19 November 2011

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

Substance name:	Dinoseb	
CAS number:	88-85-7	
EC number:	201-861-7	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Repr. 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. 	
8	2012/10/18	Member State
Norway	The Norwegian CA supports that dinoseb should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment.	
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 Dinoseb 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.	
6	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		
9	2012/10/16	Company
Nufarm UK Limited 
United Kingdom	Please refer to the document attached under section IV.	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.

Topics such as 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 are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.
	
			See also:
Comment 9 attachment (2012-10-16 Revised Comment for List of Intention final.pdf).pdf		
4	2012/10/11	Member State
Germany	We appreciate 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 by the MS 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 uses Dinoseb is registered for are “Polymer Formulation Step” and Manufacture. It is to be used mainly in closed systems; furthermore it is registered in relatively low tonnage.

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	2012/10/04	Company
Nufarm UK Limited
United Kingdom	Please refer to document attached in Section IV.	Thank you for your comment. 

See response to comment 9 above.
	
			See also:
Comment 3 attachment (2012-10-04 Comment for List of Intention Final.pdf).pdf		
2	2012/09/25	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.	Thank you for your comment.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2012/10/16	Company
Nufarm UK Limited 
United Kingdom	Please refer to the document attached under section IV.	Thank you for your comment. 

See response to comment 9 in section “General comments on the SVHC proposal”
	
			See also:
Comment 9 attachment (2012-10-16 Revised Comment for List of Intention final.pdf).pdf		
4	2012/10/11	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 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.
	
3	2012/10/04	Company
Nufarm UK Limited
United Kingdom	Please refer to document attached in Section IV.	Thank you for your comment. 

See response to comment 9 in section “General comments on the SVHC proposal”
	
			See also:
Comment 3 attachment (2012-10-04 Comment for List of Intention Final.pdf).pdf		

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	
9	2012/10/16	Company
Nufarm UK Limited 
United Kingdom	Please refer to the document attached under section IV.	Thank you for your comment. 

See response to comment 9 in section “General comments on the SVHC proposal”
	
			See also:
Comment 9 attachment (2012-10-16 Revised Comment for List of Intention final.pdf).pdf		
5	2012/10/16	Company
Germany	Reference is made to the listing of the substance Dinoseb / 2,4-Dinitro-sec-butylphenol (DNBP), EC-No. 201-861-7, CAS-No. 88-85-7, on the Registry of current SVHC Intentions. We are supporting the substitution of this chemical not only because of its critical ecotoxicological and toxicological properties but also due to the potential risks associated during handling and disposal on workers and the environment.

DNBP is mainly used as a processing aid in the production of styrene which is used as a monomer in large quantities. The substance is generally delivered as a highly concentrated solution in ethylbenzene in drums, intermediate bulk containers (IBCs) or iso-containers, from which it is usually transferred into storage tanks or directly into the process at the customer site. The trans loading process has a medium risk of spillage and usually requires a certain degree of manual handling. Since DNBP is absorbed through the skin, it is essential to wear full personal protective equipment. Furthermore, DNBP is delivered as a molten solid. In these cases, the risk of exposure is enhanced due to the higher temperatures involved.

DNBP leaves the styrene production process after distillation with the tar stream that contains all the materials with a higher boiling point than styrene. This tar stream typically contains around 1-9% DNBP, as well as styrene, other aromatic compounds and styrene polymers. The tar stream is used either as a fuel for industrial power generation or disposed of by incineration. This is carried out on-site, but in many cases the tar stream is sent off-site. Incineration of DNBP contaminated tar streams can potentially contribute to NOx emissions.

There is also the potential that due to the relatively high vapour pressure low levels of DNBP are still present in the finished styrene after distillation and may be carried into the subsequent products. 

A further source of exposure to workers and the environment is via plant maintenance operations, such as filter changes, tower entry, and others. Styrene plants are usually cleaned by high pressure water jetting, and the wash water and subsequently the environment may be contaminated with DNBP.

If DNBP is spilt, there is the potential that it can enter water courses although it is only slightly water soluble. Treating DNBP contaminated waste water to remove DNBP or degrade DNBP into harmless compounds is a demanding process due to its stability in water and its toxicity to water organisms.

The substitution of DNBP is possible as alternative substances have already been successfully applied to European styrene plants. Especially one alternative substance has a number of properties considered to be advantageous in comparison to DNBP, e.g. a significantly lower acute toxicity via oral and dermal route, no sensitization potential, no eye and skin irritation potential and a significantly lower acute and chronic aquatic toxicity. Furthermore the alternative substance referred to has not shown any potential for reproduction toxicity for the time being and also no genotoxic potential is evident.

Taking into account the critical toxicological and ecotoxicological properties of DNBP as well as risks related to handling and disposal, we consider the substitution of DNBP for specific uses as appropriate.	Thank you for your comment. 

See response to comment 9 in section “General comments on the SVHC proposal”
	
3	2012/10/04	Company
Nufarm UK Limited
United Kingdom	Please refer to document attached in Section IV.	Thank you for your comment. 

See response to comment 9 in section “General comments on the SVHC proposal”
	
			See also:
Comment 3 attachment (2012-10-04 Comment for List of Intention Final.pdf).pdf		

Attachments

Comment number	Public attachment	
3	
Comment 3 attachment (2012-10-04 Comment for List of Intention Final.pdf).pdf	
9	
Comment 9 attachment (2012-10-16 Revised Comment for List of Intention final.pdf).pdf