19 November 2011

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

Substance name:	1-bromopropane [n-propyl bromide]	
CAS number:	106-94-5	
EC number:	203-445-0	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Repr. 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	
17	2012/10/18	Industry or trade association
Aerospace Industries Association
United States	1-bromopropane was identified as having use in Aerospace industry by several companies.   It is used in solvents, vapor degreasing and cleaning.   Elimination of this substance would impact processes to producte end product articles.
Used in the Aerospace industry. Changes to degreasing processes may involve capital expenditure expense in the supply chain, and can take time. This substance has been pushed as an alternative to ODS substances, as less environmentally damaging. Degreasing in manufacture is a product safety issue, options may exist. However, change is needed across large parts of the supply chain which will take significant time and investment.
AIA supports the comments filed by ASD and GIFAS for this substance.	Thank you for your comment. 

See response to comment 16 in section “PART II: Comments and responses to comments on uses, exposures, alternatives and risks”	
16	2012/10/18	Industry or trade association
Aerospace Industries Association
United States	N,N-dimethylformamide; dimethyl formamide was  identified as a substance used by several  Aerospace companies.  Two specifications associated with this substance is IPC-4101/26 and IPC-4101/29.  It is a solvent in sealants and strippers and also a constituent in printed circuit laminates and epoxy inks. If this substance became unattainable, removal of elastomeric coating and epoxy prepreg used in printed wiring boards would be somewhat manageable, but potentially very inconvenient and expensive.  There would be an impact on processes of circuit card manufacture.  Companies using circuit cards could see impact in the supply chain if this substance is banned.	This comment is not relevant for 1-bromopropane. The same comment is included in the response to comments table of N,N-dimethylformamide and the respective response can be found there. 
	
15	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. 	
14	2012/10/18	Industry or trade association
GIFAS
France	Please refer to attached document	Thank you for your comment and the information provided. 

Regarding dossier content and quality see response to comment 12 below, part “dossier content”

Regarding the information provided on uses see response to comment 16 in section “PART II: Comments and responses to comments on uses, exposures, alternatives and risks”.	
			See also:
Comment 14 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf		
13	2012/10/18	Member State
Norway	The Norwegian CA supports that 1-bromopropane; n-propyl bromide should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment. 	
12	2012/10/18	Company
Netherlands	On September 3, 2012, the European Chemicals Agency (ECHA) submitted for public consultation a Annex XV dossier proposing to identify n-propyl bromide (nPB) as a substance of very high concern (SVHC) under Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The dossier on nPB is part of a batch of Annex XV dossiers for 37 substances that ECHA is currently proposing to identify as SVHCs on the basis of their harmonized classification as Cat. 1A or 1B CMRs in accordance with Annex VI to Regulation (EC) 1272/2008 on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation).
As is laid out in this submission, the majority of nPB is used as an intermediate, with all uses either strictly controlled or industrial uses subject to occupational exposure levels significantly below the NOAEL identified in the CMR classification process. Given these facts, we would like to understand the basis for seeking to include nPB from among 100s of substances listed as CMR 1b in Annex VI of the CLP Regulation in the candidate list at this time. Were selection criteria applied, and if so what are they? Is there a ranking system which ECHA uses when choosing CMR substances to include in the Candidate list? What risk was the cause for concern that ECHA considers needs to be addressed by a REACH Authorisation in addition to the existing regulatory framework applicable for nPB? 
Dossier Completeness:
The industry would like to take this opportunity to raise some comments on the completeness of the nPB dossier. According to Article 59 of REACH ECHA, upon request of the Commission, and Member States may propose the identification of SVHCs by submitting an Annex XV dossier.  Annex XV provides that a dossier for the identification of a SVHC shall include:
(i) a proposal identifying the substance and whether it is proposed as a SVHC because it is a CMR Cat. 1A or 1B, PBT, vPvB, or a substance raising an equivalent level of concern; 
(ii) a justification as to why the substance is a PBT, vPvB or a substance raising an equivalent level of concern; and 
(iii) the available use and exposure information, and information on alternative substances and techniques.  

While the industry understands that legally there are no obligations to include extensive information on all available alternatives into the Annex XV dossier, the absence of any such information is contrary to ECHA’s own recommendation and indeed past practice. Prior to this summer’s batch of 37 SVHC Annex XV dossiers, the vast majority of ECHA submissions for inclusion of CMR substances in the candidate list included an assessment of available alternatives. As the nPB Annex XV dossier links to the nPB Registration file, no information on alternative substances or techniques is provided. We therefore believe that the absence of information from the Annex XV dossier ignores the legitimate expectations of nPB manufacturers and importers, as well as being a breach of good administration. Furthermore, this deviation from normal practice is in effect discriminatory against nPB manufacturers. We would welcome a clarification from ECHA.
ECHA’s Guidance on the Preparation of Annex XV dossiers to Identify SVHCs (SVHC Guidance) recommends Member States and ECHA to include an assessment of the alternatives in order to provide the information that will be needed at the next phase of the process. We support this recommendation particularly for a substance such as nPB where the majority of uses are intermediate and not covered by Title VII of REACH. In this regard, I SVHC Guidance states that: 
“[f]or dossiers identifying CMR substances for inclusion in the candidate list for eventual inclusion on Annex XIV, the dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC [now Annex VI to the CLP Regulation]. This reference may be sufficient to include the substance in the candidate list. Having only a reference to Annex I to Directive 67/548/EEC may not be enough for the purpose of priority setting. Therefore, it is recommended that the Authority includes in the Annex XV dossier available information on exposures, alternative substances and risks.”  
EU Courts have held that, while guidance of EU Institutions and agencies are not legally binding, such organisations are still obliged to follow them or to explain the reasons for their own departure. It is important to note that to the best of our knowledge there are no alternatives to nPB which are not already included in the list of candidates for Authorisation as SVHCs. 
Furthermore, ECHA did not consult with industry during the drafting of the Annex XV dossier on nPB, in contradiction to its own guidance. Discussion during the development of the dossier would have allowed the industry to seek greater clarification as to the exposure which is the concern authorities feel need addressing urgently.  

