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

Substance name:	sodium peroxometaborate	
CAS number:	7632-04-4	
EC number:	231-556-4	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Art. 57(C)

Disclaimer: Comments provided during the public consultation are made available in this document 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. 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	
10	2014/04/17	Member State
Belgium	Belgium supports the proposal to identify Sodium peroxometaborate as SVHC. The substance is classified as  Repr. 1B and therefore meets the Art.57(c)criteria.	Thank you for the support	
8	2014/04/17	International NGO
Health and Environment Alliance (HEAL)
Belgium	The Health and Environment Alliance supports the nomination of Sodium peroxometaborate as an SVHC, due to its properties.	Thank you for the support	
1	2014/03/21	Member State
Norway	The Norwegian CA supports that Sodium peroxometaborate should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for the support	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
11	2014/04/17	International NGO
European Environmental Bureau (EEB)
Belgium	The EEB supports the inclusion of Sodium peroxometaborate in the candidate list due to its reprotoxic properties. Sodium peroxometaborate’s reproductive adverse effects are mediated by an endocrine disruption mechanism so this should be taken into account, especially for low dose effects. Moreover the substance is genetoxicant (http://toxnet.nlm.nih.gov/cgi-bin/sis/search) so it should be considered as non threshold substance. There is very high scientific uncertainty for a safe threshold being set.

Studies related with developmental toxicity (endocrine disruption): 
1  
Rat embryo-fetal development study on sodium perborate tetrahydrate. 
Bussi R; Chierico G; Drouot N; Garny V; Hubbart S; Malinverno G; Mayr W
Teratology 1996 May;53(5):26A [DART]	
2  
Antiproliferative Effect Of Bleaching Agents Against Two Established Cell Lines. 
Koulaouzidou EA; Papazisis KT; Economides N; Karanika-Kouma A; Kortsaris AH
Reprod Toxicol 2004 July;18(5):733 [DART]	
3  
Reproductive toxicity parameters and biological monitoring in occupationally and environmentally boron-exposed persons in Bandirma, Turkey. 
Duydu Y; Başaran N; Üstündağ A; Aydin S; Ündeğer Ü; Ataman OY; Aydos K; Düker Y; Ickstadt K; Waltrup BS; Golka K; Bolt HM
Arch Toxicol. 2011, Jun; 85(6):589-600. [Archives of toxicology] [PubMed]
PubMed Citation
 	Thank you for the support. However, we have decided not to look at ED properties in this submission	
9	2014/04/17	Member State
Austria	The Austrian CA agrees with the proposal to identify “sodium peroxometaborate” as a substance of very high concern. It fulfils the criteria of Art 57(c) of REACH Regulation. Although it is currently not registered under REACH, it should still be considered relevant for SVHC identification as suggested under the Commission  SVHC roadmap to 2020: “There might be however cases in which non registered substances can still be considered relevant for identification. One example might be a substance that is currently not produced or used in Europe, but might be used as an alternative to another relevant SVHC. This exemption is particularly relevant when the most appropriate approach is the category approach (i.e., analogous substances."
	Thank you for the support, and we agree with your argumentation	
7	2014/04/17	Industry or trade association
A.I.S.E.
Belgium	No comment	-		
6	2014/04/16	Company
United Kingdom	Uses reported in the Annex XV dossier are:
• PBS is mainly used as bleaching agent in laundry detergents and machine dishwashing products
• PBS is (per mid 2013) only manufactured by two ompanies   in Europe. Worldwide, no other production exists.
• Exposure at the workplace (production and formulation) is by far the most important source of human exposure to PBS. Consumer exposure concentrations to PBS are in all situations expected to be very low.

In the comments uploaded confidentially we describe our uses in more detail.

Confidential comment submitted

The purpose is submitting these comments is to ensure that ECHA is familiar with certain critical uses of PBS for direct nucleic acid labelling and in detection reagents – allowing for detection of minute protein quantities.

