts a generally ready biodegradability and low to moderate aquatic toxicity.
The environmental and consumer exposures are negligible and the exposure in the workplace is lower than the TLV.” Item 5.1.a), page 21;
- “DMAC has no effect on fertility.
Oral and inhalatory studies on rabbits do not show clear teratogenic effects related do DMAC. They indicate that high doses of DMAC can cause both maternal and embryofetaltoxicity.
The rat inhalation study showed no adverse effects at the highest concentration (300 ppm) other than reduced maternal and fetal weight.” Item 5.1.b), page 21;
- “DMAC is clearly not mutagenic in a battery of tests including Ames test, dominant lethal in rats or mice, UDS in vitro assay, cytogenetic analysis in bone marrow, in Drosophila SLRL test, and in sperm abnormality test in mice.
DMAC was not carcinogenic in a two-year drinking water study in rats and in a 18-month inhalation study in rats and mice. Also in a epidemiological cohort study it is concluded there is no relationship between DMAC exposure and mortality from tumours. 571 workers simultaneously exposed to acrylonitrile for at least for 12 months (Mastrangelo et al., 1993).” - Item 5.1.b), page 22
3. - CONCLUSIONS
The Dossier prepared in accordance with Annex XV of the REACH Regulation recognizes that in the case of acrylic fibres it does not seem to existence of alternative solvents. This document identifies the use of dimethylformamide stating that it will be banned in China in the manufacturing of elastane. It is not excluded that some alternatives may join to the candidate list SVHC.
The Annex XV Dossier does not give relevance to the document "OECD, 2001, N, N dimehylacetamide (DMAC) CAS Nº: 127-19-5, SIDS Initial Assessment Report for 13th SIAM, Bern, Switzerland, 6-9 November 2001". On page 23, this document refers that "Considering, toxicological and ecotoxicological data and the overall limited exposure for man and environmental because this compound is produced for industrial use only, it can be concluded the chemical is not a candidate for further work”.
So, we ask that ECHA consider the study conclusions referred. 
As a result of the above, we consider inappropriate to integrate DMAC in the list of Substance of Very High Concern or subject it to eventual use restrictions that reduce the competitiveness of industries using the DMAC.	Thank you for your comment and the information submitted.

On your point on “EFFECTS ON HUMAN HEATH AND ENVIRONMENT”, please note that as the substance is toxic for reproduction, Repr. 1B according to Regulation (EC) No 1272/2008, Annex VI, part 3, Table 3.1, it fulfils Article 57(c) of Regulation (EC) 1907/2006 (REACH). Therefore it can be identified as a substance of very high concern following the procedure set out in Article 59 of the same regulation.

Proposals for revision of an existing entry in Annex VI to the CLP Regulation can be submitted by a Member State Competent Authority (MSCA) (Article 37(1) of the CLP Regulation). 

According to  Article 37(6) of the CLP Regulation (Regulation (EC) No 1272/2008) manufactures, importers and downstream users who have new information which may lead to a change of the harmonized classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal […] to the competent authority in one of the member states in which the substance is placed on the market. The MSCA will then decide if it is appropriate to prepare a CLH dossier and submit it to the Agency in order to revise the existing harmonised classification.

On the other points, provided that the substance will be identified as SVHC this information may, where relevant, be considered at later stages of the risk management process.

See also response to comment #23 at the General comments section.	
			See also:
Comment 20 attachment (Initial Assessment Report - DMAC.pdf).pdf		
18	2011/10/13	Company
Denmark	2.3.2
Within the pharmaceutical sector DMAC is used as a solvent in the production process of insulins. Changes to the process (substitution of DMAC) require extensive redevelopment and associated authorisation from health authorities in order to ensure the quality of the finished product.	 Thank you for your comment and the information submitted.

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
16	2011/10/12	Company
United States	Exposure

The manufacture of Active Pharmaceutical Ingredients (APIs) and associated intermediates are performed in enclosed reactor trains in accordance with Good Manufacturing Practices.  DMAC (and other solvents) are introduced into the reactors via transfer systems designed to minimise environmental release, by trained personnel using appropriate protective equipment, and are thus contained within the process stream.  Since the residual amount of DMAC is safety-limited by the ICH Q3C (Guideline for Residual Solvents), in practice virtually all the DMAC used during manufacture would be present in the waste streams that are then disposed in accordance with local environmental regulations.  Thus, the risks of environmental exposure of DMAC in the pharmaceutical manufacturing environment are minimized by the equipment design and operational controls; disposal and record-keeping procedures exist within the oversight of the quality system. 
	Thank you for your comment and the information submitted.
Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 16 attachment (DMAC_CLEAN-Final text 11Oct2011.doc).doc		
14	2011/10/12	Company
DuPont (U.K.) Industrial Limited
United Kingdom	Exposure Information