Risk Management Options:
While not explicitly foreseen in REACH, industry is also convinced that a thorough Risk Management Option (RMO) analysis for potential SVHC is an important element to confirm the need for EU wide Risk Management identification and to determine the most effective legal instrument to manage the potential risks. 

According to REACH, the aim of title VII is “to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.”

ECHA’s failure to include an assessment of the available risks management options in the Annex XV dossier of nPB means that the industry cannot understand what is the worker exposure risk that ECHA considers is not already adequately addressed under EU regulation or industry best practice and therefore requires the inclusion of nPB as a candidate for Authorisation. The Commission has acknowledged the need to assess the risk management options before proposing the identification of a SVHC. The minutes of the meeting of the CARACAL of 16-17 March 2009 state that the Commission “particularly welcomed the proposal to conduct the analysis of the best risk management options as early as possible, preferably before the introduction of a new Annex XV dossier.”

The lack of such RMO analysis before announcing the listing on the SVHC may therefore result in ineffective action or extensive administrative burden with limited or no gain for chemicals management.  ECHA and the Commission have agreed to consider RMOs as good practice, and therefore in our opinion, not including this information infringes the right to a Good Administration of nPB manufacturers and importers.  

Moreover, as more than two thirds of the uses are exempt from the regulatory requirements, and the remaining uses are industrial uses controlled under worker exposure legislation, the industry believes that nPB can be evaluated under other risk management options than a listing in the candidate list for authorisation.	Thank you for your comment. 

Proposal to identify the substance as SVHC: 

In accordance with REACH Article 59 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. 

Please note that the SVHC identification process, as set out in REACH Article 59(1) is intended to identify substances meeting the criteria referred to in Article 57 and establishing a candidate list of substances for eventual inclusion in Annex XIV. Hence, no further precondition than meeting criteria referred to in Article 57 needs to be fulfilled in order to include a substance in the candidate list in accordance with the procedure set out in Article 59. 

Dossier content: 
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 on the suggested transitional arrangements in accordance with Article 58 of REACH and can provide comments. 

No RMOA performed: 

Preparation of a risk management options 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. 

As the commenter states there is no obligation to include discussion of risk management options or justification for risk in a dossier for SVHC identification and this has never been done so far. As stated above, the purpose of the RMOA is to facilitate agreement between authorities on the appropriate risk management activities but not to discuss those activities or potential risks with stakeholders.

Information on uses provided in your comment: 

See response to comment 16 in section “Specific comments on use, exposure, alternatives and risks”.	
11	2012/10/17	Company
Enviro Tech Europe Ltd
United Kingdom	We do not believe that n Propyl Bromide should be put on the candidate list.
Stabilised 1-Bromopropane or N Propyl Bromide (nPB) has been used for many years as a direct replacement for the carcinogenic Trichloroethylene in vapour degreasing equipment.  We believe it has many advantages which makes it more acceptable than Trichloroethylene.
•	Lower boiling point means lower energy costs and smaller carbon footprint.
•	No chlorine which means proven less possibility of hydrogen embrittlement in titanium metals which is important in aerospace and military applications. 
•	Non carcinogenic
•	Fast environmental breakdown means does not accumulate in the environment. Hydrolysis rate is faster than any alternative.	See response to comment 11 below in section “Specific comments on the justification”.

			See also:
Comment 11 attachment (SVHC Comments.zip).zip		
10	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 1-bromopropane; n-propyl bromide 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.	
9	2012/10/17	Company
PPC
France	On September 3, 2012, the European Chemicals Agency (ECHA) submitted for public consultation a Annex XV dossier proposing to identify n-propyl bromide (nPB) as a substance of very high concern (SVHC) under Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The dossier on nPB is part of a batch of Annex XV dossiers for 37 substances that ECHA is currently proposing to identify as SVHCs on the basis of their harmonized classification as Cat. 1A or 1B CMRs in accordance with Annex VI to Regulation (EC) 1272/2008 on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation).
As is laid out in this submission, the majority of nPB is used as an intermediate, with all uses either strictly controlled or industrial uses subject to occupational exposure levels significantly below the NOAEL identified in the CMR classification process. Given these facts, we would like to understand the basis for seeking to include nPB from among 100s of substances listed as CMR 1b in Annex VI of the CLP Regulation in the candidate list at this time. Were selection criteria applied, and if so what are they? Is there a ranking system which ECHA uses when choosing CMR substances to include in the Candidate list? What risk was the cause for concern that ECHA considers needs to be addressed by a REACH Authorisation in addition to the existing regulatory framework applicable for nPB?
Dossier Completeness:
The industry would like to take this opportunity to raise some comments on the completeness of the nPB dossier. According to Article 59 of REACH ECHA, upon request of the Commission, and Member States may propose the identification of SVHCs by submitting an Annex XV dossier.  Annex XV provides that a dossier for the identification of a SVHC shall include:
(i) a proposal identifying the substance and whether it is proposed as a SVHC because it is a CMR Cat. 1A or 1B, PBT, vPvB, or a substance raising an equivalent level of concern; 
(ii) a justification as to why the substance is a PBT, vPvB or a substance raising an equivalent level of concern; and 
(iii) the available use and exposure information, and information on alternative substances and techniques.  

