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

Substance name:	Dibutyltin dichloride [DBTC]	
CAS number:	683-18-1	
EC number:	211-670-0	

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. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
17	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 support.	
16	2012/10/18	Industry or trade association
GIFAS
France	PLEASE REFER TO ATTACHED DOCUMENT	Thank you for information on use and that the alternative solutions are potentially available soon for DBT.	
			See also:
Comment 16 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf		
15	2012/10/18	Member State
Norway	The Norwegian CA supports that dibutyltin dichloride (DBT) should be identified as a substance of very high concern and should be included in the Candidate List based on the classification as toxic to reproduction. In addition we would like to express our concern for DBTs potentially long lasting harmful effects to the environment. DBT has been shown to be a potential PBT substance (Ref. 1, 2) and may also qualify for inclusion on the candidate list according to article 57d.

Ref 1: Opinion adopted by SCHER, 14th plenary, 30 November 2006 "Revised assessement of the risks to health and the environment associated with the use of the four organotin compounds TBT, DBT, DOT and TPT
Ref 2: Impact Assessment of Potential Restrictions on the Marketing and Use of Certain Organotin Compounds, RPA, October 2007.	Thank you for your support. DBT has a low potential for bioaccumulation and we believe it might not satisfy the Article 57d criteria.	
14	2012/10/18	Individual
Japan	The nomination of dibutyltin dichloride (DBTC) (EC No: 211-670-0, CAS No: 683-18-1) as an SVHC (Substances of Very High Concern) candidate substance is to virtually ban this substance to be used in articles. We strongly oppose to this idea.	DBT satisfies the formal criteria for identification as a SVHC. In the dossier risks related to occupational exposure to DBT have been emphasized.	
13	2012/10/18	Individual
Japan	The nomination of dibutyltin dichloride (DBTC) (EC No: 211-670-0, CAS No: 683-18-1) as an SVHC (Substances of Very High Concern) candidate substance is to virtually ban this substance to be used in articles. We strongly oppose to this idea.	DBT satisfies the formal criteria for identification as a SVHC. In the dossier risks related to occupational exposure to DBT have been emphasized.	
12	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Dibutyltin dichloride (DBT) 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 support.	
10	2012/10/16	Member State
United Kingdom	Given the low tonnages that are in scope for authorisation, current restrictions and a CSR that shows all risks to workers are controlled it seems likely that this substance will be a very low priority for Annex XIV inclusion.	We share your thought. This point has been acknowledged in the Risk Management Option Analysis which has been submitted for comments to the Member States.	
9	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 support.	
8	2012/10/16	Company
Germany	The dossier has been prepared in a simplified procedure without a reassessment of the harmonized classification.	Reassessment of harmonised classification is not a part of SVHC identification process.	
			See also:
Comment 8 attachment (DBTC_Comments_Galata_161012.docx).docx		
7	2012/10/16	Member State
Belgium	The BE MSCA supports the proposal to identify this substance as SVHC as the proposals is based on article 57 (c) of the REACH Regulation.	Thank you for your support.	
6	2012/10/16	Company
TIB Chemicals AG
Germany	The proposal is justified with an entry in the list of harmonized classification and labeling of hazardous substances (Part 3 of Annex VI, Table 3.1 1272/2008/EC and Part 3 of Annex VI, Table 3.2 1272/2008/EC). From this entry is concluded to SVHC properties. Current state of scientific knowlegde is not accounted.

pp.9	Reassessment of harmonised classification is not a part of SVHC identification process.	
			See also:
Comment 6 attachment (Comment DBT svhc canidate.pdf).pdf		
5	2012/10/16	Individual
Japan	The nomination of dibutyltin dichloride (DBTC) (EC No: 211-670-0, CAS No: 683-18-1) as an SVHC (Substances of Very High Concern) candidate substance is to virtually ban this substance to be used in articles. We strongly oppose to this proposal.