1)The IOELV for DMAc is based on the most sensitive toxicity endpoint which is also protective of reproductive toxicity characteristics. (Pages 15 and19).  The dossier notes the IOELVs “were set to prevent the development of respiratory irritation in workers and do not take account of reprotoxocity.”  This is not a true reflection of the justification provided in the SCOEL document.  The SCOEL document states, “[t]he critical effects of DMAc are respiratory tract irritation and hepatoxicity”.  Moreover, the document also states that “[r]eprotoxicity has not been observed in inhalation studies at levels which do not cause maternal toxicity.”  This statement does not mean that reprotoxicity was not accounted for in the development of the IOELV.  Rather, it clarifies that for inhalation exposures, adverse effects on the respiratory tract and liver in mothers are manifested at dose levels much lower than the levels that would trigger developmental effects.  Since the Annex XV dossier is a public and government document, this should be clarified in the dossier because this information could be used and misquoted elsewhere.

2)The dossier focuses mostly on inhalation exposures and does not provide sufficient information on typical measures used to control dermal exposure. (Pages 15, 19, 46). DMAc is known to be absorbed dermally and the OELs developed by regulatory organizations include a skin notation for DMAc to indicate that skin contact should be avoided.  (Note that dermal exposure to end users has been assessed and is below levels of concern, in alignment with the Annex XV dossier conclusion that “quantities of residual DMAc present in consumer goods are negligible and no consumer exposure to DMAc is anticipated” [page 15]).  Therefore, not only are workplace risk management measures used to reduce worker exposure to DMAc in the air, PPEs such as gloves and coveralls are also required to limit skin contact during steps where contact with DMAc may occur.  Thus, risk management measure (RMM) information provided by the respondent on page 19 is typical rather than an anomaly.  In addition, biological monitoring programs (see also Comment 9) ensure that a worker’s total exposure, not just exposure from inhalation, is considered.

3)Mass balance information overestimates amount of DMAc released to the environment. (Pages 20, 21, 28, 30, 55).  The volume and release information provided in the dossier overestimates the actual volume of DMAc used in for fibre processing and overestimates the amount released to the environment.  The European man-made fibres association (CIRFS) has estimated that total amount of DMAc used for fibre production in the EU is about 2900 tons, which is below the range noted in Section 2.2.7.  Also, the amount of DMAc released to air during processing and throughout the life-cycle of the fiber is significantly less than the amount presented in Table 3.7 of the dossier.  See Comments 7 and 8 on waste disposal of fibers and releases of DMAc to the environment.

4)Use of Nomex® paper missing from Table 2.1. (Page 23).  In line 3 of Table 2.1 Electrical component industry, the application of insulation papers and multilayer films is missing.  Nomex® paper is imported into the EU and sold downstream in a variety of industrial applications where electrical insulation is required.  Residual levels of DMAc in the paper may be up to 0.6% wt/wt.  Major end uses are in transformers, motors, and generators.  Since these components are embedded in a matrix in the final product, there is no direct contact with Nomex® paper by consumers.  See Comment 10 for release information on Nomex® paper.

5)MSDS information in Table 2.3 is outdated and comes from other regions (Page 29).  Some of the sources of SDS listed in Table 2.3 are questionable.  Note that the range of residual content of DMAc in Nomex® products come from third party websites.  In addition, the link to the MSDS for Sontara Spunlaced fabrics is no longer functional.

6)Service life of produced articles (Page 37).  Residual content of DMAc in Kapton® films is dependent on the individual film thickness.  The maximum level mentioned in Table 2.7 refers to MSDS developed for U.S. requirements.  While for some Kapton® grades, the actual residual DMAc level is below 0.1%, for other grades the residual level is between 0.1 and 1%.

7)Clarifying information about waste disposal of fibers. (Pages 28, 30).  The last paragraph refers to Section 2.2.7 for further information on waste treatment, but only discusses quantities involved.  Additional waste disposal information is provided below.

During fibre processing, a significant amount of DMAc may end up in out-of-spec fibres generated during, for example, start-up or switch over products.  This out-of-spec material is disposed of either via incineration where DMAc is effectively destroyed, or sent to certified landfills according local waste permits.  Even assuming DMAc leaches out of the off-spec material, DMAc is readily biodegradable (see General Comment 2), does not persist in the environment, and will not bioaccumulate via the foodchain.  Other waste material, such as old filter media replaced during regular maintenance work on the polymerization units, spinning facilities, and the DMAc recycling units, are all disposed of as dangerous waste according to the waste permits for the plant.