While the industry understands that legally there are no obligations to include extensive information on all available alternatives into the Annex XV dossier, the absence of any such information is contrary to ECHA’s own recommendation and indeed past practice. As the nPB Annex XV dossier links to the nPB Registration file, no information on alternative substances or techniques is provided. We therefore believe that the absence of information from the Annex XV dossier ignores the legitimate expectations of nPB manufacturers and importers, as well as being a breach of good administration. We would welcome a clarification from ECHA.
ECHA’s Guidance on the Preparation of Annex XV dossiers to Identify SVHCs (SVHC Guidance) recommends Member States and ECHA to include an assessment of the alternatives in order to provide the information that will be needed at the next phase of the process. We support this recommendation particularly for a substance such as nPB where the majority of uses are intermediate and not covered by Title VII of REACH. In this regard, I SVHC Guidance states that: 
“[f]or dossiers identifying CMR substances for inclusion in the candidate list for eventual inclusion on Annex XIV, the dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC [now Annex VI to the CLP Regulation]. This reference may be sufficient to include the substance in the candidate list. Having only a reference to Annex I to Directive 67/548/EEC may not be enough for the purpose of priority setting. Therefore, it is recommended that the Authority includes in the Annex XV dossier available information on exposures, alternative substances and risks.”  
EU Courts have held that, while guidance of EU Institutions and agencies are not legally binding, such organisations are still obliged to follow them or to explain the reasons for their own departure. It is important to note that to the best of our knowledge there are no alternatives to nPB which are not already included in the list of candidates for Authorisation as SVHCs. 
Furthermore, ECHA did not consult with industry during the drafting of the Annex XV dossier on nPB, in contradiction to its own guidance. Discussion during the development of the dossier would have allowed the industry to seek greater clarification as to the exposure which is the concern authorities feel need addressing urgently.  

Risk Management Options:
While not explicitly foreseen in REACH, industry is also convinced that a thorough Risk Management Option (RMO) analysis for potential SVHC is an important element to confirm the need for EU wide Risk Management identification and to determine the most effective legal instrument to manage the potential risks. 

According to REACH, the aim of title VII is “to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.”

ECHA’s failure to include an assessment of the available risks management options in the Annex XV dossier of nPB means that the industry cannot understand what is the worker exposure risk that ECHA considers is not already adequately addressed under EU regulation or industry best practice and therefore requires the inclusion of nPB as a candidate for Authorisation. The Commission has acknowledged the need to assess the risk management options before proposing the identification of a SVHC. The minutes of the meeting of the CARACAL of 16-17 March 2009 state that the Commission “particularly welcomed the proposal to conduct the analysis of the best risk management options as early as possible, preferably before the introduction of a new Annex XV dossier.”

The lack of such RMO analysis before announcing the listing on the SVHC may therefore result in ineffective action or extensive administrative burden with limited or no gain for chemicals management.  ECHA and the Commission have agreed to consider RMOs as good practice, and therefore in our opinion, not including this information infringes the right to a Good Administration of nPB manufacturers and importers.  

Moreover, as more than two thirds of the uses are exempt from the regulatory requirements, and the remaining uses are industrial uses controlled under worker exposure legislation, the industry believes that nPB can be evaluated under other risk management options than a listing in the candidate list for authorisation.
PPC is a French chemical company located in Thann, east of France. Our chemical plant is one of the oldest in Europe, the production began in 1808.
PPC is a 250 employees company and his activity is based since years 1920s on potassium chloride electrolysis. As bromine is a by-product of potassium chloride purification process, PPC developed since many years a fine chemical activity around bromine.
Today PPC is producing a large catalog of organic brominated compounds. Fine chemical activity is based on discontinuous processes and we produce by campaigns all over the year. Depending of the needs, campaigns go from few days to few weeks. PPC have a good knowledge of the bromine chemistry including reaction, handling of products and analysis.
Most of our customers are using our products as intermediates in pharmaceutical or agrochemical industries.
Propyl bromide is one of this product family and since few years the produced quantity has been reduced to some 10s tons. We have very few customers for nPB, all in pharmaceutical industry.
PPC is producing the organic brominated compounds, especially nPB, in well-closed equipments.
As a responsible company, PPC is doing work atmosphere analysis. Since 5 years, all the results are under 10 ppm which is the value of OEL defined by ACGIH in 2003.	Thank you for your comment. 

See response to comment 12 above
	
8	2012/10/17	Company
Albemarle Europe SPRL
Belgium	Albemarle Europe SPRL acts as the European headquarters of Albemarle Corporation, which is a global developer and manufacturer of specialty chemicals headquartered in Baton Rouge, Louisiana. Amongst its activities, Albemarle Corporation produces n-propyl bromide at one site based in Magnolia, Arkansas, USA.  Albemarle Europe imports n-propyl bromide into the EU, where it is used exclusively as a precursor in the manufacturing of pharmaceutical products such as anticonvulsant and mood-stabilizing drug, in the treatment of epilepsy amongst others.
 
Albemarle Europe SPRL is a founding and active member of the Brominated Compounds consortium dealing with n-propyl bromide, which was officially created in July 2009, and has thus participated in the work undertaken to prepare for the registration of the said substance. 

Albemarle Europe SPRL submitted a registration dossier on n-propyl bromide by 1st December 2010, acting as an importer. As 100 % of the substance put on the EU market is exclusively used by our European customers as an intermediate under strictly controlled conditions, the substance has been registered as such.  
 
Albemarle Europe SPRL would like to draw the attention of Member States on the following points relating to the procedure, the content of the dossier as well as the exemption from the authorization of the nPB it imports into the EU considering it is exclusively used as an intermediate. 

First of all, Albemarle deeply regrets the fact that ECHA did not consult with industry during the preparation of the Annex XV dossier on nPB, in contrast with its own recommendations. Indeed, ECHA’s Guidance on the Preparation of an Annex XV dossier on the Identification of Substances of Very High Concern (June 2007) page 15, states that “authorities are encouraged to engage stakeholders and other interested parties in the development of the dossier as early in the process as possible”. It adds that such informal consultation “will facilitate the timely collection of the necessary information and will contribute to the transparency and representativeness of the dossier”. This is also in clear contrast with the current practice of some Member States.

We note that this dossier merely copies the harmonized classifications of the substance specified in Annex VI to the CLP Regulation, and under Part II (Information on Use, Exposure, Alternatives and Risks), it solely provides a link to the website of ECHA and states that “ECHA has not carried out further analysis of this information”. 

