comments and response to comments on …echa.europa.eu/.../a4a_comment_response_79_0012-02_… ·...

COMMENTS AND RESPONSE TO COMMENTS ON AUTHORISATION

Substance name: Lead chromate molybdate sulphate red (C.I. Pigment Red 104)EC number: 235-759-9CAS number: 12656-85-8Broad information on use applied for (title): Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer useConsultation number: 0012-02Applicant name: DCC Maastricht B.V. ORConsultation period: 12/02/2014 - 09/04/2014

Reference number and date:

Submitter: Alternative: Attachments:Type Generic

nameEC Number

CAS Number

Description of technical alternative

Classification and Labelling

Ref.No: 537Date: 2014/04/09

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Non-governmental organisation (NGO)Name of org/company:European Environmental Bureau (EEB)Country:Belgium

Reflective material, such as reflective marking tape, reflective film, etc.

Comment_537_Attachment.doc

Applicants’ response:

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Applicants reply to comments 536-547Contributing third party: EEBECHA consultation numbers 0012-01 to 0012-12

Thank you for your comment.

Your comments provided in Comment no. 536-547, refer to different suppliers and distributors of reflective materials (tapes/films/sheets) that are available on the market. The use of tapes, films or sheets often have a temporary effect and are mainly a different way of applying a signage or marking, but do not explicitly exclude the use of Pigment Yellow 34 and/or Pigment Red 104. The technology in the production of reflective tapes is within the adhesive and polymer backbone. The selection criteria for the pigment to colour the tapes are the same as for coatings and plastics. These selection criteria are shade functionality, chroma, durability, opacity etc.Based on the above and in reference to assessing reflective tapes as an alternate technology to Pigment Yellow 34 and Pigment Red 104 (i.e. providing information on alternative substances or technologies for the uses for which the authorisation application has been submitted), the provided comments do not sufficiently show reflective tapes as an alternative technology. In particular as the pigment selection criteria to colour the tapes are the same where PY.34 and PR.104 may be selected.

Reflective tapes do find use in applications such as temporary road marking in construction zone areas. They are indeed not used for permanent road marking as the adhesive used is not able to withstand ongoing traffic wear and tear, not able to withstand ongoing seasonal temperature variation and not able to withstand the impact of road equipment such as snow ploughs.

Looking at the purpose of the public consultation for continued use of Pigment Yellow 34 and Pigment Red 104 (i.e. providing information on alternative substances or technologies for the uses for which the authorisation application has been submitted), your comments are not relevant and do not sufficiently prove that the referred to application techniques (tapes/films/sheets) are suitable replacements for the uses of PY.34 or PR.104 in the long term. Your comments provide no additional information on alternatives for the uses applied for in the Authorisation application being industrial, professional, non-consumer uses to provide colour to plastic, paint/coatings formulations and applications.

In addition, due to the use of Pigment Yellow 34 and Pigment Red 104 in the colouration of coatings and plastics, the replacement value of the end product is maintained, enhancing the longevity, and reducing the need to repair or repaint on places that are difficult to reach, in dangerous situations, or where idle time of equipment would incur high costs. In almost all cases, the choice for Pigment Yellow 34 and Pigment Red 104 in paints and coatings is driven by the need for extreme durability and reliability of the end coating on whatever product is being coated as well as the signal and contrast function of the colour. The use of tapes, films or sheets often have a temporary effect and lack these abilities: use of lower performing pigments or other techniques inevitably leads to poorer safety or unclear dangerous areas inside industrial installations. The risk of accidents during road marking is far higher than any residual risk associated with the use of a more durable marking using PY.34 and PR.104.

Finally to confirm the poor durability that reflective tapes exhibit, one example provided was from 3M, http://bcnramonas.com/cmsupload/3m.pdf. 3M themselves state:

“Specifically, we do not warrant this film for the following:• Regulated traffic signs

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http://bcnramonas.com/cmsupload/3m.pdf

• Applications to corrugated surfaces• Application to stainless steel• Non-vertical applications• Graphics made for automotive Original EquipmentManufacturers (OEM); contact 3M Automotive Division at 1-800-328-1684, Ext. 444, for alternatives”

The above confirms that such tapes do not have the durability to withstand the elements. In particular it should be noted they do not warrant for horizontal or road marking applications.Applications 3M is only willing to warrant are very limited as follows:

“These applications are warranted by the 3M_ MCS_Warranty.• Graphics produced with the GERBER EDGE™ thermal transfer printing system• Vehicle graphics, commercial signs, and striping• Vertical applications only”Reference number and date:


nameEC Number

CAS Number



Ref.No: 530Date: 2014/04/09

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Non-governmental organisation (NGO)Name of org/company:European Environmental Bureau (EEB)Country:Belgium

Rutile, Iron and Perovskite based pigments

CLPSeveral substances, several classifications



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Applicants reply to comments 530-535Contributing third party: EEBECHA consultation numbers 0012-02, 0012-04, 0012-06, 0012-08, 0012-10, 0012-12

For more than 30 years the pigment manufacturers have been offering lead free alternatives and even after 30 years PY.34 and PR.104 remain. The reason for this is that the performance of the alternatives simply is not good enough. In addition to performance issues, the extra cost makes the alternatives even more unsatisfactory.

DCC has one of the widest ranges of PY.34 and PR.104 alternatives, including organic, inorganic and hybrid blend pigments. DCC has been offering these for many years and as such is well versed in the difficulties and impossibilities to replace both PY.34 and PR.104 due to the compromises in performance that has to be made. The possible alternatives were presented in our Analysis of Alternatives. This document demonstrated that every alternative had shortcomings that dismissed them as candidates for 1:1 substitution of PR.104.

There are issues with the alternative pigments that the European Environmental Bureau (‘EEB’) stated in their comments to DCC, namely PBr.24, PR.101 and perovskite based pigments. The EEB cited various references in their comments that did not cover the breadth of applications for which authorization is applied for.

Technical feasibility

PBr.24With respect to PBr.24, the EEB submission makes reference to other manufacturers (BASF, HEUBACH, Rockwood, Ferro) using this pigment for the colouration of paints and plastics, however clearly stating it needs to be combined with other pigments to achieve brilliant shades with high hiding power, in other words addressing the shortcomings of PBr.24 as a 1:1 replacement for PR.104. It also cannot be seen as a replacement to PY.34 due to its very low chroma and shade functionality.This confirms DCC’s comment in the Analysis of Alternatives that from PBr.24 it is impossible to make a bright red colour and so in all cases where that is required today, PY.34 and PR.104 are still used. The shade functionality of mixed metal oxides is simply too limited to be a realistic alternative for PY.34 and PR.104.

PR.101As mentioned in our Analysis of Alternatives, PR.101 is not a viable 1:1 alternative for the similar reasons as PBr.24: the shade functionality, chroma, metamerism, dispersibility and heat stability is inferior to PR.104.Here again, the EEB submission makes reference to other manufacturers (BASF, HEUBACH, Rockwood, Ferro) using this pigment for the colouration of paints and plastics, however clearly stating it needs to be combined with other pigments to achieve brilliant shades with high hiding power, in other words addressing the shortcomings of PR.101 as a 1:1 replacement for PR.104.

As most of these are pigment blends, it is difficult for DCC to assess the suitability without additional information on the pigment composition. These blends offer a “colour matching service” to the customers but by no means they provide the same performance compared to PR.104.

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Perovskite-based (calcium titanium oxides) inorganic pigments-Tantalum(V) nitride and oxidenitrides: CaTaO2 and LaTaON2

The reference included in the EEB submission infers the use of these perovskite based pigments in ceramic applications, a use not included in the DCC Authorisation application. The perovskite pigments mentioned in the article, CaTaO2N and LaTaON2, are targeted as cadmium pigment replacements. It states “their brilliance, tinting strength, opacity, dispensability, light-fastness and heat stability rival that of the cadmium pigments, while their colour can be tuned through the desired range, from yellow through orange to deep red, by simple composition adjustments.”

Without additional information, it is difficult to comment on the colouristics and pigment performance. The reference cited did not address the key performance attributes such as durability, chroma, solvent resistance and metamerism. The perovskite which is a calcium titanium oxide mineral species composed of calcium titanate found in the Urals and Switzerland, Arkansas and some chondritic meteorites may require expensive processing to remove impurities (i.e. lead). As such, price and processing of perovskite may impact the commercial availability of this type of pigment.

Economic feasibilityIn regard to the comments on economic feasibility, the impact of the oversupply of titanium dioxide was mentioned to have influenced the prices of rutile based pigments. While this price reduction of TiO2 may have impacted the cost of these products, it is known that TiO2 impacts the performance of organic pigments. The TiO2 will improve the opacity, however the weatherfastness will be compromised.

Health HazardsThe EEB submission also addressed the hazard and classification of PBr.24, PR.101 and pervoskite pigments. PBr.24 contains antimony and chrome. There is therefore no material improvement compared to PR.104. PR.101 has classification issues as toxic to the environment as well as being a respiratory, skin and eye irritant, it is also known to cause pneumoconiosis, therefore it does not materially improve safety.In this regard, it should be noted that no consumer uses were included in the authorization application. Moreover, the Chemical Safety Assessment has demonstrated that the use of PR.104 will remain below the accepted risk for worker health and will not result in a risk for the environment.

Overall, in the context of the Authorisation application the EEB submission did not sufficiently prove that the proposed alternatives are suitable replacements for PR.104.Reference number and date:


nameEC Number

CAS Number



Ref.No: 458Date: 2014/04/08

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Industry or trade associationName of

Please refer to the non-confidential attachment "VdMi_comments_20140408.pdf"

Comment_458_Attachment.pdf

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org/company:Verband der Mineralfarbenindustrie e. V.Country:Germany


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Applicants reply to comments 457-468Contributing third party: VdMiECHA consultation numbers 0012-01 to 0012-12

Reply applicant:

HazardThe VdMi lists summarized hazard data for a number of alternative pigments. This pigments and hazard profiles listed are for the large part the same as the ones listed in the comments by BASF.

We do agree with VdMi’s bioaccessibility arguments that poor solubility leads to low bioavailability and subsequently to low, if any, toxicity. Especially for Vanadium compounds VdMi makes this argument, stating that 300 – 5000 fold higher solubility of soluble Vanadium compounds compared to Bismuth Vanadate makes this difference and justifies dismissing the vanadium toxicity as not relevant for PY.184. In our case the differences in chromium solubility are 7,200 -80,000 fold, which is more than an order of magnitude higher than that of Vanadium.

