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

Substance name: 1-vinylimidazole
CAS number: 1072-63-5
EC number: 214-012-0

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 the consultation are made available 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 has been prepared by the competent authority of the Member State preparing the proposal for identification of a substance of very high concern. 

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	
5363
2020/04/07	IPI Global Ltd,
Company,
United Kingdom	Attachment: 5363_1-VINYLIMIDAZOLE .pdf
	Thank you for the information provided. 

The justification for SVHC identification is based on the intrinsic properties of the substance.
Information on technical alternatives may, where relevant, be considered at later stages of the risk management process. 	
5365
2020/04/08	BASF SE,
Company,
Germany	We would like to point out that the use of the substance is only intermediate or monomer, respectively (see comments on part II). Inclusion into the candidate list may therefore be not a regulatory risk management option with impact going beyond the recently enacted harmonized classification of 1-vinylimidazole (Reg 2018/1480 – end of transition period for classification and label chance 20 May 2020). We consider the harmonized classification as a very effective and efficient risk management option, but also as already being sufficient.	Thank you for your comment and for sharing your views on the most appropriate risk management option for this substance. 

Sweden has concluded that SVHC identification and authorisation for those uses covered is a relevant risk management for this substance.	
5368
2020/04/15	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks Sweden for its proposal to identify 1-vinylimidazole as SVHC under article 57(c) and we fully support this proposal.
Considering that the substance has previously been classified as toxic to reproduction category 1B by ECHA’s Risk Assessment Committee (December 2016) under the CLP regulation (regulation 1272/2008), we consider the proposed SVHC identification unequivocal.	Thank you for your support.	

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5363
2020/04/07	IPI Global Ltd,
Company,
United Kingdom	See the corresponding embedded attachment in table 1 of Part I: 5363_1-VINYLIMIDAZOLE .pdf	Thank you for the information provided. 

The justification for SVHC identification is based on intrinsic properties of the substance. Information on technical alternatives may, where relevant, be considered at later stages of the risk management process. 	
5365
2020/04/08	BASF SE,
Company,
Germany	Comment BASF SE / lead registrant:
The SVHC Proposal is based on the harmonized classification of 1-vinylimidazole as reprotoxic Cat. 1B (H360D). Consequently, there is no comment to part I of the Annex XV SVHC report.
We consider the harmonized classification as a very effective and efficient risk management option, but also as already being sufficient (see “Further comments on the Annex XV report”).	Thank you for your comment.
 	
5372
2020/04/16	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of  1-vinylimidazole  in the REACH candidate list owing to its classification as reproductive toxicant 1B which fulfills the criterion of article 57 c).	Thank you for your support.	
5381
2020/04/16	Germany,
Member State	The German CA supports the SVHC identification of 1-vinylimidazole.	Thank you for your support.	
5388
2020/04/17	Norway,
Member State	The Norwegian CA supports that 1-vinylimidazole should be identified as a substance of very high concern and should be included in the Candidate List.
Totally produced and imported to Norway in 2018 (as notified to the Norwegian Product Register):
0,026 ton, consumer and professional use, paint, lacquer, solvent.
Norway also has a concern for other structurally similar imidazoles and is assessing them for action under CLP/REACH.	Thank you for your support and the information provided.	
5401
2020/04/17	ChemSec,
International NGO,
Sweden	ChemSec agrees on the SVHC identification of this substance based on its classification as toxic for reproduction.	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	
5363
2020/04/07	IPI Global Ltd,
Company,
United Kingdom	Page 5: We are proposing a Technical alternative to the handling recommendations provided in this document for reducing exposure to 1-vinylimidazole significantly below OELs in accordance with the EU [1], [2], [3] directives on carcinogens and mutagens – the IPI closed system has been proved effective for handling CMR liquids in Europe.
These Directives clearly acknowledge the usefulness of a closed system for the protection of workers. In fact, it is specifically mentioned that “where possible, a carcinogenic (mutagenic and reprotoxic)substance should be substituted with a less-hazardous alternative – otherwise carcinogens (mutagenic and reprotoxic) must, so far as is technically possible, be manufactured and used in a closed system to prevent exposure of workers”.
Together with the OQEMA-HSE study on Hydrazine Hydrate (Carc.1B) with level below 0.02 ppm, Archroma exposure result for Formaldehyde (carc.1B) with level around 0.03 ppm and Safechem exposure to Tetrachloroethylene 25 times below the established level recommended, it confirms that using our closed loop system can help to reduce drastically the exposure of the operator and the environment even further below the threshold recommended by scientists and EU and World Regulatory Agencies.
Moreover, closed loop technology can also help compliance with the EU Circular economy[5] stipulations and amended EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 94/62/EC of 20 December 1994 on packaging and packaging waste[6] with the latest Commission Implementing Decision (EU) 2019/665 of 17 April 2019[7]  and the UN SDG[8] to protect the environment reducing the amount of plastic, metals, water, raw material, energy, etc. and gives a significant economic return for companies.	Thank you for the information provided. 

