17 December 2010
Responses to Comments Document (RCOM) for Lead sulfochromate yellow (EC number: 215-693-7)

This document provides ECHA’s responses to the comments received during the public consultation on the 2nd recommendation for inclusion of substances in Annex XIV of REACH which took place between 1 July and 30 September 2010.   

I - General comments on the recommendation to include the substance in Annex XIV, including the prioritisation of the substance:
#	Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
1	2010/09/24

Confidential attachments removed

	Company, United Kingdom	The lead chromates CI Pigment Red 104 (CAS 12656-85-8 EC 235-759-9) and CI Pigment yellow 34(CAS 1344-37-2 EC215-693-7) have been classified as (a)carcinogen category 2, R 45 (May cause cancer), (b)toxic to reproduction category 1, R61 (May cause harm to the unborn child)   Due to this classification, these substances were added to the candidate list for authorisation in January 2010. Manufacturers and developers of Gas Turbines agree with this classification.   We also support the principle of prioritisation based on classification in combination with the additional criteria of wide dispersive uses and high production volumes.   In this particular instance, the company is finding there is limited availability of this substance, and consequently would question whether the substance is still available in the EU in high production volumes, and additionally the wide dispersive uses may no longer exist. 
The manufacturers of gas turbines for a variety of applications would like to draw the attention of the EC, ECHA and the Competent Authorities for the Member States to one particular application of lead chromate family substances which has extremely low volumes of use, across industry results in very few individuals being exposed, in an easily controlled environment, which does not have wide dispersive use, and is currently vital for the development, testing, and improvement of new, safe and efficient gas turbines, and for the improvement of manufacturing techniques across all industry sectors. This use is specific to product and process oriented research and development of gas turbines and engines.   We have noted that under Article 56 (3) of REACH there is an opportunity for you to consider uses that have a very low risk for possible exemption from the authorisation requirement. We would ask that this use of this substance and also the other lead chromate pigment be considered for exemption. Article 56 states: “General provisions A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV… 2. A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use. 3. Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted.” What is PPORD in the context of Gas Turbine Development?   PPORD in this context meets one or more of the following criteria:   (a) The substance is used to demonstrate an attribute of the design of the product or process, for example use on a first of type, or rig test, or prototype manufacturing process (b) Where it is used on a main production product, it is used during the product’s development to assess an attribute of the design and would not be applied to every product as part of the manufacturing process. (c) The use of the substance is necessary to demonstrate compliance with other regulatory requirements (such as building a case to demonstrate that the product is safe in use)   In the context of Gas Turbine Development, a PPORD substance would have no function in the finished article. It would be pointless to develop the use of a substance that would be essential to a finished article, if the substance is likely to be subject to restriction or authorization in future. Examples that we believe ARE PPORD: a) Use of a substance on prototypes for the purposes of proving that a design functions correctly and is optimal in terms of use of resources / structural integrity etc. before committing to series production. (b) Development of a new application of a chemical, which is on the candidate list / Annex XIV, for the above use, unless where it can be proven to be the best environmental option / least hazardous option when all alternatives are on the candidate list (Development of the “least worst”). Examples that we believe are NOT PPORD: (a) Development of a new use of a chemical, which is on the candidate list / Annex XIV, with the intention of using the new use in production when the development is complete, unless the new use meets the criteria which exempts it from Authorisation (such as use as an intermediate). (b) Use of a chemical, which is on the candidate list / Annex XIV as part of a product in series production, or as a routine part of operation of a product   We believe that the Gas Turbine related uses of Lead Chromate Pigments meet the definitions we have proposed for PPORD above. Quantity used per annum: The total industry consumption of both these Lead Chromates combined in Europe for this particular use is probably less than 10kg per annum. The consumption of the company submitting these comments is approximately 2kg p.a. (1.18kg/yr Yellow 34 and 0.46kg/yr Red 104 average over 17 years). We have attached the following documents for your consideration: (a) Our letter explaining the technical uses of lead chromate pigments including their use to prove the safety of the product (Attachment 1). (b) A commercially confidential step-by-step explanation of the use of the pigments, from receipt to final disposal, with relevant operational conditions and risk management measures (Attachment 2). (c) Commercially confidential occupational and industrial hygiene reports for our facilities (Attachments 3 to 5). (d) Commercially confidential COSHH and risk assessments for the various processes on our facilities (Attachments 6 to 11). 	Thank you for your comment.

Regarding your first point, on the availability of the substance in EU, please note that – as mentioned in the background document - information provided by EMLC (European Manufacturers of Lead Chromate and Lead Molybdate pigments e.V.) and some importers of the lead chromate pigments accounts for an EU use in the range of > 5,000 to < 10,000 t/yr. Nevertheless, consultation with industry suggested also that the number of manufacturers of these substances is decreasing.

With regard to your request to exempt small amounts of lead chromate pigments (C.I. 34 Yellow and C.I. 104 Red) from authorisation for PPORD use in the development of gas turbine prototypes, we took note that these pigments are used as thermal paints in the development of gas turbine casing prototypes. These casings have to be designed to withstand high pressure and failure of the moving parts of the turbine (e.g. breakage of rotor blades), keeping the damage and debris inside. During product development, the producer needs to prove to himself and the certification authorities that in the event of a turbine blade breakage the blade will not brake through the turbine casing. The containment calculations have to assume that the released blade will hit the hottest sector of the casing, because this is the casing’s weakest point. Consequently, for accurate calculations, the hottest parts of the casing need to be identified. To identify these hottest parts, thermal paints containing the two mentioned lead chromate pigments are needed as these are the only thermal paints that provide the appropriate colour change points over the temperature range needed for turbine casings. The hot spots can be across very small areas and cannot be detected by other technical means.