In addition, the lack of information on risk management options in the Annex XV dossier deeply contrasts with some Member States’ recent practice, where Risk Management Option Analysis is conducted prior to SVHC proposal, which ECHA and the Commission acknowledged to be a good practice. The summary and conclusions of a workshop of ECHA and the Member States on the Candidate List and Authorization as Risk Management Instruments of January 2009 (proceedings available on the Internet: http://echa.europa.eu/documents/10162/13639/authorisation_workshop_proceedings_20090121_en.pdf) emphasizes the need to do an assessment of risk management options for all Annex XV dossiers. The ECHA and Member States agreed that ‘the analysis of the best Risk Management Option should preferably be conducted as early as possible in the development process of any new Annex XV dossier, and shared with the other authorities, even if not entirely finalized”.
The lack of such RMO analysis before announcing the listing on the SVHC may therefore result in ineffective action or extensive administrative burden with limited or no gain for chemicals management.  ECHA and the Commission have agreed to consider RMOs as good practice, and therefore in our opinion, not including this information infringes the right to a Good Administration of nPB manufacturers and importers.  

Together with other industrial companies, Albemarle supports the opinion that the objectives of the authorization procedure “to ensure good functioning of the internal market while assuring that the risks of substances of very high concern are properly controlled” may only be met if and when a prior RMO analysis is been properly conducted, which is clearly not the case here. 

A further analysis of the information available (conducted through a risk assessment) might have allowed ECHA to identify the incorrect translation of the nPB classification from the Dangerous Substances Directive 67/548/ECC to the CLP (see below specific comments on Part 1 

Furthermore, considering that 100% of the volumes that Albemarle imports in the EU is used by our customers as intermediates under strictly controlled conditions and intermediates are legally exempted from the authorization procedure in accordance with the provisions of Article 2 Paragraph 8 of the REACH Regulation, we consider that submitting this substance to the authorization process does not appear particularly relevant nor proportionate. 

We therefore regret the conditions under which the Annex XV dossier on nPB was prepared i.e.: the decision was taken without any prior consultation with stakeholders as recommended and without any RMO consideration despite the fact that this has been recognized as a good practice. 

Considering the fact that information on uses, exposure, alternatives and risks are very limited or simply lacking, we are concerned about the future steps of the process and especially the ability for competent authorities to take a full informed decision regarding potential priority setting. In this respect, we urge the Member States and the ECHA to take into account the fact that this substance is used as an intermediate in pharmaceutical applications. 	Thank you for your comment. 

Regarding the information provided in part II of the Annex XV report please  
see response to comment 12 above.

On the issue of RMO analyses see response to comment 12 above.

Regarding the comment on the classification please see response to comment 12 in section: PART I “Specific comments on the justification”.	
7	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.	
5	2012/10/08	Member State
Germany	The German CA appreciates ECHA´s efforts to compile SVHC-Dossiers on such short notice. We do not fully understand the selection criteria, which are different to the approach taken so far for SVHC-identification.

Even though the substances can easily be put on the Candidate List due to their CMR properties, it should be carefully analyzed whether placing them on the candidate list really is the best risk management option.
1-Bromopropane is mainly used in industrial settings and as intermediate. 

Therefore we would suggest, that thorough RMO-Analyses are prepared and shared with MSCAs as soon as possible
	Thank you for your comment. 

In accordance with REACH Article 59 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 options 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.	
4	2012/09/25	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.	
2	2012/09/18	Company
United Kingdom	I do not feel the inclusion of 1-bromopropane; n-propyl bromide (EC number 203-445-0 CAS number 106-94-5)justifies inclusion in the potential svhc listings. 	Thank you for your comment. 	
1	2012/09/17	Individual
Germany	Used in a closed loop cleaning system Npb has a fantastic precision cleaning power, lowering the enviromental footprint dramatically compared to other water based cleaning systems. With short cleaning times and usage values 3-4 LT per day (Depending on equipment !) are possible. In critical Industries ie Aerospace where low volumes are in use, Npb should be allowed to be used.
 	Thank you for your comment. 

As regards information on the uses provided in your comment please refer to response to comment #16 in “PART II: Comments and responses to comments on uses, exposures, alternatives and risks”.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
12	2012/10/18	Company
Netherlands	Page 7– Classification of nPB:
While the official classification of n-propyl bromide (nPB) as toxic to reproduction category 1B to the  Globally Harmonized System (GHS) for fertility effects, fulfils the requirements of article 57c, we are convinced that the aim of article 55 of REACH (Regulation EC 1907/2006) “to ensure good functioning of the internal market while assuring that the risks of substances of very high concern are properly controlled” can be reached via other risk management options than a listing in the candidate list for authorisation.
Regarding the classification of nPB, we would like to make the following comment related to the accuracy of the classification following its transition from the Dangerous Substances Directive (DSD) to the Globally Harmonized System (GHS).  For the developmental endpoint, the classification was category 3 according to Directive 67/548/EEC, but this is not correctly reflected in the current harmonized CLP classification. nPB should be classified as category 2 for developmental toxicity and  category 1B for fertility, but not category 1 B for fertility and developmental toxicity. The developmental toxicity classification is based on a study, in which only slight substance related effects on fetal body weight and ossification were observed at dose levels that also impaired maternal body weight gain and body weights. It is likely that the observed effects in the offspring were secondary to the maternal effects observed.  A distinction should be made to reflect the difference between the classification of nPB for fertility and developmental toxicity effects. 
nPB was classified for fertility effects due to results in a rat two-generation study leading to impaired fertility at very high exposure concentrations of 3800 mg/m3. In this study a clear No Effect Concentration of 503 mg/m3 was identified. The same NOAEL was identified in a developmental toxicity study, for both maternal and developmental toxicity (the LOAEL in this study was 2540 mg/m3). The concentrations at which effects occurred in the animal studies were far above concentrations that would normally occur in industrial environments.  Existing national occupational exposure levels (OELs) for nPB are approximately 50 times lower than the concentration which the study demonstrated to be the level of exposure necessary to see the adverse effect.  The REACH dossier (joint submission of the brominated compounds consortium members) for n-PB derived a DNEL, long term inhalation of 20 mg/m3 for workers according to the ECHA guideline which corresponds to a recommended 8 hour occupational exposure limit.
The substance is mainly used as intermediate under strictly controlled conditions and all other uses are industrial only. In the industrial settings in the EU the worker DNEL is adhered to as an occupational exposure limit under the REACH regulation and this should already ensure the safe use of this substance. As toxicity to reproduction is an effect that has a threshold, and in the underlying studies for this substance a clear NOAEL has been identified, and the concentrations at which effects occurred in the animal studies were far above concentrations that would normally occur in industrial environments, we consider any additional risk management, such as inclusion in the candidate list of substances of very high concern as disproportionate.
	Thank you for your comment and the information provided. 