At first glance the disseminated information from the REACH registration dossiers seems to confirm that the listed pigment alternatives are not classified. However, a random review of the registration dossier of PY.183 (a calcium mono azo yellow) shows that the fertility & developmental/reproductive toxicity for PY.183 was assessed by Read Across to a structural analogue. Read Across combines the toxicity data for whole group of structurally related compounds. This is a generally accepted method, although it reduces the Klimisch score for the studies to “2” (reliable with restrictions). The key study for reproductive toxicity (OECD 421 reproduction screening study) with this structural analogue of PY.183 shows histopathological and weight changes in both male and female reproductive organs (prostate and uterus) at the high-dose tested (1000 mg/kg bwt/day). The registrant has marked these changes as not adverse, which is at least questionable, since macro- and microscopically apparent atrophy of the prostate probably constitutes an adverse effect, related to fertility and reproduction. Dismissing such a change as “not adverse” will clear the path for all structural analogues in this category regarding this endpoint. If only a quick scan of the disseminated data in the registration dossiers of one or two of the proposed alternatives already shows equivocal or questionable results, we can’t help wondering if the reproductive (and other) toxicity of this category of pigments isn’t underestimated and reevaluation of the study results isn’t warranted.

In general, it is very costly and time consuming for the applicant to perform an in-depth hazard and risk assessment for each and every proposed alternative. The original study data are not publicly available and the disseminated REACH information gives us only the opportunity to screen the hazard information superficially. We hope and expect that the ECHA will make the proper hazard and risk assessment for each of the pigments the RAC/SEAC will consider promising alternatives. So there may be many issues with the organic pigments that VdMi passes over by simple reference to the basic registration file. We have already described in our AoA that PCB contamination of some organic pigments is a reality and that concerns over DCB and diketene are all matters of record. Moreover, in our AoA we have indicated health related concerns e.g. for PO.34, PY.13, PY.83 etc. We indicated that these issues are not primarily related to the pigment itself but with some formulated pigment products (hence several MSDS' can be found that state them as toxic). For example many diarylide pigments are formulated with colophony (rosin), which is classified as a skin sensitizer. In a recent presentation to a major conference the head of the REACH enforcement authorities group Szilvia Deim confirmed that at least one major European enforcement authority (France) was performing controls on Azo pigments1 due to issues such as those reported by the applicant in its submission. The German environmental label ‘Blue Angel’ sets – for example – limits and bans on the use of Azo colorants and dyes2.

1 Presentation at Chemcon Istanbul 1st April 2014.2 http://www.crtib.lu/Leitfaden/content/FR/134/C602/

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The applicant believes that barring more comprehensive submissions by VdMi their simple statement that risks are lower cannot be taken at face value. Instead the more sophisticated and documented submission of the applicant should prevail.

Other comments Chroma & Hue. We agree to the statement: “Since chroma and hue are specific to a pigment the search for a 1:1 replacement cannot

succeed”, which confirms our view that PY.34 and PR.104 are irreplaceable. Opacity, Heat stability, Weather fastness. VdMi basically confirms our argument in our AoA. VdMi states that each of these properties

may be matched to the superior quality of PY.34 or PR.104 by smart combination of different (in)organic pigments, but each of these combinations will most probably lead to compromising one or more of the other performance properties.

Dispersibility. We do not agree to the statement : “In principle inorganic, hybrid pigments and dry pigment preparations are easier to disperse compared to organic pigments”. Hybrid pigments are often a combination of organic and inorganic pigments. Organic pigments are typically harder to disperse compared to inorganic pigments. As such any hybrid pigment will be as difficult to disperse as the organic component it contains. We would agree that inorganic pigments and pigment preparations are easier to disperse than organic pigments. However, PY.34 and PR.104 are always the easiest to disperse compared to any of the potential alternatives presented.



nameEC Number

CAS Number



Ref.No: 388Date: 2014/04/08

Affiliation:BehalfOfACompanyType/Role in the supply chain:ManufacturerName of org/company:ConfidentialCountry:Confidential

SubsInMixture

pigment mixture

CLPAs stated in Appendix I of the document.



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Applicants reply to comments: 387-392 and 395-398Contributing third party: HeubachECHA consultation numbers 0012-01 to 0012-10

There are some aspects of their submission that we would like to highlight separately:1) Heubach’s submission supports DCC’s application;2) Hybrid pigments are not a solution for the uses applied for;3) Dispersions of pigments;4) Markets, availability and volumes.

Heubach’s submission supports DCC’s applicationHeubach states: ‘There is not a single alternative pigment existing to exactly replace a specific PY 34 or PR 104 pigment.’ And ‘Higher formulation costs must however often be accepted. The final costs depend on the colour shade and the required performance.” These contentions are identical to the claims of the applicant – in the absence of a convincing analysis why it is that all applications can be substituted it is only Heubach’s opinion that the inevitable compromises and increases in cost are acceptable for the final customer. Heubach and DCC are both in agreement that there are no 1:1 alternatives to PY.34 and PR.104 and that compromises in performance would be required. Heubach and DCC are also in agreement that high formulation costs are also inevitable as highlighted in the Social Economic analysis.

Heubach also states that it is working to debottleneck production in case demand picks up after the sunset date. This implicitly recognizes that there is an issue there and that Heubach has not yet resolved it – again completely consistent with the claim of the applicant that volumes for substitutes are insufficient.

Hybrid pigments

General remarksHeubach efficiently represents their range of hybrid pigments and makes it appear that they are somehow special or innovative. Instead it is a set of pigments pre-blended to create certain characteristics and colours. This is done more for the convenience of the customer (paint and plastics manufacturers). It does not resolve the complex and very difficult nature of replacing PY.34 or PR.104. Reading the submission the applicant had the feeling he was reading some marketing material by Heubach who are obviously keen to sell their hybrids but should know that most customer prefer to buy single pigments.The applicant also offers such sets of pre-blended pigments that are sold as possible alternatives for PY.34 and PR.104. These blends offer a “colour matching service” to the customer but by no means provide the same level of performance in terms of durability, chroma, opacity/hiding power, metamerism, solvent resistance, heat stability to name a few properties. These blends always have a higher cost ratio due to the use of the needed higher cost organic pigments. Some customers can accept such a degradation of technical quality in certain applications with their poor price/quality ratio. However others cannot. These blends – whilst as good as it’s going to get in terms of alternatives – still cannot match the quality required for the uses we have applied for in the authorization.

Colour index and hybridsThe colour index will never list any proprietary blend of unique pigments because they are mixes of already known pigments and therefore add nothing to the existing list. The blends simply result in an averaging of the component parts and do not magically add anything additional in terms

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of performance. Blends are the property of the company making the blend. Choosing to use such a hybrid range will lock in a client for life because the contents are often proprietary and are not typically made known by the pigment manufacturer. They are therefore unsuitable for anyone with any serious level of sophistication in the pigments business:

1) Colour matchers cannot use the pigments because their added value lies in doing exactly what the blending does except they need to know precisely what is inside the mix to ensure all characteristics of their colour business are met, such as durability, solvent resistance, heat stability, etc;

2) Masterbatch makers in plastics and dispersion manufacturers for coatings will not use them – unless out of convenience – because they need to know what chemistries are inside the blends to ensure there are no adverse reactions, at their downstream users, with the substrate or their resin system or the foreseen use of the final plastic or coated product;

3) Specialist coating and plastic makers will not trust them for much the same reasons as the masterbatch and dispersion manufacturers. Indeed many paint companies refuse to use hybrids or blends as often the pigment company refuses to disclose what is in them as intellectual property or knowledge and thus the paint company is at risk of selecting the wrong product for the application and would be at risk of claims;

4) Machine tool manufacturers (for blending, mixing, masterbatch making etc…) cannot use them because they compete in a global market where they have to be able to use PY.34 and PR.104 to offer complete spectrum coverage whilst knowing the qualities of the pigments in them. Proprietary pre-mix – even if they met the quality criteria which they do not – would force a machine tool maker to sell his machines indicating that it only functions with pigments available from only one company.

Lack of suitability for purpose of hybridsIn any case anyone with a moderate knowledge in pigments is able to create these hybrids as they are solely constituted with pigments that are covered in the AoA of the submission. Heubach suggests the addition of TiO2 to aid in opacifying organic pigments but this has a known negative effect on weather fastness. The addition of TiO2 almost always results in a detrimental impact on the weatherfastness of organic pigments. What further complicates the use of hybrids is that the end use or product (such as a paint) will always have other pigments added as well – if one does not know the constitution of the hybrid one cannot predict what adverse reactions there might be. The importance of this element cannot be overstated – the reaction of the component chemicals in the final use is a key element of determining a choice of pigment and paint/plastic. If you know the coating is used in an alkaline environment – for example – you might want to avoid certain chemistries known to degrade in these environments. As any final use has a mix of pigments the exact composition plays a role in this and must be known to the paint maker. For this reason users tend to prefer working with as few pigments in their mix as possible – every addition creates a complication and this is even more true when the constitution (in a hybrid or blend) is not known.Heubach’s submission lists their proprietary products and the user will need to take their word for it that there will be no adverse effects. The examples Heubach shows are also conveniently chosen for a shade and chroma that is easy to replicate – the green shade of the yellow is a key issue with the use of PY.184 that Heubach shows it is incapable of avoiding. Furthermore where they admit there is a series of challenges in substitution they choose different blends to show how to meet individual ones. So to match shades they use one blend and for weatherability another but this means that the two characteristics are not combined which is exactly the great strength of PY.34 and PR. 104. The fact they submit proprietary blends of unknown content makes it very hard for the applicant to respond and show where these blends will fail. That they do fail is certain or the market would gladly have taken them up as they have been available for many years and to the applicant’s knowledge have not been a massive success. Simply put, Heubach’s technical submission on the suitability of their blends or hybrid products falls down because:

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1. They do not show the complete performance of each hybrid product in terms of the key performance attributes such as durability, chroma, opacity, solvent resistance, metamerism, heat resistance etc. They have been selective in presenting one or two performance criteria for each only.

2. End users have not widely adopted such blends as such products do not offer any true added “state of the art” technology to them. The component pigment parts and their performance weaknesses remain.

Technical remarks on Heubach’s comparative analysis

Comparison is not like for likeWhen analyzing the technical feasibility Heubach is not truly comparing like for like. In graph 1, Heubach used Chroma and hue value measured without gloss (resulting in high C values) whereas in the tables Chroma and hue values they are inclusive of gloss (lower C values). Measurement with or without gloss affects mainly the C value and reduces the hue values. Therefore a correlation between the data in the tables and the graphs is not easy to make for experts let alone for non-pigment professionals.

Film thickness is unrealistic and often unusableHeubach uses a pigmentation level of "only" 5% and apply it at a wet film thickness of 500 microns (HEUBACH GRAPH 3), which is a quite thick layer and in practice not usable for one coat systems. What is therefore omitted in their submission is that this represents two but more probably three layers of coatings. Far more than would be necessary for PY. 34 or PR. 104 formulations, unusable for some applications as it is too thick and adding a lot of expensive in labour, solvents etc… The applicant believes that this makes a reasonable comparison impossible and unfair.

Choice of unrealistic pigmentation level to confuse the comparisonThe one reason for doing that could be to be able to make a comparison with one pigmentation level of 5% and therefore adjusted to the lowest level. Of course, inorganic pigments can have a pigmentation level of up to 30 or 40% depending on system. By doing the comparisons in this way, they eliminate the most critical factor for lead-free formulations which is the lower hiding at practical (thin) film thicknesses. The applicant could likewise come up with a very nice hiding power with just a single pigment as long as the thickness of the film was increased sufficiently. The comparison that Heubach makes therefore seems to deliberately ‘hide’ the key advantage of PY. 34 and PR. 104 formulations.

