COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC : PROPOSAL AND JUSTIFICATION

Substance name:	Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid	
CAS number:	7738-94-5, 13530-68-2, -	
EC number:	231-801-5, 236-881-5, -	

Reason of the submission of the Annex XV: CMR

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. 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. The comments were received during the public consultation of the Annex XV dossier.
The table does not contain any confidential information.

General comments
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
25

	2010/10/28	MSCA,
France	see attachment	Thank you very much for the detailed comments and the additional information in the letter. The information will be valuable during the prioritisation procedure in annex XIV.	
24	2010-10-14	Industry or trade association,
ASSOGALVANICA,
Italy	I stress that acids generated from chromium trioxide are intermediate substances used in hard chromium and decorative plating and that they are not present in the final articles. 	Thank you for your comment. Since chromium trioxide is used to achieve another function (plating) we can not go along with this interpretation of intermediate. On this issue the ECHA Guidance for Intermediates states: As soon as the main aim of the chemical process is not to transform a substance (A) into another substance (B), or when substance (A) is not used for this main aim but to achieve another function, substance (A) used for this activity should not be regarded as an intermediate under REACH.
Although there is no chromium VI in metallic chromium coverings, the production of these layers is related to chromium VI exposure (see Tab. 17 & 18 on page 36 – 38 and Fig. 4 on page 60 of the report).	
			I underline the existence of the Risk Reduction Strategy for hexavalent chromium that limits the effects on Environment, Health and Safety of the workers/people. 	In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still a significant exposure that gives rise to concern.	
23	2010-10-14	International NGO,
Health and Environment Alliance,
Belgium	We support the inclusion of the chromium trioxide & oligomers -generated acids group on the candidate list on the basis of the Annex XV dossier	Thank you for the supporting statement, no response necessary.	
22	2010-10-15	Industry or trade association,

Belgium	Chromium trioxide has already been thoroughly evaluated under the Regulation 793/93 on Existing Substances (ESR) which, has now been repealed and replaced by the Regulation (EC) No 1907/2006 on REACH.   

Chromium trioxide is classified as a CMR substance (CLP Regulation (EC) No 1272/2008).

Risk assessments and risk management measures for limiting risks have been introduced and implemented. The United Kingdom was Rapporteur Country for the Chromium trioxide ESR review, and the resulting Commission conclusions and recommendations of 30 May 2008 were published in the Official Journal of 18 June 2008.

We agree that Chromium trioxide is classified as a CMR substance (CLP Regulation (EC) No 1272/2008).  However REACH does not require automatic inclusion of CMRs into the candidate list. 	Thank you for the comment. It begins with a statement, which requires no response.	
			We would ask that inclusion needs to be on the basis of overall risk posed by the substance to workers and to the environment.  Member states provide an Annex XV dossier based on best possible data on the risks that the substance poses.  At this point in time, there is data on risk still being generated in the UK (outlined below) which is very important to the Annex XV dossier and needs to be included.	Thank you for the additional information. Actually, Germany is also generating further information e.g. an exposure risk relationship. In our opinion, further information (from UK, Germany or any other source) should be regarded during the discussions on the inclusion of chromium trioxide in annex XIV.	
			As the European representatives of these industries, we are not convinced about the necessity to add any supplementary regulatory measures via REACH to reduce the use of the Chromium trioxide and its acids.

Consequently we would ask that the addition of this substance to the candidate list be delayed until the HSL report can be considered and wait until effective dialogue has been had with all our sectors, seeking effective controls. 

Specific comments on Part II “Information on Use, Exposure, Alternatives and Risks”.   	As CLEPA gives the concrete information, in response to part II of the report that HSL is working on information on workplace exposure, please see below for detailed response.	
			There are several uses of Chromium trioxide for which, to date, R&D across all our sectors has found no technically or economically feasible substitute for the majority of applications:   
-	chromium plating,  
-	chromate conversion layer for powder coatings of aluminium,  
-	passivation of aluminium and other metals,  
-	sulfo-chromium stripping of ABS plastics, chromic acid,  
-	anodising,  
-	control of bi-metallic welding and ceramography,  
-	chromic acid tests of anodic layers.   

A business sector may find an alternative where there is a simple geometry, or where shorter part-life is not essential for product viability and this has resulted in substitution. 

Therefore these remaining uses are technically essential to our industries and in some case essential for the safety of our products (Indeed for the Aerospace Industry, substituting any substance for another, either in the manufacturing process or in the equipment itself, requires the modified process or equipment to be recertified by European safety Agency (EASA), US Federal Aviation Administration (FAA) and other  airworthiness authorities - a process that can take several years as extensive testing is required to demonstrate that safety is by no means compromised) their withdrawal within the European Union would have serious socio-economic consequences in the various stages of the industrial chains concerned.	The unfeasibility of alternatives can not generally be disclaimed. In a later step of the authorisation process the applicant shall analyse alternatives considering the risks, technical and economic feasibility for each specific use. As the analysis of alternatives is a mandatory part, as described in Article 60(4c), 62(4e) the applicant should define and document any relevant research and development activities in regard to substitute Cr(VI) species.
The general procedure is outlined in EC 1907/2006, Articles 56 – 66, and on the ECHA website

See previous 
	
			Given that the authorisation process is deliberately costly, and that we already have no producers of hexavalent chromium remaining in the EU, we would like to draw your attention to the fact that there is already considerable risk of delocalisation in national industries throughout the European Union, and this additional cost burden could easily accelerate the trend.	It is not the intention of the German CA to delocalise the use of chromium towards countries outside the EU especially third world countries. This would in no way lead to an increase in occupational safety. 
The granting of authorisation (following the inclusion in annex XIV) gives the opportunity to identify workplaces where the risks are inacceptable on a case by case basis. Authorisation of a substance under the REACH-regulation does not imply a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overweigh the risk to human health (or the environment) resulting from its use and suitable alternatives or technologies are not available. In the case of chromium VI the second options is relevant.	
			The companies we represent are all actively seeking to substitute uses of chromium trioxide, its acids and salts and in many cases have been doing this for many years. R&D has made significant advances in this field and these have resulted in a variety of substitutes, contributing to the major decrease in consumption of this substance in European countries.	We appreciate your efforts at substitution of CrO3. The identification of a substance as SVHC or the inclusion in Annex XIV may further support companies seeking for alternatives by preventing distortion of competition in favour of less responsibly acting companies.	
			Regulations described in the working and environmental directives strictly regulate these uses. Risk assessments and risk management measures for limiting risks have been introduced and implemented as a result of the evaluation under the Regulation 793/93 on Existing Substances (ESR) which, has now been repealed and replaced by the Regulation (EC) No 1907/2006 on REACH.  The United Kingdom was Rapporteur Country for the Chromium trioxide ESR review, and the resulting Commission conclusions and recommendations of 30 May 2008 were published in the Official Journal of 18 June 2008 	In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still an measurable exposure that gives rise to concern.	
			As the European representatives of these industries, we are not convinced about the necessity to introduce an Annex XV dossier for a substance that has already been thoroughly investigated and which has undergone extensive R&D work in certain applications in order to replace it.   	Statement, no response necessary	
			p.12  6.2 CMR assessment-wording correction Classification according 67/548/EEC as Carc. 
Cat 1; R45, Mut. Cat. 2, R46, Repr. Cat. 3, R62 and according to Regulation (EC) No 1272/2008 (CLP): Carc. 1A, H350; Muta 1B, H340, Repr. 2, H361f	We agree that chromium trioxide is classified as mentioned. Nevertheless, in the view of the German CA only classification as Cat 1 or 2 (according to 67/548/EEC) is relevant in the context of Article 57 a, b, or c. As a result, Repr. Cat 3, R62 is not mentioned in the German report.	
			p.43 3.1.1.5 Chromium (III) based coatings By stating "in many cases possible" it means that in the rest of the cases it is not. Chrome III with sealer cannot be used in many applications to replace Chome VI if the same degree of protection is to be afforded. Extensive testing has been carried out by some companies and it was found that in the case where Chrome III and sealer was used  to replace Chrome VI on evaporators that the sealer was very quickly washed away by the condensate leaving just the Chrome III layer as the protection layer.	Thank you for your extensive explanation about your specific application. A more detailed discussion on the (un)suitability of specific alternative substances or processes is only foreseen in the framework of an authorisation request. (See above)	
			P.18 WORKER EXPOSURE This statement is inaccurate. Please refer to Annex II of the ELV (5th amendment). Also there is a threshold of 0.1%w/w of homogeneous material for hexavalent chrome.  