Regarding the allegedly flawed classification:
The substance is classified as reprotoxic, 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 (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. 

As the above cited harmonised classification is applicable law at present, it will not be questioned or discussed in the context of the currently ongoing SVHC identification process.

We are aware of legal actions of a company before the European Court of Justice in regard of the classification of 1-bromopropane, However, such actions do not have suspensive effect and therefore there is no need to wait for the outcome of the Court’s judgment before deciding whether or not the substance meets the criteria for identification as a SVHC and its possible inclusion in the candidate list. 
Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification of a substance in Part 3 of Annex VI of Regulation (EC) No 1272/2008 may submit a revision proposal in accordance with the second subparagraph of Article 37(2) of Regulation 1272/2008 to the competent authority in one of the Member States in which the substance is placed on the market.

Please note that the SVHC identification process, as set out in REACH Article 59(1) is intended to identify substances meeting the criteria referred to in Article 57 and establishing a candidate list of substances for eventual inclusion in Annex XIV.
Hence, no further precondition than meeting criteria referred to in Article 57 needs to be fulfilled in order to include a substance in the candidate list in accordance with the procedure set out in Article 59. 

With respect to the hazard statement, we agree that there is a mistake in the current part 3 of Annex VI, Table 3.1 (list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008. The hazard statement code for reprotoxicity Repr. 1B should be H360Fd instead of H360FD, showing that the developmental toxicity results from the classification Repr. Cat. 3, R63, according to part 3 of Annex VI, Table 3.2 (list of harmonized classification and labelling of hazardous substances from Annex I of Council directive 67/548/EEC) of Regulation (EC) No 1272/2008. This will be corrected accordingly in the support document for identifying 1-bromopropane as SVHC. Nevertheless, this does not affect the fact that the substance fulfils the criteria set out in Art. 57 of REACH and therefore can be identified as a Substance of Very High Concern following the procedure set out in Art. 59 of the same regulation. 

Regarding SVHC identification and candidate listing please refer to response to comment #12 above in section “General comments on the SVHC proposal” (heading “Proposal to identify the substance as SVHC”). 

With respect to the information on uses provided see response to comment #16 in section “Specific comments on use, exposure, alternatives and risks”.	
11	2012/10/17	Company
Enviro Tech Europe Ltd
United Kingdom	P7-9
According to Annex VI, point 4.2.3 of Directive 67/548, a substance can only be classified as toxic to reproduction, category 2, on the basis of clear evidence in two animal species or, if there is only clear evidence in one animal species, there should be supporting evidence on mechanisms of action or site of action, or chemical relationship to other known anti-fertility agents. Classification as category 2 repro toxin was based on 2-generation report on rats and Structural Activity Relationship to its isomer 2-Bromopropane or iso Propyl Bromide (iPB) a known reproductive toxin. Since the 2 generation study only used a single species, the only way nPB could be classified as category 2 Reproductive toxin was if it behaved similarly to iPB. Since that time it has been found that iPB and nPB breakdown and metabolise along different pathways. Therefore it cannot be assumed that if iPB is a reproductive toxin, then nPB will be one as well. The attached report by Dr M Stelljes details this argument. (Stelljes Report 6/9/2005 attached- Mechanistic approach.pdf).

The International Brominated Solvents Association (IBSA) attempted to get the Technical Committee for Classification and Labelling of the ECB to reconsider the category 2 repro toxin classification At Ispra in 2006 it was announced they would not reconsider. The attached documents relate to the case for reclassification. (6207a17-I_IND_npropylbromide.pdf and 6207a17-II_IND_npropylbromide.pdf)
There have been four case studies in the USA concerning workers who were exposed to stabilised nPB (see attached document Stelljes 5/12/2006). It was concluded that no reproductive effects were noted. (selfclassification_tox_date.pdf)
An in-vitro bioassay study (Adeli et. al.) published in 2006 looked at a number of solvents promoted as vapour degreasers and concluded stabilised nPB was one of the least toxic with respect to Cytotoxicity, DNA Strand Break, DNA Repair Activity and EROD (see attached 301.pdf). Part of the original REACH brief was to promote in vitro studies and this one is particularly relevant.
The U.S EPA has issued a Final Ruling that  nPB is an acceptable solvent for vapour degreasing with a voluntary acceptable exposure limit (AEL) of 25ppm (TWA 8 hours) which is easily achievable in a vapour degreaser. Reference: 40 CFR Part 82 [EPA–HQ–OAR–2002–0064; FRL–8316–8]. The typical iPB contamination of nPB is typically less than 100ppm now. It used to be 500ppm. Therefore this much improved.

Therefore the classification of nPB as a category 2 reproductive toxin should be revisited. The inclusion of nPB on to the candidate list should be delayed until the classification is confirmed. In the light of these arguments why put priority on making nPB an SVHC when it can be allowed to replace the carcinogenic trichloroethylene already on the candidate list? If left off, it will give industry opportunity to stop using carcinogens while given time to find more benign solutions.	Thank you for your comment.