		See the corresponding embedded attachment in table 1 of Part I: 5363_1-VINYLIMIDAZOLE .pdf		
5365
2020/04/08	BASF SE,
Company,
Germany	Select Main subject:
Exposure information
Comment BASF SE / lead registrant:

Chapter 7. Registration status (p.8)
1-vinylimidazole has a full registration; however, it is used solely as monomer and intermediate on industrial sites. Currently there are only two registrants of this substance.
The total numbers of notifiers according to the C&L inventory is rather low (352) in comparison to other substances – we also like to point out that any company knowing a substance can do a C&L notification.

Chapter 9. Information on uses of the substance, p. 8-9
The only uses of 1-vinylimidazole according to the registration are manufacturing, monomer and intermediate use at industrial sites. The other uses mentioned in the Annex XV dossier are actually product quality assurance (= Laboratory use), transport and filling of a chemical reactor ( = Charging and discharging use) and mixing chemical substances in a chemical reactor (Formulation of mixtures). These additional uses are consequently required for a meaningful use of 1-vinylimidazole in the manufacturing, intermediate and monomer use. This is correctly summarized by table 6 (p.9): all registered uses are not in scope of authorization.
We, as lead registrant, take entries in the SPIN database and other consumer product registers cited in the Annex XV dossier very seriously and consequently did some investigation regarding these entries. The SPIN database listed 1-vinylimidazole as being used in mixtures including paint and lacquers especially used for repair and maintenance of motor vehicles and motorcycles as well as construction in Sweden in significant amounts in 2015. For 2017 and 2018 the registered volumes are below the level of accuracy in this database. Concentrations on these mixtures are reported to range 0.6-4.5 %.
We suspect that these numbers are a misinterpretation or a mixing up of partly correct numbers.

• We know that the 1-vinylimidazole-polymer is used in mixtures for repair and maintenance for motor vehicles and motorcycles as well as for construction in concentration of roughly 1-5 % 1-vinylimidazole-polymer. – This means that consumers exposure residual 1-vinylimidazole monomer impurity was at ppm level and by no way at % level.

• We like to point out that harmonized classification was implemented just recently by the EU regulation 2018/1480. This regulation even grants a transition for changing the classification and labeling in the EU until the 20th May 2020 – After May 2020 consumer products containing residual monomer > 300 ppm are completely forbidden by existing restrictions (Annex XVII Reach). – this level of 300 ppm is far below the general level considering SVHC substances under Reach of 1000 ppm.

• As clearly visible in the SPIN data base, industry has reacted already during the discussion of the harmonized classification of 1-vinylimidazole. This is shown by the clear drop from 3 t in Sweden in 2015 to <100 kg in 2016 and 2017. As this level is below the accuracy level of the data base it demonstrates that there is no product on the Swedish market containing 1-vinylimidazole even as impurity in significant amounts. We would like to point out that, after May 2020, consumer products containing residual monomer >300 ppm 1-vinylimidazole are completely forbidden by existing restrictions (Annex XVII Reach).	Thank you for your comments and the information provided.