Although our uses of these substances are in limited volumes and laboratory scales, the uses are critical for the manufacture of ECL detection kits as used in research into the role of proteins in disease processes, in research into the effects of genetic modification on protein expression, and by forensics science laboratories for detection of minute protein quantities.  This is a specialty use of PBS and is not the general use application as bleaching agents described in the dossier.  There are currently no known substitutes for these uses. 
	Thank you for the information that was unknown to us. 

5	2014/04/15	National NGO
CHEM Trust
United Kingdom	CHEM Trust supports the inclusion of sodium peroxometaborate in the REACH candidate list on the basis of 57 (c).  	Thank you for the support	
4	2014/04/15	Member State
Germany	The DE CA supports the proposal of the DK CA to identify sodium peroxometaborate as SVHC.

The DE CA proposes to indicate all the CAS numbers referred to in the Justification part of the dossier right at the beginning, where the target substance of the proposal for identification of a substance as SVHC is given. Otherwise the scope of the dossier might not be clear, as parts of the dossier uniquely refer to the substance proposed for SVHC identification and other parts refer to a group of substances (PBS). This leads to inconsistencies: On the one hand, on page 3 it is declared that no registration of the substance is available, on the other hand in the conclusion (page 3) the relevance for inclusion on the Candidate List is based on the fact that “the substance” (which in this case refers to other members of the group of PBS) has been registered.
In the “Type of substance” field in section 1.1 of the IUCLID file the information on the origin of the substance is missing. The IUCLID file does not contain information about the molecular weight range, the InChI code or the structural formula of the reference substance
although appropriate information are given in the assessment report.
Editorial comment: A reference link on page 21 is broken.	Thank you for the support. 

The inconsistences are due to a late splitting in two dossiers – it will be corrected

IUCLID files will be updated accordingly	
3	2014/04/10	Member State
Sweden	The Swedish CA agrees that sodium peroxometaborate, being classified as Repr. 1B, meets the criteria according to Article 57(c) in REACH and is thus eligible for identification as a substance of very high concern.

Sweden agrees with DK that also non registered substances are relevant for identification as SVHC.

SE notes that there is one sodium salt of a boric compound, orthoboric acid, sodium salt (Index number 005-011-00-4, EC number 237-560-2, CAS number 13840-56-7), that is harmonized classified as Repr. 1B (H360FD: C ≥ 4.5%) (Reg (EC) No 1272/2008 (CLP)) that is not included in the dossier, and neither already on the candidate list (referring to its EC number and CAS number). If this compound would be included in the dossier all boric acid compounds that today are harmonized classified as Repr. 1B would be on the candidate list. SE also notes that Poland has notified a Registry of Intention for Harmonised Classification and Labelling for this substance, with proposed classification as ReprCat2 (Reg (EC) No 1272/2008 (CLP)). We wonder if this is the reason to why it is not included in the dossier?	Thank you for the support

Based on the guidance: Guidance on the preparation of an Annex 
XV dossier for the identification of 
substances of very high concern
it is stated that
Where the SVHC identification is based on an adverse effect for which classification criteria have been defined in the CLP Regulation and the substance has not yet been classified for such adverse effect, it is strongly recommended to first use the process set out in the CLP Regulation to conclude whether these criteria are met before proposing such substance to be identified for inclusion in the candidate list.
So, based on the Polish intention, we do not take the suggested substance in.	
2	2014/03/25	National NGO
ChemSec
Sweden	Page 8

We fully support the identification of sodium peroxometaborate as a SVHC, and agree that the evidence laid out in the dossier is sufficient to characterise the substance as being:

Toxic for reproduction 1B 	Thank you for the 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, Organisation/MSCA)	Comment	Response	
11	2014/04/17	International NGO
European Environmental Bureau (EEB)
Belgium	Sodium peroxometaborate may be found in consumer products as it is used in US (http://hpd.nlm.nih.gov/cgi-bin/household/brands?tbl=chem&id=1917&query=7632-04-4&searchas=TblChemicals :
Products that contain this ingredient (Brand):

Cascade Pure Rinse and Complete Tablets-Old Product

Clorox Ultra 2 Color Safe Bleach (Dry)

Cascade Power Tabs-02/02/2005

DIP-IT Food & Beverage Stain Cleaner Powder-01/08/2010 

Cascade Power Tabs-Old Product

Electrasol Automatic Dishwashing Detergent, 2 in 1 Tabs with Jet-Dry Powerball Rinse	Thank you for the information.