Regarding the comment on the classification please see response to comment 12 in this section.	
			See also:
Comment 11 attachment (SVHC Comments.zip).zip		
9	2012/10/17	Company
PPC
France	Page 7– Classification of nPB
While the official classification of n-propyl bromide (nPB) as toxic to reproduction category 1B to the Globally Harmonized System (GHS) for fertility effects, fulfils the requirements of article 57c, we are convinced that the aim of article 55 of REACH (Regulation EC 1907/2006) “to ensure good functioning of the internal market while assuring that the risks of substances of very high concern are properly controlled” can be reached via other risk management options than a listing in the candidate list for authorisation.
nPB was classified due to results in a rat two-generation study leading to impaired fertility at very high exposure concentrations of 3800 mg/m3. In this study a clear No Effect Concentration of 503 mg/m3 was identified. The concentrations at which effects occurred in the animal studies were far above concentrations that would normally occur in industrial environments. Existing national occupational exposure levels (OELs) for nPB are approximately 10 times lower than the concentration which the study demonstrated to be the level of exposure necessary to see the adverse effect. Moreover, the manufacturers of nPB recommend that the occupational exposure limit (OEL) for nPB should be between 10-25 ppm based on the latest science available, as included in the Registration dossier for nPB.   Following industry best practice, workers are not exposed to nPB at the level that causes the adverse effect for which nPB was classified.
Regarding the classification of nPB, we would also like to make the following comment related to the accuracy of the classification following its transition from the Dangerous Substances Directive (DSD) to the Globally Harmonized System (GHS).  For the developmental endpoint the classification was category 3 according to Directive 67/548/EEC, but this is not correctly reflected in the current harmonized CLP classification. nPB should be classified as category 2 for developmental toxicity and  category 1B for fertility, but not category 1 B for fertility and developmental toxicity. The developmental toxicity classification is based on a study, in which only slight substance related effects on fetal body weight and ossification were observed at dose levels that also impaired maternal body weight gain and body weights. It is likely that the observed effects in the offspring were secondary to the maternal effects observed.  A distinction should be made reflect the difference between the classification of nPB for fertility and developmental toxicity effects. 	Thank you for your comment.

Regarding the comment on the classification please see response to comment 12 in this section.	
8	2012/10/17	Company
Albemarle Europe SPRL
Belgium	p. 4, Summary of how the substance meets the criteria set out in Article 57 c of REACH
While the official classification of n-propyl bromide (nPB) as toxic to reproduction category 1B to the  Globally Harmonized System (GHS) for fertility effects, fulfils the requirements of article 57c, we are convinced that the aim of article 55 of REACH (Regulation EC 1907/2006) “to ensure good functioning of the internal market while assuring that the risks of substances of very high concern are properly controlled” can be reached via other risk management options than a listing in the candidate list for authorisation
p.7-8 classification:
Regarding the classification of nPB, we would, like to make the following comment related to the accuracy of the classification following its transition from the Dangerous Substances Directive (DSD) to the Globally Harmonized System (GHS).  For the developmental endpoint the classification was category 3 according to Directive 67/548/EEC, but this is not correctly reflected in the current harmonized CLP classification. nPB should be classified as category 2 for developmental toxicity and  category 1B for fertility, but not category 1 B for fertility and developmental toxicity. The developmental toxicity classification is based on a study, in which only slight substance related effects on fetal body weight and ossification were observed at dose levels that also impaired maternal body weight gain and body weights. It is likely that the observed effects in the offspring were secondary to the maternal effects observed.  A distinction should be made to reflect the difference between the classification of nPB for fertility and developmental toxicity effects. 
p. 9 6.1 CMR assessment
nPB was classified for fertility effects due to results in a rat two-generation study leading to impaired fertility at very high exposure concentrations of 3800 mg/m3. In this study a clear No Effect Concentration of 503 mg/m3 was identified. The same NOAEL was identified in a developmental toxicity study, for both maternal and developmental toxicity (the LOAEL in this study was 2540 mg/m3). The concentrations at which effects occurred in the animal studies were far above concentrations that would normally occur in industrial environments.  Existing national occupational exposure levels (OELs) for nPB are approximately 50 times lower than the concentration which the study demonstrated to be the level of exposure necessary to see the adverse effect.  . The REACH dossier (joint submission of the brominated compounds consortium members) for n-PB derived a DNEL, long term inhalation of 20 mg/m3 for workers according to the ECHA guideline which corresponds to a recommended 8 hour occupational exposure limit.
p. 9 4 Human health hazard assessment:
The data that were collected by the Brominated Compounds consortium show that this substance is largely  used as intermediate (about two third of the volumes reported by members of the consortium) and all other uses are industrial only. In the industrial settings in the EU the worker DNEL is adhered to as an occupational exposure limit under the REACH regulation and this should already ensure the safe use of this substance. As toxicity to reproduction is an effect that has a threshold, and in the underlying studies for this substance a clear NOAEL has been identified, and the concentrations at which effects occurred in the animal studies were far above concentrations that would normally occur in industrial environments, we consider that the inclusion of nPB in the candidate list of substances of very high concern as disproportionate. These considerations should in our opinion be included in the human health hazard assessment.	Thank you for your comment.

Regarding the comment on the classification please see response to comment 12 in this section.	
5	2012/10/08	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.	
2	2012/09/18	Company
United Kingdom	As a distributor for EnSolv one of the solvents in this category that includes NPB I know how and why the product works and how with due dilligence it is one of the safest solvents for use for its application as a safer alternative to the use of the carcinogenic product Trichloroethylene (TCE. EnSolv is used extensivly in vapour degreasing applications within generally enclosed sealed technology degreasing machines. We work with end users to ensure that they use as little solvent as possible and when using any solvent ensure it is used as safely as possible. THERE IS AN ON GOING APPEAL IN THE COURTS TO CHALLENGE THE PREVIOUS R60 CLASSIFICATION OF N-PB AND THE INCLUSION WITHIN THE PROPOSED LISTING SHOULD BE DELAYED AT LEAST UNTIL THE OUTCOME OF THE COURT APPEAL HEARING.I have been privy to independent (and in a lot of cases PEER reviewed data that was offered to the HSE in the UK and rejected out of hand)This data has both physiological and practical evidence that it is not a reproductive toxin or carcinogen and feel that this evidence should at least be looked at by experts who have the expertise to digest and understand the content of the data, I beleive this will bring a differant perspective of the sometimes false and certainly major company suppported lobbying because it is such a good and safer alternative to things like TCE which in the main industrial sectors is used predominantly as a vapour only degreasing medium. 	Thank you for your comment.

Regarding the comment on the classification please see response to comment 12 in this section.

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	
17	2012/10/18	Industry or trade association
Aerospace Industries Association
United States	1-bromopropane was identified as having use in Aerospace industry by several companies.   It is used in solvents, vapor degreasing and cleaning.  Elimination of this substance would impact processes used to manufacture aerospace products.
 Changes to degreasing processes may involve capital expenditure expense in the supply chain, and can take time. This substance has been pushed as an alternative to ODS substances, as less environmentally damaging. Degreasing in manufacture is a product safety issue, options may exist. However, change is needed across large parts of the supply chain which will take significant time and investment,	Regarding further information on uses provided: 

See response to comment #16 in this section below.	
16	2012/10/18	Industry or trade association
Aerospace Industries Association
United States	If this substance became unattainable, removal of elastomeric coating and epoxy prepreg used in printed wiring boards would be somewhat manageable, but potentially very inconvenient and expensive.  There would be an impact on processes of circuit card manufacture.  Companies using circuit cards could see impact in the supply chain if this substance is banned.
	Thank you for the information provided. 

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.

Topics such as the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use as well as information on the low level of risk associated to a use are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.	
12	2012/10/18	Company
Netherlands	Annex XV of REACH indicates that for a dossier identifying a chemical as a Substance of Very High Concern ECHA, or the Member State, shall include the available use and exposure information, and information on alternative substances and techniques.  As this dossier links only to the nPB REACH Registration file it does not include any information on alternative substances or techniques. 
Page 10 – Uses: 
According to the information collected by the REACH Consortium for Brominated substances, 69% of nPB is used for intermediate purposes, therefore more than 2/3 of nPB uses are  exempt from REACH Title VII. In this regard, we do not understand the benefit of submitting an Annex XV dossier for SVHC.  Furthermore, 31% of these intermediate uses of nPB are under strictly controlled conditions.  
In all other non-intermediate industrial uses, nPB is applied as a vapour degreasing solvent for metal parts. Most vapour degreasing equipment used nowadays is enclosed and hermeticallly sealed to minimize exposure to workers and the environment. Following is a list of equipment manufacturers having the lion share of the vapour degreasing equipment sales in the EU.
CC Hydrosonics in the UK
www.cchydrosonics.com
EVT in Germany
www.evt-gmbh.de
Cemasti, AMA in Italy
www.cemasti.it
Other solvents, but no viable alternatives, offered in the EU market for the purpose of vapour degreasing are following
-Trichloroethylene (EC no: 201-167-4): Already on the Candidate List.
-Dichloromethane aka methylene chloride (EC no: 200-839-9): with a low boiling point of 39.6 degC compared to 70-71 degC of nPB. Methylene chloride due to its lower boiling point is a less efficient vapour degreaser.   
-HFC/HFE solvents all based on Trans 1,2 dichloroethylene aka tDCE (EC no: 208-750-2): structurally similar to trichloroethylene. 
-Tetrachloroethylene aka perchloroethylene (EC no: 204-825-9): with a high boiling point of 121degC it is energy intensive and treated metal parts come out too hot to handle.
Inclusion as a Substance of Very High Concern in the list of candidates for Authorisation, sends an important signal to the market that this substance must be substituted for listed uses. As such a significant amount of nPB applications are exempt from Title VII  of REACH, in the case of a candidate listing of nPB, the industry would like to request that a clear indication should be included specifying that the listing does not apply to the intermediate uses as they are exempt. This is in order to avoid unfair market de-selection due to any potential misunderstanding. 	Thank you for your comment. 

Regarding information provided on uses and alternatives please see response to comment #16 above in this section.

Regarding the information provided in part II of the Annex XV report please see response to comment #12 in section “General comments on the SVHC proposal” above.

11	2012/10/17	Company
Enviro Tech Europe Ltd
United Kingdom	P10
When used in vapour degreasing equipment it can be shown that the exposure of nPB to the operators is much less than 25ppm which was considered a safe level by the US EPA. Recent typical Italian study showed maximum 20ppm (99990 microgm per cu metre) see attached files Tab Risultati in inglese 10 08 10(1).pdf and EnSolv workplace determination Fondaz Maugeri.pdf If normal handling and use is taken into account there should be no reason to put nPB into Annex XIV.

What else can industry use? There are currently no other effective alternative solvents for vapour degreasing. Aqueous cleaning is not always suitable and always has much increased energy costs meaning much bigger carbon footprint. Vapour degreasing is really condensation cleaning. Effective vapour degreasing relies on a significant difference between vapour temperature and ambient temperature. When the boiling point is too low then not enough solvent condenses on the surface to clean effectively, since when surface temperature reaches vapour temperature no more condensation occurs and cleaning stops.
Solvents offered as alternatives for vapour degreasing are:
•	Trichloroethylene – higher boiling point so bigger carbon footprint. Is a category 2 carcinogen and also known to be a repro toxin. Already on candidate list. Chlorinated solvents can give hydrogen embrittlement in titanium alloys. Should we not encourage users to switch from carcinogens?
•	Methylene Chloride – boiling point is so low that vapour degreasing is inefficient. Vapour degreasing is really condensation degreasing. The part is suspended in the vapour and solvent condenses on it, rinsing off contamination. The part will gradually warm up to the temperature of the vapour at which stage cleaning stops. At 38C for Methylene Chloride this will be quite quick meaning cleaning time is too short leaving residues. In warm weather where parts are already warm the time is so short that practically no cleaning takes place. Is also a cat 3 carcinogen
•	HFC/HFE’s are also lower boiling meaning effective cleaning is not achieved. All are based on trans 1,2 dichloroethylene (tDCE) which is structurally similar to trichloroethylene. Much play was made of the similarity of iso propyl bromide (iPB) and nPB, but no one seems to raise the similarity of tDCE to Trichloroethylene, cis 1,2 dichloroethylene and 1,1 dichloroethylene all of which are toxic but apparently tDCE is not! Also it is flammable and its flammability controlled by the HFC/HFE. HFC and HFE solvents have high global warming potential. Even when blended with tDCE the resulting mixture has Global Warming Potential (GWP) of the order of 150 times that of carbon dioxide compared to 0.31 for nPB (100year). The replacement of traditional vapour degreasing solvents by HFC/HFE will release global warming solvents to the atmosphere at a greatly increased rate. Is this acceptable in light of the current concern of global warming and reduction of polar ice and glaciers?
•	Perchloroethylene is also a cat 3 carcinogen and has environmental problems associated with it and its breakdown products have been found in drinking water. Its high density, low volatility and stability to hydrolysis mean that it rapidly moves down through soil to the water table. Its boiling point at 121C is too high. It is energy intensive and parts come out too hot to handle.
•	Other solvents are highly flammable and are therefore more hazardous to control with respect to flammability and explosions.

