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

Disclaimer: Comments provided during the 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.

Substance name: 2,2-bis(bromomethyl)propane1,3-diol (BMP), 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA), 2,3-dibromo-1-propanol (2,3-DBPA)
CAS number: 3296-90-0, 36483-57-5, 1522-92-5, 96-13-9
EC number: 221-967-7, 253-057-0, 202-480-9

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

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	
5478
2021/04/22	ICL,
Company,
Netherlands	See attachment, related to TBNPA classification and grouping	Regarding your comments to the classification of TBNPA, this is not relevant for the SVHC process.

Please find all the relevant CLH documents, including our RCOM, in the link: 2,2-dimethylpropan-1-ol, tribromo derivative;... - Registry of CLH intentions until outcome - ECHA (europa.eu)	
		Attachment: 5478_TBNPA comments ICL to SVHC 2021 final.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5460
2021/04/13	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks Norway for its proposal to identify 2,2-bis(bromomethyl)propane1,3-diol (BMP), 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA), and 2,3-dibromo-1-propanol (2,3-DBPA) as substances of very high concern under article 57(a). We fully support this proposal.

We consider the proposals to be unequivocal due to:
- Existing CLP classifications: C1B and M1B for BMP and C1B for DBPA;
- The proposed RAC classification as C1B for TBNPA (included in the 18th ATP).	Thank you for your support	
				
5464
2021/04/17	CHEM Trust Europe,
National NGO,
Germany	CHEM Trust supports the inclusion of the brominated alkyl alcohols 2,2-bis(bromomethyl)propane1,3-diol (BMP)
2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) and  2,3-dibromo-1-propanol (2,3-DBPA)  in the REACH candidate list owing to their classification as carcinogens 1B fulfilling the criterion of article 57 a).	Thank you for your support	
				
5478
2021/04/22	ICL,
Company,
Netherlands		See our response above	
		See the corresponding embedded attachment in table 1 of Part I: 5478_TBNPA comments ICL to SVHC 2021 final.pdf		
5483
2021/04/22	ANSES,
National Authority,
France	The harmonised classification or RAC opinion of Carc 1B-H350 for these substances fulfils the criteria to identify the substance as an SVHC under article 57(a) and the SVHC identification is supported.	Thank you for your support	
				
5503
2021/04/22	Netherlands,
Member State	NL supports the proposal to include 2,2-bis(bromomethyl)propane1,3-diol (BMP), 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) and 2,3-dibromo-1-propanol (2,3-DBPA) in the candidate list of SVHC in accordance with Article 57(a) of Regulation (EC) 1907/2006 (REACH) given the carcinogenic properties.	Thank you for your support	
				
5525
2021/04/23	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of these brominated compounds as Substances of Very High Concern, based on the agreed classification as carcinogenic 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	
5478
2021/04/22	ICL,
Company,
Netherlands		See our response above	
		See the corresponding embedded attachment in table 1 of Part I: 5478_TBNPA comments ICL to SVHC 2021 final.pdf		
5525
2021/04/23	ChemSec,
International NGO,
Sweden	As brominated flame retardants have long been on the regulatory radar, many alternative substances and technologies exist, a number of these can be found on the ChemSec marketplace: https://marketplace.chemsec.org/Alternatives	Thank you for the information