A large amount of the remaining residual DMAc in fibres will be removed via further processing such as dyeing.  Therefore, as correctly noted in this dossier, the level of DMAc in final product is very low (e.g., pages 26, 28, 49).   The dyeing process involves use of aggressive alcohols to chemically swell the fibre structure.  This results in the release of DMAc directly into the dye bath.  Waste streams from the dyeing process are strictly controlled by local authorities according to the permit of the facility.  

For the remaining DMAc in articles, the articles are disposed of like any other solid waste and may be incinerated or sent to landfills at the end of the article’s service life.  As already indicated above, DMAc is easily destroyed via incineration.  

8)Releases of DMAc to the environment are not large, and any released material does not persist and bioaccumulate in the environment as the Annex XV Dossier infers, but is removed through natural degradation processes. (Pages 28-30, 54).

Residual DMAc does not “evaporate” into the air from the fibre (last paragraph page 28, 1st paragraph page 29).  For Nomex® fibre, DMAc forms a stable complex with CaCl2 and as a result, the remaining DMAc is chemically bound to the fibre.  Nomex® has a high degree of crystallinity in the polymer and the DMAc molecule, being relatively large, cannot pass through the crystalline structure unless extreme heat is applied.  DuPont has performed TGA-GC/MS studies which identify DMAc being liberated between 250 and 350oC, which is above the maximum temperatures experienced by Nomex® products during manufacturing or service life.  Thus, the fibre itself does not constitute a significant or continuous source of release of DMAc.

Furthermore, during fiber processing, wastewater containing DMAc is pre-treated at a wastewater treatment plant before discharge to surface water.  Measured data show that the amount discharged to surface water is below the detection limit.  Taking a conservative approach and assuming DMAc is released at detection limit, it is important to note that DMAc does not persist in the environment.  This is supported by an independent study carried out by Environment Canada, who has concluded that “DMAc does not meet the persistence criteria in water, soil, sediment and air” (Environment Canada, Health Canada, “Screening Assessment for the Challenge, Acetamide, N,N-dimethyl, August 2009).

9)Evidence of community-wide measures to protect pregnant workers.  (Page 46).  There are existing community-wide regulations to protect pregnant and breast-feeding women from exposure to substances classified for reprotoxicity.  Directive 92/85/EEC has been implemented by all 27 Member States of the EU (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:71992L0085:EN:NOT).  DMAc is also specifically listed for additional monitoring in some Member States.  For example, in France, seven substances, which includes DMAc, are subject to additional workplace enforcement control (Décret n° 2009-1570 du 15 décembre 2009).  In Spain, DMAc air monitoring is required for a job-related health risk assessment that is performed annually by an external prevention society to ensure health and safety to workers (Spanish Law 31/1995; RD 474/2001).  Also, biomonitoring of workers exposed to DMAc is routinely used to assess the effectiveness of the industrial hygiene controls.  These regulations ensure that workplace exposure to DMAc, especially for the most sensitive subpopulation, is enforced and well controlled by local authorities.

10)We agree that no substantial exposure (human or environmental) to DMAc in films would be expected, and provide additional information to support this conclusion. (Pages 15, 37, 52, 55).  The dossier concludes that since DMAc content of imported films is very small, no substantial exposure to DMAc is expected during industrial use of the films (Section 3.1.6.2).  Elsewhere (Section 2.5.2.2), the dossier states information on use of films further downstream was not received; therefore, fate of DMAc further downstream is unknown.  Below is additional information that can be used to estimate exposure to downstream users of films:

DMAc is imported as an impurity in DuPont films to the EU.  No significant release to the environment is expected during the life-cycle of these films.  

For Tedlar® films, residual DMAc is removed during processing that occurs at temperatures between 90oC to 180oC.  DMAc released during processing is removed from the waste stream typically by incineration, so we expect there is no significant release to the environment.

There are no significant releases of DMAc to the environment during the life cycle of Kapton® film.  From the estimated 0.6 tonnes/yr of residual DMAc being imported in Kapton® film into the EU, even at 400°C, only a maximum of 55 ppm is released.  This relates to 6 kg/yr of potentially out-gassing DMAc. Therefore, the DMAc remains contained through the waste cycle where it is handled according to local regulations.  Even assuming the unlikely scenario that DMAc leaches out of the film, DMAc is readily biodegradable and not expected to persist in the environment or bioaccumulate via the food chain (see also General Comment 2).

