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

Substance name:	Methyloxirane [Propylene oxide]	
CAS number:	75-56-9	
EC number:	200-879-2	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carc. 1B and Muta. 1B

Disclaimer: Comments provided during public consultation are made available in this document 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 (RCOM) has been prepared by the European Chemicals Agency. 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	
11	2012/10/18	National NGO
Action for Breast Cancer Foundation
Malta	We support the nomination of this chemical to the Candidate List as a substance of very high concern’	Thank you for your comment.
	
10	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for your comment.
	
9	2012/10/18	Member State
Norway	 The Norwegian CA supports that propylene oxide; 1,2-epoxypropane; methyloxirane should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment.
	
8	2012/10/18	Company
Sweden	The purpose with submitting these comments is to ensure that ECHA is familiar with certain critical uses of Methyloxirane. Although our uses of this substance are in small volumes, the uses are critical for the manufacture of fine chemicals that are used by the Pharmaceutical and Biopharmaceutical industries to manufacture and purify Active Pharmaceutical Ingredients. Methyloxirane is used under strictly controlled conditions in closed systems as process chemical (reagent) and thus Methyloxirane is not part of the final fine chemicals. There are currently no known technically equivalent substitutes for this use.

The Pharmaceutical and Biopharmaceutical industries use the final fine chemicals, which are NOT medicinal products, to make medicinal products. The inability to use Methyloxirane or introduce less hazardous alternatives in the manufacturing processes of the fine chemicals used by the Pharmaceutical and Biopharmaceutical industries will adversely impact the production of Active Pharmaceutical Ingredients and medicinal products. Approved pharmaceutical products available on the global market where chromatography media (manufactured using Methyloxirane as process chemical) are included in the production processes, are used in the treatment of Newcastle Disease Virus, Foot-and-Mouth Diseases, influenza virus, cancer, allergic diseases, asthma and arthritis. 

Methyloxirane is used in the manufacture of fine chemicals in which 1,2-dichloroethane is also used as process chemical (solvent) in the manufacture process. 1,2-dichloroethane has recently been proposed for prioritization for inclusion on Annex XIV (Authorization list). Therefore, future prioritization of Methyloxirane for inclusion on Annex XIV would require extensive design and validation activities to introduce less hazardous alternatives both to Methyloxirane and 1,2-dichloroethane in the manufacturing processes of the fine chemicals. 	Thank you for the information. 

If the substance is identified as SVHC, this information, where relevant, will be taken into account at later stages of the authorisation process.

Even though information provided during public consultation is taken into account, we would like to stress that the registrations are the standard tool and route to communicate information on a substance and its uses to the authorities The registrations are the authorities’ principal source of information when assessing the need of further risk management for a substance or (some of) its uses. Therefore, it is of utmost importance that registrants keep the information provided in the registration dossiers up to date and adequately describe the current use and exposure situation, including the operational conditions and risk management measures in place.

If certain uses are not covered by the provided exposure scenarios, downstream users can either communicate this through supply chain communication (via their suppliers) to the registrants, who then need to update their registrations accordingly, or prepare their specific chemical safety report and submit a downstream user report to ECHA.	
7	2012/10/17	Other contributor
Belgium	Any use of a substance as a transported isolated intermediate is not subject to authorisation (i.e. Title VII – Authorisation - does not apply) (Article 2(8)(b)). This is also valid for intermediates used as monomers for the synthesis of polymers. (citation from ECHA guidance document -GUIDANCE ON INTERMEDIATES)	Thank you for your comment and the information provided.

Regarding the information provided in part II of the Annex XV report: 

The current proposal for identifying the substance as a substance of very high concern (SVHC) is in accordance with REACH Article 59(2) based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The additional mentioned information is not relevant for determining whether the substance meets the criteria for identification as SVHC. However, when examining whether the substance should be recommended for inclusion in Annex XIV, ECHA will indeed have to assess available information on uses and exposures. In addition, information on work already done by industry to identify and assess potential alternatives is used in defining transitional arrangements in the draft Annex XIV entries for the recommended substances. This information will be collected by ECHA before prioritising the substances and defining the transitional arrangements for its recommendation. The generic approaches for prioritisation and defining the draft Annex XIV entries are available at: http://echa.europa.eu/documents/10162/13640/axiv_prioritysetting_general_approach_20100701_en.pdf and http://echa.europa.eu/documents/10162/13640/draft_axiv_entries_gen_approach_4th_en.pdf.
If ECHA intends to recommend the substance for Annex XIV inclusion, interested parties can provide comments on ECHA’s recommendation, including the suggested transitional arrangements in accordance with Article 58 of REACH.

Regarding further information on uses provided: 

See response to comment 8 above. 	
			See also:
Comment 7 attachment (PO SVHC_Final response to Annex XV report_121015.docx).docx		
6	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Propylene oxide; 1,2-epoxypropane; methyloxirane as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thank you for your comment.
	
5	2012/10/16	National NGO
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for your comment.
	
4	2012/10/11	Member State
Germany	According to the REACH Regulation it is formally correct to identify substances as SVHC based on their CMR classification listed in Annex VI of the CLP directive solely. However, up to now MS have provided some specific information to identify concerns. Therefore, the instrument of preparing RMOA prior to annex XV preparation has been established e.g. to avoid duplicate work. The German CA would appreciate to continue this practice. This guarantees that relevant substances are identified.

