19 November 2011

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

Substance name:	dimethyl sulphate	
CAS number:	77-78-1	
EC number:	201-058-1	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carc. 1B

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.

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	
10	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for your comment. 	
9	2012/10/18	Member State
Norway	 The Norwegian CA supports that dimethyl sulphate should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment.	
8	2012/10/17	Industry or trade association
EDF SA & CEA
France	1. Background
Dimethyl sulphate is used in the French nuclear industry for control tests on radioactive iodine trapping devices (iodine traps), employed in nuclear ventilation systems. 
Ventilation system iodine traps, composed of vegetable carbon, are designed to reduce the activity level of iodine released in normal operating conditions or in the event of an accident. They contribute to nuclear building containment and play an important safety role. National regulations stipulate that these tests must be carried out on an annual basis.
The dimethyl sulphate quantities used annually for this analysis are low (2 to 5 ml per iodine trap test and no more than 350 tests per year performed by EDF, for example).
To date, no substitutes for dimethyl sulphate have been identified.

2. Detail of the process and risk assessment
2.1 Process Description
Principle of iodine traps 
Iodine traps and their monitoring are governed by national regulations:
• Article 11 of the French Order of 31/12/99 laying down the regulations designed to prevent and limit nuisances resulting from the operation of basic nuclear installations stipulates: "Installations shall be designed, maintained and operated in such a way as to prevent or limit, in the event of an accident, the direct or indirect release of toxic, radioactive, inflammable, corrosive or explosive gases". These provisions are retained in the French Order of 7 February 2012 laying down the general regulations relative to basic nuclear installations (articles 2.5.3 and 2.5.4) due to come into force on 01/07/2013.
• In addition, the Decrees authorising the creation of the nuclear installations concerned stipulate that "The discharge system at the exhaust stack shall be equipped with non-flammable dust filters, iodine traps and a device for the continuous monitoring of discharge activity. The efficiency of all filters and iodine traps shall be checked before they are brought into operation. Thereafter, periodic checks shall be performed".

Efficiency check
On-site efficiency checks on the iodine trapping components of an air cleaning system are designed to verify that these components have not deteriorated from the point at which their ex-factory compliance was checked to installation at the site, and to make sure that the overall efficiency of the installation is not reduced as a result of inadequate sealing due to incorrect assembly of these filter components.
They are also designed to monitor component ageing and, if necessary, to help determine whether components need to be replaced, the objective being to permanently guarantee a level of efficiency that exceeds the safety criterion, as required in the general regulations governing the operation of nuclear installations.
These tests are performed once per year.
An iodine trap efficiency test, performed in accordance with French standard NF M 62-206 , firstly involves the injection of a given quantity of activity upstream of the iodine trap, in the form of radioactive methyl iodide (131ICH3) generated from dimethyl sulphate and sodium iodide, followed by the simultaneous sampling of the air above and below the trap through air sampling cartridges. The activity bound to these sampling devices is then analysed in the laboratory by spectrometry and an efficiency coefficient is determined by calculating the ratio between the quantity of activity penetrating the trap and the quantity not retained.

Radioactive methyl iodide is produced by the reaction between dimethyl sulphate and radioactive sodium iodide. The process is performed in a radioactive iodine generator, which consists of:
- A class 2 glove box in accordance with French standard NF 62-200, maintained at negative pressure relative to ambient air and equipped with its accessories (air inlet and outlet filter cartridges, manometers, etc.)
- A radioactive iodine injection line maintained at negative pressure relative to the glove box. 
Dimethyl sulphate disappears due to a chemical reaction with sodium iodide according to the following reaction:

2 131INa + (CH3)2S04 -----> S04Na 2 + 2  131ICH3

2.2 Replacement of CMR products
To date, no substitutes for dimethyl sulphate with the characteristics required for its use in the nuclear industry have been identified. 
In addition, this use is governed by a standard (NF M 62-206) . This standard is currently being revised by the Association Française de NORmalisation (AFNOR -French Standards Association) and is the subject of a draft international standard (PWI16659) submitted to the International Organisation for Standardisation. In this draft standard, the radioactive methyl iodide method using dimethyl sulphate remains the only reference method for checking the filtration ratio of iodine traps given the reliability of the results obtained. Other methods exist to test iodine traps, but they are not capable of determining the filtration ratio of an iodine trap. Such methods are employed purely to check correct assembly of the filtration component prior to the efficiency test using the methyl iodide method. The use of dimethyl sulphate has thus been restricted to control of the filtration ratio of an iodine trap.

2.3 Risk management
Given the carcinogenic nature of dimethyl sulphate, its use is subject to specific traceability controls, particularly if it is not injected into the system.
Wherever possible, iodine trap efficiency tests are grouped by testing campaign at the same site. Each campaign is generally performed over one or several days. 
Test teams consist of at least two operators (one performing the test and the other responsible for technical control). The operation is conducted in accordance with the regulatory radiation protection provisions in force and the required safety measures. In addition, each operator must be medically fit and certified in the field of radiation protection.

Access to the storage zone is restricted to authorised personnel only. During injection of dimethyl sulphate, the use of a respiratory protection system is compulsory. Protective overalls, gloves and safety glasses must also be worn. Injection is performed inside an injection glove box maintained at negative pressure, to prevent any release reaching the operators. Wearing respiratory protection system multiplies the containment efficiency by a factor of 100 to 1000. Before use, the dimethyl sulphate is transported in an unbreakable vial. It is only introduced into the source at the last moment, once it has been ascertained that all the prerequisites prior to injection have been complied with. 