p.19 Summary of exposure data Strange wording: (apparently with the exception of chromium trioxide) Surely this is known by the originator of Annex XV!!  	We agree, the ELV states that a concentration up to 0.1 % by weight “shall be tolerated”. Nevertheless, this does not mean that such a concentration has to be regarded as “safe”. Your comment will be used during the prioritisation process of the report.	
			p.45 Develop processes based on nanotechnology ??? Use nanocrystalline metal coating processes or using nanomaterial-enhanced metal or non-metal substrates. Nano- is the “flavour of the month” and industy does not know what will happen in the future. Nanomaterials could end up on the candidate list.	The alternatives mentioned in the dossier were not evaluated in relation to risks, because, for example, the development is not completed or the technical processes are not comparable to the CrO3-based ones and might change the exposition. The list can be used as a thought starter for further development of substitutes. For each specific case the Commission is responsible for taking decisions.
We agree that such a discussion should also include evaluation of any adverse effects from substitutes where not all safety information is yet known.	
			General comment: There are in general too many “may”, “probable” and “estimate” included in this Annex XV dossier 	Searching for “may” gives 30 strikes for the chromium trioxide report. Nevertheless, a closer look shows that in 18 cases the month May is meant within the References. “Probable” resp. “Probably” can only be found once. The word “estimate” was used in two contexts: firstly it was used to describe industries statements on tonnages (3 times). Secondly it is used in the context of an exposure risk association (23 times). Actually no agreement has been found on the quantitative expression of this association between exposure and risk. Nevertheless, Germany is actually preparing such quantification. As it will take some time until it is finalised, we regard the presented correlations as “Estimates”. This does in no way mean that the values given haven’t been prepared according to the guidance documents, especially Chapter R8. As a summary, we do not regard this “General Comment” as substantial.	
21	2010-10-14	Industry or trade association,
GIFAS,
France

	Copy of the affixed letter:
The European Chemicals Agency (ECHA) published, end of August, 2010, proposals to identify 11 chemicals as Substances of Very High Concern (SVHC) and possible candidates for authorisation. 
GIFAS, the French Aerospace Industries Association, involved in the field of aerospace applications from the design, the development, the manufacturing and the maintenance, would like to provide its comments to the Agency regarding the intention to include chromium trioxide (CAS # 1333-82-0) and the acids derived from it in Annex XIV. Our concerns, hereafter described, are shared with many European trade industrial associations.	Introductory statement, no response necessary.	
			Chromium trioxide is classified as a CMR substance (CLP Regulation (EC) No 1272/2008) for which the companies we represent have been already developing since years in various substitution programmes which have resulted in many alternative options, as evidenced by the major decrease in consumption of this substance in European countries. 	We appreciate your efforts at substitution of CrO3. The identification of a substance as SVHC or the inclusion in Annex XIV may further support companies seeking for alternatives.	
			Nevertheless, there are several essential uses of chromium trioxide and its acids for which, to date: 

•	Either, R&D has found no technically or economically feasible substitutes (chromium plating, chromate conversion layer for powder coatings of aluminium and other metals, sulfo-chromium stripping of ABS plastics, control of bi-metallic welding and ceramography, chromic acid tests of anodic layers, mordanting of magnesium-based alloys,...) 

•	Or, some alternatives have been found but the industrial supply chain conversion is not totally achieved (eg: chromic acid anodising for our aerospace applications) 

Or, some remaining applications of this substance are mandatory to maintain in operational conditions the existing equipments and ensure their appropriate maintenance throughout their life cycle (idem for applications above described). 	The unfeasibility of alternatives can not generally be disclaimed. In a later step of the authorisation process the applicant shall analyse alternatives considering the risks, technical and economic feasibility for each specific use. As the analysis of alternatives is a mandatory part, as described in Article 60(4c), 62(4e) the applicant should define and document any relevant research and development activities in regard to substitute  CrVI  species.
The general procedure is outlined in EC 1907/2006, Articles 56 – 66, and on the ECHA website

We would like to urge industry to continue their efforts in this direction, and it is to be expected that the supply chain will adjust to your new requirements.	
			These uses are technically essential to our industries to provide the required high level of quality, reliability and safety we need to maintain throughout the long life cycle of the manufactured products (typically 30-40 years); Any unjustified withdrawal within the European Union would have detrimental socio-economic and safety consequences in the various stages of the industrial chains concerned.	Potential socio-economic impacts should be analyzed in the SEA as part of the application for authorisation.	
			Regulations described in the working and environmental directives strictly regulate these uses. Indeed, Chromium trioxide has already been thoroughly evaluated under the Regulation 793/93 on Existing Substances (ESR) which, has now been repealed and replaced by the Regulation (EC) No 1907/2006 on REACh. Risk assessments and risk management measures for limiting risks have been introduced and implemented. The United Kingdom was Rapporteur Country for the Chromium trioxide ESR review, and the resulting Commission conclusions and recommendations of 30 May 2008 were published in the Official Journal of 18 June 20081. Any additional administrative measure would significantly impact our sectors already largely voluntarily mobilised to progressively but effectively eradicate these substances and strangle our current efforts by additional administrative burden. 

We are not convinced about the necessity to add any supplementary measures to reduce the use of the chromium trioxide and its acids. We also question the need to introduce this substance in the Annex XIV. Should it finally be decided that measures are indeed needed, a case by case assessment should be performed, and this should ensure an appropriate comprehensive evaluation of the various alternatives is made to allow relevant sunset dates are appropriately defined for these applications. 
We remain at your disposal for any information you may require.	In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still a significant exposure that gives rise to concern.	
20	2010-10-14	MS CA, UK	It would be useful to include some information from the risk reduction strategy on the current operating conditions and risk management measures that are applied since this information will help determine what future regulatory action may be required.  

If possible, it would be helpful to include some indication of the hazards/risks associated with the alternatives that have been identified.	Thank you for your comment. Risks related analyses were not performed because the specific operating conditions related to alternatives which might change exposition are not known to us.
The list can be used as a thought starter for further development of substitutes. A detailed analysis has to be done by companies when applications for authorisation are prepared.	
			We find the description of the reaction of chromium trioxide with water misleading. The terms “dissolution” and “chromic acid solution in water” should not be used. Chromium trioxide undergoes an equilibrium reaction with water to produce chromic acid, dichromic acid and their oligomers which are different substances in their own right. “Dissolution of chromium trioxide” could be changed to “addition of chromium trioxide to water”. It should be clarified that it is the acids that are in solution in water not chromium trioxide. 	We agree with the opinion that there is an equilibrium reaction between chromium trioxide and the corresponding chromic or dichromic acid or the higher oligomers. The question whether or not chromium trioxide and its corresponding acids are two substances on their own will be discussed in the upcoming MSC meeting. The German CA is aware that chromium trioxide in water is a borderline case.	
19	2010-10-14	Industry or trade association,
Aluminium Finishing Association,
United Kingdom

	Having been through the Existing Sustances Regulation (ESR) review process, including an implemented Risk Assessment, the substance should not be a priority for inclusion in the Candidate List. 	Thank you for your comment. 
The content of this comment is comparable with the comments given for chromium trioxide from the ESTAL association.

We do strongly disagree with this statement which we want to justify as follows.
The nomination of a substance and its inclusion in the candidate list does not mean a change in its classification. Substances that are listed in the candidate list are not more dangerous than other substances that fulfil the criteria of article 57. On the other hand, the granting of authorisation (following the inclusion in annex XIV) gives the opportunity to identify workplaces where the risks are inacceptable on a case by case basis.

In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still a significant exposure that gives rise to concern.

We stress the fact that insertion of Chromium trioxide in the candidate list for Annex XIV does, by itself, neither prejudice agreement of the commission to include this in Annex XIV, nor narrow details of a potential authorisation.

Potential socio-economic impacts should be analysed in the SEA as part of the application for authorisation.

We have indication from personal communications with companies active in this field as well as from literature that alternatives may be available for conversion.
Some of those have already been included in Table 20 of the dossier.

The unfeasibility of alternatives can not generally be disclaimed. In a later step of the authorisation process the applicant shall analyse alternatives considering the risks, technical and economic feasibility for each specific use. As the analysis of alternatives is a mandatory part, as described in Article 60(4c), 62(4e) the applicant should define and document any relevant research and development activities in regard to substitute  CrVI  species.
The general procedure is outlined in EC 1907/2006, Articles 56 – 66, and on the ECHA website

It is well known that there exists a problem with the residual content of chromium VI in conversion layers especially in conjunction with the requirements of the End of Life Vehicles Directive (Directive 2000/53/EC and the EU-Directive RoHS (Restriction of the use of certain hazardous substances in electrical and electronic equipment), (Directive 2002/95/EC).
Even if there were no chromium VI in the chromium coverings, the production process of these layers can be related to chromium VI inhalation as well as dermal exposure of workers (see page 22).

Chromium trioxide was chosen for two reasons:
Firstly, the German CA came to the conclusion that workplace exposure towards chromium trioxide is associated with an unacceptable risk for workers to suffer from cancer. 
Secondly, as chromium in the oxidative state VI is the ultimate carcinogen, it was regarded helpful to regulate all relevant chromium VI compounds during a short period of time.

As you surely are aware, France has introduced sodium dichromate to the candidate list in 2008. The substance fulfils the criteria for a prioritisation for an inclusion in annex XIV. Nevertheless, the member state committee regarded it not conducive to prioritise a single substance out of a group sharing the same ultimate active agent. 
Member states have discussed and decided that chromium VI compounds have a high priority in the context of authorisation. On this basis the German CA has taken the opportunity to announce the preparation of an annex XV dossier on chromium (VI) oxide. As a result there was no need for the French CA to further announce an intention.

Although there is actually no production of chromium trioxide in Europe occupational exposure exists during the further processing of the substance in the uses described. In consequence we do not agree with the conclusion drawn here.

Actually we are supporting a process within a European regulation. Within this process UK as well as other countries has the opportunity to comment on the inclusion in the candidate list. 
Finally, chromium trioxide has not been amongst the first to be put on the candidate list as 39 substances in 3 previous nomination steps have already been put on the list during the last two years.	
18	2010-10-14	National Authority,
RIVM,Netherlands	Nl supports the proposal to include acids of chromium trioxide in the candidate list of substances of very high concern. 	Supporting statement, no response necessary.	
17	2010-10-14	International NGO,
WWF European Policy Office,
Belgium	WWF and CHEM Trust support the inclusion of acids generated from chromium trioxide and their oligomers in the candidate list due to their carcinogenic properties.	Supporting statement, no response necessary.	
13	2010-10-13	National Authority,
Climate and Pollution Agency,
Norway	The Norwegian CA supports that acids generated from chromium trioxide and their oligomers containing: chromic acid (CAS number 7738-94-5), dichromic acid (CAS  number 13530-68-2) and oligomers of chromic acid and dichromic acid should be identified as  substances of very high concern and should be included in the Candidate List.   	Supporting statement, no response necessary.	
12	2010-10-13	International NGO,
International chemical secretariat,
Sweden	Full support regarding its identification as a SVHC.  	Supporting statement, no response necessary.	
11	2010-10-13	European institution,
Council of Europe, Directorate for the Quality of Medicines and HealthCare,
France	Article 56(3) of the Regulation (EC) No 1907/2006 corr applies. Chromium trioxide should remain on the market as a reagent for the convention on the elaboration of the European Pharmacopoeia (European Treaty Series 50) and the protocol to the elaboration of the European Pharmacopoeia, which are necessary for the implementation of the Directive 2001/82/EC on the community code relating to veterinary medicinal products and Directive 2001/83/EC on the community code relating to medicinal products for human use.	Authorisation of a substance under the REACH-regulation does not mean a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overwhelms the risks resulting from its uses while suitable alternatives are not available. In addition,  according to EC 1907/2006, Article 58(2) a category of uses (like an analytical method) may be exempted if the risks in this application are properly controlled.	
9	2010-10-13	Company,
Stork Prints BV,
Netherlands	public consultation on Chromic Acid and Chromium Trioxide

Dear Sir, Madam,  Please allow us to introduce ourselves before we deliver our comments to the public consultation on Chromic acid (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8).   

Stork Prints B.V. and its subsidiaries (together the Stork Prints Group) is a global leading company in the textile and graphics printing market. Providing total system solutions: from screens, lacquers and engraving to a broad range of coating and rotary printing systems. Being the expert in electroforming this not only entails highly reliable rotary screen technology but also an extensive program of precision metal products. The group achieved worldwide a turnover of  € 180 million in 2008. Through continuous innovation and a powerful distribution network Stork Prints adds significant value to its customer’s processes and products.  

Part of the Stork Prints Group are (amongst others) the companies as listed below: Stork Prints B.V. (head office) Stork Prints America Inc.  Stork Prints America Inc. - New York office  Stork Prints Austria GmbH  Stork Prints Baski Sistemleri Tic. ltd. Sti - Turkey Stork Prints Brasil Ltda.  Stork Prints Mexico S.A. de C.V.  Stork Prints Pakistan (Pvt) Ltd.  Stork Textile Systems Wuxi - China Stork Veco B.V. Stork Veco International, Inc. Stovec Industries Ltd. - India Tecan Ltd. - UK  Note: this list is not complete.   

In many of our processes, the use of chromic acid is of vital importance. For example, our purchasing volume of Chromic acid in our Boxmeer plant = 10.000 kg/y and our total emission Chromium is (air/water/soil) = 3,33 kg/y = 0,033%. For our other European (galvano) activities similar figures apply.  As we will explain below, Stork Prints feels that it is necessary to object against bringing Chromic acid (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8) to Annex XIV. Of course we will explain our objections in this letter.  Our comments can be divided into three chapters, which are listed as follows:  

1. Compliance with European legislation compared to ECHA proposal; 
2. Research on alternatives for Chromic acid / Chromium trioxide; 
3. Consequences for the business.  	Thank you for the comment. It begins with a statement, which requires no response.	
			Ad 1: European and Dutch legislation compared to ECHA proposal  To our opinion, Chromic acid is already subject to strict regulation under a range of downstream EU legislation, intended to protect workers and consumers. This legislation includes:  
-	-IPPC directive 96/61/EG and modification 2008/1/EG ???
-	Seveso Directive 82/501/EEC Seveso I and  II Council Directive 96/82/EC 
-	Nederlandse Emissie Richtlijn Lucht NER 
-	ARBO-wet (Occupational Health and Safety legislation) 
-	Wvo-permit and regulation (Surface Waters Pollution Act) 
-	Wm-permit and regulations (Environmental permit)  

At Stork Prints risk assessments and risk management measures for limiting risks have already been implemented. The United Kingdom was Surveying Country for the Chromium trioxide ESR review, and the resulting Commission conclusions and recommendations of 30 May 2008 were published in the Official Journal of 18 June 2008.  

Our compliance to those directives and regulations and extensive information can be found in the chapters as listed in Annex A to this letter. Summaries are included, complete reports are confidential and can be reviewed at our Head-Office. Please contact Mr. J. Bongers, Manager Safety, Health, Environment and Quality or Mr. K. de Kok, Plantmanager Consumables. Both can be reached at our Boxmeer office, phone: 0031-485-599194 or 0031-485-599245.  

Conclusion ad 1:   The statements above serve to show that, at Stork Prints we already act in full compliance with all environmental legislation, both Dutch and European. Therefore, in our opinion, bringing Chromic acid (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8) to Annex XIV brings no extra benefit to mankind nor to the environment.   .         	We appreciate your ongoing efforts.

In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in  compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still an measurable exposure that gives rise to concern.	
			Ad 2: Research on alternatives for Chromic acid / Chromium trioxide  

Our second objection is that - despite strong R&D efforts ??? there still is no substitute available.  

Chromium trioxide / Chromic acid are classified as a CMR substance (CLP Regulation (EC) No 1272/2008) for which, at Stork Prints, we are actively seeking a substitute(s) in the field of certain applications.  

Stork Prints uses chrome trioxide in two processes in its production facilities.  These include hard chrome plating and a selective metal etching process.  In the past much work has been done, also in cooperation with Stork Veco, to find alternatives to the use of chrome trioxide in these processes.  The Research and Development department has investigated new processes, new commercial products (from, for example: Xtalic, Rohm & Haas, Integran) and regularly carries out literature research in order to find possible alternatives and when found, a test program is initiated to determine their viability.    

A list of references to company reports outlining these projects is given in Annex B to this letter. For over twenty years our Research and Development department has been exploring possible alternatives, but despite all these efforts, and huge costs made, we still have not yet found a viable substitute for the use of Cr03 in our processes. Based on our experiences we - unfortunately - are convinced that no alternative material will become available within short notice.  This is mainly due to the combination of criteria required, e.g. passivity in combination with wear and chemical resistance and adhesion of coatings for one application and etch selectivity for another. As far as we know, the above also goes for our competitors and/or other parties in the field. If necessary, Stork Prints is prepared to disclose information about the costs involved in the research mentioned above. Such in strict confidentiality of course.  

Conclusion ad 2:  Stork Prints still depends heavily on the use of Chromic acid / Chromic Trioxide. Given the fact that - on one hand there is no alternative and - on the other hand - we are compliant to all possible requirements regarding the safety for people and the protection of our environment, we are of the opinion that bringing Chromic acid (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8) to Annex XIV, puts us in a disproportionate difficult position, which is of no extra benefit to mankind nor to the environment.  	We appreciate your efforts at substitution of CrO3. The identification of a substance as SVHC or the inclusion in Annex XIV may further support companies seeking for alternatives.

The unfeasibility of alternatives can not generally be disclaimed. In a later application for authorisation the applicant shall analyse alternatives considering the risks, technical and economic feasibility for each specific use. As the analysis of alternatives is a mandatory part, as described in Article 60(4c), 62(4e) the applicant should define and document any relevant research and development activities in regard to substitute CrVI species.
The general procedure is outlined in EC 1907/2006, Articles 56 – 66, and on the ECHA website.	
			Ad 3: Consequences for our business and the employment of our personnel  

Business wise Stork Prints is - for example - worldwide market leader in producing consumables for Rotary Screen Printing for Textile, Rotary Screen Printing for Graphics and for the production of Metal Precision Products. Each day a number of around 500+ workers are employed within these fields of business. These are our fields of business which depend the most on the use of these specific chemicals.  Our specific products are produced by Galvanic Electroforming and Etching, whereby Chromium trioxide is applied for internal use only. Our production process complies with both Dutch and EU legislation. These chemicals are of vital importance in our production processes. We simply are not able to produce our products without them.   We would like to draw your attention to the fact that, if Stork Prints is no longer allowed to use Chromium trioxide compliant to below mentioned legislations, a risk of delocalization could occur throughout the European Union and more than 500 jobs will be lost in Stork Prints Group companies.  

Conclusion ad 3:  Stork Prints depends heavily on the use of Chromic acid and Chromium trioxide. We have already explained that no alternatives are available yet. If these chemicals might be included in Annex XIV and an authorisation is not granted, such will endanger the existence of 500+ jobs in the European Union.  	Potential socio-economic impacts should be analyzed in the SEA as part of the application for authorisation.	
			Final conclusion  

As we stated above, Stork Prints is compliant to all - both Dutch and European - legislation in the field of Safety, Health and Environment. Resulting in our opinion that bringing Chromic acid (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8) to Annex XIV provides no extra benefit to mankind nor to the environment.  As we also stated, there still is no substitute available. Combined to the fact that these specific chemicals are of vital importance to our main processes, we fear that bringing Chromic acid  (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8) to Annex XIV might endanger the employment of hundreds of our employees.  Therefore we would like to use this opportunity to ask you to reconsider the intended placing of Chromic acid (Cas-number 231-801-5) and Chromium trioxide (Cas-number 215-607-8) to Annex XIV.   If such might turn out to be impossible, for whatever reason, we would like to ask you to be granted an authorisation for the use of these chemicals.   A copy of this letter will be sent to the Ministry of Housing, Spatial Planning and the Environment, the Ministry of Economic Affairs of the Netherlands and FME-CWM, the Association of technological industry for the Netherlands.   Please do not hesitate to contact us in case you have any questions on the above.  Yours sincerely,    Stork Prints B.V. Dick Joustra CEO Stork Prints Group  Annex A Reports and results is mentioned in Part I "Justification" Annex B reports on alternatives for Chromic acid / Cromium trioxide is mentioned in Part II "Information on Use,Exposure,Alternatives and Risks"         	The German CA is of the opinion that the authorisation is an adequate measure to overcome the problems associated with the use of hexavalent chromium especially at workplaces. We have pointed out why we do not share the views of Stork.
Actually we are supporting a process within a European regulation. Within this process each country has the opportunity to comment on the inclusion in the candidate list.	
8	2010-10-11	Company,

United Kingdom	Page 17 B) & C) Chromic acid used in the application of anodising aluminium.	Thank you for the statement, no comment necessary (see below).	
7	2010-10-06	Company,

Germany	Re :  Chromium trioxide / Trioxochromium CAS No.1333-82-0  and Chromic acid CAS No. 7738-94-5  Annex XV to REACH regulation Consultation ref. Art. 59 Reach October 6, 2010  

Dear Ladies and Gentlemen, we have learned that Germany has applied for introducing Chromic acid (CAS No. 7738-94-5) as an annex XV file which could lead to the inclusion of these substances in the annex XIV (substances requiring authorisation), according to the European REACH Regulation.
 In our opinion, the sole fact of setting in motion the process of nominating the substance for the candidate list not only has a stigmatizing effect on the substance itself, but also on the whole industry which uses this substance or has to use it because of a lack of alternatives. We are of the opinion that currently not enough thoughts are given on a possible additional limitation as alternative, which would be more appropriate and would take into consideration the various industries and the possible applications. We want to point out again that the introduction of the substance into the annex XIV of the REACH regulation and, as a result, an authorisation of the substance would have serious consequences for our member companies   	Thank you for the comment.  The nomination of a substance and its inclusion in the candidate list does not mean a change in its classification. Substances that are listed in the candidate list are not more dangerous than other substances that fulfil the criteria of article 57. On the other hand, the granting of authorisation (following the inclusion in annex XIV) gives the opportunity to identify workplaces where the risks are inacceptable on a case by case basis.	
			For us, it is not comprehensible why France renounced to introduce the substance whereas Germany, a country with numerous industrial companies that require the substance in order to be able to carry out specific processes, declares its intention to introduce an annex XV file for chromium 
In aluminium surface treatment, after the processes of surface cleaning and surface etching, a chemical conversion layer is applied on to the surface in order to prevent corrosion and to improve the adherence of the coating layer (powder). The powder is applied by an electrostatic process and the layer is then baked at a temperature of approximately 200o.  	As you surely are aware, France has introduced sodium dichromate to the candidate list in 2008. The substance fulfils the criteria for a prioritisation for an inclusion in annex XIV. Nevertheless, the member state committee regarded it not conducive to prioritise a single substance out of a group sharing the same ultimate active agent. Member states have discussed and decided that chromium VI compounds have a high priority in the context of authorisation. On this basis the German CA has taken the opportunity to announce the preparation of an annex XV dossier on chromium (VI) oxide. As a result there was no need for the French CA to further announce an intention.	
			In the process described above, the chemical conversion of the surface is normally done with chromic acid. One critical characteristic of the resulting layer is that it is self-healing, i.e. the layer regenerates itself in case of breaking of the coating, providing thus a protection against corrosion. In addition, only an anodic layer produced with chromic acid is elastic enough to be used and also therefore sold for specific industrial applications such as those in the aerospace industry, in the electronic branch, and for specific parts, also in the military sector. These products can fulfill the quality requirements and parameters imposed by the customers only because of the pre-treatment. Especially in the sensitive industries named here above, the customers’ very high requirements call for the use of chromic acid. Up to now, there are no equivalent alternatives available on the market, although much research has been conducted over the years to develop alternative processes.   	Description, no response necessary.	
			The specific relevance of chromium compounds is stated in the Reference document on Best Available Techniques for Surface treatment on metals and plastics (BREF STM) which has been established for the European Directive IPPC (Integrated Pollution Prevention and Control). In the past, some chromium compounds have already been classified as CMR under EU Directive 67/548/CEE (now under REACH). In addition chromium compounds have already been thoroughly evaluated under the Existing Substances Regulation (EEC 793/93). Risk assessments and risk management actions have been introduced and implemented.  The review of this directive and the resulting Commission conclusions and recommendations were published as 2008/C152/01 in the Official Journal of 18.06.2008. 	In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still a significant exposure that gives rise to concern.	
			Because of the already extensive treatment of chromium compounds we question the necessity to include this substance into the annex XV of the REACH regulation (classification as svhc), which would result in tough consequences for our companies and their customers. 	The workplace exposure as it is documented in the MEGA database led the German CA to the conclusion that these workplaces are associated with intolerable risks. Therefore, we can not agree with the statement given.	
			We also want to draw again the attention to the fact that in 2009 the French authorities, after consulting with stakeholders, eventually decided not to introduce an Annex XV dossier for CrO3, although they had earlier announced their intention to do so.  	Above, the company states: “it is not comprehensible why France renounced to introduce the substance whereas Germany, a country with numerous industrial companies that require the substance in order to be able to carry out specific processes, declares its intention to introduce an annex XV file for chromium“ The German CA has responded there.	
			Our industries fully comply with the restrictions in force, and exercise due care in the management of their processes, in particular with regards to the protection of their workers, as well as to the protection of nature and environment. Considerable investment has been made not only in the coating lines themselves, but also in the treatment of the effluents from our industry. 
We ask you to take the worries of our industry sector and of its customers seriously. The use of chromium compounds still remains technically  indispensable, in order to guarantee the quality requested for certain specific applications, so that the end products can be used and sold worldwide. As an association, we fear that the inclusion of chromium oxide in the annex XIV of the REACH Regulation will lead to huge competitive disadvantages for Germany and also for the European industry in this sector.
Contrary to other states such as Asia and South America, which are not confronted with additional barriers, our industry sector would be banned from Europe in the short or long term.  For the companies in Germany and in the neighbour European States this could mean that customers would have to look for industry sectors located outside of the European Union. Given the current critical economic situation, we think that this is not in the interest of Germany or of the European Union, to destroy established industry sectors although those sectors have taken all possible measures to protect human beings, nature and environment.  We take the position that the inclusion into annex XV should be abandoned.  We would be pleased if you could make sure that chromium oxide is not included in the annex of the REACH Regulation and that the present status quo remains because we are of the opinion that it already takes of all relevant issues into consideration.  Yours sincerely,  Alufinish  GmbH  & Co.KG, Andernach - Germany Technical Management Thomas Sondermann 	The granting of authorisation (following the inclusion in annex XIV) gives the opportunity to identify workplaces where the risks are inacceptable on a case by case basis. Authorisation of a substance under the REACH-regulation does not imply a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overweigh the risk to human health (or the environment) resulting from its use and suitable alternatives or technologies are not available (Art. 60 (4)). In the case of chromium VI the second option is relevant. 	
6	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	We strongly support grouping in the authorisation process in the case of Cr(VI) compounds. "Chromium or compounds thereof are listed" (106) in Annex I of the Commission Recommendation concerning the European schedule of occupational diseases (2003/670/EC). The various Cr(VI) compound are used in a variety of different ways. Thus we think they are uses must be seen as wide and dispersive.	Thank you for the supporting comment. Chromium trioxide has been introduced to the authorisation due to the fact that some chromium compounds might replace others on the candidate list or – in future – on Annex XIV. Therefore grouping of Chromium (VI) compounds is on the agenda of the German (and French) CA.	
			We suggest miss “equivalent level of concern” as a reason for proposal that is part of the dossier but not in the “commenting table” on site: http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp. 	The German CA actually is preparing a position paper on the criteria relevant for including substances according to 57 f. In our opinion such criteria should be harmonised first. Therefore, we would prefer to omit such a proposal.
For the inclusion of chromium in the candidate list and annex XIV adding these properties is not necessary. They should be regarded later e.g. when socio-economic analyses are preformed.	
5	2010-10-06	Company,