DBTC is also used as an essential substance in catalyst applications, and alternatives that can give equivalent performance are very difficult in the present
state of affairs.

At present, the use of dibutyltin substances in mixtures and articles for general use has already been strictly restricted in REACH Annex XVII, in the category of the ban of products containing metallic tin by 0.1 % or above. 

Moreover regulations are considered unnecessary.	DBT satisfies the formal criteria for identification as a SVHC. 
Discussion on alternatives will be taken into account later in the process.
In the dossier risks related to occupational exposure to DBT has been emphasized.	
4	2012/10/09	Member State
Germany	The German CA thanks the Swedish CA for preparing the dossier and supports the identification of dibutyltin dichloride as SVHC. 
As mentioned in the dossier the existing restrictions do not address the exposure concerns for workers.	Thank you for your support.	
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 support.	
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 support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
14	2012/10/18	Individual
Japan	According to Annex XV dossier (Annex XV - IDENTIFICATION OF DIBUTYLTIN DICHLORIDE AS SVHC), concern about exposure to DBTC is not the problem of inclusion of SVHC in articles, but the problem of work environment for manufacturing articles using DBTC. Since the risk of exposure is limited, the application of avoiding measures is not considered much difficult. For instance, the proper protective attires (use of goggles, mask, and/or gloves) for workers, and/or the sufficient air ventilation of work places will solve this problem. In addition, the tires that are manufactured in the category of “use in tire application” in the dossier are for use in specific vehicles at specific places, not the use in vehicles on common roads. Therefore, the risk of exposure to general public is considered very low.
  From another viewpoint, DBTC is also used as an essential substance in other applications, and alternatives that can give equivalent performance are very difficult to find at present.
  At present, the use of dibutyltin in mixtures and articles for general use has already been strictly restricted in REACH Annex XVII, in the category of the ban of products containing metallic tin by 0.1 % or above. Additional regulation is considered unnecessary.
	In the dossier risks related to occupational exposure to DBT have been emphasized.

Discussion on alternatives will be taken into account later in the process.
	
13	2012/10/18	Individual
Japan	According to Annex XV dossier (Annex XV - IDENTIFICATION OF DIBUTYLTIN DICHLORIDE AS SVHC), concern about exposure to DBTC is not the problem of inclusion of SVHC in articles, but the problem of work environment for manufacturing articles using DBTC. Since the risk of exposure is limited, the application of avoiding measures is not considered much difficult. For instance, the proper protective attires (use of goggles, mask, and/or gloves) for workers, and/or the sufficient air ventilation of work places will solve this problem. In addition, the tires that are manufactured in the category of “use in tire application” in the dossier are for use in specific vehicles at specific places, not the use in vehicles on common roads. Therefore, the risk of exposure to general public is considered very low.
  From another viewpoint, DBTC is also used as an essential substance in other applications, and alternatives that can give equivalent performance are very difficult to find at present.
  At present, the use of dibutyltin in mixtures and articles for general use has already been strictly restricted in REACH Annex XVII, in the category of the ban of products containing metallic tin by 0.1 % or above. Additional regulation is considered unnecessary.	In the dossier risks related to occupational exposure to DBT have been emphasized.

Discussion on alternatives will be taken into account later in the process.
	
8	2012/10/16	Company
Germany	The role of the process caused impurity tributyltin chloride (TBTC) in conjunction with dibutyltin dichloride has been and still is underestimated in it’s contribution to the reprotoxicity of the substance in concern. We believe that a DBTC manufactured in a purity of a state of the art production process, containing <=0.1 % TBTC needs not to classified as Repr. 1B and thus should not be an SVHC candidate. The detailed arguments as well as the literature citations are expained in the attachment.	Reassessment of harmonised classification is not a part of SVHC identification process.	
			See also:
Comment 8 attachment (DBTC_Comments_Galata_161012.docx).docx
		
6	2012/10/16	Company
TIB Chemicals AG
Germany	In thue the current state of scientific knowlegde is not not accounted in the dossier TIB discuss the current knowleght

pp.9	Reassessment of harmonised classification is not a part of SVHC identification process.	
			See also:
Comment 6 attachment (Comment DBT svhc canidate.pdf).pdf		
4	2012/10/09	Member State
Germany	Dibutyltin dichloride hydrolyses in water. Therefore the values reported of some physico-chemical properties like water solubility, partition coefficient and other may have been influenced by hydrolysis products. Remarks should be added where appropriate.

