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

Substance name: 2-methylimidazole
CAS number: 693-98-1
EC number: 211-765-7

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 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	
5369
2020/04/15	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks Sweden for its proposal to identify 2-methylimidazole 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 2017) under the CLP regulation (regulation 1272/2008), we consider the proposed SVHC identification unequivocal.	Thank you for the support.	
5384
2020/04/16	BASF SE,
Company,
Germany	Comment BASF SE / lead registrant:

8. Tonnage of the substance / 9. Information on uses of the substance, p. 8-9:
Since our first dossier submission in 2013 we have registered the substance for being used subsequently in industrial settings only:
• Use in industrial chemical processes
• Use as intermediate
• Use in polymerization reactions (catalyst)

In the Annex XV dossier, the reference reporting several diverse uses in the literature might not be up to date with respect to exposure and broad use, as it was published by the US National Toxicology Program in 2004. Furthermore, the use pattern of the chemical substance are different in Europe and USA.
However, the document of the US National Toxicology Program correctly mentions the major (only) use of 2-methylimidazole which is polymerization and crosslinking accelerator and hardener for epoxy resin systems in semiconductor industry sector. This use is described as polymerization reaction catalyst in the registration dossier.

Due to its classification as reprotoxic category 1b substance in 2013, we have already observed decreasing volumes of 2-methylimidazole (2-MI) in Europe.
We are not aware of 2-MI being present in any consumer products (formulations). Beyond this, a consumer product containing more than 0.3% 2-MI impurity would be an illegal product according to Reach Annex XVII.
As lead registrant we take entries in the SPIN database cited in the Annex XV dossier very seriously and consequently did some investigation regarding these entries.
According to the Annex XV dossier, SPIN database lists 2-MI as being used in the manufacturing of chemicals (= intermediate use) as well as for the manufacturing of machinery and equipment.

To our knowledge, the use in the manufacturing of machinery and equipment is the use as polymerization and crosslinking accelerator and hardener for epoxy systems (already mentioned above). As these hardener systems contain more than 1% but usually less than 5% accelerator, they are not allowed to be sold to consumers according to REACH annex XVII anyway. Because 2-MI being hardener component in epoxy systems it may be mentioned as being present in equipment with an epoxy coating as a potential impurity. But again, at this stage 2-MI already has reacted and residual 2-MI in a ppm range is tightly embedded in a polymer matrix.

Beyond this we are not aware of any use of 2-MI as ingredient of a paint, lacquers or varnishes in a classical manner. Such kind of products do not really make sense to us. The description as a paint or lacquer again is the use as polymerization and crosslinking accelerator for epoxy systems (powder coating) for metal equipment. The industrial user describes their use as follows:“[trade name] Epoxy Curing Agent is a phenolic hardener designed for powder coating applications. It is fully compatible with epoxy resins and can be formulated into high gloss, good flow decorative or protective powder coatings …. The performance of phenolic cured epoxy powder coating formulations and particularly their adhesion to metal substrates will be greatly affected by the quality of the surface preparation…”

Based on our knowledge, crosslinking regulator for epoxy resin systems is really the major use. And again, this is for sure no professional or consumer use and, at the stage of the powder coated metal equipment article, 2-MI already has reacted and residual 2-MI in a ppm range is tightly embedded in a polymer matrix. Finally, the total amount of 1.9 tons/per Scandinavian country rather fits to potential residual monomer in a polymer matrix scenario for a substance that is manufactured >> 100 tons/year. – The expression “potential residual monomer” refers to the fact that we expect that it is not possible to extract 2-MI without destroying the molecule itself.
The substance is manufactured in a medium tonnage size in closed processes wherever possible. Apart from the industrial uses described in our registration dossier, no professional and/or consumer uses of the substance have been reported to us. Thus, there is no wide-dispersive use for 2-methylimidazole within the EU.	Thank you for the information. It may, where relevant, be considered at later stages of the risk management process. 

The RAC opinion for 2-methylimidazole was adopted in December 2017 and is included in the 15th ATP. The restriction according to Reach Annex XVII (article 30) in consumer products will therefore be effective in 2022 at the earliest.	

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5373
2020/04/16	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of 2-methylimidazole  in the REACH candidate list owing to its classification as reproductive toxicant 1B which fulfills the criterion of article 57 c).	Thank you for the support.	
5380
2020/04/16	Germany,
Member State	The German CA supports the SVHC identification of 2-methylimidazole.	Thank you for the support.	
5384
2020/04/16	BASF SE,
Company,
Germany	Comment BASF SE / lead registrant:
The SVHC Proposal is based on the harmonized classification of 2-methylimidazole as reprotoxic Cat. 1B (H360D). Consequently, there no comment to part I of the Annex XV SVHC report.	Thank you for the comment.	
5389
2020/04/17	Norway,
Member State	The Norwegian CA supports that 2-methylimidazole 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): 0,636 ton, consumer and professional use, paint, lacquer, filler
Norway also has a concern for other structurally similar imidazoles and is assessing them for action under CLP/REACH.	Thank you for the support.	
5399
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 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, submitter type, country)	Comment	Responses	

No comments received