The substance methyloxirane [propylene oxide] has been nominated by the German CA for Substance Evaluation (SEv) for 2014. The SEv was proposed to check whether, in view of reported uses outside an industrial setting, an identification as SVHC would be the most appropriate risk managing measure for the substance (see SEv Justification Document). If the substance is identified as SVHC now, one of the reasons for evaluating the substance will be removed. Additionally, it will be hard to explain why a substance already identified as SVHC would need to be evaluated to gain further data.

The substance is formally a candidate for identification as SVHC and the identification might per se be useful. However, the German CA is of the opinion that it would have been better to wait with the identification until the Substance Evaluation has been finished. 

Proposals to identify substances as SVHC should not be prepared without an in-depth evaluation to settle the concern.
	Thank you for your comment. 

In accordance with REACH Article 59 only the Member States and the Commission have the right to propose substances for identification as substances of very high concern (SVHC) meeting the criteria of Article 57. ECHA has received a request from the Commission to prepare an Annex XV dossier proposing the identification of this substance as SVHC, which was followed by the Agency. 

Preparation of a risk management option analysis (RMOA) before proposing the identification of a substance as SVHC is a voluntary step in the co-ordination of risk management activities among the Competent Authorities for REACH but not a requirement of REACH. 

Nevertheless, ECHA agrees on the importance of identifying the most appropriate route(s) for risk management and on the co-operation and co-ordination of the regulatory risk management activities between the authorities.

In any event identification of the substance as a SVHC and its inclusion in the candidate list does not prevent the German CA from continuing the substance evaluation in order to decide on the most appropriate risk management measure of the substance. Indeed, as long as the substance has not been included in Annex XIV it is still possible to choose another risk management option than authorisation.	
3	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.
This substance is included in the Trade Union Priority List for REACH authorisation see: http://www.etuc.org/a/6023	Thank you for your comment.
	
2	2012/09/26	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.	Thank you for your comment.

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
4	2012/10/11	Member State
Germany	No information about the physical properties is given in the report or in the technical dossier. In the report a link to the Chemical Substance Search on the ECHA website is given instead. It would be better to provide these data directly in the report and technical dossier, so that no further search in a database is necessary.	The proposal for identifying the substance as SVHC is based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The physical properties of the substance are in this particular case neither necessary to define the identity of the substance addressed in the dossier nor to demonstrate that it meets criteria set out in Article 57. 

If however information on the physical properties would be required to describe the substance identity or to conclude on its SVHC properties those data should be included in the Annex XV dossier.

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	
8	2012/10/18	Company
Sweden	We always handle Methyloxirane under strictly controlled conditions in quantities <5 tons per year. Qualitative industrial hygiene risk assessments (IHRA) are performed for the handling of Methyloxirane and exposure of workers is minimized through the whole process.

Occupational exposure is monitored by qualitative exposure assessments (IHRA), to recognize and use site-specific information to develop an index of criteria to rank the potential risks in the facility, which are audited, as all substance uses, by the national competent authority. The exposure assessment examines the three key risk components, sources of risk, exposure pathways (inhalation, dermal, ingestion). The risk assessment lends itself to developing mitigation or exposure control measures.

The major part of the used substance that has not reacted in the manufacturing process is handled as hazardous waste and treated by authorized waste vendor. The amount of the substance that is released to air is regulated by our environmental permission from the local authorities for release of VOC. No release of the substance to water or soil.

Use descriptors for use of Methyloxirane:
•	SU3 Industrial uses: Uses of substances as such or in preparations at industrial sites
•	SU9 Manufacture of fine chemicals - C20.5.9 Manufacture of other chemical products n.e.c.
•	SU24 Scientific research and development 
•	PC19 Intermediate
•	PC21 Laboratory chemicals 
•	PROC3 Used in closed batch process (synthesis or formulation)  
•	ERC4 Industrial use of processing aids in processes and products, not becoming part of articles. 

There are currently no known technically equivalent substitutes for the use of Methyloxirane as process chemical (reagent) in the manufacture of fine chemicals that are used by the Pharmaceutical and Biopharmaceutical industries to manufacture and purify Active Pharmaceutical Ingredients.

Methyloxirane is used in the manufacture of fine chemicals for which 1,2-dichloroethane is also used as process chemical (solvent) in the manufacture process. 1,2-dichloroethane has recently been proposed for prioritization for inclusion on Annex XIV (Authorization list). Therefore, future prioritization of Methyloxirane for inclusion on Annex XIV would require extensive design and validation activities to introduce less hazardous alternatives both to Methyloxirane and 1,2-dichloroethane in the manufacturing processes of the fine chemicals. Methyloxirane is not part of the final fine chemical.

We therefore request ECHA’s consideration to exempt from the authorization requirement the use of Methyloxirane as process chemical (reagent) in the manufacture of fine chemicals used in the development, manufacture and purification of Active Pharmaceutical Ingredients by Pharmaceutical and Biopharmaceutical industries.	Thank you for your comment.

Regarding further information on uses and exposure provided: 

See response to comment 8 in section “General comments on the SVHC proposal” above. 

Attachments

Comment number	Public attachment	
7	
Comment 7 attachment (PO SVHC_Final response to Annex XV report_121015.docx).docx