To the IUCLID-file:
Information on physico-chemical properties is only given in the report and missing in the technical dossier.
	Thank you for the comment. Remarks will be made if necessary.

Information on physico-chemical properties in the SVHC Annex XV technical dossier is optional.	

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	
11	2012/10/17	Industry or trade association
Tin compounds Environmental Technical Association
Japan	The nomination of dibutyltin dichloride (DBTC) (EC No: 211-670-0, CAS No: 683-18-1) as an SVHC (Substances of Very High Concern) candidate substance is to virtually ban this substance to be used in articles. We strongly oppose to this idea.

According to Annex XV dossier (Annex XV - IDENTIFICATION OF DIBUTYLTIN DICHLORIDE AS SVHC), concern about exposure to DBTC is not the problem of inclusion of SVHC in articles, but the problem of work environment for manufacturing articles using DBTC. Since the risk of exposure is limited, the application of avoiding measures is not considered much difficult. For instance, the proper protective attires (use of goggles, mask, and/or groves) for workers, and/or the sufficient air ventilation of work places will solve this problem. In addition, the tires that are manufactured in the category of “use in tire application” in the dossier are for use in specific vehicles at specific places, not the use in vehicles on common roads. Therefore, the risk of exposure to general public is considered very low.
  From another viewpoint, DBTC is also used as an essential substance in other applications, and alternatives that can give equivalent performance are very difficult to find at present.
  At present, the use of dibutyltin in mixtures and articles for general use has already been strictly restricted in REACH Annex XVII, in the category of the ban of products containing metallic tin by 0.1 % or above. Additional regulation is considered unnecessary.	DBT satisfies the formal criteria for identification as a SVHC.
 
In the dossier risks related to occupational exposure to DBT have been emphasized.

Discussion on alternatives will be taken into account later in the process.	
4	2012/10/09	Member State
Germany	The Annex XV dossier provides information on the uses of DBTC but acknowledges that "existing previous information might not be relevant" given the recently implemented restrictions. Perhaps a modified wording such as "has been used" instead of "is used" might be more appropriate.

The BfR information No. 018/2007 of 1 June 2007 on the "Introduction to the problems surrounding garment textiles" [1] contains a short paragraph on organotin compounds:
"In recent years there have been repeated reports of organotin compounds in garment textiles. Organotin compounds, in particular tributyltin (TBT) compounds have an antimicrobial effect. Monotin and dialkylated tin derivatives are used as [heat and light] stabilisers in PVC for coatings, applications and prints on textiles. According to the current German Catalogue of Textile Auxiliaries 2000 three textile auxiliaries are commercially available which contain organotin compounds. However, they are not used to give a biocide finish to textiles but to provide material protection for heavy textiles like tarpaulins, marquees and tents. According to information from the manufacturers a TBT content of 0.1 % (i.e. 1 g/kg) must be achieved in order to produce an anti-microbial effect. High levels on this scale have not been detected up to now in the measurements of textiles undertaken by various offices."

[1] http://www.bfr.bund.de/cm/349/introduction_to_the_problems_surrounding_garment_textiles.pdf	Thank you for the comment. Rephrasing will be done.

This information is already covered under the “Uses” section in the dossier.	

Attachments

Comment number	Public attachment	
6	
Comment 6 attachment (Comment DBT svhc canidate.pdf).pdf	
8	

Comment 8 attachment (DBTC_Comments_Galata_161012.docx).docx	
16	
Comment 16 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf