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

Substance name:	sodium perborate; perboric acid, sodium salt	
CAS number:		
EC number:	239-172-9, 234-390-0	

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. 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	
3	2014/04/17	International organisation
United Kingdom	It is recognised that there is a reproductive effect of boron compounds in laboratory animals under experimental test conditions. However, more recent studies and scientific evidence demonstrate that such effects are not found in humans, even when exposed to high levels. Additionally, our company has handled boron compounds at many sites in- and outside Europe for a number of years and under the appropriate conditions of use no known human health effects, potentially resulting from these boron compounds are known during formulation nor were reported to us from our customers, the industrial users.
In a previous public consultation the European Borates Association (EBA) presented a consolidated response on the case for a Category 2 Toxic to Reproduction reclassification for Borates based on the previously not considered scientific data from the human studies. From the human studies in highly exposed workers evaluations of sperm parameters have demonstrated no effects on male fertility which appears to justify the removal of the fertility classification. No developmental effects have been seen in highly exposed populations. However, as epidemiological studies of developmental effects are not as robust as the fertility studies, a Category 2 H361d: suspected of damaging the unborn child was considered appropriate.  This proposal was rejected by the ECHA Risk Assessment Committee (RAC) during their meeting in March this year. 
Even though the proposal for the reclassification of borates was rejected by the RAC we as a downstream user of boron compounds (including sodium borates such as sodium perborate; perboric acid, sodium salt) request that ECHA do not support Denmark’s proposal to include sodium perborate; perboric acid, sodium salt on the SVHC list.	The classification is Repr. 1B and has not been changed. The RAC have considered this very carefully and gave a negative opinion about declassification. The substance is classified 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.
	
4	2014/04/17	Member State
Belgium	Belgium supports the proposal to identify Sodium perborate (perboric acid, sodium salt) as SVHC. The substance is classified as Repr. 1B and therefore meets the Art.57(c) criteria.	Thank you for the support. 	
7	2014/04/17	Industry or trade association
European Borates Association (EBA)
Belgium	See attachment Under Section IV	The request for a RMOA is considered valid; however, the reasoning for this proposal is the result of such deliberations within the Danish Authorities including considerations about treating the borates with the same classification the same way in general.	
			See also:
Comment 7 attachment (EBA comments on PBS_SVHC.pdf).pdf		
5	2014/04/17	International NGO
Health and Environment Alliance (HEAL)
Belgium	The Health and Environment Alliance supports the nomination of Sodium perborate; perboric acid, sodium salt as an SVHC, due to its properties.	Thank you for the support.	
17	2014/04/15	Other contributor
PBS REACH Consortium
Belgium	Please find attached comments prepared by PBS REACH Consortium	The classification is Repr 1B and has not been changed and we know that RAC considered this very carefully and gave a negative opinion about declassification, so we see no reasons for withdrawal of our proposal. 

The substance(s) fulfil the criteria for inclusion in the candidate list as laid down in the roadmap on SVHCs (like many other borates), and even though the CSRs are concluding “no risk” they still fulfil these criteria. 

One of the reasons given in the dossier is that these borates should be treated as other borates with same classification.

The PBS REACH Consortium claims that the data for the Nordic countries are not representative for the whole EU, but the association has not given any other figures/information that document this. 

An inclusion to the candidate list might negatively affect companies involved; this might be true but other companies might benefit from this if they are producing/importing/using alternatives.	
			See also:
Comment 17 attachment (Comments on Annex XV Report for PBS.pdf).pdf		
15	2014/03/21	Member State
Norway	The Norwegian CA supports that Sodium perborate; perboric acid, sodium salt 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	
1	2014/04/17	International NGO
European Environmental Bureau (EEB)
Belgium	The EEB supports the inclusion of Sodium perborate; perboric acid, sodium salt in the candidate list due to its reprotoxic properties. Sodium perborate’s reproductive adverse effects are mediated by an endocrine disruption mechanism so this should be taken into account, especially for low dose effects. As a consequence there is very high scientific uncertainty for a safe threshold being set.	Thank you for the support. However, we have decided not to look at ED properties in this submission	
6	2014/04/17	Member State
Austria	The Austrian CA agrees with the proposal to identify “Sodium perborate; perboric acid, sodium salt” (PBS) as a substance of very high concern:
It fulfils the criteria of Art 57(c) of REACH Regulation and also the relevance criteria suggested in the Commission SVHC roadmap: The substance is manufactured, imported and/or used in the EU in a relevant quantity and it has been registered under REACH not only for intermediate use as it is used as bleaching agent mainly in household and professional detergents, which are uses that are not exempted from the scope of authorisation. The available information does not demonstrate a risk that is not adequately controlled and needs to be addressed at EU level. However, concern arises as the risks to consumers from combined exposure to the degradation product, boric acid/borates, which have not been addressed in previous risk assessments may lead to significant risk characterisation ratios.
As alternatives exist, authorisation is considered a proportionate measure for pushing the substitution of the remaining use of PBS. Furthermore, the SVHC identification of PBS would ensure coherence with the SVHC identification of boric acid/borates.	Thank you for the support, and we agree with your argumentation.	
7	2014/04/17	Industry or trade association
European Borates Association (EBA)
Belgium	None	The request for a RMOA is considered valid; however, the reasoning for this proposal is the result of such deliberations within the Danish Authorities including considerations about treating the borates with the same classification the same way in general.	
			See also:
Comment 7 attachment (EBA comments on PBS_SVHC.pdf).pdf		
10	2014/04/17	Industry or trade association
A.I.S.E.
Belgium	No comment	-		
9	2014/04/16	Member State
Slovenia	Eventhough harmonised classification is included in CLP regulation and it can not be challenged it is a classification where there are facts which we can not ignore. Classification for repro tox (RepCat 1B) was based on read accross instead of available test on this substance. In this case where there is a doubt regarding classification, identification as SVHC substance is not justified.	We do not agree. The classification is Repr. 1B and has not been changed. The RAC have considered this very carefully and gave a negative opinion about declassification 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 in Art. 59 of the same regulation.	
8	2014/04/16	Company
Slovenia	Classification and labeling	Submitter listed as basic source of information EU RAR (2003 and 2007a), where in point 4.1.2.9 Toxicity for reproduction is stated, that listing into Repr. Cat. 1B is consequence of decision by SCTEE, which took for base “read across the classification of boric acid/borates” and not 28-day limit dose study (Degussa, 1989), which was performed with Sodium Perborate Tetrahydrate. Belinka Perkemija d.o.o. does not agree with this decision which means that classification does not base on relevant study and this is not substance for inclusion on SVHC list.	We do not agree. The classification is Repr. 1B and has not been changed and we know that the RAC have considered this very carefully and gave a negative opinion about declassification, so we see no reasons for withdrawal of our proposal. 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.	
11	2014/04/15	National NGO
CHEM Trust
United Kingdom	CHEM Trust supports the inclusion of Sodium perborate in the REACH candidate list on the basis of Article 57 c).	Thank you for the support	
12	2014/04/15	Member State
Germany	The DE CA supports the proposal of the DK CA to identify "Sodium perborate; perboric acid, sodium salt" as SVHC.

The dossier for sodium perborate covers several substances, although not all possible hydrates of sodium perborate are listed in the report. Resulting from this in section 1.1 of the report it is stated:  
Please note that any other possible hydrate of sodium perborate which is not explicitly mentioned in this Annex XV dossier is still, in principle, within the scope of the proposal.
According to this, in Table 1 of the assessment report describing the substance identity, several CAS numbers are listed. Although the given CAS numbers do not represent an exhaustive list of substances that should be covered by this SVHC dossier, the CAS numbers should be listed in the IUCLID file as well. Please add all known/relevant CAS numbers in the IUCLID file under “Related CAS information” for the reference substance.
Furthermore, in the assessment report two EC Numbers are given. The second EC number not included in the reference substance should be mentioned in the IUCLID file as well. Please add this information to the IUCLID file (e. g. under “Group / category information” for the reference substance). 
The IUCLID file does not contain information about  the molecular formula,  the molecular weight range, the InChI code or the structural formula of the reference substance although the assessment report contains appropriate information. 
In section 1.1 of the IUCLID file it is stated that sodium perborate is a multi-constituent substance (No composition is given in section 1.2 of the IUCLID file). In contrast to this, in section 1.2 (Composition of the substance) of the assessment report it is stated that the substance is a mono-constituent substance with a purity ≥80%. We recommend revising the information on the type of substance according to the substance composition and adding the substance composition to the IUCLID file.
Furthermore in the “Type of substance” field in section 1.1 of the IUCLID file the information on the origin of the substance is missing.	Thank you for your support. The IUCLID file will be modified as suggested.

	
17	2014/04/15	Other contributor
PBS REACH Consortium
Belgium	Please find attached comments prepared by PBS REACH Consortium	Please see response to Comment 17 under “General comments on the SVHC proposal” above.	
			See also:
Comment 17 attachment (Comments on Annex XV Report for PBS.pdf).pdf		
14	2014/04/10	Member State
Sweden	The Swedish CA agrees that sodium perborate; perboric acid, sodium salt, 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. 	
16	2014/03/25	National NGO
ChemSec
Sweden	Page 10

We fully support the identification of Sodium perborate, perboric acid, sodium salt as 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	
18	2014/03/05	Trade union
European Trade Union Confederation
Belgium	The European Trade Union Confederation supports the identification of Sodium perborate; perboric acid, sodium salt as a SVHC. That substance is included in the Trade Union Priority List for REACH authorisation (see www.etuc.org > REACH)	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	
2	2014/04/17	Company
United States	General Comments

Our company manufactures and distributes In Vitro Diagnostics (IVD) products in the European Union. These products are tests performed on biological samples (derived from the human body) to provide information to assist in clinical decision making. There is no direct physical contact between a patient and these medical devices. Furthermore, our products are not of the self-testing type, i.e. they are used in professional laboratory settings, by professionally trained staff, and are not placed on the market for use by the general public (e.g. a glucose meter or a pregnancy test). 

All In Vitro Diagnostic (IVD) products meet the regulatory requirements in the EU as defined by the IVD Directive (Directive 98/79/EC). The essential requirements of the IVD Directive aim to ensure that conforming IVD products do not compromise the health and safety of patients and users. Requirements for management and mitigation of health risks to patients or users of IVD products due to the presence of any substance contained within these products are addressed within the requirements of this Directive. Additional regulation of the use of chemicals in in vitro diagnostic products under REACH is also not warranted as stated in Article 60(2) of the REACH Regulation itself:

The Commission shall not consider the risks to human health arising from the use of a
substance in a medical device regulated by 
•	Council Directive 90/385/EEC of 20 June 1990
on the approximation of the laws of the Member States relating to active implantable
medical devices, 
•	Council Directive 93/42/EEC of 14 June 1993 concerning medical
Devices, or 
•	Directive 98/79/EC of the European Parliament and of the Council of
27 October 1998 on in vitro diagnostic medical devices.

As mentioned above, IVD products are designed to be used in a clinical laboratory setting by professionally trained staff for the benefit of human health.  Therefore, there is no risk of unwitting exposure to members of the general public to materials used in these products. Risk to the professionally trained users of these products is mitigated by the use of standard precautions as well as protective clothing and processes as specified by local regulations, standard professional practices and occupational health and safety guidelines. The products themselves are designed in such a way as to minimize contact by the trained professional users under standard conditions of use. 

Specific Comments on use, exposure, alternatives, and risks

EXPOSURE/RISKS:

For IVD products, exposure by professional users is NOT an issue (even though these substances are below the threshold stated in the EU Dangerous Substance Directive) because:
	The volumes used per year are very small, < 0.0001% of the estimated total 2013 EU production as stated in the Annex XV Report – Identification of Sodium Perborate; Perboric Acid, Sodium salt as SVHC1.
	The concentrations within the IVD products containing borates are very low.
	 In Vitro Diagnostic products are designed to be used in a professional clinical laboratory setting where trained users do not come in contact with the components of these products under standard conditions of the product use.
	They are used in a clinical laboratory environment by professionally trained clinical laboratory professionals
	Laboratory practices,  professional guidelines and standard precautions are implemented that are designed to protect individuals from biohazards associated with the samples being measured by the IVD products
	Commercial IVD products are designed in a way to ensure that laboratory personnel never come into contact with the products or the product waste during their normal usage and disposal. 
ALTERNATIVES:

IVD reagent products typically require biocides in their formulations to prevent reagent deterioration during their storage that could result in potential misdiagnosis and harm to patients.  Borates have been specifically chosen to support the biocide function in certain reagents, while also maintaining compatibility with the chemistry of the product formulations (i.e. proteins and other biological substances remain stable). Additionally, borate compounds are very commonly used as ionic strength adjustment buffers in biological preparations. It is the combination of these properties which render borates ideal for use in IVD products. Our company is not aware of an alternative to borates which would deliver all these properties. The original formulation of our borate-containing products took many years to develop and no other viable options were available to achieve the parallel goals of stability and reagent function.  

REFERENCES:
1) http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification/-/substance/5501/search/+/term 	Thank you for the information that was new to us.	
7	2014/04/17	Industry or trade association
European Borates Association (EBA)
Belgium	None	-		
			See also:
Comment 7 attachment (EBA comments on PBS_SVHC.pdf).pdf		
10	2014/04/17	Industry or trade association
A.I.S.E.
Belgium	Sodium perborate is 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 toxic to reproduction 1B classification.
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 perborate 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 perborate 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.
	
13	2014/04/16	Company
Germany	The applications are routine analytical uses in a laboratory within the scope of scientific R&D. The risk for the environment and consumers is very low. Usually the volumes and the concentration of the substance are low. The disposal of the substance is also controlled.
Therefore, the use of sodium perborate as analytical standard should be exempted from authorisation (scientific R&D) as well as the formulation of mixtures for R&D purpose and packaging/refilling of the pure substance and mixtures into small packages for this use.	
Thank you for the information about this use that we didn’t know about. 	
17	2014/04/15	Other contributor
PBS REACH Consortium
Belgium	Please find attached comments prepared by PBS REACH Consortium	Please see response to Comment 17 under “General comments on the SVHC proposal” above.	
			See also:
Comment 17 attachment (Comments on Annex XV Report for PBS.pdf).pdf		
14	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.

Attachments

Comment number	Public attachment	
7	
Comment 7 attachment (EBA comments on PBS_SVHC.pdf).pdf	
17	
Comment 17 attachment (Comments on Annex XV Report for PBS.pdf).pdf