Stabilised nPB is also used in Asphalt testing as a replacement for Trichloroethylene. This is a laboratory test whereby nPB dissolves the bitumen out of Asphalt to separate it from the aggregate and the solvent then distilled off and collected for re-use.	Thank you for your comment. 

Regarding the information provided on uses and alternatives please see response to comment #16 above in this section.

	
			See also:
Comment 11 attachment (SVHC Comments.zip).zip		
9	2012/10/17	Company
PPC
France	Annex XV of REACH indicates that for a dossier identifying a chemical as a Substance of Very High Concern ECHA, or the Member State, shall include the available use and exposure information, and information on alternative substances and techniques.  As this dossier links only to the nPB REACH Registration file it does not include any information on alternative substances or techniques. 
Page 10 – Uses
According to the information collected by the REACH Consortium for Brominated substances, 69% of nPB  is used for intermediate purposes, therefore more than 2/3 of nPB uses are  exempt from REACH Title VII. In this regard, we do not understand the benefit of submitting an Annex XV dossier for SVHC.  Furthermore, 31% of these intermediate uses of nPB are under strictly controlled conditions.  
PPC customers for nPB are part of pharmaceutical industry. Pharmaceutical processes are guided by Good Manufacturing Practices. Al our customers are using nPB as an intermediate in a long reaction chain to produce an active molecule. During the chemical processes nPB is completely consumed. It would be very difficult to substitute nPB in this chain, as this would be a major change.
Inclusion as a Substance of Very High Concern in the list of candidates for Authorisation, sends an important signal to the market that this substance must be substituted for listed uses. As such a significant amount of nPB applications are exempt from Title VII  of REACH, in the case of a candidate listing of nPB, the industry would like to request that a clear indication should be included specifying that the listing does not apply to the intermediate uses as they are exempt. This is in order to avoid unfair market de-selection due to any potential misunderstanding.	Thank you for your comment. 

Regarding the information on uses provided please see response to comment #16 in this section above.

Regarding part II of the Annex XV report please see response to comment 12 in section: “PART I: Comments and responses to comments on the SVHC proposal and its justification”.

Concerning the intermediate status of the substance please see response to comment 12 in this section above.
	
8	2012/10/17	Company
Albemarle Europe SPRL
Belgium	The whole volume of nPB that Albemarle imports into the EU and puts on the European market (the volumes are reported in our individual REACH dossier and are still in the same range) is used as an intermediate in the manufacturing of pharmaceutical products (Valproic acid (VPA) production), such as anticonvulsant and mood-stabilizing drugs, in the treatment of epilepsy in particular.

During this process, nPB is completely consumed and is certainly not present in the final product. 

It is sold to a very limited number of customers who use the substance under strictly controlled conditions, so there is no risk of wide dispersive uses.	Thank you for your comment. 

Regarding the information on uses provided please see response to comment #16 above in this section.
	
6	2012/10/15	Industry or trade association
ASD - Aerospace and Defence Industries of Europe
Belgium	Used in Aerospace and Defence industry as a degreasing agent in parts manufacture. Change to degreasing processes may involve significant capital expenditure expense across the supply chain, and can take time. This substance has been encouraged as an alternative to legislated Ozone Depleting Substances, as less environemtally damaging. Degreasing in manufacture is a product safety issue, options for substitution may exist in many cases. However, change is needed across large parts of the supply chain.	Thank you for your comment. 

Regarding the information on uses provided please see response to comment #16 above in this section.
	
2	2012/09/18	Company
United Kingdom	npB based solvents work in a similar way to TCE in that they degrease by condensating the hot solvent onto the cold part and returning the solvent vapour to a liquid that then drops off the parts with the oils back into the sump of the degreasing bath. This process is both very fast and very efficient requiring very little energy and thus reducing the CO2 generation that other alternative options like water based chemistries require. Modern degreasing equipment is both fast and effective and because of additional cooling coils, higher free board areas, etc,mean that losses of solvents to both the immediate and external areas around the machine or building where it is sighted reduces losses and VOC generation dramatically and improves safety for both the operators and surrounding environments as well. No operator should be exposed to levels around the modern machines of more than 5ppm if they use it as recommended. Even if misused that exposure should not exceed 25ppm. The waste disposal side is minimal with the increasing use of on site solvent recovery systems. So I think the cost and time would be better invested in looking at the risks associated with water based chemistries and including the waste generated and energy used within these systems as the CO2 issue is the one side of the targets that has never been achieved because energy generation using water based systems can be as high as 20 or even 30% more than that of a solvent system so point the focus on these areas rather than wasting time on areas that generally are self policed by the industry	Thank you for your comment. 

Regarding the information on uses provided please see response to comment #16 above in this section.

Attachments

Comment number	Public attachment	
11	
Comment 11 attachment (SVHC Comments.zip).zip	
14	
Comment 14 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf