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

Substance name: Disodium octaborate
CAS number: 556-67-2
EC number: 209-136-7

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Toxic for reproduction (Article 57c)

Disclaimer: Comments provided during public consultation are made available as submitted by the commenting parties. It was 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, submitter type, country)	Comment	Responses	
4986
2018/04/17	European Borates Association ,
Industry or trade association,
Belgium	-	Thank you for your comments.

The substance meets the criteria and goal of the SVHC roadmap 2020. The identification of a SVHC brings, not only obligations but also, valuable information to suppliers, professional users and consumers. This does not necessarily mean that there is an exposure or risk for consumers.

Information on type of uses and alternatives is  used at a later stage of the authorisation process 

The appropriateness of grouping lead bis(tetrafluoroborate) with other borates will be considered later in the process.	
		Attachment: 4986_EBA Comments on Annex XV for DOT.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4967
2018/04/12	ChemSec,
International NGO,
Sweden	ChemSec supports the inclusion of Disodium octaborate on the Candidate List based on its official classification as Toxic for Reproduction.	Thank you for your support.	
4975
2018/04/13	Germany,
Member State	The German CA supports the proposed identification of Disodium octaborate as a substance meeting the criteria of Article 57 (c) of Regulation (EC) No 1907/2006 (REACH) owing to its classification in the hazard class reproductive toxicity category 1B.
Identity of the substance:
p.4/5: We assume that the candidate list entry will mention the CAS numbers for the anhydrous (CAS 12008-41-2) and hydrated (CAS 12280-03-4) forms like it is indicated in the corresponding Annex VI entry and in the RMOA.
Could you please clarify this?	Thank you for your support and question. 

The EC entry 234-541-0 covers also the substance disodium octaborate tetrahydrate, CAS 12280-03-4 (as explained on p. 5 in the SVHC dossier). This has been confirmed by ECHA who also adds that ‘A substance included in the candidate list is normally described by the identifiers as published in the EC inventory. In this case CAS entry 12008-41-2 is associated to EC entry 234-541-0 therefore it is envisaged to specify this CAS entry in the Candidate List. However indicating the CAS number of this specific hydrated form in the Candidate List entry may create ambiguities on whether hydrated forms other than the tetrahydrate would be covered by the entry. For this reason, it is not planned to list the CAS number for the hydrated form (CAS 12280-03-4) in the Candidate List.’	
4986
2018/04/17	European Borates Association ,
Industry or trade association,
Belgium	-	Thank you for your comment.

Please find answers to your comments in table 1 to Part 1.	
		See the corresponding embedded attachment in table 1 of Part I: 
4986_EBA Comments on Annex XV for DOT.pdf		
4994
2018/04/18	Finland,
Member State	The Finnish CA supports identification of disodium octaborate as a SVHC substance according to Article 57 (c) of Regulation (EC) No 1907/2006 (REACH) owing to its harmonized classification Repr. 1B; H360FD: “May damage fertility. May damage the unborn child”. The Finnish CA notes that Risk Management Option Analysis (RMOA) conclusion document has been published on the ECHA website. According to the RMOA the substance is considered to meet the SVHC Roadmap to 2020 criteria.	Thank you for your support.	
5023
2018/04/20	Norway,
Member State	Norway supports that disodium octaborate should be identified as a substance of very high concern and should be included in the Candidate list. Disodium octaborate has a harmonised classification as toxic to reproduction in category 1B and meets the criteria for inclusion on the Candidate list in Article 57 c) in REACH.	Thank you for your support.	
5029
2018/04/20	Norway,
Member State	Norway supports that disodium octaborate should be identified as a substance of very high concern and should be included in the Candidate list. Disodium octaborate has a harmonised classification as toxic to reproduction in category 1B and meets the criteria for inclusion on the Candidate list in Article 57 c) in REACH	Thank you for your support.	
5067
2018/04/23	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports the inclusion of Disodium octaborate in the REACH candidate list owing to its classification as reproductive toxicant 1B.	Thank you for your support.	

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, submitter type, country)	Comment	Responses	
4986
2018/04/17	European Borates Association ,
Industry or trade association,
Belgium	p.10-12 We would like to bring to your attention that most of disodium octaborate’s volume (around 95%) is used in fertilisers as a micronutrient. As correctly concluded by the Danish Environmental Protection Agency (DEPA, 2015), there are no suitable alternatives for the majority of the uses of the borates, including plant micronutrient, thus uses such as this one will never achieve the EU’s stated goal of authorisation (i.e. substitution). The disodium octaborate registration dossier will be submitted for an update by the end of May 2018, removing all identified uses which are no longer in practice.

In addition, the link with lead bis (tetrafluoroborate) and disodium octaborate is misleading and false. These substances have different chemical properties and functions, therefore any connection amongst the two substances can only bring confusion.	Thank you for your comments.

Information on type of uses and alternatives is used at a later stage of the authorisation process 

The appropriateness of grouping lead bis(tetrafluoroborate) with other borates will be considered later in the process.	
		See the corresponding embedded attachment in table 1 of Part I: 
4986_EBA Comments on Annex XV for DOT.pdf