Operator exposure measurements reveal values below the limit of detection. 

Furthermore, access to the iodine trap is regulated and restricted for any operation on the iodine trap for a period of time that is sufficient to ensure radioactive decay of the iodine bound in the carbon inside the iodine trap.

Removal of dimethyl sulphate potentially contained in the source residue following the chemical reaction of dimethyl sulphate and sodium iodide is performed using an accredited disposal process.	Thank you for the information provided. 

If the substance is identified as SVHC, this information, where relevant, will be taken into account at later stages of the authorisation process.

Even though information provided during public consultation is taken into account, we would like to stress that the registrations are the standard tool and route to communicate information on a substance and its uses to the authorities The registrations are the authorities’ principal source of information when assessing the need of further risk management for a substance or (some of) its uses. Therefore, it is of utmost importance that registrants keep the information provided in the registration dossiers up to date and adequately describe the current use and exposure situation, including the operational conditions and risk management measures in place.

If certain uses are not covered by the provided exposure scenarios, downstream users can either communicate this through supply chain communication (via their suppliers) to the registrants, who then need to update their registrations accordingly, or prepare their specific chemical safety report and submit a downstream user report to ECHA.

	
			See also:
Comment 8 attachment (10-2012-Response to public consultation ECHA- 77-78-1.pdf).pdf		
7	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 Dimethyl sulphate 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.	Thank you for your comment. 	
5	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	Thank you for your comment. 	
4	2012/10/09	Member State
Germany	The German CA appreciates ECHA´s efforts to compile SVHC-Dossiers on such short notice. 

We do not fully understand the selection criteria, which are different to the approach taken so far for SVHC-identification.

Even though these substances can easily be put on the candidate list due to their CMR-classification, careful assessment of the relevance (tonnage, wide-spread use, exposure, prevention of substitution by equally hazardous substances) should be carried out for justification of the SVHC-identification. The RMO analysis is a crucial step in the process not only to share and discuss risk management options with MS but also to provide a justification for such far reaching measures.

The substance has been registered as intermediate only. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are registered as intermediates only, the inclusion on the candidate list and subsequent inclusion in Annex XIV might be the most appropriate risk management option. Without further information on potential risks that may be related to any other uses of this substance, the reason to identify this substance as SVHC remains unclear.
Therefore, we would suggest that thorough RMO analyses are prepared and shared with MSCAs as soon as possible.	Thank you for your comment. 

In accordance with REACH Article 59 the Member States and the Commission have the right to propose substances for identification as substances of very high concern (SVHC) meeting the criteria of Article 57. 
ECHA has received a request from the Commission to prepare an Annex XV dossier proposing the identification of this substance as SVHC, which was followed by the Agency. 

Preparation of a risk management options analysis (RMOA) before proposing the identification of a substance as SVHC is a voluntary step in the co-ordination of risk management activities among the Competent Authorities for REACH but not a requirement of REACH. 

Nevertheless, ECHA agrees on the importance of identifying the most appropriate route(s) for risk management and on the co-operation and co-ordination of the regulatory risk management activities between the authorities. 	
3	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.
This substance is included in the Trade Union Priority List for REACH authorisation see: http://www.etuc.org/a/6023	Thank you for your comment.	
2	2012/09/26	National NGO
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.	Thank you for your comment.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
4	2012/10/09	Member State
Germany	No information about the physical properties is given in the report or in the technical dossier. In the report a link to the Chemical Substance Search on the ECHA website is given instead. It would be better to provide these data directly in the report (and the technical dossier), so that no further search in a database is necessary.	The proposal for identifying the substance as SVHC is based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The physical properties of the substance are in this particular case neither necessary to define the identity of the substance addressed in the dossier nor to demonstrate that it meets criteria set out in Article 57. 

If however information on the physical properties would be required to describe the substance identity or to conclude on its SVHC properties those data should be included in the Annex XV dossier.

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	
6	2012/10/17	Company
Germany	Dimethyl sulfate is used as an alkylating agent, and therefore as an intermediate, to prepare methyl derivatives of phenols, amines, and thiols in scientific R&D. All formulations mentioned in the uses described above are used in the laboratory by industrial and professional users that are well-trained.
The packaging/refilling into small packages for this use in order to avoid handling of big volumes in laboratories should be exempted from authorization.
	Thank you for the information provided. 

See response to comment 8 in section “General comments on the SVHC proposal”

Regarding exemption for laboratory use:
Please note that although uses for scientific research and development of a substance are exempted from the authorisation requirement in accordance with Article 56(3) this appears to only apply to its final use for SRD purposes under the conditions defined in Article 3(23).

However, use of a CMR substance included in Annex XIV, on its own or in a mixture (above the lowest of the concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation)), for e.g. formulation of test kits or analytical standards with the intention to supply them for SRD purposes, would therefore probably require authorisation.

As dimethyl sulphate is a carcinogen, there is a strong societal interest to protect humans, in particular workers handling the substance, from risks potentially arising from its uses. An authorisation requirement for dimethyl sulphate will accordingly ensure that the health of workers in the EU involved in the uses of this substance is protected.	

Attachments

Comment number	Public attachment	
8	
Comment 8 attachment (10-2012-Response to public consultation ECHA- 77-78-1.pdf).pdf