From the use description provided by you, it becomes evident that the pigments are used in the development of prototypes of gas turbine casings. Once the optimal design for the casing of a particular turbine type is found, the development phase is over and the pigments are neither used in the serial production of the turbine casings, e.g. for quality control purposes, nor are they used as integral constituent of the casings. These facts appear to be relevant when considering whether the described use would fulfil the definition of PPORD in Article 3(22). However, ECHA has considered that it is not appropriate to recommend an exemption for PPORD for this use as there is not enough certainty whether this use actually fulfils the criteria for PPORD.

Nonetheless, according to your description, the pigments in the thermal paint are used as indicator (analytical agent) for analysis of temperature patterns across the surface of turbine casing prototypes. These facts appear to be relevant when considering whether the described use would fulfil the definition of scientific research and development (SRD) in Article 3(23). Article 3(23) defines SRD as “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year”. It is noted that SRD covers analysis for e.g. monitoring and quality control purposes, as long as the chemical substances used for this analysis are used under controlled conditions and in a volume of less than one tonne per year.

We would suggest that you examine whether the use of the pigments C.I. 34 Yellow and C.I. 104 Red in the development of gas turbine casings can be regarded as SRD in accordance with the definition set out in Article 3(23). If you conclude that this is the case, this use can benefit from the exemption of SRD from authorisation as set out in Article 56(3) and no authorisation would be required to continue the use after the sunset date.	
2	2010/09/29 	National authority
RIVM
Netherlands	The Netherlands CA agrees with the prioritization of lead sulfochromate yellow (C.I pigment Yellow 34) based on its CMR properties, the relevant volume for authorization and uses that can be designated as widespread use and in some applications as wide dispersive use.
	
Thank you for your support.	
3	2010/09/29 	Germany	Comment for the German CA:
We support the ECHA proposal on prioritisation of lead sulfochromate yellow.
Background document for lead sulfochromate yellow, p.4: 
Uses are listed as verified/confirmed. We would appreciate a publication of the technical report, in order to provide a transparent documentation of the verification/confirmation procedure.  
Background document for lead sulfochromate yellow, p.5:
According to an evaluation of exposure potential for primary recipients based on data in Nordic product registers on lead sulfochromate yellow, CAS No. 1344-37-2, one or several uses communicated to the Swedish and to the Norwegian product register (latest year 2008) indicate a probable consumer exposure and one or several uses communicated to the Danish product register (latest year 2008) indicate a potential consumer exposure. 
(SPIN Exposure Toolbox, 2010, http://195.215.251.229/Dotnetnuke/Home/tabid/58/Default.aspx)

Please note that there is no technical report available for lead sulfochromate yellow. Uses were verified on the basis of the information provided in the Annex XV Dossier by France, and complementary data collected on a basis of questionnaires developed by ECHA and sent to individual companies and organisations. 

In the background document the respective source of the information related to each use is cited accordingly.

Thank you for the information	
4	2010/09/29 

	Company
Netherlands	For our general comments, please see the attached pdf document under IV Attachment
	Thank you for your comment.

Your point in regard to the inherent properties (carcinogenicity and toxicity to reproduction) of the two Lead Chromate Pigments is not relevant for this part of the authorisation process, as the identification of the substances as Substances of Very High Concern has already been agreed by the Member State Committee. According to Article 37(6) of the CLP Regulation (Regulation (EC) No 1272/2008) manufactures, importers and downstream users who have new information which may lead to a change of the harmonized classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 of this Article to the competent authority in one of the member states in which the substance is placed on the market.

Furthermore, we would like to stress that the availability and suitability of alternatives have not been taken into account by ECHA for prioritising substances for inclusion in Annex XIV. The respective information may be provided as part of the applications for authorisation that will have to be submitted to ECHA (art. 62.4 (e) – analysis of alternatives) and will be discussed and taken into account in the decision procedure on authorisations (Art. 64).

Similarly, information on a low level of risks may be part of the applications for authorisation to be submitted to ECHA (art. 62(4) (d) – Chemical Safety Report), and may be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.

C.I Pigment Yellow 34 and C.I Pigment Red 104 have been identified as SVHCs and included in the Candidate List for eventual authorisation. Please note that in the process of assessing whether these pigments should be recommended for inclusion in Annex XIV (List of substances subject to authorisation) we are not assessing the impact of potential restrictions. 

Socio economic aspects are not part of the considerations to be taken into account in the “recommendation for inclusion in Annex XIV” phase of the authorisation process. However, in accordance with Article 60, those considerations can be brought forward in the authorisation application in the form of a socio-economic analysis. In these cases the socio-economic effects will be evaluated by ECHA’s Socio Economic Analysis Committee and taken into account by the Commission when deciding whether or not to grant an authorisation for a use.

Import of articles containing Lead Chromate Pigments is indeed not directly affected by the authorisation requirement and a restriction process has to be applied if there is a need to restrict such import. 

After the sunset date defined in Annex XIV for a given substance, ECHA has an obligation under Article 69(2) to consider whether the substance in articles poses a risk and, if yes, prepare an Annex XV restriction dossier. Such a dossier could e.g. cover placing on the market and use of all articles containing the substance with a derogation for placing on the market and use of those articles which result from uses for which an authorisation is granted or it could be limited to certain articles.

Finally, as regards the comment on the scoring approach as applied for the lead chromate pigments, we consider that there is no need for amendment, on the basis of the argumentation we provide below on existing legislation (please see response to comment #16).	
5	2010/09/30 	International NGO
WWf European Policy Office
Belgium	We support the prioritisation for inclusion in Annex XIV due to high volumes and widespread use.
	
Thank you for your support.	
6	2010/09/30 	National authority
Health and Safety Authority
Ireland	IE wish to acknowledge the work that ECHA has done in prioritising and recommending the 8 substances for inclusion in Annex XIV of the REACH Regulation
Following the 1st July commencement of the public consultation on ECHA’s recommendation of priority substances to be included in Annex XIV, the Irish Central Competent Authority forwarded a communication to possible Irish stakeholders, inviting them to comment as part of this public consultation. We have not been made aware of any relevant information which could be provided, in particular on uses which should be exempt from the authorisation process. 
On the basis of this, we have no objection to the recommendation to include the 8 substances in Annex XIV of REACH.

 Thank you for the information and your support.	
7	2010/09/30 	International NGO
International chemical secretariat
Sweden	This substance deserves to be placed on Annex XIV considering its hazardous properties and its wide dispersive use in Pigments.	Thank you for your support.	
8	2010/09/30 	National authority
Portuguese Environment Agency - PT
Portugal	Taking into consideration the high volume and wide disperse use of Lead sulfochromate yellow (C.I. Pigment Yellow 34) we consider that this substance fulfills the prioritisation criteria. However we consider that further analysis is required considering the proposed latest application date and sunset date.	See response to comment #9 below.

II - Transitional arrangements. Comments on the proposed dates: 
#	Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
9	2010/09/29 	National authority
RIVM
Netherlands	In the first round of Annex XIV prioritization, ECHA argued that the minimum time needed to prepare an application for authorization was 24 months (ECHA/MSC-8/2009/021). The Netherlands CA is of the opinion that in this and future rounds of setting dates for Annex XIV entries, this minimum time of 24 months needed should no longer be applied as the default value.
Furthermore, we suggest that the 24 month period could normally be considered as a maximum while a new minimum default time could be applied in this and future recommendations. 
It can be reasonably expected that, once ECHA gives it’s Annex XIV priority recommendation to the Commission, industry will anticipate this decision or even already will have anticipated the decision, since both the candidate list and the criteria for prioritization are publicly available.
In situations where no relevant information on the production cycle for a specific use is available (see REACH art. 58(1)(c)(i) ), a short standard time to the sunset date (and consequently the application date) can be recommended. In situations where the production cycle for a specific use is known and complex, a longer time for the application date could be considered. 
Default (minimum) times for Annex XIV entries with no specific information on the production cycle for specific uses, or evidence of simple supply chains could lead to e.g. 30 months for the sunset date and 12 months for the application date . NB In the draft recommendation for prioritization of DIBP (ECHA document ECHA/MSC-12/2010/029 (1)), 12 months is seen as the minimum time needed to prepare an application for authorization.
Likewise, maximum default application and sunset dates could be used.
Of course, pragmatic arguments related to the capacity of ECHA to process the applications for authorization (REACH article 58(3) should also be taken into account in the recommendation. 
On the basis of the information provided we see no reason to propose a differentiation in the application date or sunset date for different use categories.
We suggest to apply the shortest realistic and pragmatic possible application date.
	Thank you for your comments.

ECHA developed the draft Annex XIV entries for the second recommendation based on the “Guidance on inclusion of substances in Annex XIV”. 

In the guidance, the time needed for preparation of an authorisation application is estimated to amount to 18 months (roughly 12 months worktime for drafting the application plus an additional buffer of 6 months for consulting required external expertise). Therefore, a time period of 18 months should normally be given to allow for the preparation of a well documented application for authorisation. This recommended time period has been considered for suggesting the shortest application dates. As the time interval between application date and sunset date cannot be shorter than 18 months (Art. 58), the corresponding shortest sunset dates were set to 36 months.

The anticipated workload of the agency with regard to processing of authorisation applications was accounted for by grouping the proposed substances in 3 groups and spreading the application and sunset dates over a period of six months,, resulting in a combination of application/sunset dates of 18/36, 21/39 and 24/42 months for the three groups.

The time period of 12 months after entry into force suggested as application date for DIBP derived from the fact that ECHA’s first recommendation included three phthalates with similar uses. To avoid substitution of these by DIBP, ECHA proposed to set the sunset date as close as possible to the sunset date of the already recommended phthalates. However, it was recommended to concede at least 12 months because this time is recommended in the guidance as standard time necessary to prepare authorisation applications. In the particular case of DIBP it was not deemed necessary to consider 6 further months for consulting of external expertise, as no further expertise beyond that required for the other three phthalates seemed to be necessary.

However, analysis of the anticipated entry into force of the Commission Regulation amending Annex XIV to the REACH Regulation for the first time (i.e. January 2011) suggested a revision of the dates as there presumably would be overlap between the application dates of the first amendment of Annex XIV and the second one, which will implement the current (2nd) recommendation, if this latter Commission Regulation would enter into force in January 2012. In this case there may be overlap between the application dates of the phthalates included by the first amendment of Annex XIV and the arsenic oxides of the second amendment of this Annex. This needs to be revised in order to avoid overload of the Agency and its committees with authorisation applications. As quite many applications for at least some phthalates are expected, it seems to be advisable to adjourn the application dates of the arsenic oxides by 3 months and combine those with the application dates for lead chromate and the lead chromate pigments (for these substances less applications are anticipated so that there is not so much concern of overload of the Agency by authorisation applications). There is as well not so much concern regarding overload of the Agency due to overlap of the application date for HBCCD of the first recommendation and TCEP and 2,4 DNT of the second one. Therefore this overlap seems to be tolerable.

As a different date of entry into force of the second recommendation than January 2012 would again lead to a different situation, the general proposal for amendment of the transitional arrangements is to recommend to the Commission: 
i)	Consider potential overlap of the application dates between 1st and 2nd recommendation in order to avoid overload of the Agency with authorisation applications. 
ii)	Consider the recommendation of the guidance regarding the time that normally should be given for preparing authorisation applications (18 months) as starting point for calculating the latest application dates.
iii)	Consider grouping of the substances of the second recommendation in 2 lots with a time interval of 3 months between the lots (rather than 3 lots within 6 months as originally proposed, in order to speed up the authorisation process).
	
10	2010/09/29 	Germany	Comment for the German CA:
We agree with the proposed dates.	Thank you for your support.	
11	2010/09/29 	Company
Netherlands	29 September 2010
European Chemical Agency
Annankatu 18
P.O. Box 400, FL-0D121
Helsinki, Finland
Re:	Comments on Review Periods for Specific Uses for Exemption of Dominion Colour Corporation to the European Chemical Agency on The ECHA’s Recommendation for the Inclusion of Substances in Annex XIV C.I. Pigment Yellow 34 and C.I. Pigment Red 104 as Annex XIV Authorization Substances Pursuant to EC No. 1907-2006 REACH
Dear Sir or Madam:
These comments are provided by Dominion Colour Corporation (&quot;DCC&quot;) on behalf of its manufacturing facility and Only Representative for REACH compliance, located at DCC  Maastricht B.V., Sortieweg 39, 6219 NT Maastricht, the Netherlands , to the European Chemical Agency (the “Agency”) concerning the Agency’s second recommendation for inclusion of substances as Annex XIV Authorization Substances pursuant to EC No. 1907-2006 REACH  (the “Annex XIV Proposals”).  DCC employs one third of its world wide workforce in Europe manufacturing pigments and pigment preparations as well as representing all DCC products in the European market.
 
These comments are provided regarding Colour Index  (&quot;C.I.&quot;) Pigment Yellow 34, Chemical Abstracts Service (&quot;CAS&quot;) Number 1344-37-2, and C.I. Pigment Red 104, CAS No. 12656-85-8.  The background material supporting the Annex XIV Proposals is set forth in the July 1, 2010 background documents for C.I. Pigment Yellow 34 and C.I. Pigment Red 104, the 2009 Proposal For Identification of a Substance as a CMR Category 1 OR 2, PBT, VPVB or a Substance of an Equivalent Level of Concern, Substance name: Lead Sulfochromate Yellow C.I. Pigment Yellow 34, (&quot;2009 Proposal C.I. Pigment Yellow 34&quot;) and the 2009 Proposal For Identification of a Substance as a CMR Category 1 OR 2, PBT, VPVB or a Substance of an Equivalent Level of Concern, Substance name: Lead Chromate Molybdate Sulphate Red, C.I. Pigment Red 104 (&quot;2009 Proposal C.I. Pigment Red 104&quot;) (collectively referred to as the &quot;Background Documents&quot;). 
DCC has submitted separate General Comments and Request for Exemption, the following comments are related only to review periods for specific uses. 
 
As discussed at length in DCC's comments and Request for Exemption, the substitution of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 is not presently possible.  Given the thousands of non-consumer industrial products in which these pigments are used, any attempt to substitute these pigments for other products will require many years. 
Due to increasing worldwide regulation, demand for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 has decreased over the last ten years.  Those uses which remain are those for which substitution is not possible or is cost prohibitive.  Due to the existing regulations already in place in the  European Community many producers of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 have shuttered their facilities, with a significant loss of jobs.
 	The following existing uses have been identified for C.I. Pigment Yellow 34 and C.I. Pigment Red 104: 
1)	The following main uses of all grades of C.I. Pigment Yellow 34 and C.I. Pigment Red 104:
SU3- 	Industrial Uses, Uses of substances as such 	 or in preparations at industrial sites
SU22-	Professional Uses, public domain administrative, education, entertainment, services, craftsmen)
2)	The following specific uses of C.I. Pigment Yellow 34 and C.I. Pigment Red 104: 
AC1-		Vehicles
 
AC2-		Machinery mechanical appliances, electrical electronic articles
AC4-	  	Stone, plaster, cement, glass 			and ceramic articles
AC10-   	Rubber articles
AC 11-	Wood articles
AC 13-	Plastic articles
The specific uses described in the Background Documents which correspond to the above categories are:
1.	Colouration of plastics (~60% of the EU market for the pigments, EMLC 2009 in Annex XV Dossier) This use concerns each type of plastic material/composite (polyolefins, polyvinyl chloride and nylon) as well as each process of modeling (injection, extrusion, etc). Applications in this sector include industrial carpet fibers, automotive interiors, non food packaging, rust resistant furniture and electronic housings.  Examples of finished products include trash bags, industrial packaging, piping and tubing, PVC profiles, tarpaulins (DCC in Annex XV dossier, 2009). 
2.	Coatings (e.g. paints, varnishes) (~40% of the EU market, EMLC 2009) These pigments are used in a variety of industrial coatings. Applications in this sector include:
 	Vehicles not covered by the end of life vehicles directive (trucks, buses, commercial vehicles, vintage cars)
  	Agricultural equipment
  	Civil engineering material
  	Boats/Ships
  	Road sign and road painting / Thermoplastic road marking/Airport horizontal painting
  	General industrial: skips, plant and machinery; industrial doors, pumps, machinery; large steel structures; gas cylinders; off shore steel structures (e.g. drilling rigs)
 
  	Camouflage/ammunition, interior coatings for military equipment
  	Aeronautics
  	Coil coating
 	Coating of plastic material (PVC, PP, ABS edge bands)
  	GRP constructions (boats, auto parts, silos)
  	Coatings that can be applied to industrial surfaces by printing, such as decals (e.g. used for commercial identification)
  	Thermochromic paint
Dominion has, and continues to, object to the finding that C.I. Pigment Red 104 and C.I. Pigment Yellow 34 are carcinogenic or substances which warrant categorization as substances of very high concern by the Agency.  Additionally, Dominion has requested exemption in accordance with Article 58(2) of REACH for the existing uses described above for these pigments.  
There are no direct substitutes for C.I. Pigment Yellow 34 and C.I. Pigment Red 104.  There may be alternative product formulations but there are no pigments which can reproduce the unique attributes of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 in the thousands of non-consumer industrial applications in which these pigments are used in commerce.	DCC agrees with the conclusions reached in the Background Documents which state that:
 
&quot;According to EMLC, as well as to a non-EU manufacturer exporting the lead pigments to the EU, there are potential alternatives, but not direct substitutes for C.I. Pigment Yellow 34 and C.I. Pigment Red 104. Application requirements, such as weather resistance, light fastness, opaqueness, capacity and others are not met. Moreover, the technical implementation of substitutes is difficult and often inefficient (lack of stability, etc.). Furthermore, costs for such alternatives are four to ten times the price. Substitution may be applied for some specific uses but not for all.&quot; See 2009 Proposal C.I. Pigment Yellow 34. p.23
  	The Background Documents conclude that there are no economic alternatives to C.I. Pigment Yellow 34 and C.I. Pigment Red 104 with the same application properties, with the following statement:
“...the technical implementation of substitutes is difficult and often inefficient (lack of stability, etc.).  At least, costs for such alternatives are four to ten times the price and present an economic burden for end users and consumers alike.” See 2009 Proposal, C.I. Pigment Yellow 34 p.24
 DCC reviewed the examples of substitution provided on the Agence française de sécurité sanitaire de l'environnement et du travail website and cited in the Background Documents.  We find that the alternative formulations developed for other pigments are not adequate substitutes for C.I. Pigment Yellow 34 and C.I. Pigment Red 104.  There are no replacements for C.I. Pigment Yellow 34 and C.I. Pigment Red 104, only lower performing potential alternatives, but not substitutes for C.I. Pigment Yellow 34 and C.I. Pigment Red 104.  The alternative products require tradeoffs in performance characteristics and in formulation with multiple replacement ingredients for final products.  
 
With respect to the substitution of C.I. Pigment Red 104, DCC disagrees strongly with the conclusion that this pigment can be substituted in all applications.  The statement made in the Background Documents that:
“No achieved and complete substitution has been identified in France for the use of C.I. Pigment Yellow 34, in contrary to C.I. Pigment Red 104. According to producers, main reasons are the lack of permanent efficiency, the economic cost and the lower specific colour and brightness properties (FIPEC 2009)”. See 2009 Proposal C.I. Pigment Yellow 34, Alternative Substances, p.23.  
DCC’s experience with numerous customers indicates that C.I. Pigment Red 104 is much more difficult to substitute in virtually all applications.  This is due to the unique colour spectrum of C.I. Pigment Red 104, combined with its durability in harsh environments and in longer high stress applications.  Based on our recent discussions with customers, C.I. Pigment Red 104 is particularly difficult to replace in many paint and plastic formulations due to its unique colour spectrum, opacity, hiding power and the much higher cost associated with potential alternatives.
 
When cost is considered, there are no substitutes which perform equivalently to C.I. Pigment Yellow 34 or C.I. Pigment Red 104 in most product formulations. Substitutes do not exhibit the light-fastness or general stability in the environment that would be obtained using C.I. Pigment Yellow 34 and C.I. Pigment Red 104.  	Additionally, the cost of substituting pigments, which do not perform as well as C.I. Pigment Yellow 34 and C.I. Pigment Red 104, must be considered in the context of coloured product life cycle.  Articles or coatings made from pigments that do not perform as well in long-term harsh environments require more frequent replacement, therefore creating a larger burden for the processing of waste, the efficient use of energy and manufacture of new products in the environment. 
DCC manufactures and sells numerous organic and inorganic pigments other than C.I. Pigment Red 104 and C.I. Pigment Yellow 34.  As a result, DCC has extensive expertise in the available substitutes for these pigments.  If viable alternatives were available and feasible, DCC would very likely sell those pigments.  As has been pointed out in the Background Documents, these potential alternatives are far higher in price.  C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are unique, extremely difficult substances to replace and, where needed for industrial non consumer products, remain in strong demand by DCC customers throughout The Community. 
 
In order to identify new substitutes for  C.I. Pigment Red 104 and C.I. Pigment Yellow 34 if a potential new molecule were identified, the pilot production, testing, global inventory registration, certification and review process normally requires at least 6 to 10 years to complete. Therefore, if the Agency moves forward with its decision to place new restrictions on these pigments, the existing uses of these pigments should be exempt from authorization.  In any event, time lines should be extended to allow for the analysis and substitution of thousands of products which will require many years to complete.   
Please contact me if there are any questions or comments.  We would welcome further dialogue with the Agency to discuss these issues and assist in the process of defining correctly the risk associated with the use of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 and specifically with our silica-glass encapsulated versions of C.I. Pigment Red 104 and C.I. Pigment Yellow 34.	Thank you for your comment.

Please note that setting ‘upfront’ review periods for any uses requires that the Agency has access to adequate information. ECHA currently assesses that the information provided is not sufficient to conclude upfront on specific review periods. Therefore, we propose review periods to be determined on a case-by-case basis according to Art.60(8) of REACH, on the basis of concrete information provided in applications for authorisation.	
12	2010/09/30 	International NGO
WWf European Policy Office
Belgium	The transitional arrangements should be shortened to 12 months application date (sunset date 30 months), given the likely risk resulting from occupational exposure and releases to the environment during use and disposal.	
See response to comment #9 above.	

III - Comments on uses that should be exempted from authorisation, including reasons for that:
#	Date 	Submitted by (name, Organisation/MSCA)	Comment	Response	
13	2010/09/24 	Company
United Kingdom	The manufacturers of gas turbines for a variety of applications would like to draw the attention of the EC, ECHA and the Competent Authorities for the Member States to one particular application of lead chromate family substances which has extremely low volumes of use, across industry results in very few individuals being exposed, in an easily controlled environment, which does not have wide dispersive use, and is currently vital for the development, testing, and improvement  of new, safe and efficient gas turbines, and for the improvement of manufacturing techniques across all industry sectors. This use is specific to product and process oriented research and development of gas turbines and engines.
&nbsp;
We have noted that under Article 56 (3) of REACH there is an opportunity for you to consider uses that have a very low risk for possible exemption from the authorisation requirement.  We would ask that this use of this substance and also the other lead chromate pigment be considered for exemption.
Article 56 states:
 
“General provisions
A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV…
2.    A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use.
3.    Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted.”
What is PPORD in the context of Gas Turbine Development?
&nbsp;
PPORD in this context meets one or more of the following criteria:
&nbsp;
(a) The substance is used to demonstrate an attribute of the design of the product or process, for example use on a first of type, or rig test, or prototype manufacturing process 
(b) Where it is used on a main production product, it is used during the product’s development to assess an attribute of the design and would not be applied to every product as part of the manufacturing process.
(c) The use of the substance is necessary to demonstrate compliance with other regulatory requirements (such as building a case to demonstrate that the product is safe in use) 
&nbsp;
In the context of Gas Turbine Development, a PPORD substance would have no function in the finished article.  It would be pointless to develop the use of a substance that would be essential to a finished article, if the substance is likely to be subject to restriction or authorization in future.
&nbsp;
Examples that we believe ARE PPORD:
(a)&nbsp;Use of a substance on prototypes for the purposes of proving that a design functions correctly and is optimal in terms of use of resources / structural integrity etc. before committing to series production.
(b) Development of a new application of a chemical, which is on the candidate list / Annex XIV, for the above use, unless where it	 can be proven to be the best environmental option / least hazardous option when all alternatives are on the candidate list (Development of the “least worst”).
Examples that we believe are NOT PPORD:
(a)&nbsp;Development of a new use of a chemical, which is on the candidate list / Annex XIV, with the intention of using the new use in production when the development is complete, unless the new use meets the criteria which exempts it from Authorisation (such as use as an intermediate).
(b)Use of a chemical, which is on the candidate list / Annex XIV as part of a product in series production, or as a routine part of operation of a product
&nbsp;
We believe that the Gas Turbine related uses of Lead Chromate Pigments meet the definitions we have proposed for PPORD above.
Quantity used per annum:  The total industry consumption of both these Lead Chromates combined in Europe for this particular use is probably less than 10kg per annum.  The consumption of the company submitting these comments is approximately 2kg p.a. (1.18kg/yr Yellow 34 and 0.46kg/yr Red 104 average over 17 years).
&nbsp;
We have attached the following documents for your consideration:
(a)Our letter explaining the technical uses of lead chromate pigments including their use to prove the safety of the product (Attachment 1).
(b)A commercially confidential step-by-step explanation of the use of the pigments, from receipt to final disposal, with relevant operational conditions and risk management measures (Attachment 2).
(c) Commercially confidential occupational and industrial hygiene reports for our facilities (Attachments 3 to 5).
(d) Commercially confidential COSHH and risk assessments for the various processes&nbsp;on our facilities (Attachments 6 to 11).
	
Please see the response above, to the general comment submitted by the company (comment #1).	
14	2010/09/29 	National authority
RIVM
Netherlands	None		
15	2010/09/29 	Germany	Comment for the German CA:
We agree with the proposal not to exempt certain categories of uses.	Thank you for your support.	
16	2010/09/29 	Company
Netherlands	For our comments concerning uses exempted from the authorisation requirement, please see the attached pdf document under;IV Attachment	With regard to the request by the Company to exempt the existing uses listed under 1), 2) and 3) of silica encapsulated grades and of all grades of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 from authorisation on the basis of Article 58 (2) ECHA would like to note the following:

According to Article 58(2) of REACH it is possible to exempt from the authorisation requirement uses or categories of uses ‘provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled’.

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, we consider the following elements essential for a decision whether an exemption of a use of a substance could be included in ECHA’s recommendation: 
-	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions;
-	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the legislation in question should specifically refer to the substance to be included in Annex XIV either by naming the substance or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
-	This Community legislation imposes minimum requirements for the control of risks of the use. Legislation setting only the aim of imposing measures or not clearly specifying the actual type and effectiveness of measures to be implemented is not sufficient to meet the requirements under Article 58(2). Furthermore, it can be implied from the REACH Regulation that attention should be paid as to whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered by the legislation.

On the basis of the criteria above, we made the following observations on the argumentation brought forward by the Company:
(i)	Only existing Community legislation is relevant in the context to be assessed (no national legislation).
(ii)	Minimum requirements for controlling risks to human health and the environment need to be imposed in a way that they cover the life cycle stages resulting from the uses in question. 
(iii)	There need to be binding and enforceable minimum requirements in place for the substance(s) used.

As regards points (ii) and (iii) above, there is no consistent framework of Community legislation in place that would apply to the two pigments C.I. 34 Yellow and C.I. 104 Red in a lifecycle perspective. In particular, existing Community legislation does not appear to set out minimum requirements addressing the control of cancer risks arising from occupational and professional uses of the chromium VI constituents of the pigments. In a life cycle perspective, it is not enough that for the waste phase of some particular uses specific Community legislation seems to impose minimum requirements for both the lead and chrome VI constituents of the pigments. Decisive is that a part of the life‑cycle, namely the cancer risk arising from occupational and professional exposure to the pigments, is not properly controlled by existing Community legislation.

Workers
Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work sets out (in particular in Articles 4 and 5) stringent objectives which the employers need to fulfil, i.e. prevention and reduction of the exposure of workers to carcinogens and mutagens. The Directive also defines the hierarchy of measures to be taken (from the replacement of the carcinogenic/mutagenic substances to technical and management measures). The employer can take a measure which is lower in the hierarchy only where it is not technically possible to take a measure higher up in the hierarchy. However, the directive leaves the determination of the measures to be imposed to the employer and does not provide sufficient indicators to be used to assess whether a measure higher up would have been technically possible. On this basis it is not considered that Directive 2004/37/EC would impose binding minimum requirements for controlling risks to human health. Therefore, this Directive is not regarded as a sufficient basis for exempting uses of C.I. Pigment 34 Yellow or C.I. Pigment 104 Red from authorisation in accordance with Article 58(2) of the REACH Regulation.

Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work contains a binding occupational exposure limit value for inorganic lead and its compounds (8 hour TWA of 0.15 mg/m3). Although this limit value is applicable to all lead compounds, the limit is only set to control risks from lead and the lead cation, and is mainly based on neurobehavioural adverse effects in exposed workers (see also the Recommendation of the SCOEL for Lead and its Inorganic Compounds, SCOEL/SUM/83 final. 

Lead sulfochromate yellow (C.I. Pigment Yellow 34, EC 215-693-7) and lead chromate molybdate sulfate red (C.I. Pigment Red 104, EC 235-759-9) are variable solid mixed phase crystals containing lead chromate and lead sulfate (C.I. Pigment 34 Yellow) or lead chromate, lead sulfate and lead molybdate (C.I. Pigment 104 Red) and some other constituents in varying proportions. These substances are the result of a chemical co-precipitation reaction.

In particular with regard to the classified hazard properties of these substances, the cancer risk posed by the substances, which is due to the chromium VI constituent present in the mixed crystal pigments, is not covered by the OEL for exposure to airborne lead. Consequently, there is no binding OEL addressing the cancer risks arising from the presence of chromium VI in the pigments and therefore no sufficient basis to conclude that the existing OEL for lead compounds would properly control the risks to human health arising from the occupational and professional uses of the lead chromate containing pigments.

Further, there may be exposure of self-employed professional users (or consumers) from sanding, grinding and repair works carried out on pigment containing or coated articles. Such activities would not be controlled by the Community occupational health legislation.

Man via the environment
The substances have been identified as SVHC on the basis of Article 57(a) and 57(c). Nevertheless, release to the environment is an important step in the life-cycle with respect to exposure of man via the environment. 

It has to be noted that specific legislation should address the substances in question in an unambiguous way either by naming the substance specifically or by addressing the group the substance belongs to. 

This does not seem to be the case for the Directive 2008/1/EC (IPPC), where Annex III is an indicative list of the main polluting substances and includes large groups of substances which are not unambiguously specified. The directive does not specify how to identify polluting substances for which a permit for an installation needs to include an emission limit value. For these reasons the substances for which the minimum requirements set out in the directive apply are not specified in a way that would allow the use of the IPPC Directive as a reason for exemption under Article 58(2). It is further noted that pursuant to Article 62(5)(b)(i) an applicant may justify in his authorisation application that emissions from an installation for which an IPPC-permit has been granted do not need to be considered when deciding on an authorisation. This implies that a case specific consideration is needed to judge whether risks arising from IPPC installations are properly controlled.  

Both Directive 2002/95/EC (Directive of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment; RoHS) and Directive 2000/53/EC (Directive of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles; ELV) set a maximum concentration value of 0,1 % by weight in homogeneous materials for amongst others lead and hexavalent chromium, and according to Directive 94/62/EC on packaging and packaging waste, the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components shall not exceed 100 ppm by weight (or 0,01% w/w).
These limits are in place mainly to prevent heavy metals such as lead and hexavalent chromium to enter the waste stream and to avoid subsequent releases to the environment when waste is incinerated or landfilled. 

It could be argued that for the articles covered by these Directives,  the requirements set out in the Directives related to lead and hexavalent chromium could  be seen as “minimum requirements for controlling risks to human health and the environment” resulting from the waste phase of the articles. Such uses amongst the uses requested to be exempted by the company seem to be limited to:
-	non-food packaging
-	electronic housings
However, as noted above the occupational exposure during the previous stages of the life-cycle of the substance appears not to be sufficiently covered by existing Community legislation. 

For the other uses requested to be exempted there are no such specific minimum requirements in the waste legislation that address the substances in question in an unambiguous way. And thus for these uses of the substances in question, the requirements in waste legislation do not appear to constitute a sufficient justification for exemption under Art 58(2). Unlike suggested by the Company, only waste streams that would contain high amounts of hazardous substances would have to be treated as hazardous waste (such could be waste from manufacturing and use of the substances in question), and these requirements would not necessarily imply that risks are controlled.

In summary, the risks related to the relevant life-cycle stages resulting from the uses in question are at most partly covered by the relevant pieces of Community legislation, and as a result do not justify an exemption according to Article 58(2) for the substances lead sulfochromate yellow (C.I. Pigment 34 Yellow) and lead chromate molybdate sulfate red (C.I. Pigment 104 Red).

Apart from the issue whether there is specific Community legislation in force that provides minimum requirements for the use of the substance on the basis of which it can be concluded that the risks to human health or the environment are properly controlled, the second stipulation of Article 58(2) may be relevant in deciding whether exemptions from the authorisation requirement should be granted for (categories of) uses of the encapsulated forms of the pigments. That is the stipulation “In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form.”

Indeed, the silica-glass encapsulated grades of the sulfochromate yellow and lead chromate molybdate sulfate red pigments are enclosed in an amorphous silica glass shell, which amounts up to 20% of the weight of the encapsulated pigment particle. In a study cited by the company requesting the exemption (Pier, SM et. al., 1991: Silica encapsulation reduces bioavailability. Environmental Toxicology and Chemistry, Vol. 10, pp. 1247-1253), the bioavailability of lead and chromium from silica-encapsulated and non encapsulated lead chromate after oral administration to rats was tested (5 days per week administration over 28 days). It could be shown that the levels of lead in blood after administration of silica-encapsulated lead chromate were 3 - 13 times lower than after administration of non encapsulated lead chromate. However, the administration of the encapsulated form still resulted in 2 - 35 times higher blood lead concentrations than those found in the non-treated control groups. Similar results were obtained for lead concentrations in kidney tissue (compared to the non treated control a 60-fold increase of kidney Pb concentration when non encapsulated lead chromate was administered but still a 6-fold increase due to administration of encapsulated lead chromate). The chromium concentration in kidneys was also investigated: feeding of non-encapsulated lead chromate resulted in a 400% increase compared to the controls whereas for the encapsulated form the increase was 10%.

The data available on bioavailability of glass encapsulated lead chromate show that the encapsulation apparently reduces the release (rate) from the pigment particles but also that from the encapsulated form considerable release occurred. There is no information available as to whether the observed reduction of pigment release would be sufficient to keep concentrations in the relevant body tissues below the levels eliciting carcinogenic or reprotoxic effects. Moreover, other exposure routes (e.g. inhalation, given that lung cancer is the main concern with regard to hexavalent chromium compounds) might need to be considered as well when assessing uptake and bioavailability of the pigment constituents. Other aspects that may require further investigation are the presumable dependence of bioavailability on the degree of encapsulation and the effect of weathering on the encapsulation (i.e. bioavailability of lead and chromium VI constituents from highly weathered encapsulated pigments).

In conclusion, the information provided is neither sufficient to conclude that the risk is indeed modified (decreased) by silica encapsulation of the pigments nor to which extent this would be the case. Consequently, the information available provides no sufficient basis for exempting the silica encapsulated grades of the pigments from authorisation.	
17	2010/09/30 	International NGO
International chemical secretariat
Sweden	No exemptions should be granted since alternatives are available.
	
Thank you for your support.	

IV - Transitional arrangements: comments on the proposal and conclusion
#	Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
18	2010/09/29 	Germany	Comment for the German CA:
We agree with the proposal not to include review periods for certain uses.	Thank you for your support.	
19	2010/09/29 	Company
Netherlands	For our comments concerning uses for which review periods should be included in Annex XIV, please see the attached pdf document under &quot;IV Attachment&quot;.	
Please see our response to the comment by the same company listed in section II above (comment #11).