Purely theoretical analysisIn point 2.2, Heubach claims, that organic pigments can show good hiding power. When one compares pigments by weight this would mean lowering the amount of inorganic pigments to the same amount of organic pigments. By doing this, you decrease the amounts of inorganic particles present in the formulation by 1/2 or even 3/4 depending on the pigment used. What you will note is that the hiding of inorganic pigments decreases and compared against to organics becomes worse. This is completely artificial however as there is no technical, economic or other reason to lower the pigmentation level of inorganic pigments when these are ‘naturally’ high. If Heubach appears to say that organic pigments have greater hiding power than inorganic ones they are probably alone in that view. It is completely accepted wisdom that inorganic pigments have better hiding powers than organic ones.

In the interest of transparency in the public consultation the applicant has nevertheless input Heubach’s figures into its own systems and derived the film thickness in microns that would be required.

C.I. dE (black/white dft3 via DCC AM paint system

3 Dry film thickness11(57)

substrate) [microns]TiO2 PW 6 4 95Vanadur 1010 PY 184 15Heucodur 150plus PY 53 18 81Heucodur 3R PBr 24 5 83Heucotron 1064 PY 34 16Heucotron 1070 PY 34 12 80Heucotron 220 PR 104 2 92Monolite Yellow 107405 PY 74 8Monolite Yellow 115101 PY 151 14 112Monolite Yellow 115401 PY 154 22 112Monolite Yellow 108304 PY 83 7 119Monolite Yellow 113901 PY 139 3 95Monolite Red 311205 PR 112 2 127Monolite Red 325401 PR 254 1 115Monolite Red 325402 PR 254 1 135

This conclusively shows that the film thickness required to achieve the same level of hiding power is much greater for organics than for inorganics.

ODD comparisons in blendsIn the formulation "Combinations of PY184:PY151 60:40 with PY83" the pigmentation level is 15%, which means for PY184 with pigmentation level of 20% and for the 2 used organic pigments 8% summing up to 15%. The hue difference is 0, however the chroma difference is 3 not taking into account for the lightness and the metamerism. For PY.34, the pigmentation level of 15% was used which would normally be much higher at no cost or downside. 15% is –on the other hand – the highest achievable for a mix PY184:PY151:PY83. This shows that even at ideal comparative levels set by Heubach the alternative hybrid cannot meet the same substance function as the blend with PY.34. In reality the PY.34 would be much superior due to the greater pigmentation level and better metamerism as well as deeper colour. One cannot escape the impression that Heubach tortured the data until it yielded a result that suited their purpose.

Heubach exemplifies the ‘dull’colour of the alternativesThe examples in Fig 3 and Fig 4 visually are already really dull compared to PY.34 and PR.104 – this exemplifies one of the key problems of alternatives even in blends: dirty shades, dull colours and lack of chroma. In the applicants original application numerous examples can be found of the bright colours that are easily achievable with PY. 34 and PR. 104. Heubach – even when choosing their own best blends – shows that it is impossible to meet these colouristic aspects.

Weathering comparison between best in class versus worst in classThe weathering results for the lead chromate HT 1064 and the molybdate HT 220 are based on a lower performance PR.104. Higher performance ones exist that would be much better than the one presented by Heubach. If better grades were used, the weathering would become much better

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so again it seems a deliberate choice was made to suit the argument of the submitter rather than reality. The applicant on the other hand has explicitly granted the pigments with good weatherfastness their due in every submission it has made. The fact that the weatherfastness of alternatives comes at an unacceptable cost in other aspects is one of the key problems associated with substituting PY.34 and PR.104.

Dispersions and DispersibilityOrganic pigments and blends are substantially harder to disperse in the final product than PY.34 and PR.104. Heubach state there are stir in organic pigment available on the market but users do not uses these in large volumes as they contain additives that interfere with their end product performance (such as adhesion).In addition Heubach states that dispersion companies are able to provide a service of dispersing the more difficult organic pigments. This completely passes by an important cost issue – any analysis of product offerings by a dispersions producer will show the marked price difference.

Markets and availabilityHeubach indicates that the fall in PY. 34 and PR. 104 usage is due to substitution and certainly this substitution occurred. That was however much longer ago than the time space that Heubach references. Instead the drop in use spotted by Heubach was due to the switch from yellow reflective roadmarkings in some countries to less reflective TiO2 PW. 6 based ones. This caused safety compromises4 but the substitution in volumes for that application was easy because TiO2 is available in large quantities. Heubach also mentions de-bottlenecking operations – in other words it recognizes that there are currently already capacity issues. In the absence of concrete proof of what Heubach’s debottlenecking operations involve we should be cautious about presuming this to make any material difference to available capacities.Reference number and date:


nameEC Number

CAS Number



Ref.No: 381Date: 2014/04/08

Affiliation:BehalfOfACompanyType/Role in the supply chain:ManufacturerName of org/company:BASF SECountry:Germany

Mixtures of organic and inorganic pigments



4 DCC refers to its application where EU research into visibility of roadmarkings.13(57)

Applicants reply to comments 370-375 and 380-385Contributing third party: BASFECHA consultation numbers 0012-01 to 0012-12

Coatings and plastics applicationsDCC will respond to some of the technical aspects mentioned in the submission below as those points are common to some other responses. The summary below gives a summary of the response to the complete document highlighting the most important concepts in it:

a) BASF’s submission indeed supports the applicant’s submission;b) BASF makes statements without proof or oversimplifies issues;c) BASF makes some incorrect, irrelevant or misleading statements.

A brief detail of each of these points is given below. Firstly it must be pointed out that BASF is the largest manufacturer of pigments worldwide. Despite its submission that there are many adequate alternatives to PY.34 and PR.104 there has been an overwhelming submission from downstream users, actual users of PY.34 and PR.104, that there are no adequate alternatives for these valuable performance pigments. Many hundred EU downstream user comments were received supporting the applicant’s authorization application and providing ample actual user evidence that refutes BASF’s claim as a pigment manufacturer.The applicant underlines that in section c) we will show that BASF has made incorrect statements explicitly denied by the companies they purport to be quoting. The applicant suggests that this calls into question all other claims and assertions BASF makes throughout the rest of its paper.

BASF Submission supports the DCC applicationDCC notes that the BASF submission supports its own application on several points:

1) BASF admits that some of its customers are unable to transition away from the use of PY. 34 and PR. 104;2) BASF admits there is no 1 for 1 replacement to PY. 34 and PR. 104;3) BASF admits the European colour matching industry will be unable to use its full colour range on the world market.

Inability of some customers to transitionBASF states: “most of our customers have either successfully converted to lead chromate free formulations or are prepared to do so….” This means that SOME of their customers have not and are unable to transition which is exactly the point that the applicant has made in his submission. BASF also states: “DUs will be supplied with a bunch of different products across a wide range of inorganic and organic pigments based on their specific uses…. since decades” as well as “since more than 30 years the pigment manufacturers have been offering lead free alternatives to the coatings industry”. This eloquently proves that completely replacing PY. 34 and PR. 104 is impossible or it would have been done in those intervening decades. The applicant itself has one of the widest ranges of PY.34 and PR.104 alternatives, including organic, inorganic and hybrid blend pigments. DCC has been offering these for many years and as such is well versed in the difficulties and impossibilities to replace both PY.34 and Pr.104 due to the compromises in performance that has to be made.In plastics BASF quotes Clariant: “Clariant MB Europe stepped completely out to produce Masterbatch based on Lead chromates in the different European facilities. The reformulation of the existing products was done together with the influenced costumers and in most of the cases without significant problems”. Again this confirms there are customers unable to transition as the statement that in MOST cases a solution could be found is one the applicant can agree with. Clariant MB remains a user of PY.34 and PR.104 in countries outside the EU. The applicant believes that Clariant MB has moved its Masterbatch production to countries outside the EU and has not terminated it as the quote seems to suggest. In light of other incorrect and tenuous claims BASF has made about customers the applicant respectfully suggests that the alleged statement as reported by BASF

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should not be taken into account.The real problem is that as the quote does indicate, solutions cannot be found for ALL customers which is why authorization is necessary. It is not a coincidence that DCC customers in plastics are primarily based in Southern Europe where the sun plays a far more important role than in the North. Southern Europe is also a large exporter to the Middle East and Northern Africa where exterior durability is a large need as well as being competitive. The Southern European customers will lose its competitive edge vs non EU competitors in these markets, in terms of performance and commercial issues should they be forced to not use PY.34 and PR.104. The one big customer that is based in Belgium makes very high quality and durability products and is subject to the same challenges. It is for such customers as these that authorization is requested for, not for all of those that can and have made the change.BASF is by far the largest pigment producer in the world, according to its annual report it has sales of >€ 3.5 billion for pigments in the coatings sector5. By comparison the applicant turns over a fraction (less than 5%) of this revenue in pigments for coatings, plastics and inks of all colours. When BASF indicates that ‘some’ of its customers cannot transition this likely covers a huge number of small users6. The user community is very large and comprises large numbers of SME customers with very specific applications. Large corporations like BASF tend to be unable to service such customers and are not organized in a manner that is able to supply their needs compared to the applicant and others. All of this confirms the applicant’s contention that the uses applied for cover a small volume of absolutely unsubstitutable uses which companies like BASF can afford to ignore due to their high volume sales in areas that do not have these requirements.The reality is that numerous BASF customers in the EU and elsewhere have turned to the applicant for supply of PR.104 and PY.34 because they lack an alternative that works for them. The large response in support of DCC’s application confirms what it stated in the original application that customers need the pigments.

Lack of 1 on 1 replacementBASF states: “There is no 1 to 1 plug-in substitute for lead chromate, but there are organic and inorganic pigments available to be mixed or blended to formulate lead free paints and coatings.” This statement is completely in harmony with the applicant’s contention in the submission that it is impossible to substitute PY. 34 and PR. 104 but that one has to look further and take into account whether combinations of other pigments would be able to arrive at the same result.No one should be better aware than BASF that the markets for the different pigments are not substitutes for each other as it was the key conclusion of the European Commission in the merger decision BASF-CIBA7. In that case BASF contended that there were alternatives 1 for 1 for PY. 34 and PR. 104 but this was rejected by the Commission based on a market analysis in 20098. The Commission also underlined that the inorganic and organic pigments markets are separate ones. Had the above argument of BASF that blends provide comprehensive solutions been valid (seeing as they have been available for decades) they would have put that contention to the Commission. The fact they did not prove that – as DCC contends – it is only a stop gap measure that will work in some cases but cannot be deemed a full and adequate substitute. BASF’s statement regarding blends must therefore be regarded as an argument of convenience that benefits their commercial strategy for vertical integration of pigment production and pigment blending.We also refer to our answer to the Heubach submission regarding the unsuitability of hybrid pigments (or blends) as alternatives to PY.34 and

5 http://www.basf.com/group/corporate/en/function/conversions:/publishdownload/content/about-basf/facts-reports/reports/2013/BASF_Report_2013.pdf P. 70 ‘management report’ and various other places. This covers only pigments for coatings not for plastics which are quoted separately under performance chemicals, in its statement BASF announced that per 2014 all pigment sales will be quoted under the same heading..6 On the basis of a turnover extrapolation one could surmise several hundred customers of BASF are unable to switch to alternatives – for BASF this is no doubt a small number and the volumes compared to their other sales are insignificant. The impact for the sector is nevertheless going to be very large.7 http://ec.europa.eu/competition/mergers/cases/decisions/m5355_20090312_20212_en.pdf PP. 19-308 In EU merger decisions participation in the market analysis by competitors and downstream users is mandatory and responses must be truthful on pain of severe penalties. The Commission’s conclusion can therefore be said to be based on the one and only truly transparent market inquiry into pigments devoid of opinion or marketing claims.

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http://ec.europa.eu/competition/mergers/cases/decisions/m5355_20090312_20212_en.pdf

http://www.basf.com/group/corporate/en/function/conversions:/publishdownload/content/about-basf/facts-reports/reports/2013/BASF_Report_2013.pdf

PR.104.

Colour matching industryBASF states: “Using colour matching tools (software and equipment) is a common standard within the entire paint and coatings industry. That means the industry is experienced to match all important shades by a selection of pigments. Usually paint companies offer a broad range of colours which are achieved easily via blending of selected pigments even for small batches. Colour matching supported by electronic tools is technical standard in the industry.”

In our submission we have pointed out that the first victim of a denial of the authorization application would be Europe’s colour matching and machine tool industry. These companies need to be able to offer a complete gamut of colour and colour mixing abilities to compete on the global market. The downstream users the applicant surveyed exported 40-60% outside of the EU. BASF’s statement confirms that these companies by being denied access to PY. 34 and PR. 104 will be forced to offer a more limited and less comprehensive offering to their non-EU customers. This competitive disadvantage is important because buyers of such technologies rely on the ability – as BASF states - to make every colour and mix.

BASF makes statements without proof or oversimplifies issuesIn its submission BASF several times makes statements of fact without providing any more substantiation for it than that it is their well considered expert opinion. As the applicant has provided extensive detail for many of his own contentions DCC believes that BASF should be held to the same standard and offer better substantiation of its claims. There are also points where BASF has oversimplified certain complex issues to make its point resulting in erroneous statements.

1) Many statements are made without proof;2) Simplification of the substitution through blends;3) Omission of hazard aspects of component molecules within pigment products.

Unproven claimsIt would go too far to detail every unproven claim made in the BASF paper but the list below should be indicative of the depth of the issue in relation to the submission.

- The hazard profile of the alternatives provided by BASF is based solely on the substances themselves – not on the component molecules or their fate in the end pigment product or in the end application;

- Availability of other pigments is repeatedly stated without any proof that this is true. In fact in more than a few cases BASF is the ONLY supplier or one of just two suppliers. Furthermore the applicant also reviewed the availability of the raw materials for the production of the so called alternatives. BASF did not review this;

- Production capacity is also lacking – PY 184 for example created a market of 3000 tp/a when substitution of PY. 34 were done in earnest already some time ago. The volume substituted was 50,000 t p/a9. This means that for the remaining tonnage of PY. 34 an additional market of 2700 t p/a of PY. 184 would be required. The applicant’s internal assessment (as a producer of PY. 184) is that the world-wide production capacity is not more than 3500 t p/a. Powder coatings in Europe are ‘mainly’ lead free – which bypasses the fact that as a consequence of the EU going ‘lead-free’ in the early 2000’s the production of PY.34 and PR.104 based powder coatings increased significantly in Turkey. This is the concern with regards to many downstream users that production will simply move to non EU countries making the EU based downstream users non competitive technically and commercially. History has shown this will happen. In addition, the word “mainly” gives no indication

9 The discrepancy in volume is due to markets being abandoned or moved outside of the EU and the use of other pigments in different mixes as PY. 184 cannot substitute all functions of PY. 34;

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whether that means there is 1,5,10,25 or 40% still using PY. 34 and PR. 104;- No single substitute to PY. 34 and PR. 104 is required – no explanation is given for the issues highlighted by the applicant or the metamerism

issue BASF completely passes over;- General industrial paints are stated to require ‘medium durability’ – this is not correct in DCC’s opinion and BASF provides no proof for this

statement. General industrial paints cover a wide gamut of applications requiring low to medium to high durability. This is a significant benefit of PY.34 and PR.104 compared to the alternatives that BASF suggests;

- BASF’s example on a more cost-effective lead-free alternative in comparison to PR.104 for a RAL3000 formulation is not substantiated by proof. Calculations based on the average costs/kg for each of the pigment components in the two formulations show the opposite: the lead containing formulation is always more cost-effective that the lead-free formulation. Of course there may be other (undisclosed) factors that BASF considered in their comparison, but without all necessary information such a comparison may be misleading;

- On hazards BASF speculates that bioavailable metal ions in some of their inorganic alternatives come from impurities – no proof is given of that statement.

Simplification of the problems related to blendsBASF has provided some statements regarding what it believes is necessary to find matches for PY. 34 and PR. 104 and has some examples of what it says are successful alternatives for PY. 34 and PR. 104. The applicant is willing to agree that there may be an application for which BASF’s example works but it would be equally easy to find examples where it will not. BASF amongst others passes over the following points:

1) The lack of shade functionality leads to metamerism issues in the final product;2) Lower chroma means dirtier colours – BASF euphemistically speaks of the customer accepting some compromises – but fails to reveal how

extensive that compromise could be;3) Durability is almost always lower –there are situations where this is acceptable but those are not the ones for which use authorisation has

been applied for;4) BASF’s examples do not show opacity comparisons thereby avoiding the inevitable consequence of the requirement for additional coatings to

achieve the required hiding. Additional coatings results in the use/need for more paint and therefore has an environmental impact due to higher amounts of resins and solvents required;

5) Solvent resistance of the alternatives is not mentioned by BASF – this is an issue for many applications;6) Dispersibility is poorer of the blends leading to much higher energy costs to produce the final coating;7) BASF makes no reference to issues that the alternatives can have in the final use when it is an aggressive environment or very long

durability is required;8) BASF suggests mixing white pigment into organic pigments for opacity but this has a major impact on the durability and shade of the final

product. When white pigment (normally titanium dioxide) is added to organic pigments to increase opacity the durability is almost always immediately reduced resulting in performance issues. In addition the final shade can appear washed out or less bright meaning some colours cannot be matched;

9) BASF’s examples for red colour matches chose particularly easy to match shades;10)Where BASF says powder coatings in the EU went lead free – they fail to add that when that happened a significant increase in volume was

noted in Turkey for PY. 34 and PR. 104 – essentially the EU industry moved out as they could no longer compete technically or commercially.

Risks associated with component moleculesWe do agree with BASF’s argument that poor solubility leads to low bioavailability and subsequently to low, if any, toxicity. Especially for example for Vanadium compounds BASF makes this argument, stating that 300 – 5000 fold higher solubility of soluble Vanadium compounds compared to

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Bismuth Vanadate makes this difference and justifies dismissing the vanadium toxicity as not relevant for PY.184. In our case the differences in chromium solubility are 7,200 -80,000 fold, which is more than an order of magnitude higher than that of Vanadium.

At first glance at the disseminated information from the REACH registration dossiers seems to confirm that BASF’s organic pigment alternatives are not classified. However, a random review of the registration dossier of PY.183 (a calcium mono azo yellow) shows that the fertility & developmental/reproductive toxicity for PY.183 was assessed by Read Across to a structural analogue. Read Across combines the toxicity data for whole group of structurally related compounds. This is a generally accepted method, although it reduces the Klimisch score for the studies to “2” (reliable with restrictions). The key study for reproductive toxicity (OECD 421 reproduction screening study) with this structural analogue of PY.183 shows histopathological and weight changes in both male and female reproductive organs (prostate and uterus) at the high-dose tested (1000 mg/kg bwt/day). The registrant has marked these changes as not adverse, which is at least questionable, since macro- and microscopically apparent atrophy of the prostate probably constitutes an adverse effect, related to fertility and reproduction. Dismissing such a change as “not adverse” will clear the path for all structural analogues in this category regarding this endpoint. If only a quick scan of the disseminated data in the registration dossiers of one or two of the proposed alternatives already shows equivocal or questionable results, we can’t help wondering if the reproductive (and other) toxicity of this category of pigments isn’t underestimated and reevaluation of the study results isn’t warranted.

In general, it is very costly and time consuming for the applicant to perform an in-depth hazard and risk assessment for each and every proposed alternative. The original study data are not publicly available and the disseminated REACH information gives us only the opportunity to screen the hazard information superficially. We hope and expect that the ECHA will make the proper hazard and risk assessment for each of the pigments the RAC/SEAC will consider promising alternatives. So there may be many issues with the organic pigments that BASF passes over by simple reference to the basic registration file. We have already described in our AoA that PCB contamination of some organic pigments is a reality10 that needs to be carefully controlled by manufacturers, and that concerns over production and handling of semi products. Concerns over DCB and diketene used in the manufacture of the alternatives are all matters of record. Moreover, in our AoA we have indicated health related concerns e.g. for PO.34, PY.13, PY.83 etc. We indicated that these issues are not primarily related to the pigment itself but with some formulated pigment products (hence several MSDS' can be found that state them as toxic). For example many diarylide pigments are formulated with colophony (rosin), which is classified as a skin sensitizer. In a recent presentation to a major conference the head of the REACH enforcement authorities group Szilvia Deim confirmed that at least one major European enforcement authority (France) was performing controls on Azo pigments11 due to issues such as those reported by the applicant in its submission. The German environmental label ‘Blue Angel’ sets – for example – limits and bans on the use of certain Azo colorants12. The applicant believes that barring more comprehensive submissions by BASF their simple statement that risks are lower cannot be taken at face value. Instead the more sophisticated and documented submission of the applicant should prevail as production and use of organic and inorganic pigments have inherent risks too that need to be appropriately managed.

Incorrect, irrelevant or misleading statementsAs has been shown above the examples of substitution given by BASF are themselves oversimplified and fail to cover the breadth of applications for which authorization is applied for. In addition to that general statement the applicant wants to point out the following.

Incorrect statementsBASF makes claims regarding some customers quoting them as regards their willingness to go ‘lead-free’. DCC has verified most13 of these statements and has received a large response that BASF has quoted them without their authorization and that the statements themselves are not 10 We refer to our response to ETAD where we have given extensive links to the issue of PCB pollution of organicpigments.11 Presentation at Chemcon Istanbul 1st April 2014.12 http://www.crtib.lu/Leitfaden/content/FR/134/C602/

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http://www.crtib.lu/Leitfaden/content/FR/134/C602/

correct and do not represent the corporate policy of the company. PPG has authorized us to quote them on the record regarding BASF’s claim:

“The statement made by BASF, attributed to PPG, was made without PPG's knowledge or consent. It should be removed from the record.” Minesh Shah, PPG Industries SARL.

As we have heard similar responses from other customers mentioned in BASF’s submission we believe that most customer claims put forward by BASF in their document are very likely to be incorrect.Whereas we do not want to claim BASF’s statements are deliberately false we believe that the public consultation is the place for customers to make their views known. DCC has also quoted its customers but that was in the framework of the supply chain analysis performed as part of the authorization application and the applicant was very cautious in the manner it represented its customers. BASF has taken upon itself to represent downstream users without it appears requesting authorization to do so. Unless BASF wants to show written proof of the quotes made by the customers we would contend they should all be withdrawn. As a result of the public consultation process, DCC on the other hand can point to the several hundred supportive responses which are ‘on the record’ unlike the unattributed quotes by BASF.

Irrelevant statementsBASF’s submission several times quotes uses and customers which do not use and do not need to use PY. 34 and PR. 104 as support for its contention that substitution is possible. This relates particularly to the decorative paints industry and the automotive industry. The decorative paint sector has not been using PY.34 and PR.104 for many years and does not need the performance attributes these pigments offer. DCC supports a lead free decorative paints policy. In addition quoting the automotive industry is particularly misleading because of the way it decided to go ‘lead-free’ in the mid nineties:

- A two coat system was introduced – a base colour coat covered by a protective clear coat;- Durability (wear and tear) needs of automotive coatings are vastly inferior to those of agricultural machines with dangerous moving parts;- Clear coat delamination is a known issue with current car coatings occurring well after the end of the warrantee and OEM tests i.e. after 5+

years.The application of two coats is not always possible and adds a level of cost that makes some uses uncompetitive. Furthermore a simple internet search for “clear coat delamination” will show extensive examples of weatherfastness and durability issues with automotive coatings. Once the clear coat is damaged the coloured undercoat also shows issues.

13 There was no time to contact all of the customers mentioned in the period given for us to respond. Of three the applicant managed to reach all responded that the statements of BASF were untrue and unauthorised.

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14

Views disagree as to the causes of this with some pointing to weathering, exposure to aggressive environments or just the passage of time. It is noted it tends to happen after a number of years have passed. Some contend that to prevent such delamination the car industry has proceeded to add further clear coats but this is apparently not universal.

This is consistent with the applicant’s point that further applications of coatings are required to substitute PY. 34 and PR. 104. Automotive OEM applications are not part of DCC applied for uses. It is applications such as agricultural machines that are of importance. In agricultural machines - with a predicted use well beyond that of the average life time of a car - the PY. 34 and PR. 104 provide for contrast and warning signals which are far more important than the esthetic quality of the coating of a car. In our technical submissions we give further details of real weathering tests. The above result is acceptable for automotive – not for machinery.

Responses to individual suggested alternativesBASF makes it sound very simple to substitute pigments whereas this is not true. According to their statement it suffices:

o To cover the entire colour space

14 These images are just random examples of thousands that can be found on the internet detailing this issue. Car enthusiast websites actively discuss causes, remedies and question the quality of the automotive paints as a consequence. Automotive OEM’s are understandably reluctant to admit to this problem.

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o To supply clean colour shadeso To fulfill high opacity requirementso To cover different performance levelso To give heat resistance >200Co To have no bleeding issueso To fulfill technical requirements regarding coating manufacturing equipment

What they do not add is that no pigment can match all of these characteristics at once and that blending inevitably leads to further quality compromises. The tables below provide brief summaries of the deficiencies in terms of performance, supply chain and potential hazards of the alternatives.

Summary of possible alternatives to PY.34PY.34 – strengths wide shade functionality, durable, opaque, solvent resistant, high chroma, no metamerism, easy to disperse, good colour strength

Pigment Performance Availabilities Hazard ProfileCI No. Class Strengths Weaknesses Raw material Pigment Raw material Pigment

manufacturingPigment

PY.53 CICP DurableOpaqueSolvent resistant

Poor shade functionalityChromaMetamerismVery low colour strength

Available Available Uses toxic nickel salts

High energy intensive process

No known concerns

PBr.24 CICP DurableOpaqueSolvent resistant


Available Available Uses toxic nickel, chromium and antimony salts


No known concerns

PY.184 BiVa DurableOpaqueSolvent resistantChroma

Poor shade functionalityMetamerismLow colour strengthLower dispersibility

Bismuth and Vanadium limitedin supply. Bismuth is aby product of lead mining.Bismuth is limited in supply

Limited supply and globallyincreasing demand.

Vanadium pentoxide

Handling of vanadium pentoxide

No known concerns

PY.138 Quinophthalone High colour strengthSolvent resistantChroma

Poor shade functionalityMetamerismLow durabilityTransparentLower dispersibility

Only available from BASF

Only available from BASF

Limited availability of 8-aminoquinaldine. Only BASFmakes this raw material and isonly used for internalconsumption

Solvent handling requirements

No known concerns

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PY.139 Isoindoline DurableChromaOpaqueSolvent resistant

Poor Shade functionalityMetamerism

Diiminoisoindoline limited in supplyPhthalodinitrile availableBarbituric acid regulated in some countries

Limited availability (page 98 AoA 2)

None known Solvent handling requirements

No known concerns

PY.74 Azo Limited chroma Poor shade functionalityPoor durabilityMetamerismMore transparentPoor solvent resistanceLower dispersibility

Available Available The amines are acutely toxic andmust be handled as such

No major concern No known concerns

PY.151 Benzimidazolone Solvent resistant Poor shade functionalityMetamerismLower chromaLower durabilityLower opacityLower dispersibilityPoor alkali resistance

Anthranilic acid is a controlled substance. Issues in supply chainAABD limited number of suppliers. <5 good suppliers

Available but limited to <10 significant ones

No significant concerns





PY.42 Iron oxide DurableOpaqueSolvent resistant

Poor Shade functionalityMetamerismVery low chroma/dirtyDispersibility lower

No known issues No known issues

No known issues

No known issues No known concerns

PY.83 Diarylide Good solvent resistance

Poor shade functionalityPoor durabilityLower chromaMetamerismMore transparentLower dispersibility

Limited suppliers for 3,3’-dichlorobenzidine (DCB)

Available DCB is a suspect human carcinogen. Special handling and human health monitoring

Handling of DCB Control of trace DCB content within pigment.Formulated products often requiring

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required labelling as sensitisers.

PY.128 Dis-azo condensation Good solvent resistanceHigh colour strengthGood durability

Poor shade functionalityLower chromaMetamerismMore transparentLower dispersibility

Unknown by applicant Only two known suppliers – BASF and Synthesia

Unknown by applicant

Synthesis typically requires handling of chlorinated solvents

No known concerns




PY.194 Benzimidazolone Solvent resistant Poor shade functionalityMetamerismLower chromaLower durabilityLower opacityLower dispersibility

AABD – only available from Asia.3 known sources.


Ortho anisidine is a suspect human carcinogen. Special handling required

Handling of ortho anisidine

No known concerns

PY.154 Benzimidazolone Solvent resistant Poor shade functionalityMetamerismLower chromaLower durabilityLower opacityLower dispersibility

2-triflouromethyl aniline <5 sources

AABD limited number of suppliers.

Few major sources

Special handling of 2-triflouromethyl aniline required to protect workers

Handling of the amine

No known concerns

PY.216 CICP DurableOpaqueSolvent resistant


Available Available High energy intensive process

No known concerns




PY.110 Isoindolinone DurableSolvent resistant

Poor shade functionalityMetamerismLower chromaMuch lower opacityLower

No known issues by the applicant

<5 sources Special handling of PCl5 required.Special solvent handling requirements needs

See raw material section

Concerns over hexa chlorobenzene and PCB content exists

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dispersibilityPY.65 Azo Limited chroma Poor shade

functionalityPoor durabilityMetamerismMore transparentPoor solvent resistanceLower dispersibility

Available Available The amines are acutely toxic andmust be handled as such


Summary of possible alternatives to PR.104PR.104 – strengths wide shade functionality, durable, opaque, solvent resistant, high chroma, no metamerism, easy to disperse, good colour strength



PR.254 DPP ChromaOpaqueSolvent resistant

Poor Shade functionalityMetamerismLower durability

No major issue known Limited to two major sources and 4 minor

None known Handling of sodium metal often required. Solvent handling requirements

No known concerns

PR.112 Naphthol AS Limited chroma Poor shade functionalityPoor durabilityMetamerismMore transparentPoor solvent resistanceLower dispersibility

Trichloroaniline limited in suppliers

Available Special handling of amines required

Special controls for pigment manufacture due to use of conc sulphuric acid and nitric acid. Certain routes of mannufacture prone to explosion potential

Careful control of pigment manufacture needed in order to control PCB content

PR.101 Iron oxide DurableOpaqueSolvent resistant

Poor Shade functionalityMetamerismVery low chroma/dirtyDispersibility lower

No known issues No known issues

No known issues

No known issues No known concerns




PO.34 Diarylide Good solvent Poor shade functionality Limited suppliers for Available DCB is a Handling of DCB Control of trace 26(57)

resistance Poor durabilityLower chromaMetamerismMore transparentLower dispersibility

3,3’-dichlorobenzidine (DCB)

suspect human carcinogen. Special handling and human health monitoring required

DCB content within pigment.Formulated products often requiring labelling as sensitisers.

PO.67 Pyrazolo quinazolone

Chroma Poor shade functionalityPoor durabilityMetamerismMore transparentPoorer solvent resistanceLower dispersibility

Coupling component only manufactured by BASF

Global volumes for PO.67 areunknown as it is a niche pigmentonly manufactured by BASF.

None known Solvent handling requirements

No known concerns

PO.73 DPP DurableSolvent resistant

Poor Shade functionalityMetamerismTransparentVery low chroma/dirtyDispersibilitylowerVery bad rheology

No known issues Only two dominant/major suppliers – BASF and CINIC

None known Handling of sodium metal often required.Solvent handling requirements

No known concerns




PR.48:4 BON Red 2B Good solvent resistance

Poor shade functionalityPoor durabilityLower chromaMetamerismMore transparentLower dispersibilityVery deep in shade and rarely considered a PR.104 alternative

Available Available No major concerns

No major concerns – aqueous process

No known concerns

PO.82 CICP DurableOpaqueSolvent resistant


Available One known source – BASF


No known concerns

PO.13 Diarylide Good solvent resistance

Poor shade functionalityPoor durabilityLower chromaMetamerismMore transparentLower dispersibility

Limited suppliers for 3,3’-dichlorobenzidine (DCB)

Available DCB is a suspect human carcinogen. Special handling and human health

Handling of DCB Control of trace DCB content within pigment.Formulated products often requiring labelling as

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monitoring required

sensitisers.




PO.36 Benzimidazolone Solvent resistantDurability

Poor shade functionalityMetamerismLower chroma/dirtyLower opacityLower dispersibility

PCONA limited in supplyAABD limited number of suppliers. <5 good suppliers


PCONA, 2-trifluoromethyl anilineand ortho-anisidine aretoxic/hazardous and thusadequate protection of workersand the environment must betaken. Ortho-ansidine is asuspect human carcinogen

Handling of PCONA No known concerns

PR.170 Naphthol AS Limited chromaSolvent resistant

Poor shade functionalityPoor durabilityMetamerismMore transparentLower dispersibility

Limited supply of the amine and coupling component

Available No major issues No major issues No known concerns

PR.254 DPP DurableSolvent resistant

Poor Shade functionalityMetamerismTransparentVery low chroma/dirtyDispersibilityLower

No known issues Two dominant suppliers

None known by applicant

Handling of sodium metal often required.Solvent handling requirements

No known concerns




PR.122 Quinacridone DurableSolvent resistant

Poor Shade functionalityMetamerismTransparent

No known issues Available Requires poly phosphoric acid and para

Significant amounts of phosphate waste

No known concerns

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Low chroma/dirtyDispersibilityLowerPR.122 is too deep to be considered a viable PR.104 alternate

toluidine both hazardous chemicals

that must be handledSolvent handling requirements needed too

Summary of possible alternatives to PY.34 and PR.104PY.34/PR.104 – strengths wide shade functionality, durable, opaque, solvent resistant, high chroma, no metamerism, easy to disperse, good colour strength



PW.6 Titanium dioxide

PW.6 is a white pigment normally used to provide opacity to the much more transparent organic pigments. The problem with this approach is that the more PW.6 is added the already less durable organic pigments become even less durable. In addition the shade of the organic pigments become two pale and “washed out” looking.

Available Available

Specific RAL Matches – Economic feasibilityThe matches offered by BASF are rather convenient for their purpose in this case but even so they cannot stand the test of a real comparison. The following key points are glossed over by BASF and not taken account in their economic comparison of the pigments:

1) RAL 1021 – yellowa. Metamerism of this pigment is much higher this will cause a problem for the user that BASF fails to mention or offer a solution for;b. PY. 151 is far more transparent than PY. 34 – opacity comparisons are conveniently omitted – this means that far more coatings will be

required to obtain the same coverage;c. Pigmentation of PY. 151 is much lower and therefore more resins and solvents need to be added to make the coating. This additional

cost is not taken into account by BASF;d. The pigment is much harder to disperse than PY. 34 so it will be commensurately more expensive as a masterbatch and therefore a

coating;e. Even without taking all of this into account BASF arrives at a cost that is higher than for PY. 34.The reality is much worse and the

technical function of the substance is not adequately met.2) RAL 3000 – red colour

a. As mentioned BASF chose one of the easiest shades to match;b. Metamerism of this pigment is much higher this will cause a problem for the user that BASF fails to mention or offer a solution for;c. Pigmentation of PR.254 is much lower and therefore more resins and solvents need to be added to make the coating. This additional

cost is not taken into account by BASF;d. The pigment is much harder to disperse than PR. 104 so it will be commensurately more expensive as a masterbatch and therefore a

coating;e. The costing BASF offers certainly excludes the above costs and therefore is not a legitimate comparison;

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f. The final costing is not believable – as opposed to the applicant BASF has failed to give a breakdown of his calculations so it is impossible to examine how they arrived at the result that they did however the applicant is convinced it is impossible if only because PR. 254 is at least 2.5 times more expensive than PR. 104. We have attempted to reconstruct the calculation but based on known pigment prices alone we arrive at the conclusion that the PR. 254 mix is 68% more expensive than the PR.104 mix15;

g. The calculation also includes the very cheapest added alternatives PR. 101 and PR. 53 for the PR. 254 mix, which completely lack shade functionality (this is likely why BASF chose to match the simplest colour in red). In the PR.104 mix the very expensive PR.122 is added which substantially increases the cost.

The applicant believes that attempting to compare mixes – which are in any case only punctual solutions for particular applications – BASF is making any real debate on the pros and cons of alternatives impossible and confusing the issue. Pigments are always used in mixes and should therefore be compared on their relative merits regardless of the mix they end up being used in.



nameEC Number

CAS Number



Ref.No: 363Date: 2014/04/07

Affiliation:BehalfOfACompanyType/Role in the supply chain:OtherName of org/company:AkzoNobel N.V.Country:Netherlands

SubsInMixture

bismuth vanadate, mixed metal oxides, iron oxides, organic pigments

14059-33-7

GHSCAS number of alternative GHS classification 14059-33-7 H373 8007-18-9 Unclassified 68186-90-3 Unclassified 51274-00-1 Unclassified 1309-37-1 H411



15 Pigment prices used are those in our original submission appendix. The values were multiplied by the percentage of pigment BASF says are necessary and then compared on a percentile basis.

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Applicants reply to comments 260-267 and 362-369Contributing third party: AkzoECHA consultation numbers 0012-01 to 0012-06, 0012-11, 0012-12

The general content of the Akzo submission warrant a few remarks.

PY. 34 and PR. 104 customersAkzo is a professional and reputable company that has decided it does not require PY.34 and PR.104 for the markets it serves. As with all users, Akzo has a right to choose the markets it serves and the raw materials it uses. However, the over whelming response in support of the applicant’s application, numbering in the many hundred, provides ample evidence of the need for these pigments in the applications applied for. The respondents are for the most part small to medium sized companies providing a specific product for a niche application.This is the main issue in regards to Akzo’s comments. Akzo is not a paint manufacturer for which PY. 34 and PR. 104 are is appropriate. There are however dozens and dozens of smaller specialized paint makers – which are in large part buyers of PY. 34 and PR. 104 – and who are SME’s (with turnover <100M Euro) or even larger paint companies (turnover <1B€uro) who have profiled themselves into specialist markets. These small specialist markets are not serviced by Akzo who with its general large overhead and focus on volume production find it uneconomic to serve them. That Akzo as a decorative paints market leader prides itself on being lead free is therefore hardly surprising. The Applicant also supports lead free for decorative paints.Akzo claims that its customers have not objected to the use of PY. 34 and PR. 104 free formulations raises the question whether these customers had need for those coatings in the first place or whether they simply chose to obtain these coatings from other sources than Akzo. Evidently – as with the situation in road markings – Akzo is not in the relevant market segment where the characteristics of PY. 34 and PR. 104 are required.Furthermore insofar as Akzo had sales of PY.34 and PR. 104 based coatings, they were likely insignificant on Akzo’s total coatings sales. PY.34 and PR. 104 account for at most 0.02% of world-wide paint sales which proportional to Akzo’s coatings sales would account for just € 1-2 million of sales p.a. of coatings – in other words a market that Akzo could easily abandon to its smaller competitors. A denial of the authorization request is therefore a measure that primarily affects SME’s adversely whereas Akzo will benefit.

FeasibilityBased on Akzo’s submission the Applicant believes they are not best placed to remark on the feasibility of transition as they appear to either not service or to have deliberately moved out of the market that required the specific characteristics of PY.34 and PR.104. Their statements are however not backed up by any substantive proof – so the Applicant refers to its extensive submissions so far regarding the realities in the market. As regards the economic feasibility Akzo also incorrectly presumes that environmental costs are not taken into account as part of the full life cycle – this is of course the case and costs are discounted in the Socia-Economic analysis to reflect this.

SuitabilityAkzo claims that it has experience in markets that fall under the uses applied for. However it shows a misunderstanding of DCC’s application for authorization:

(1) The formulation use is applied for because it has a separate exposure scenario and therefore must be separately authorised according to ECHA guidance. As the applicant stated in its submission the substance has no function at this stage and the existence (or lack thereof) of alternatives is irrelevant;

(2) Industrial and professional applications of the uses applied for have simply bought specialized coatings from competitors to Akzo. As

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mentioned above the volume of paint involved for a company like Akzo is so minimal that they are unlikely to notice the difference. Furthermore Akzo’s greatest strengths in these markets lie in paints that have different characteristics than the coatings produced with PY. 34 and PR. 104.

Other remarksThe Applicant concurs with Akzo that coatings used in Airports and plastic hot melts used in road markings are subject to specifications that cannot and should not be lightly changed. As Akzo admits they are not a player on these markets. Companies that are active in these markets have voiced very different views in the public consultation regarding this issue and the Applicant believes their opinion should prevail.Reference number and date:


nameEC Number

CAS Number



Ref.No: 261Date: 2014/04/07

Affiliation:BehalfOfACompanyType/Role in the supply chain:OtherName of org/company:AkzoNobelCountry:Netherlands

SubsInMixture

see non confidential attachment

CLPsee attachment

Comment_261_Attachment.docx


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Applicants reply to comments 260-267 and 362-369Contributing third party: AkzoECHA consultation numbers 0012-01 to 0012-06, 0012-11, 0012-12

The general content of the Akzo submission warrant a few remarks.

PY. 34 and PR. 104 customersAkzo is a professional and reputable company that has decided it does not require PY.34 and PR.104 for the markets it serves. As with all users, Akzo has a right to choose the markets it serves and the raw materials it uses. However, the over whelming response in support of the applicant’s application, numbering in the many hundred, provides ample evidence of the need for these pigments in the applications applied for. The respondents are for the most part small to medium sized companies providing a specific product for a niche application.This is the main issue in regards to Akzo’s comments. Akzo is not a paint manufacturer for which PY. 34 and PR. 104 are is appropriate. There are however dozens and dozens of smaller specialized paint makers – which are in large part buyers of PY. 34 and PR. 104 – and who are SME’s (with turnover <100M Euro) or even larger paint companies (turnover <1B€uro) who have profiled themselves into specialist markets. These small specialist markets are not serviced by Akzo who with its general large overhead and focus on volume production find it uneconomic to serve them. That Akzo as a decorative paints market leader prides itself on being lead free is therefore hardly surprising. The Applicant also supports lead free for decorative paints.Akzo claims that its customers have not objected to the use of PY. 34 and PR. 104 free formulations raises the question whether these customers had need for those coatings in the first place or whether they simply chose to obtain these coatings from other sources than Akzo. Evidently – as with the situation in road markings – Akzo is not in the relevant market segment where the characteristics of PY. 34 and PR. 104 are required.Furthermore insofar as Akzo had sales of PY.34 and PR. 104 based coatings, they were likely insignificant on Akzo’s total coatings sales. PY.34 and PR. 104 account for at most 0.02% of world-wide paint sales which proportional to Akzo’s coatings sales would account for just € 1-2 million of sales p.a. of coatings – in other words a market that Akzo could easily abandon to its smaller competitors. A denial of the authorization request is therefore a measure that primarily affects SME’s adversely whereas Akzo will benefit.

FeasibilityBased on Akzo’s submission the Applicant believes they are not best placed to remark on the feasibility of transition as they appear to either not service or to have deliberately moved out of the market that required the specific characteristics of PY.34 and PR.104. Their statements are however not backed up by any substantive proof – so the Applicant refers to its extensive submissions so far regarding the realities in the market. As regards the economic feasibility Akzo also incorrectly presumes that environmental costs are not taken into account as part of the full life cycle – this is of course the case and costs are discounted in the Socia-Economic analysis to reflect this.

SuitabilityAkzo claims that it has experience in markets that fall under the uses applied for. However it shows a misunderstanding of DCC’s application for authorization:

(1) The formulation use is applied for because it has a separate exposure scenario and therefore must be separately authorised according to ECHA guidance. As the applicant stated in its submission the substance has no function at this stage and the existence (or lack thereof) of alternatives is irrelevant;

(2) Industrial and professional applications of the uses applied for have simply bought specialized coatings from competitors to Akzo. As

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mentioned above the volume of paint involved for a company like Akzo is so minimal that they are unlikely to notice the difference. Furthermore Akzo’s greatest strengths in these markets lie in paints that have different characteristics than the coatings produced with PY. 34 and PR. 104.

Other remarksThe Applicant concurs with Akzo that coatings used in Airports and plastic hot melts used in road markings are subject to specifications that cannot and should not be lightly changed. As Akzo admits they are not a player on these markets. Companies that are active in these markets have voiced very different views in the public consultation regarding this issue and the Applicant believes their opinion should prevail.Reference number and date:


nameEC Number

CAS Number



Ref.No: 249Date: 2014/04/06

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:OtherName of org/company:Allgemeine UnfallversicherungsanstaltCountry:Austria

Risk Management Measures


Applicants’ response:Applicants reply to Comments 248 - 259Contributing third party: Algemeine Unfallversicherungs Anstalt, AustriaECHA Consultation numbers: 0012-01 to 0012-12Comment AUA: RAC has established a Reference Dose Response Relationship for the carcinogenicity of hexavalent chromium. This relationship indicates an excess lung cancer risk for workers exposed during work lifetime of 4:100,000 (1 EE –6 per year) if the airborne exposure concentration is not higher than 0,01 µg Cr(VI)/m³ = 10 ng Cr(VI)/m³.Pigment Yellow 34 consists of ~70% PbCrO4 and ~30% PbSO4. The content of Cr(VI) in this mixture is 11,26 %.Therefore an airborne exposure concentration of 0,089 µg PY34/m³ is associated with a work lifetime cancer risk of 4:100,000.

Pigment Red 104 consists of ~81% PbCrO4, ~13% PbSO4, ~6% PbMoO4. The content of Cr(VI) in this mixture is approximately 13,03 %.Therefore an airborne exposure concentration of 0,077 µg PR104/m³ is associated with a work lifetime cancer risk of 4:100,000.

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Reply applicant: In the current registration dossiers for PY.34 and PR.104 a DMELworker, long term, systemic, inhalation was derived for carcinogenicity of Cr(VI). For the cancer risk after inhalation exposure only the respirable fraction was considered in the Chemical Safety Assessment. The lung cancer risk of the two pigments was assessed, using the Occupational Exposure Limit for hexavalent chromium compounds as described by Seidler et al. (2012) and as recommended by the RAC. Based on a maximum chromium level of 15% in PY.34 and PR.104, this value corresponds to a Cr (VI) exposure for both pigments of 0.0667 µg/m3. The SCOEL (2004) definition for poorly soluble Cr(VI) compounds and the bioelution study in simulated interstitial fluid from the REACH registration dossier were used to justify an Assessment Factor of 44.4 for poor solubility of the pigments. Thus arriving at a DMELworker, long term, systemic, inhalation of 2.96 µg/m3 for both PY.34 and PR.104.The DMEL for inhalation was set at such a level that if a worker is continuously exposed for 40 hours per week, 40 weeks per year and for 40 year the additional cancer risk resulting from this exposure is 4:100,000. This is in accordance with societal and political consent to be deemed “acceptable” low. An employer has met his minimisation16 burden which is laid down in the EU worker protection directives. An exposure/DMEL ratio in our CSR below 1 shows that this risk level is achieved, assuming that all pigment is deposited in the lungs. Therefore we are able to conclude that for any individual worker, using the pigments in the manner described in our CSR the risk can be deemed “acceptable” low.In order to calculate the additional cancer risk for monetisation in the socio-economic analysis the respirable fraction was used to calculate the additional lung cancer risk for the EU working population. The non-respirable fraction is assumed to be ingested through mucociliary clearance. The intestinal cancer risk has also been taken into account in our original submission by comparison to a DNEL, as in line with the RAC’s draft risk analysis of the pigments. Subsequently, we related the intestinal cancer risk to the non-threshold dose-response curve the RAC concluded upon in their final risk assessment. When taking the DMELs for both lung cancer and intestinal cancer into account, the addition to the overall cancer risk increases by approximately 10%.

Comment AUA: An airborne exposure concentration of ~0,08 µg Pigment/m³ (as a TWA limit value) must not be exceeded to provide an „acceptable“ low cancer risk in accordance with societal and political consent reached in EU countries e.g. in Germany (work lifetime excess cancer risk not higher than 4:100.000). It should be emphasised that the submitted SEA documents explicitly confirm the risk of 4:100.000 as that work lifetime excess cancer risk which is aimed at. This intention is most welcome.In the SEA documents (chapter “Basic assumptions”), it is argued that the inhalatory DMEL (for lung cancer) is set at a level which warrants an additional individual lung cancer risk (work lifetime) of 4 EE–5 (i.e. 4:100.000), “taking into account the percentage of the pigments which is respirable”.In the SEA documents is stated that only a percentage of 2.2 to 12% of the pigments is respirable when handling the pigment powder or spraying pigment-containing paints. There is only poor scientific evidence for this prediction. Toxicity may be much higher because particles of larger size may be deposited in the upper respiratory tract and resorbed and/or ingested into the body.

16 The directives on the protection of workers clearly stipulate that an employer shall first determine the necessity of the use of a CMR substance. If the CMR is needed, the employer needs to determine if the risk is acceptable low. Based on societal and political consensus a use is not allowed if the additional lifetime cancer risk (based on 40 hours per week, 40 weeks per year and 40 years per career) exceeds 4:1000. If the additional risk of CMR is lower than 4:1000 the employer needs to minimise exposure until the acceptable” low cancer risk of 4:100000 has been achieved. The results of exposure and risk assessment need to be documented, added to the personal files of the workers exposed and kept until 40 years after cessation of the exposure.

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Reply applicant: Indeed for this reason and in accordance with the RAC recommendation, the rest of the inhalable pigment dust is considered as oral exposure and the intestinal cancer risk is calculated for this fraction. The combined inhalation and oral cancer risks are considered in the Chemical Safety Assessment.

Comment AUA: The starting point of the risk characterisation that only 12% of the pigment is respirable – in other words: 88% of airborne particles do not cause toxicological concern – is doubtful und so far not adequately justified .

Reply applicant: this assumption of the Algemeine Unfallversicherungs Anstalt is not correct. The 88% is taken into account for oral cancer risk. In fact, the worst case was used in the majority of the exposure scenarios: considering 12% for inhalation exposure and 98% for oral exposure, leading to 110% coverage of the dose. The percentage of the substance that is respirable stems either from information in the registration dossiers of PY.34 and PR.104 or from published literature, for the spraying of paint. We have used the 12% value as a worst case estimate for the respirable fraction of all uses in which the pigments are not handled as powder. For the vast majority of uses we base our authorisation request on, it is safe to assume that the respirable fraction will be lower. As the lung cancer risk based on dose (µg) is larger than the risk of intestinal cancer we overestimate the additional cancer risk to individual workers and the EU working population.

Comment AUA: But even if one assumes that only 12% of the airborne pigments are respirable, a “DMEL” of 0,66 µg Pigment/m³ would be the maximum limit concentration in air (0,08 * [100/12]). In contrast to this, the exposure scenarios mostly rely on a DMEL of 3 µg Pigment/m³; already this implies a 5-fold higher cancer risk compared to the objective to warrant a work lifetime cancer risk not higher than 4:100.000, as declared by the submitted SEA document.

Reply applicant: the Algemeine Unfallversicherungs Anstalt has correctly deduced the DMEL of ca. 3 µg/m3, as described in our reply above. The Assessment Factor of 44.4 applies to the inhalable pigment dust containing 15% Cr(VI). The justification for this was given in the REACH registration dossiers for PY.34 and PR.104 and in our answers to the RAC/SEAC questions submitted on the 4th of April 2014. In short:

1. the chromates that were assessed for the derivation of the OEL by Seidler et al. (2012) were all highly soluble chromates. PY.34 and PR.104 have very limited bioavalability, which is highly dependent on solubility. The soluble chromates from which the cancer risk was derived, were 7,200x - 80,000x more soluble than PY.34 and PR.104.

2. As described by the RAC, a clear mode of action for Cr(VI)-induced tumours has not been established. The evidence indicates genotoxicity of Cr(VI) in vivo, but clear evidence of mutagenicity in vivo in the target tissues (lung and intestine) by relevant routes of exposure is lacking. Cr(VI) seems only weakly mutagenic in vivo and its mutagenicity, if any, is most likely to be only one contributory factor in the carcinogenic process, together with tissue injury, irritation, inflammation and cell proliferation. PY.34 and PR.104 are only mutagenic in vitro once they have been solubilized by nitrilotriacetic acid (NTA). In vivo the same relation between lack of chromate solubility and mutagenicity was observed. In vivo PY.34 and PR.104 were not genotoxic, while the water soluble sodium dichromate was.

3. The reductive capacity of the human lungs is more than sufficient to metabolize any solubilized Cr(VI) from PY.34 or PR.104 to Cr(III) and

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excrete this Cr(III) from the body.

The ample reductive capacity of the lungs, in combination with the low solubility and lack of mutagenicity of the pigments support the justification of the AF of 44.4, leading to the DMELworker, long term, systemic, inhalation of 2.96 µg/m3 (for more details see our answer to RAC/SEAC questions, submitted on 4th of April 2014).

Comment AUA: In each case, pursuant to European OSH legislation (Article 6 Paragraph 2 (h) of Directive 89/391/EEC) collective protective measures have to be given priority over individual protective measures.In any circumstance, the employer must ensure that the risk is reduced to a minimum by application of protection and prevention measures (Pursuant to Article 6 Paragraph 2 of Directive 98/24/EC = CAD). These must include, in order of priority:(1) design of appropriate work processes and engineering controls and use of adequate equipment and materials, so as to avoid or minimise the release of hazardous chemical agents which may present a risk to workers' safety and health at the place of work;(2) application of collective protection measures at the source of the risk, such as adequate ventilation and appropriate organizational measures;(3) where exposure cannot be prevented by other means, application of individual protection measures including personal protective equipment.

Reply applicant: The modelled uses were based on a large number of visits of European facilities handling the substance, our vast experience in the field of Industrial Hygiene for both the paint and the plastic sector, and the information from relevant OECD publications. For several activities we list more than 1 manner of handling the substance, all resulting in an exposure that can be deemed ‘acceptable’ low. An example is the dosing of the substance, which can be performed semi-automated or manually. Another example is the spraying of paint, which is listed as an automated activity and a manual activity.