Germany	We note with interest that an Annex XV dossier has been submitted for Chromic Acid EC No. 231-801-5, Dichromic Acid EC No. 236-881-5 and oligomers of Chromic Acid and Dichromic acid in addition to the Annex XV dossier for Chromium Trioxide EC No. 215-607-8.  We are aware that in recent years there has been some discussion at the European level regarding the appropriate hazard classification of chromium trioxide dissolved in water(chromic acids)  .This discussion followed the reclassification of  chromium trioxide as very toxic ,T+, according to the 29th ATP of Council Directive 67/548/EEC.  The REACH  Regulation (EC No.1907/2006) article 3(2) defines a preparation as a mixture or solution of two or more substances. This is reflected in the final paragraph of section 1.1 of the Annex XV dossier  for Chromic Acid,Dichromic Acid and oligomers prepared by the German authorities which states " aqueous solutions are regarded as mixtures".  The principal registrants of chromium trioxide have followed this line of thinking and considered chromium trioxide dissolved in water to be a preparation or mixture of chromium trioxide. This is reflected in the registration dossier submitted by the lead registrant and the relevant exposure scenarios in the chemical safety report.We expect that our registration of chromium trioxide is sufficient for those applications involving aqueous solutions of chromium trioxide as defined in the registration submission.	The question whether or not chromium trioxide and its corresponding acids are two substances on their own will be discussed in the upcoming MSC meeting. The German CA is aware that chromium trioxide in water is a borderline case.	
4	2010-10-06	MS CA, Sweden	Sweden supports the proposal to identify Chromium acid, Dichromium acid and oligomers of chromic acid and dichromic acid as substances of very high concern.	Thank you for the support.	
3	2010-09-29	Industry or trade association,
ZVO Central Agency of surface treatment,
Germany	Die Galvano- und Oberflächentechnik ist eine wichtige Schlüssel- und Querschnitts-Technologie und damit einer der Motoren des technischen Fortschritts. Innerhalb der Galvanotechnik bilden Überzüge aus Chrom und Chromverbindungen einen besonderen Schwerpunkt, mit wachsender wirtschaftlicher Bedeutung. 
Zu einem großen Anteil werden 1. elektrochemisch abgeschiedene Chromschichten zur Verchromung und 2. Konversionsschichten zur Passivierung von Zink-, Zinklegierungen, Guss und Aluminiumschichten aus Chrom-VI haltigen Lösungen genutzt. Zur Verbesserung von Verschleiß- und Korrosionseigenschaften von Metallen werden Hartchromschichten ausschließlich aus Chrom-VI haltigen Lösungen abgeschieden.	Thank you for the comment. It begins with a statement, which requires no response. Later it gives extensive explanation about the many excellent properties obtained by either decorative or functional hard chromium applications.	
			Zur Herstellung einer gebrauchsfertigen Lösung wird dazu Chromtrioxid in Wasser gelöst. Es handelt sich also nach dem Verständnis der Branchen nicht um eine Herstellung von Chromsäure als Stoff, sondern explizit um eine Auflösung des bereits unter REACh registrierten Stoffes Chromtrioxid in Wasser; zur Verbesserung der Schichteigenschaften werden außerdem weitere, für den Beschichtungsprozess erforderliche Additive zugesetzt. Es wird lediglich der bereits unter REACh registrierte Stoff Chromtrioxid in Wasser gelöst, welches keine Herstellung von Stoffen im eigentlichen Sinne von REACh bedeutet (REACh Anhang V, Ausnahmeregel 4a). Dieser Arbeitsgang ist zwingend und dem direkten Verwendungszweck vorgelagert. Weder Chromtrioxid noch Chromsäure (EG 231-801-5) werden bei der Verwendung in der Galvanotechnik aus dem Ionengemisch isoliert. Monochromsäure, Dichromsäure und deren Oligomere sind nach Artikel 3 Absatz 1 der Verordnung 1907/2006/EG nicht als Stoffe zu definieren, da das Lösungsmittel, in diesem Falle Waser, von dem Stoff nicht ohne Beeinträchtigung seiner Stabilität und ohne Änderung der Zusammensetzung abgetrennt werden kann. Wenn man versucht einer wässrigen Chromsäurelösung das Wasser abzutrennen, erhält man wieder Chromtrioxid und keine Monochromsäure. 	The question whether or not chromium trioxide and its corresponding acids are two substances on their own will be discussed in the upcoming MSC meeting. The result of this discussion will influence the further process.	
			Schlussbetrachtung Im Bereich der Oberflächenbehandlung findet ausschließlich eine industrielle Verwendung des Chromtrioxids statt. Seitens des Zentralverbandes Oberflächentechnik e.V. wird diese Stellungnahme anlässlich der Internetkonsultation abgegeben. Die heute geübte Praxis zur sicheren Verwendung dieses Stoffes in wässriger Lösung muss beibehalten und nicht weiter verschärft werden.	Statement, no response necessary.	
2	2010-09-06	Company,
OVAKO Redon SAS,
France	You describes different alternatives to subsitute chromic acid, but there is no economical comparison and some of them are far more expensive and cannot comply with mass production such as piston rods.	Thank you for the comment. Potential socio-economic impacts should be analyzed in the SEA as part of the application for authorisation.	
1	2010-09-03	Trade union,
European Trade Union Confederation,
Belgium	ETUC supports the inclusion of Acids generated from chromium trioxide and their oligomers in the Candidate List.	Thank you for the support.	

COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC : PROPOSAL AND JUSTIFICATION

Substance name:	Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid	
CAS number:	7738-94-5, 13530-68-2, -	
EC number:	231-801-5, 236-881-5, -	

Reason of the submission of the Annex XV: CMR

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The European Chemicals Agency is not responsible for the content of this document. 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. The comments were received during the public consultation of the Annex XV dossier. The table does not contain any confidential information.

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
24	2010-10-14	Industry or trade association,
ASSOGALVANICA,
Italy	A study carried out on chromosome of the workers of the plating shops in North-eastern Italy proved that they are not evidence of no major exposition to cancer.	We cannot verify this statement, because of the missing bibliographic data. Generally speaking, a single negative study cannot challenge the body of evidence for the carcinogenicity of CrO3.	
22	2010-10-15	Industry or trade association,

Belgium	Section 1: See comments on Annex XV dossier 
Section 2: We do not dispute the existing classifications for chromium trioxide or its acids (the entry in the Annex XV dossier has been corrected in the first section) 
Section 3: See comments on Annex XV dossier
Section 4: See below 
Section 5: No comments 
Section 6: See comments on Annex XV dossier 	Statement, no response necessary.	
			Section 4 comments: We wish to submit that the data that underpins the studies used are in some cases, not the latest versions of the data, and therefore needs to be re-assessed. The data used to create table 21 is based largely on work undertaken in the  US either for NIOSH or OSHA, if we look at the UK’s HSE Burden of Occupation Cancer in Great Britain the following statement is made:   
a)	Risk estimate: Cole and Rodu (2005) reviewed 84 papers of 49 epidemiologic studies published since 1950, and undertook a range of meta-analyses relating chromium VI (CrVI) exposure to mortality. The conclusion was that CrVI was a weak lung carcinogen, when examining the studies that controlled for smoking. It has been postulated that the relationship is weak because of the lung’s capacity to reduce CrVI to the non-carcinogenic CrIII (De Flora, 2000). A meta-analysis of 26 studies that controlled for smoking gave a meta-SMR of 1.18 (95% CI 1.12-1.25). In total 46 papers had been published on these studies, with 1,325 cases observed and 1,118 expected. This will be used for the estimate for the high group.  Crump et al. (2003) also concluded that CrVI is a weak carcinogen, estimating that the lifetime additional risk of lung cancer mortality associated with 45 years of occupational exposure to 1g/m3 CrVI was 0.002.”  This would support the lower risk estimates in table 21 rather than the higher risk estimates and also supports the work identified below  	The risk assessment in Crump et al. [2003] and the meta-analysis of Cole and Rodu [2005] were already taken in account by the NIOSH Review from 2008 mentioned in the dossier.	
				Ongoing study into exposure in the workplace:  Further information in relation to human health, based on a comprehensive study using biological monitoring across UK surface engineering industry, will be available soon in relation to electroplating uses of hexavalent chromium including chromium trioxide and its acids, and some of the potential alternatives (using soluble nickel salts).  
	This is via a study being done at the UK’s Health and Safety Laboratory, under the direction of the Health and Safety Executive.  We would suggest that this work is essential for the assessment of human health as it will demonstrate the effectiveness of the controls in existing HSE guidance in the UK at controlling the risk.    This study completes next year. Early indications seem to show that where the guidance of the HSE is strictly followed, the worker exposure can be controlled to an accepted background level.  We respectfully ask that the evaluation of the risk posed by this hazardous substance needs to wait until the HSL study is finalised.    	It is not common to consider ongoing studies in this kind of dossier.	
20	2010-10-14	MS CA, UK	Identity; 
The sentence “As aqueous solutions are regarded as mixtures…” should be removed. 	We agree, the Support Document has been changed.	
16	2010-10-14	Company,
Vopelius Chemie AG,
Germany	Astonished we’ve noticed the planned inclusion of chromic acid EC No. 231-801-5, dichromic acid EC No. 236-881-5 and oligomers of chromic acid and dichromic acid into a list that is said to be valid for substances.  In this connection we want to point out that the above mentioned potential candidates may not be regarded as substances but as preparations (of chromium trioxide and water), as shown by art. 3(2) resp. 3(1) of regulation EC No.1907/2006. The last passage of 1.1 of the accompanying annex XV report also describes them as preparations. A separation of the solvent does not yield a substance of one of the above given names but of the starting material chromium trioxide. The toxic characteristics can be traced back to chromium trioxide. A lot of parameters of chromium trioxide only can be tested in solution. An aquatic toxicity of chromium trioxide only can be tested by dissolving in water for example.
Chromium trioxide is used in industrial processes only and most of the processes definitely require the dissolving in water before the next step without any intention to produce a new substance. This aspect has been considered in the registration dossiers of the registrants of chromium trioxide.	The question whether or not chromium trioxide and its corresponding acids are two substances on their own will be discussed in the upcoming MSC meeting. The German CA is aware that chromium trioxide in water is a borderline case.	
14	2010-10-14	Company,
Meggitt Polymers and Composites - Oregon,
United States

	Chromic acid used in mixture as Alodine 1132 which allows touch-up of previously surface treated aluminum alloy aircraft parts to prevent surface corrosion.	Thank you for the information on a specific use of the compound.	
12	2010-10-13	International NGO,
International chemical secretariat,
Sweden	The classification is clearly justified due to its CMR properties and its wide dispersive use. 	Statement, no response necessary	
11	2010-10-13	European institution,
Council of Europe, Directorate for the Quality of Medicines and HealthCare,
France	The quality of medicines including their containers and raw materials may be compromised, if chromium trioxide is withdrawn from the market.	The granting of authorisation (following the inclusion in annex XIV) gives the opportunity to identify workplaces where the risks are inacceptable on a case by case basis. Authorisation of a substance under the REACH-regulation does not imply a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overweigh the risk to human health (or the environment) resulting from its use and suitable alternatives or technologies are not available. In the case of chromium VI the second options is relevant.	
9	2010-10-13	Company,
Stork Prints BV,
Netherlands	ANNEX A Reports and results 

 Regarding our statements Ad 1 above, the legislation, reports and results mentioned are listed in the annex to our letter. Complete reports are confidential and can be reviewed at our Head-Office. Please contact Mr. J. Bongers, Manager Safety, Health, Environment and Quality. Mr Bongers can be reached at our Boxmeer office, phone: 0031-485-599 194.  

1.1	IPPC directive 96/61/EG and modification 2008/1/EG:  

Compliance checks on: Reference document BAT for surface treatment of metals and plastics Reference document BAT on emissions from storage Reference document BAT in the energy efficiency Reference document BAT to industrial cooling systems Reference document BAT on general principles of monitoring  

Current environmental permit is compliant to IPPC-regulations. Site inspections are continuously undertaken by the local authorities/RMB to verify compliance with the permit requirements.  Reports: Safety and Environmental reporting annually 1990 - 2009 E-PRTR / EMVJ reporting 2006 - 2009 IPPC - emission report 2007  E-PRTR / EMVJ reporting 2006 - 2009  Results Emission on water, limit value Cr = 50 kg/y Stork Prints’ value in 2009 Cr = 3,07 kg  Emission on air, limit value Cr = 100 kg/y Stork Prints’ value Cr in 2009 = 0,26 kg  Emission on soil, limit value Cr = 50 kg/y Stork Prints’ value Cr  in 2009 = 0 kg  
Conclusion: Stork Prints is compliant.   

1.2	Seveso Directive I  82/501/EEC and  II Council Directive 96/82/EC (BRZO ???99)  
Reports: Safety report July 2010 version-2 Maintain reports Authorities  

Site inspections are continuously undertaken by the Dutch authorities and “Arbeids Inspectie” to verify compliance with the Seveso/BRZO requirements.   

Conclusion: Stork Prints is compliant to aforesaid requirements.

1.3	Nederlandse Emissie Richtlijn Lucht NER ( Dutch Emission Guideline concerning the Air)  

According to the calculations with the “model stacks 91” are the immission of chromium VI in all scenario lower than the MTR. In scenario 0 (2007) the immission is however still higher than the target level. In the scenario 1, 2 and 3 (2009 after achieving measures) the immission also satisfy to target level. The scenario to comply to MTR-value and for the situations 2009 after adjustments are therefore largely satisfied also to the target level. Scenario 1 is the current company situation at Stork Prints BV. With the current adaptation in the form of additional (chromium) scrubber at stack position 6051 and the phasing-out of stack position 6102 Stork Prints meets/complies the MTR and VR as noted in the NER regulations.  

Reports: Immission investigation Stork Prints 2009_v23_06_09  MD-MO20075881 Imissieonderzoek2007  

Results CrVI target value on MTR = 0,0025 ??g/m3 and VR 0,000025 g/m3 (= negligible risk) SPGPrints value Cr  in 2009 -> VR = 0,00001950 g/m3  Conclusion: Stork Prints is compliant.  

1.4 ARBO-wet (OSHAS 18001)  

Stork Prints is dedicated to provide a healthy and safe work environment for employees, contractors and visitors. To help achieve this goal, the ARBO-wet (Occupational Health and Safety Assessment legislation) specifications have been used to develop a comprehensive Occupational Safety and Health management system. Stork Prints is committed to achieve registration for all operations as a primary mechanism to eliminate or minimize risks in all their activities.  Stork Prints maintains and continually improves on health and safety by: 
-	clearly stating occupational health and safety policies, programs and objectives 
-	identifying occupational health and safety risks and legal requirements, 
-	taking a proactive approach to occupational health and safety risks and involving our employees in the development and implementation of procedures, ??? controlling and/or or eliminating risks to prevent accidents, 
-	monitoring occupational health and safety system performance, and 
-	ensuring continual reviews, evaluation and improvement of the activities.  

Report: Overview immission (to employees) measurements 2002 - 2010 (exposure to chromium) RIE assessments on all activities and ARBO-items  Results: MAC-value Cr = 0,025 mg/m3 Stork  Prints’ average Cr in 2009 = 0,0015 mg/m3  Report: Exposure measurements by TAUW 2004 -2009  Results: Stork Prints’ average < 3% of the Maximal allowable concentration. CrVI concentration far below level of prohibition level of the Council of Health. Based on the Annex-3 (NEN 589) can be concluded that exposure is on a safe level.	This represents an annex to the statement given in Section „General Comments”. For response see there (number 9 above).	
			Report: Chromium measurement in urine by ArboNed 2005 -2010  Results: Stork Prints’ average less than  3% limit value Chromium (measurements based on 200 employees).  

Conclusion: Stork Prints is compliant.  

1.5 Wvo-permit and regulation  Stork Prints operates under a permit Surface Waters Pollution Act (SWPA - Wet verontreiniging oppervlaktewateren) issued by the Water Board Aa en Maas on 18 November 2004. The wastewater permit deals among others with the wastewater stream process water from electroforming processes (Chromium).  

The waste water from all processes is discharged onto the onsite waste water treatment plant in the Waste Water treatment department, which is a so called ONO-installation (Detoxify, Neutralize, Dehydrate) noted as BAT/BREF and therefore IPPC compliant. From the waste water treatment facility, waste water is discharged into the municipal sewage system. In the discharge permit, the following discharge limits have been set to process water = 0.5 mg Cr/lt.  According to the annual Health, Safety and Environment report 2000 - 2010 of Stork Prints B.V., water treatment plant worked without failures and no permitted discharge limits had been exceeded in all years.  Site inspections are undertaken by the Water Board “Aa en Maas” continuously to verify compliance with the permit requirements. All results are reported yearly by letter to the local authorities.  Report: Annual reporting effluent results waste water treatment plant to Water Board.  Results: Emission on water effluent, limit value Cr = 0,5 mg/l Stork Prints’ average Cr in 2009 = 0,02 mg/l  Emission on water, limit value Cr total amount = 35 kg/y Stork Prints’ amount Cr  in 2009 = 1,81 kg  Conclusion: Stork Prints is compliant.  

1.6 Wm-permit and regulations /  Environmental permit(s)  Stork Prints in Boxmeer is located in several facilities and all operations are covered by two environmental permits. The permit that covers the operations of the facility at W. de Körverstraat was issued on 25 May 2004, whereas the permit of 30 November 2004 covers all parts of the operations at the Raamstraat and Exportstraat. The permits were both issued by the municipality of Boxmeer. This is demonstrated by the annual reporting by Stork Prints that include all facilities that are under both permits, as well as by the fact that site inspections by the authorities are done for both permits together. The environmental permits cover all activities of Stork Prints and have unlimited validity. The current permit does take into account the EU-IPPC regulations and the associated Best Available Techniques Reference document (BREF). The environmental permit as well as the operation is updated to BREF standards by October 2007. Stork Prints is continuously in contact  with the authorities on the approach of bringing operations in line with future IPPC regulations.  Reports: Environmental reporting annually 1990 - 2009 Visiting report Municipality Boxmeer  Conclusion: Stork Prints is compliant.   Boxmeer, October 11, 2010	In Germany and in NL no health based MAK-value or biological limit value exists because CrVI is carcinogenic.  These data do not invalidate our argumentation.	
5	2010-10-06	Company,
Germany	see general comments above	-	
1	2010-09-03	Trade union,
European Trade Union Confederation,
Belgium	see comments made on chromium trioxyde.	-	

INFORMATION ON USE, EXPOSURE, ALTERNATIVE AND RISKS ON ANNEX XV SVHC
Substance name:	Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid	
CAS number:	7738-94-5, 13530-68-2, -	
EC number:	231-801-5, 236-881-5, -	

Reason of the submission of the Annex XV: CMR

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. 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. The comments were received during the public consultation of the Annex XV dossier.
The table does not contain any confidential information.

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
24	2010-10-14	Industry or trade association,
ASSOGALVANICA,
Italy	Some great mistakes concerning the proposed alternatives.
 - HVOC does not allow the control of thickness.
 - PVD and CVD often require chromium plated substrate.
 - As far as the substitution with stainless steel is concerned it should be considered that while welding the high temperature releases vapours of hexavalent chromium and the exposition of welders is hundred of times higher than plating workers.	The most commonly used technology for replacing hard chrome plating is thermal spray (primarily, but not exclusively, HVOF). Thermal spray coatings are readily sprayed up to 500 microns thick. See Part II Chapter 3.1.1.1
Several information sources indicate that vacuum coatings are possible alternative technologies to replace CrVI-compounds.
The comparison of the risks arising from the use of SVHC and potential alternatives should be done by the applicant on the basis of certain criteria in an application for authorisation.	
			 - Other suggested alternatives are based on substances that in turn are the object of SVHC consultation (i.e. cobalt compounds). 	Detailed analysis of alternatives for each specific application is beyond the scope of the German dossier. It does not make any claim on completeness. See footnote 5 on page 41 of the Dossier.	
22	2010-10-15	Industry or trade association,

Belgium	General comments regarding use (specific to ASD) Section 1: General comments regarding use   Work is ongoing in the Aerospace and Defence Sector to establish all of the alternatives for all hexavalent chromium compounds that are available and the limitations that there are on use.  
  ASD-Europe would like the opportunity to share our findings with ECHA, EC and competent authorities.	According to article 2(3) of the REACh-regulation, the use of chromium (VI) in a military context as it is mentioned is not in the focus of the REACH-regulation.
Thank you for offering the opportunity to share your findings on alternatives. 	
			Lack of alternatives to hard chrome plating for heavy industrial uses in the Nordic region where the use of chromates is banned has often resulted in the plating being moved to the UK.  	It is not the intention of the German CA to delocalise the use of chromium towards countries outside the EU especially third world countries. This would in no way lead to an increase in occupational safety.	
			Comments applicable to all three associations: The ELV Directive prevents the incorporation of hexavalent chromium compounds into articles with the exception of those exemptions listed in Annex II. The remaining uses of hexavalent chromium in surface treatment do not result in the substance being present in the surface of the article.  Ongoing uses of hexavalent chromium are considered essential for such things as corrosion resistance of a long life-cycle product.	Although there is no chromium VI in metallic chromium coverings, the production of these layers is related to chromium VI exposure (see Tab. 17 & 18 on page 36 – 38 and Fig. 4 on page 60 of the report).	
			Although chromium trioxide and its acids are undoubtedly hazardous, phasing them out using  authorisation or prohibition using restriction may not be the most effective way of controlling the risk arising from surface treatments used throughout manufacturing industry; some form of licensing or other legal process may be more effective at minimising risk, given that use will have to continue for many years due to lack of alternatives.
Given that industry feels that we cannot replace the substance for some considerable time, the cost of continuous authorisation will be ongoing and will have an effect on the economic viability of continuing production in the EU. It is likely to accelerate the existing move away from the EU of general manufacturing industry.	In the Official Journal of the European Union (2008/C152/01) the Commission communicates their conclusion on risk assessment for CrO3. It is stated “that there is a need for specific measures to limit the risks” especially for workers and consumers. The proposed measures are in compliance with at that time existing regulations. REACH was developed to overcome caveats of the former chemicals legislation. As the Commission states that “the substance has been identified as a non-threshold carcinogen” meaning that any exposition comprises a risk the proposed measures under the REACH legislation are not contradictory to the conclusions from the Commission in 2008. 
Data provided in the Part II, Chapter 4 of the dossier shows that there is still a significant exposure that gives rise to concern.
The granting of authorisation (following the inclusion in annex XIV) gives the opportunity to identify workplaces where the risks are inacceptable on a case by case basis. Authorisation of a substance under the REACH-regulation does not imply a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overweigh the risk to human health (or the environment) resulting from its use and suitable alternatives or technologies are not available. In the case of chromium VI the second options is relevant.	
			Section 2:  Worker exposure  The current work being undertaken by the Health and Safety Laboratory will provide considerably more insight into worker exposure than is given here.  The work shows the effectiveness of controls that have been introduced across UK industry and should now be standard practice.	Data on worker exposure collected in the UK are regarded to be helpful for the inclusion of chromium trioxide into the candidate list as well as for the prioritisation towards annex XIV. Nevertheless we do not agree with the criticism of the exposure data presented in the report. The published data (3755 in total from the MEGA database) were provided by the IFA Institute for Occupational Safety and Health of the German Social Accident Insurance. Within Europe MEGA is regarded as a widely accepted high standard data source. The chromium (VI) data presented were collected at real work places in the German industry during 2000 – 2009. Therefore, the German CA regards this as a realistic description of the occupational exposure situation in Europe, at least in Germany.	
			Where this is not the case, there may be ways of enforcing this without needing to phase the substance out, and manufacturing sectors wish to collaborate with regulators in this area.	The fact that several uses are connected to high exposure values led to the conclusion that authorisation is the adequate measure to improve occupational safety and health.	
			Section 3: Alternatives  Generally in section 3 it is worthy of note that long ??? life cycle products will undergo repair or replacement during their lifetime.  With aerospace parts can last 40 years.  To date. it is not possible to repair a hexavalent chromium based coating system with a system using a different chemistry.  Where it is possible to substitute a hex chrome coating system part with a replacement, the new coating invariably will not last as long, resulting in an identical part with a shorter life, giving rise to a serious human error risk of mistiming part replacement.  This is not acceptable in safety related products.  3.1.1.1 The regulator should be aware of the health hazards associated with the use of this alternative:  it may not be safer than the hexavalent chromium for this use, and usually is not as effective.  3.1.1.2 The regulator should be aware that PVD and plasma spray are line-of-sight applications and therefore cannot cover anything other than simple geometries. CVD applications in aerospace remain limited due to the complex geometries of the majority of components undergoing the current hexavalent chromium treatment.  Therefore as a replacement these are often not effective.    3.1.1.3 The regulator should be aware that the use of zinc based systems is not possible at the extremes of operation found in some industries due to the limitations of the basic chemistry.  3.1.1.4 The regulator should be aware that nickel based coatings using soluble nickel as a part of the process is probably not a safer alternative to the use of hexavalent chromium.  Certain nickel based coatings may use a nickel powder as a start-point, and this also has its risks and may not be effective on complex geometries.  3.1.1.5 The regulator should be aware that many trivalent chromium systems require a strike-coat which is usually uses a soluble nickel compound which is not safer than the hexavalent chromium system.  Some systems use a soluble cobalt compound which is also not safer.  The use of nanotechnology is promising yet the innate hazards of nanoparticles up until they are bound in a matrix are not necessarily as well understood as the risks associated with hexavalent chromium.  3.1.1.6 Part modification: Large complex assemblies such as gas turbines and automotive products generally cannot simplify parts to a sufficient degree to enable the alternatives to be effective to date.  Also the operating conditions for some sectors are onerous, and the test requirements for alternatives are stringent to meet safety requirements.  Finding suitable alternatives is difficult if not impossible.  	See response in general comments.	
20	2010-10-14	MS CA, UK	Exposure information; Page 16: a 10 % assumption of installations using Chromium trioxide is made; however this is not explained or validated. What is the assumption based on?  Would it be possible to have a summary table of the uses in the EU with corresponding number of employees etc. 	Thank you for this comment.
The citation behind this assumption is “Human health risk reduction strategy for chromates”, prepared by Health and Safety Executive (UK).
We underline the request to have more statistical data in Europe to correlate uses with the corresponding number of employees.
The German CA also states that there is necessity for more data and we anticipate that the REACH registration process will deliver more detailed information from industry. We would appreciate, if you could support us by providing appropriate data.	
			 P 40. It would be helpful to give the reasons why these particular sectors have been identified as requiring further risk management measures. Also, it is not clear why the manufacture of pigments and dyes has not been identified as a sector where further risk reduction measures may be required since this sector was identified in the risk reduction strategy.	According to our information the uses in metal surface treatment and wood preservation cover about 90% of all CrVI applications. This means the majority of workers potentially exposed to CrVI species are to be found in these areas, and the impact of measures in these areas can be expected to be the highest.	
			 Alternatives substances and techniques; The dossier presents the technical feasibility of alternatives very well. The analysis presented in the table is very useful, but the section could benefit from a reference to the cost implications of the alternative.   	This may differ for each specific application. And a detailed analysis is beyond the scope of an Annex XV dossier.	
19	2010-10-14	Industry or trade association,
Aluminium Finishing Association,
United Kingdom	It is the experience of the aluminium finishing industry that the available alternatives to chrome VI pretreatments are not as effective or reliable. Any move towards enforced substitution must wait until alternatives of equal performance are available.	The unfeasibility of alternatives can not generally be disclaimed. In a later step of the authorisation process the applicant shall analyse alternatives considering the risks, technical and economic feasibility for each specific use. As the analysis of alternatives is a mandatory part, as described in Article 60(4c), 62(4e) the applicant should define and document any relevant research and development activities in regard to substitute CrVI species.
The general procedure is outlined in EC 1907/2006, Articles 56 – 66, and on the ECHA website.	
15	2010-10-14	Industry or trade association,
ESTAL, association for European Surface Treatment on Aluminium,
Switzerland

	Please send enclosed letter already sent by post mail on 5th October 2010.	The affixed letter is identical with that of Alufinish. For detailed response see there (number 7 of section “General Comments”)	
14	2010-10-14	Company,
Meggitt Polymers and Composites - Oregon,
United States	Unsure of any alternatives.  Any alternatives must be approved through various organizations for use on aircraft parts.	Because we are not sure about your specific application, we cannot give further indications, other than refer to the various options shown in Table 20 of the dossier.	
12	2010-10-13	International NGO,
International chemical secretariat,
Sweden	These substances are most probably used in a very similar way as Chromium Trioxide that is in Chromium plating, copper stripping, aluminum anodizing, photography, surface treatment of metals. Source: HSDB	Supporting statement, no response necessary.	
11	2010-10-13	European institution,
Council of Europe, Directorate for the Quality of Medicines and HealthCare,
France	Chromium trioxide is reagent 1019900 used in -General chapter 2.5.25 determination of carbon monoxide in gases for method I as impregnation material for gas detector tube (alternatives are not known) -Preparation of reagent 101970 (chromic acid cleansing mixture) -Monograph 0011 Benzocaine for Identification test C -Monograph 0533 Triamcinolone acetonide for identification test C, preparation of test and reference solution	According to EC 1907/2006, Article 58(2) a category of uses (like an analytical method) may be exempted if the risks in this application are properly controlled.	
9	2010-10-13	Company,
Stork Prints BV,
Netherlands	ANNEX B R&D reports on alternatives for Chromic acid / Chromium trioxide:  1. Rapportage slijtvastheid rasterwals, 1985 2. Fe-Ni-Cr depositie uit water-dimethylformamide volgens el-Sharif, 1988 3. Planning R&D concept X 1990 4. Evaluatie 1e fase concept X, 1991 5. 1e Halfjaarverslag. Onderzoeksfase: titaannitride coating rasterwals, 1991 6. Eindverslag haalbaarheidsstudie slijtvaste coating rasterwalsen, 1991 7. Resultaten keramische matrijs, 1991 8. Keramische matrijs t.b.v. electroformeer proces, 1992 9. Evaluation of PVD-coating, 1992 10. Halfjaarverslag PBTS-project: Titaannitride coating Rasterwals, 1992 11. Maandverslag maart 1992 R&D groep matrijzen, sleeves en rasterwalsen, 1992 12. Resultaten onderzoeksprogramma keramische matrijs, 1992 13. Titaannitride coating rasterwals, 1993 14. Keramische matrijs t.b.v. electroformeer proces, 1993 15. Periodeverslag keramische matrijs, 1993 16. Eindverslag keramische matrijs, 1994 17. eigenschappen van electrolytisch gevormde Ni-W-B legeringen en mogelijke toepassing binnen SSIG, 1994 18. Etsdip natrium peroxodisulfaat als alternatief voor chroom trioxide, 1994 19. De bruikbaarheid van Amplate voor Stork Screens, 1995 20. Kwaliteitscriteria voor keramische slijtlagen op matrijzen, 1995 21. Bezoek Chemijos Institutas in Vilnius, Litouwen, 1997 22. Fundamenteel electrochemisch onderzoek aan NiWB legeringen en mogelijke toepassingen de activiteiten van de SSIG, 2000 23. Ultrachem coating, chroomvervanger, 2003 24. Elektrodepositie van Fe-Ni-Cr met roestvast staal eigenschappen, 2007 - 2010 25. Chroom trioxide substitutie, onderzoek naar Cr3+ bad Rohm & Haas, 2009 26. Fe-Ni-Cr depositie via pulse plating, 2009 27. Pulls plating technology with Cr III - Faraday Technology Inc., 2009 28. Chroom III proces bij Prints, 2010 29. Chroomets vervanger, selectief wegetsen koper, 2010 30. Research on Cr III plating bath Rohm and Haas, 2010 31. Ion liquids by Scionix Leicester University, 2010 	This represents an annex to the statement given in Section „General Comments”. For response see there (number 9 above)	
8	2010-10-11	Company,

United Kingdom	Page 17 B) & C) Chromic acid used in the application of anodising aluminium components for the aerospace industry. Currently no alternative process available and therefore any restriction on the use of chromic acid for this process would result in an inability to supply product under the long-term Airbus contract resulting in cessation of aircraft build at Broughton (Chester - UK).	Authorisation of a substance under the REACH-regulation does not imply a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overweigh the risk to human health (or the environment) resulting from its use and suitable alternatives or technologies are not available. In the case of chromium VI the second options is relevant.	
6	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	P21 Within table 4 we see inhalation measured and estimated exposures above the Austrian occupational exposure limit values. Therefore we strongly support that Cr(VI) compounds will be included 	Supporting statement, no response necessary.	
5	2010-10-06	Company,
Germany	ECHAs press release of August 30 indicates that "comments should focus primarily on the hazardous properties that qualify the chemicals as SHVCs and that the aspects of "uses,exposures and safer alternatives or techniques" will be "mainly considered at the next stage of the process (ie selection of substances for authorisation), which includes a new round of public consultation". It is our intention to submit detailed comments on these aspects at that stage.	Statement, no response necessary.	
2	2010-09-06	Company,
OVAKO Redon SAS,
France	In hard chrome plating , there is no equivalent to chromic acid in terms of productivity, costs and quality of the plating. The alternative to keep low costs and remain competitive in a global market is to relocate in countries where the regulations are more favourable. The question is " do you want kill the industry in europe? "	Authorisation of a substance under the REACH-regulation does not imply a complete ban of a substance. The regulation explicitly states that the substance is allowed to be further used if either the risk can be reduced to an acceptable level or, if this is not possible, the benefit of its use overweigh the risk to human health (or the environment) resulting from its use and suitable alternatives or technologies are not available. In the case of chromium VI the second options is relevant.