7	2014/04/17	Industry or trade association
A.I.S.E.
Belgium	Sodium peroxometaborate are already restricted under REACH Annex XVII with interdiction to supply to the general public when the individual concentration are higher to specific concentration limit of 6.5%, 9%, due to the classification toxic for reproduction 1B.
This Restriction was adopted even though the former EU Risk Assessment process had already concluded in 2007 that there was no risk from the uses of sodium peroxometaborate in laundry detergents and household cleaners. Safe use had also been demonstrated with HERA. A time-limited derogation of 30 months expired on 30 June 2013, thus the restriction is now fully applicable. 
A.I.S.E. seriously questions the need to add sodium peroxometaborate on the list of SVHC when a Risk Management Option analysis has de facto already been conducted and the substances and mixtures containing it are already covered by Annex XVII of REACH. 	The substance is classified as Repr. 1B, according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008. Consequently the substance fulfils the criteria of Article 57 (a/b/c) of the REACH Regulation and can be identified as a Substance of Very High Concern following the procedure set out in Art. 59 of the same regulation.
	
6	2014/04/16	Company
United Kingdom	Confidential comment submitted.

The enhanced chemiluminescence (ECL) Western Blotting System is used for applications ranging from routine protein detection to multiplex analysis using fluorescence based Amersham ECL PlexTM. The ECL-based detection systems allow researchers not only to avoid the necessity of handling hazardous radioisotopes, but to have a tool at their disposal that makes protein analysis faster, more sensitive and more flexible than ever before.

ECL Direct Nucleic Acid Labeling and Detection Systems are based on the direct labeling of DNA or RNA probes with horseradish peroxidase (HRP) in a simple 20-min chemical reaction. The resulting probe can be used without purification. Detection is achieved by generation of light via the HRP-catalyzed breakdown of luminol.

The risk of intentional or non-intentional release of PBS in ECL production is close to zero because the manufacturing processes are carried out in professional laboratories where high standards of operations are maintained.  The small quantities of waste chemicals resulting from the manufacturing processes are collected in the laboratory for incineration by approved contractors.  Our manufacturing laboratories fall under the jurisdiction of the Environment Agency in the UK.

Use descriptors for use of PBS:
•	SU9 Manufacture of fine chemicals – C20.5.9 Manufacture of other chemical products n.e.c.
•	SU24 Scientific research and development 
•	PROC3 Used in closed batch process (synthesis or formulation) 
•	PROC9 Transfer of substance or preparation into small containers (dedicated filling line, including weighing)
•	PROC15 Use as laboratory reagent
•	PC19 Intermediate
•	PC21 Laboratory chemicals 

Exposure scenarios applicable to our use of PBS
•	E4 - Generic formulation of borates into mixtures
•	ES22 - Transfer of substances into small containers
•	ES32 - Working in a laboratory

We believe that the uses highlighted above should be exempted from any future provisions of REACH annex XIV.
	Thank you for the information, we did not know about this specific use. 

3	2014/04/10	Member State
Sweden	Information on quantities (as such or in preparations) and number of preparations for the three CAS-numbers of PBS compounds that in the dossier had been searched for in the SPIN database (up to 2011), have been gathered from the Swedish Products Register for the year 2012:

CAS 10332-33-9, 4.1 tonnes, 10 preparations.
CAS 10486-00-7, 21 tonnes, 12 preparations.
CAS 11138-47-9, Confidential tonnes, 1 preparation.
	Thank you for the information.