Nomex® paper is used in a similar way as films for its electrical insulating properties.  Industrial uses involve lamination, cutting rolls or formed parts, wire wrapping, motor windings and honeycomb structures for mass transportation (i.e., aircrafts).  Properties of DMAc structure in Nomex® paper and its tightly bound nature in the paper is the same as that described in Comment 7 for Nomex® fibers.  At temperatures of up to 250oC, only water is observed off-gassing.  Since use temperature is, at maximum, 220oC, Nomex® paper is not expected to be a continuous source of release of DMAc.  In addition, the total volume imported as impurity is below 20 t/y, and is expected to remain in the paper until the final waste stage where it is processed according to applicable waste regulations (e.g., ROHS).  

11)Clarification of Risk Management Measures during industrial film production. (Page 52, Section 3.1.6).  The last sentence in this section states specific use of RMMs during industrial processing of films is not known.  We want to emphasize that engineering controls such as local exhaust ventilation (LEV) and only as a last resort, use of PPEs, are typically used at all industrial downstream users of Tedlar® and Kapton® films.  Direct contact by consumers of the final product is not anticipated because the films are enclosed in the end product.  In addition, as already noted throughout the dossier (e.g., page 15), residual DMAc in consumer goods is negligible so no consumer exposure to DMAc is expected.

12)Page 54, Section 3.2 on environmental releases of DMAc from films (7th paragraph).  Information on release of DMAc from films is provided in Comment 10).  

13)Incorrect section title. (Page 65 (Section 4.6). The title “use as a solvent in production of films” for this section title is incorrect because it refers only to paint strippers.  Alternatives considered for films are provided in Table 4.1 (Section 4.2).

Information on alternative substitute and techniques

14)Information on alternative solvents in man-made fibre production. (Pages 15, 66).  DuPont constantly tracks technology improvements and assesses alternative raw or process materials.  In over 50 years since the invention of poly(m-phenylene isophthalamide) (MPDI) fibre, no alternative to DMAc was found to be more suitable for this fibre.  This conclusion is based on a list of critical criteria that includes, among others, performance, manufacturability, human health and environmental impact.

Due to the requirements to develop a polymer of high strength and heat resistance, all solvents have, or are expected to have, a very similar profile from a toxicological point of view, to DMAc.  In the end, it is solvent’s capability of forming a polymer with the necessary property profile that defines the selection. 

In the particular case of DMSO, it is not considered a potential alternative to DMAc for the manufacture of MPDI fibre due to the difference in solubility properties.  DMSO has a reasonable solubility profile for the monomers, but not for the polymer with the required molecular weight.  In addition to this, DMSO is not basic or stable enough at high spinning temperatures.  Therefore, DMSO cannot be used as an alternate solvent to DMAc.
	
Thank you for your comment and the information, which, provided that the substance will be identified as SVHC, may, where relevant, be considered at later stages of the risk management process.

In case the substance is identified as SVHC and later included, by ECHA, in a recommendation for inclusion into Annex XIV, a background document for this substance will be published by ECHA, summarising mainly types of information such as those included in Parts I & II of the Annex XV report. Therein, information received during this public consultation will accordingly also be taken into account, where relevant, for reflecting better any issues that were not reflected properly in the Annex XV report.
	
13	2011/10/12	Company
Germany	In addition to the Annex XV dossier we want to emphasize that N,N-dimethylacetamide (DMAC) is used as an important solvent in the synthesis of some active pharmaceutical substances within our company. The use of N,N-dimethylacetamide (DMAC) is fixed in the relevant pharmaceutical registrations which means that it is not possible to change to an alternative solvent. Thus setting N,N-dimethylacetamide (DMAC) on the candidate list for SVHCs would result in a very serious problem for our company.	 Thank you for your comment and the information submitted.

 Please see response to comment #23 at General comments section.	
12	2011/10/12	Company
Switzerland	Use in the Pharmaceutical Industry:
N,N-Dimethylacetamide is one of a class of extremely useful solvents designated as polar aprotics to conduct reactions for producing intermediates and Active Pharmaceutical Ingredients (API). Reaction rates of certain reactions (e.g. nucleophilic substitution) are substantially enhanced due to the solvent polarity. Polar aprotic solvents such as DMAC are essential for these reactions, since they prevent unreacted materials from being carried forward in the process stream, minimize the formation of side products, and produce intermediates and Active Pharmaceutical Ingredients (API) of the highest quality.

