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

Substance name:	Silicic acid (H2Si2O5), barium salt (1:1), lead-doped	
CAS number:	68784-75-8	
EC number:	272-271-5	

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

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency. 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	
8	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for providing your opinion.	
7	2012/10/18	Member State
Norway	It is recognised globally that lead and its compounds pose a significant risk to human health and the environment and that there remains a need for a continued focus on reducing the risks posed by these substances. The concerns for lead compounds are their reprotoxic/neurotoxic properties. The Committee for Risk Assessment under REACH has stated that no threshold for the adverse effect of lead has been identified in humans.  We would also like to stress that the long lasting harmful effects to the environment are of serious concern (cf. classification of lead compounds in general and a number of specific lead compounds in CLP concerning environmental hazard;  "Aquatic Acute 1" ("Very toxic to aquatic life") and  "Aquatic Chronic 1" ("Very toxic to aquatic life with long lasting effects"). 

The Norwegian CA supports that silicic acid, barium salt, lead-doped should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for providing your opinion.	
6	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 Silicic acid, barium salt, lead-doped 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 providing your opinion.	
5	2012/10/17	Company
Japan	The Annex XV dossier is very limited, completely based on the classification of a very general index nr of CLP (082-001-00-6), and subsequently based on calculation rules as shown in section 2 of IUCLID. However, several other sections show that this conclusion might be doubted. We should have brought this forward better in the dossier, in addition none of this information is found in the Annex XV dossier.	Thank you for your comment.

Please note that the SVHC identification process, as set out in REACH Article 59(1) is intended to identify substances meeting the criteria referred to in Article 57 and establishing a candidate list of substances for eventual inclusion in Annex XIV. Hence, no further precondition than meeting criteria referred to in Article 57 needs to be fulfilled in order to include a substance in the candidate list in accordance with the procedure set out in Article 59. 

Please also refer to response to comment #5 in the section “specific comments on the justification”.	
			See also:
Comment 5 attachment (Comments to ECHA for CAS nr 68784-75-8.docx).docx
CONFIDENTIAL attachment removed		
4	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 providing your opinion.	
3	2012/10/12	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 a far reaching measure.

The substance has not been registered. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are not registered, 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. 

Please note that contrary to your statement in the comment, the substance has been registered.	
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 providing your opinion.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
5	2012/10/17	Company
Japan	Page 5-6: Composition of substance is limitedly described.
Page 7: The CLP Annex VI listing of index number 082-001-00-6 describes a specific concentration limit for reproduction toxicity which is not described here.  
Page 9: Human health hazard assessment, only reference is made to the classification, not to the respective studies.
See section IV for more information on all comments given.	Thank you for your comment. 

Please note that ECHA normally does not disclose details of the full composition of a substance but where relevant provides information on the identity of impurities and/or additives which are known to be dangerous and essential for classification and labelling.

Regarding the concentration limit: the error existing in the CLP Annex VI for the entry 082-001-00-6 is known to ECHA. 
The generic concentration limit for a category 1A reproductive toxicant is applicable in accordance with section 3.7.3 of Annex I of the CLP Regulation. This concentration limit is 0.3% lead, effective from 1 June 2015 onwards. In accordance with Art. 61.1 of the CLP Regulation, until 1 June 2015 the concentration limit from Directive 1999/45/EC, Annex II, Part B, section 6.1 applies, which is 0.5 %. In accordance with note 1, listed for Index no. 082-001-00-6 in the CLP Regulation, the above “percentages are by weight of the metallic element calculated with reference to the total weight of the mixture”, or in this case the substance.  

Please note that the SVHC identification process, as set out in REACH Article 59(1) is intended to identify substances meeting the criteria referred to in Article 57 and establishing a candidate list of substances for eventual inclusion in Annex XIV.
Hence, no further precondition than meeting criteria referred to in Article 57 needs to be fulfilled in order to include a substance in the candidate list.
The substance your comment is referring to is classified as Repr. 1A according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008 and consequently fulfils the criteria of Article 57 (c) of the REACH Regulation.

As the above cited harmonised classification is applicable law at present, it will not be questioned or discussed in the context of the currently ongoing SVHC identification process.

Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification of a substance in Part 3 of Annex VI of Regulation (EC) No 1272/2008 may submit a revision proposal in accordance with the second subparagraph of Article 37(2) of Regulation 1272/2008 to the competent authority in one of the Member States in which the substance is placed on the market.	
			See also:
Comment 5 attachment (Comments to ECHA for CAS nr 68784-75-8.docx).docx
CONFIDENTIAL attachment removed.		
3	2012/10/12	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	
5	2012/10/17	Company
Japan	Page 9: Reference to the dossier is made. 
The substance is only used for formulation into a preparation which subsequently is specifically used only to coat the sun tanning lamp (UV light source). Thus a very limited use, only industrial and no professional neither consumer use (or exposure) is considered applicable for this substance. It has been thought that the risk of emitted UV waveforms and wavelengths from this lamp is comparatively small when coated with this substance. In addition, no risk is calculated in the CSR, thus the substance is used in a safe way.	Thank you your comment and for additional information on uses.

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 describing 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.

Please refer also to response to comment #5 in the section “specific comments on the justification”. 	
			See also:
Comment 5 attachment (Comments to ECHA for CAS nr 68784-75-8.docx).docx
CONFIDENTIAL attachment removed.		

Attachments

Comment number	Public attachment	
5	
Comment 5 attachment (Comments to ECHA for CAS nr 68784-75-8.docx).docx