Exposure:
The manufacture of APIs and associated intermediates are performed in enclosed reactor trains in accordance with Good Manufacturing Practices.  DMAC (and other solvents) are introduced into the reactors via transfer systems designed to minimise environmental release, by trained personnel using appropriate protective equipment, and are thus contained within the process stream.  Since the residual amount of DMAC is safety-limited by the ICH Q3C (Guideline for Residual Solvents), in practice virtually all the DMAC used during manufacture would be present in the waste streams that are then disposed in accordance with local environmental regulations.  Thus, the risks of environmental exposure of DMAC in the pharmaceutical manufacturing environment are minimized by the equipment design and operational controls; disposal and record-keeping procedures exist within the oversight of the quality system.

Alternatives:
There are other polar aprotic solvents with similar physical properties (albeit of lower polarity) that could potentially be used in place of DMAC in some API manufacturing syntheses.  The most common ‘direct’ alternative is DMF (N,N-dimethylformamide).  Others include formamide, N methylformamide and N-methylacetamide.  However, these alternatives also carry essentially the same health hazard as DMAC.  In addition, these solvents have lower polarity and the replacement DMAC with such solvents could lead to incomplete reactions and side products that impact the safety and quality of the API. This would also result in an increase in waste streams.
	 Thank you for your comment and the information submitted.

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 12 attachment (general comments dmac.pdf).pdf		
11	2011/10/12	Industry or trade association
EDANA a.i.s.b.l.
Belgium	To our knowledge, DMAC is indeed used as a process solvent for the manufacture of ‘Elastane’/‘Spandex’ materials (pg. 22, 24 etc.). Residual DMAC content in downstream users’ finished goods utilising these materials is expected to be well below the 0.1% threshold (pg. 28).  As concluded by the OECD, “for consumers, the residual amount does not represent a risk” (pg. 28).

Further, our understanding is that viable substitutes to DMAC (as a solvent for Elastane/Spandex materials) are not presently available.  Indeed, we would like to stress that the Annex XV dossier itself points out (on page 57) that only 4 of the 11 alternatives considered are not classified; and of those 4, 3 substances are considered to be possible candidates for classification in the future.  Only the substance dimethyl sulfoxide (DMSO) is presented as a possible viable alternative to DMAC, and in the case of DMSO, it is not established that DMSO is a viable alternative for the specific purpose of manufacturing elastics.  Our experience is consistent with these findings.  Again, we are of the opinion that no viable substitutes to DMAC (as a solvent for elastics) are presently available.

Finally, we would like to express our concerns about the lack of harmonised analytical methodologies for testing DMAC levels in different kinds of articles.  Our preliminary experience has shown that various different methods exist, and are primarily in-house procedures using a variety of different extraction and analysis methods and technologies.  These can give a wide variety of results, which is problematic for any substance that may be regulated as an SVHC under REACH.	Thank you for your comment and the information submitted.

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.

With regard to your point on the analytical methodologies for substances in articles, please see response to comment #8 at the Specific comments section.
	
10	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P18 1.5 Import of the substance in articles
Certain informations according to REACH Art 31 will be available for consumers if DMAC enters the list of candidates. These will easier the handling of residuals of the substance in polymer products.
P18 1.6.1.3 Risk management measures
“The key risk management measures (RMMs) are process enclosure and automation of the filling
facilities.” Levels of exposure increase if DMAC used in batch or open processes. Thus an new stricter regulation has to decline the overall use and to restrict the use to strictly controlled conditions.
	 Thank you for your comment and the information submitted.	
9	2011/10/12	Company
Germany	N,N-Dimethylacetamide is used for analysis of residual solvents according to Ph Eur (chapter 2.4.24) and USP (Chapter <467>) for headspace gaschromatography. Usually the volumes and the concentration of the substance are low. Additionally, the substance is classified as class 2 residual solvent in pharmaceutical synthesis.
Therefore, the use of N,N-dimethylacetamide as analytical standard and for testing of residual solvents should be exempted from authorisation (scientific R&D) as well as packaging/filling for this use.
	 Please see our response to your comment at the General comments section.	
8	2011/10/12	Industry or trade association
CIRFS; European Man-mde Fibres Association
Belgium	Specific comments on Part II “Information on Use, Exposure, Alternatives and Risks”
Page 21, 23, 25, 30, 42 related to the DMAC volume used in fibres

CIRFS European Man-made Fibres Association is the industry representative association in Europe. The European man-made fibres (MMF) industry is the second-largest producer of man-made fibres in the world, and a global leader in innovation, quality and sustainable production methods according national and European legislation. CIRFS has about 40 members, representing 85% of the European Man-made fibre industry. DMAC is used for the production of acrylic, elastane and m-aramid fibre. CIRFS members using DMAC are dralon, Fisipe, Montefibre and DuPont.
At the time the actual data were requested, these were unfortunately not yet available. However, no need to say that CIRFS is always willing to cooperate and to provide data if possible. 

1. Volumes
- In the dossier, the mentioned production volumes for acrylic fibres are not correct. The dossier figures  relate to greater Europe and are much higher (3 times higher) than the volumes produced in EU27. 
The EU27 acrylic production where DMAC is involved is only about 180 kton. The trade balance (export/import) is about  110 kton positive, resulting in a volume converted in EU27 being about 70 kton only.  			
 -The volumes for elastane fibre (estimated to be about 30 kton) and m-aramid (about 6 kton) are much smaller than the acrylic volume. The trade balance for elastane fibre is estimated to be neutral, which means that a similar volume is converted in EU27. For m-aramid the trade balance is positive.
Due to these much lower figures for the acrylic production, the DMAC use for fibre production is much lower than the 25-30% of the total EU DMAC consumption as mentioned in the dossier. The total DMAC use for all fibres is at about 2900 ton.  
2. DMAC mass balance
Page 24 to 30, 54, 55, 
The man-made fibre industry is a professional industry, operating according strict legislation and self taken initiatives, reporting all DMAC use and emission to the national authorities, where a closed mass balance is a pre-requisite.
We estimate for 2010 for acrylic, elastane and m-aramid fibres using DMAC;
1. Emissions
 . to the air			 650 ton	(22%)
. to water treatment		 350 ton	(12%)		
2 . as waste 			950 ton		(33%)
3. Used in the process		500 ton		(17%)	
4. Residue in the fibre		450 ton		(16%)
 Total 			             2900 ton	(100%)		

Comment to the different topics;
Ad 1. Emissions
Emission to the air has to meet the environmental permits in place, requiring strict measuring and reporting. Adequate measures are taken at the working place to protect workers from exposure during regular or specific operations.
The strict environmental legislation also holds for the DMAC volumes going to the water waste treatment resulting in negligible/not detectable volumes going into surface water.

Ad 2. As waste
 The production waste, mainly being a result of maintenance and cleaning, and the product waste, are all disposed according authorised waste processing systems, bringing no DMAC in the environment. A typical example in Germany is the acrylic waste being authorised as an incinerator alternative fuel.  

Ad3. Used in process
It is reported that during the acrylic production a substantial part of DMAC is used (hydrolysis) in the process 

Ad4. Residue in fibre (page 28)
The man-made fibres industry (MMF) is at the beginning of the textile supply chain. 

MMF  ->  ->  -> 		Converters     -> -> ->      	Clothing manufacturers     ->   -> ->        Consumer
			(weaver, dyer)
DMAC range in fibre	
< 0,6%			< 0,6% 				<0,1%				<0,1%
<      Mostly     very     low     levels        > 

At MMF, depending on the type of fibre and the technology used, the residual content is up to 0,6%. For acrylic fibres lower than 0,3%, for elastane around 0,3% and for m-aramid on average 0,6%. 
The absolute residual volume in the fibre at MMF is expected to be about 450 ton, which is less than one third of the volume mentioned in the dossier 

In EU27, the converted volume (mill consumption) of the 3 fibre types is about 100kton/year, and the absolute volume of residual DMAC going to the converters is expected to be around 300 ton.
Almost all greige fibre is finally dyed or has been water and/or temperature treated resulting in DMAC levels below 0,1%, when it goes to the next converting step. The textile converting industry is operating according its own “Textiles industry” BREF 07.2003.
An exception has to be made for some so-called spun dyed fibres, which means that the fibre is dyed during the fibre production. These fibres need no further dying at converters level and this process is seen as environmentally friendly as it avoids the use of substantial volumes of water and chemicals needed during the conventional dying process, and the consequence water treatment. However it results in a higher DMAC content in the fibre at the final user. 

Other comment;
A remark has to be made regarding the 0,1% limit for SVHC. The limit of 0,1% has been set in the REACH legislation, but as far as we know  there is no standardized analytical method for DMAC. This makes the implementation of the obligation to inform exactly almost impossible, and will lead to irritation and damage of valuable solutions for the textile industry and the brands involved. On the top of that, and as far as we know, the discussion on how the 0,1% has to be calculated (on the original article, or on the complete article) is still not closed. 
Both omissions undermine the basis of the REACH legislation.  
Concluding; 

Page 21, 23, 25, 30, 42 related to the DMAC volume used in fibres
- The EU27 acrylic fibre volume involving DMAC is only about 180, and not the 562 kton mentioned in the dossier.  The total volume of fibres (acrylic, elastane and m-aramid) being about 215 kton.
- The DMAC volumes used for the production of acrylic, elastane and m-aramid fibre are expected to be at about 2900 ton and less than the total EU consumption mentioned in the dossier. 

Page 24 to 30, 54, 55, Mass balance
- The man-made fibre industry is a professional industry meeting environmental legislation, by measuring, controlling and reporting the DMAC uses resulting in a closed mass balance.

Page 28  residual volumes
- The absolute residual volume in the fibre at MMF is about 450 ton only, which is less than one third of the volume mentioned in the dossier.  The converted fibre volume in EU27 is expected to be about 100 kton and the corresponding absolute residual volume in the fibre is around 300 ton.
- After converting, expected to be the case for about 95-99% of all fibres, the residual content is much smaller than 0,1%.
	Thank you for your comment and the information submitted, which, provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.

On your remark regarding the 0.1% limit for SVHC, we would like to note that enforcement of compliance with the provisions of REACH is in the remit of the Member States.
 
The majority of the Member States support the interpretation described in the guidance document (Guidance on requirements for substances in articles, http://guidance.echa.europa.eu/public-2/getdoc.php?file=articles_en), i.e. that for the purpose of notification the concentration should be calculated for the whole article as imported or produced. Some MS do not support this interpretation. Consequently, companies may find diverging enforcement practices in different MS. We would agree that this is an unfortunate situation.
As described in chapter 4.2 of the guidance, companies also have the possibility to prepare their notification to ECHA on the basis of parts of articles, if preferred.
 
As described in chapter 5 of the guidance document, supply chain communication is the most important way of gathering information on the content of substances in articles because chemical analysis is often time consuming, costly, difficult and may yield ambiguous results. If other approaches to obtain information fail or become too complicated, chemical analysis may however be an option to obtain information on the composition of the article. There is some further general guidance on chemical analyses of substances in articles in chapter 5 of the guidance. When it comes to developing harmonised analytical methods for testing specific substances, this is not one of ECHAs responsibilities.	
7	2011/10/11	Company
Netherlands	Use of DMAC in the Pharmaceutical Industry

N,N-Dimethylacetamide, or DMAC, is one of a class of extremely useful solvents designated as polar aprotics. The physical properties of these solvents make them an attractive choice from a chemistry perspective in the synthesis of Active Pharmaceutical Ingredients (APIs) and associated intermediates.  Advantages of DMAC include:

•	DMAC offers generally high solubility of many APIs and intermediates, which often have very poor solubility in less polar solvents.  This facilitates processes that require minimal solvent quantities, compared with the much larger volumes of other solvents that may be required.
•	DMAC additionally offers sufficient solubility of many inorganic reagents (e.g. acids & bases) that facilitates chemical reactions that would not be practicable or robust in many other organic solvents.
•	Reaction rates of certain reactions (e.g. nucleophilic substitution) are substantially enhanced due to the solvent polarity.  Polar aprotic solvents such as DMAC are essential for these reactions, since they prevent unreacted materials from being carried forward in the process stream, minimize the formation of side products, and produce intermediates and API of the highest quality.
•	The use of these solvents can be essential (due to their relatively low acidity) when strong bases are employed as these materials would be completely consumed by side reactions if protic solvents were used.  
•	Water miscibility – for example facilitating precipitation, and subsequent isolation, of products from reaction liquors through the addition of water as an anti-solvent.
•	A high boiling point (166oC) – allowing reactions to be carried out at much higher temperatures than would be achievable in many organic solvents, without the need to operate under pressure (often not operationally feasible in typical pharmaceutical reactors, and inherently of greater operational hazard).  An additional benefit is that the potential for solvent emissions associated with processing is less than those associated with many other solvents.

DMAC is therefore used as a solvent within pharmaceutical research and development laboratories, development manufacturing pilot plants and commercial manufacturing plants.

Exposure
The manufacture of APIs and associated intermediates are performed in enclosed reactor trains in accordance with Good Manufacturing Practices.  DMAC (and other solvents) are introduced into the reactors via transfer systems designed to minimise environmental release, by trained personnel using appropriate protective equipment, and are thus contained within the process stream.  Since the residual amount of DMAC is safety limited by the ICH Q3C (Guideline for Residual Solvents), in practice all the DMAC used during manufacture would be present in the waste streams that are then disposed in accordance with local environmental regulations.  Thus, the risk of environmental exposure of DMAC in the pharmaceutical manufacturing environment are controlled by the equipment design and operational controls; disposal, and record-keeping procedures under the oversight of the quality system. 

Alternative Polar Aprotic Solvents to DMAC

A key point of consideration for the pharmaceutical industry is the regulatory implications that may be associated with changing the solvent used in any stage of a commercial manufacturing process that is registered with the appropriate regulatory health authorities.  Changes to such processes invariably require extensive redevelopment of processes and associated interaction/authorisation from health authorities in order to ensure product quality, efficacy and patient safety is not compromised.  Typically, changing a commercial process would necessarily involve a lead time of one to multiple years, large amounts of work and significant associated costs.  

There are other polar aprotic solvents with similar physical properties that could potentially be used in place of DMAC in some API manufacturing syntheses.  The most common ‘direct’ alternative is DMF (N,N-dimethylformamide).  Others include formamide, N methylformamide and N-methylacetamide.  However, these alternatives also carry essentially the same health hazard as DMAC.  The replacement DMAC with solvents having lower polarity could lead to incomplete reactions and side products that impact the safety and quality of the API. This might increase waste streams.
	Thank you for your comment and the information submitted, which, provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
3	2011/10/07	Company
United Kingdom	p16 (Alternatives):

This paragraph reads as if no alternatives have been studied by the textile industry. This is not the case.
Various alternative solvents have been studied as potential replacements of DMAc in fibre spinning processes. (DMF, NMP, NEP to give some examples). Details of the reasons why they can not be used as alternatives were submitted via the initial questionnaire that we submitted.

DMSO is unsuitable as an alternative as it has a high boiling point (189°C) and its decomposition starts at 190°C which would make re-use and re-distillation difficult. (Data taken from the disseminated dossier information on DMSO on the ECHA website). Furthermore DMSO decomposition impurities carry a distinctive odor that would be considered objectionable in the workplace as well as in products intended for textile applications. 

p17 (1.4 Import of the substance in mixtures):
Imported mixtures containing DMAc are not used in textile processing, but in the actual manufacture of the fibres. The mixtures are used to add specific additives or other polymers into the fibre spinning process.

P54 3.2 Environmental releases of DMAC:
In order to assess the risks related to potential release to the environment, we want to point out two reports that discuss the environmental fate of the substance.

The Ministers of the Environment and of Health in Canada conducted a screening assessment of DMAc and published their assessment in August 2009. The published report contains sections that discussed the environmental fate of DMAc releases to air, water, and soil.  The  report is available on-line at the website of Environment Canada (http://www.ec.gc.ca/substances/ese/eng/challenge/batch5/batch5_127-19-5_en.pdf)

The  2001 OECD SIDS report for DMAc noted in the summary section on page 4 that :
“DMAC is a colourless liquid, completely miscible with water, with a vapour pressure of 1.76 hPa at 20°C. It doesn’t hydrolyse and undergoes photochemical degradation with half-life time of 6.1 hours. A bioconcentration factor (BCF) of 0.008, calculated from log octanol/water partition coefficient (log Kow) of –0.77, indicates a low bioaccumulation potential in aquatic species. A low adsorption to soils and sediments can be assumed by a calculated Koc of 9.1. DMAC is inherently biodegradable (77-83 % after 14 days). Distribution MacKay model indicates that considering a release of DMAC into the air, it is likely to be transported in water and soil. “

Further details concerning environmental exposure and fate were included in the body of the report.	Thank you for your comment and the information, which, provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.

Please note that further information on alternatives is provided in chapter 5 of the Annex XV report for DMAC, while information submitted as confidential has been included only in the confidential annex to this report.	

Attachments

Comment number	Public attachment	
12	
Comment 12 attachment (general comments dmac.pdf).pdf	
16	
Comment 16 attachment (DMAC_CLEAN-Final text 11Oct2011.doc).doc	
20	
Comment 20 attachment (Initial Assessment Report - DMAC.pdf).pdf	
21	
Comment 21 attachment (Bullet points for Commenting DMAC - non-confidential.zip).zip	
23	
Comment 23 attachment (NT 2011_013 APEQ Position _ECHA (20 Substances List)List_DMCA.doc).doc	
28	
Comment 28 attachment (October 13 ConsultationDMAC.doc).doc