The exposure estimations that are included in the chemical safety report were modelled in the Advanced REACH Tool. The exposure estimate selected is the 90th percentile, providing robustness to the assessment. It is safe to assume that the average exposure will be below this 90th percentile and the average exposure is directly linked to the additional cancer risk. In building the exposure estimations we first included the process and technical controls, and then selected the appropriate collective technical risk management measures. The ART result does not take into account respiratory protection. This was added to the exposure scenario only if it is used in practice or if control of exposure to other substances present in the mixture in which the pigments are present requires their use. This is for instance required in the contributing scenario of spraying of paint, were respiratory protection is needed on order to limit exposure to volatile organic substances. In none of the modelled contributing scenarios were risk management applied which we have not seen in practice or have not found in literature.

Based upon the above we think that the abovementioned hierarchy of control is implemented in our risk assessment. It is the responsibility of every individual employer to select the different sets of contributing scenarios, to match the use patterns of the individual companies.

The Algemeine Unfallversicherungs Anstalt has copy pasted this section into at least one other response to an authorisation request by another

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applicant. In that submission the comment is not explained either. Directive 89/391 is a cornerstone of EU Health and Safety legislation and is broadly implemented in all the member States. There are at least two relatively recent implementation reports17 which do not point to specific problems of relevance to the current authorisation dossier. The only issue that has been raised is that in SME’s worker participation is sometimes substandard in the implementation of the safety measures. The use of PY.34 and PR.104 has already been considerably reduced and is now limited to specific applications for which the uses are absolutely essential. In the downstream user survey that was performed the applicant interviewed both management and workers and all professed awareness and involvement in the measures required to safely handle the substances. In fact the authorisation process and the survey added to the positive awareness on safety and security that directive 89/291 attempts to foster. Furthermore formulation and use of the pigments was increasingly done by specialised companies through tolling arrangements or by dedicated employees who are specially trained for the handling of the pigments. All of this involves measures that are in harmony with 89/391 and 98/24 but in reality often much further reaching practices are implemented based on national law, guidance and voluntary OHSE systems implemented by the users of the substance.

Comment AUA: However, the DMELs in fact used in the exposure scenarios are not disclosed – nor are their derivation steps.

Reply applicant: in our reply to the RAC/SEAC questions submitted on 4th of April 2014 we have provided all necessary information to ECHA to reconstruct the whole process, including detailed ART reports and excel files that show all calculations and modelling. The derivation is also part of the Chemical Safety Report, which is included in our updated registration dossiers for PY.34 and PR.104.

Comment AUA: The lack of explicitly specified exposure limit values (e.g. DMELs, DNELs) and the used data, methods and steps of their derivation should not be accepted in applications for authorisation.

Reply applicant: all relevant information has been made available to ECHA and is part the REACH registration dossiers for PY.34 and PR.104.

Comment AUA: In a large number of contributing scenarios, there is a considerable risk of inhalation of pigment powder, pigment dust, pigment abrasion or pigment aerosol.The dustiness of the powder is specified with 1006 mg inhalable dust/kg PY34 and 2363 mg inhalable dust/kg PR104 respectively. (No data are given for the respirable fraction [fraction which enters the alveolar region] and the thoracic fraction.)The referring Exposure Scenarios indicate that the exposure levels applied for risk characterisation had been calculated under the precondition that the workers have to use respiratory protection. (This allows, if desired, to postulate a “mask effectiveness of 99,5%” and simply to divide the expected air concentration by 200! E.g. PR104-chapter 9.1.21.) In reality, it is absolutely impracticable to reliably distinguish between respiratory

17 2007: http://europa.eu/legislation_summaries/employment_and_social_policy/health_hygiene_safety_at_work/c11149_en.htm2004: https://osha.europa.eu/en/legislation/directives/the-osh-framework-directive/the-osh-framework-directive-introduction

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https://osha.europa.eu/en/legislation/directives/the-osh-framework-directive/the-osh-framework-directive-introduction

http://europa.eu/legislation_summaries/employment_and_social_policy/health_hygiene_safety_at_work/c11149_en.htm

protection effectiveness of 90% – 97,5% – 99% – 99,5% – 99,75% (e.g. in chapter 9.2.12) – 99,9% (e.g. in chapter 9.3.6)! On the contrary: Work practice demands a sufficient margin of safety.However, the precondition that worker have to use respiratory protection as a main RMM would be a severe violation of EU OHS legislation (see above); this cannot be accepted.

Reply applicant: As indicated above, by modelling exposure in the Advanced REACH tool we first included the process and technical controls, and then selected the appropriate collective technical risk management measures. The ART result does not take into account respiratory protection. This was added to the exposure scenario only if it is used in practice or if control of exposure to other substances that are present in the mixture of the pigments formulation requires their use. This is for instance required in the contributing scenario of spraying of paint, were respiratory protection is needed on order to limit exposure to volatile organic substances. In none of the modelled contributing scenarios were risk management applied which we have not seen in practice of have not found in literature. In none of the exposure scenarios can RMM be seen as the main RMM.

Comment AUA: Furthermore, often the expected air concentration has been “corrected” for the “short” duration of a work task e.g. by a factor 0,4 for 2 days/week.As a feature of safety – and as a requirement of EU OSH legislation –, distinct workplaces should not represent a lower level of RMMs. The reason for this is: (a) cancer risk must be put down as far as technical feasible and (b) the frequency of working cycles can change unexpectedly.Another pawn in a game seems to be the effectiveness of local exhaust ventilation. This effectiveness is fed into the calculation with a value of 50%, of 90% or of 99%, merely to achieve an apparent RCR below 1.The exposure scenarios sometimes give the impression that the RMM and protective measures had been chosen arbitrarily — far from occupational reality, feasibility and innovative alternatives — to pretend “adequate control”, merely as a matter of formality.

Reply applicant: As indicated above, by modelling exposure in the Advanced REACH tool we first included the process and technical controls, and then selected the appropriate collective technical risk management measures. During our extensive site visits to downstream users we witnessed different types of local exhaust ventilation. This is reflected in our modelled exposure, as we tried to be as true to real life as possible. The cancer risk of a linear non-threshold substance is related to the average exposure. In those cases were our site visits clearly showed that an activity is performed for less than 40 hours per week, a time reduction was included in the risk assessment. In selecting the sets of OC and RMM any individual employer is obliged, based on the national implementation of the EU protection of workers directive, to select those relevant to his particular use pattern. The minimisation requirement, and the necessity of use determination, applies here. However, based on the aforementioned societal and political consent, further minimisation is no longer required, if the exposure can be deemed “acceptable” low. This is the case in every exposure scenario in our exposure assessment.

Comment AUA:

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The application No. 0012-01 does not specify the inhalative exposure limit value (“DMEL”) on which the risk characterisation has been based on. The retrospective calculation shows that in most scenarios a “DMEL” of 3 µg Pigment/m³ (in few scenarios 3,5 µg Pigment/m³) was used as the limit value.As explained above, a DMEL of 3 µg Pigment/m³ (or even higher) is unacceptable high in terms of associated cancer risk. An approximately 40-fold lower exposure concentration (~0,08 µg Pigment/m³) is indispensable to provide an acceptable low cancer risk not higher than 4:100.000.In the long run, a substitution by non-carcinogenic pigments is deemed necessary.Technical alternatives such as enhanced RMMs (e.g. fully closed systems, local exhaust ventilation, inherent safe container systems…) have to be implemented without delay.

In a couple of scenarios respiratory protection is to be used up to 8 hours/day. Such an exposure scenario cannot be accepted because this is an infringement of EU OHS legislation. (In the same scenario often only poor technical RMM are envisaged.)

Reply applicant: Most of the uses were modelled based on an 8 hour use pattern in order to allow a downstream user to combine tasks. Looking at the uses listed, we do not recognize and do not agree to the remark on poor technical RMM envisaged, as we built our exposure estimation starting with technical measures that minimise emission, followed by the risk management measures aimed at reducing emission and finally personal protection. In assigning tasks to a function or a worker, the employer needs to select the task appropriately, given the OC and RMM present and needed to protect the health of the worker.

Comment AUA: It should be noted that in contributing scenario 17 (chapter 9.1.18) the DMEL used for risk characterisation obviously was 29 µg Pigment/m³ (!).

Reply applicant: Contributing scenario 17, listed in chapter 9.1.18 lists an exposure estimation of 0.001 mg/m3 and an Exposure/DMEL ratio of 0.023. This leads to an apparent DMEL of 29 µg Pigment/m³ (0.001/0.023). In the remarks it is stated that the predicted 90th percentile long-term exposure is 0.001 mg/m3, the result of which is corrected by applying respiratory protection. In Table 75, this correction was erroneously not included. The exposure value that should have been listed is 0.0001 mg/m3. The RCR listed is correct and therefore the DMEL in this scenario for pigment is 2.96 µg Pigment/m³, corresponding to the correct DMEL value listed. The error has probably occurred because for “inhalation, long term, systemic”, two reference values were used, a DNEL to account for the health effects of Lead and a DMEL to account for the health effects of Cr(VI). CHESAR only allows for one reference value to be included, so all values listed were entered manually. The Excel spreadsheet that was used listed the correct values, so the proper value was used in calculating the health benefits of the non-use scenario in the socio-economic analysis.

Comment AUA: No margin of safety exists in some contributing scenarios, because the RCR is very close to 1 (eg. chapter 9.1.4, chapter 9.1.16, chapter 9.1.22) – not yet taking into account the confidence interval of exposure assessment and the fact that the used DMEL is too high by a factor of ~40.

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Reply Applicant: As stated above, the value of ~40 corresponds to an Assessment Factor to account for the extremely low solubility of PY.34 and PR.104 and is very conservative.All exposure estimations presented are the 90th percentile of the exposure estimation. The 90th percentile ensures a conservative estimating of individual worker exposure, allowing for compliance testing18. As the DMEL is set at such a level that the individual worker risk resulting from such exposure is below 4:100,000 and thus deemed ‘acceptable’ low, an RCR of below 1 suffices and no further margin of safety is required. This holds true, even if the entire exposure corresponding to the DMEL was in the respirable fraction and available for absorption in the lungs.The contributing scenario listed in chapter 9.1.4 is the manual dosing of powder. In this scenario worst case estimates were used, the exposure/DMEL ratio listed is 0.919. This qualifies for ‘acceptable’ low risk, as noted above. For this scenario, the respirable fraction is 2.2%, limiting the risk even further. Other contributing scenarios for similar activities result in lower exposure/DMEL ratios. It is the individual employer’s responsibility to account for the selected set of operational conditions and risk management measures listed in each of those contributing scenarios, based on the responsibility ensuing from the Member States implementation of EU protection of workers directives.The contributing scenario listed in chapter 9.1.16 describes the mixing of colour paste into paint in closed mixing vessels. Inputs selected were conservative, especially for the concentration of pigment in the mixture which was set over 3 times the average concentration in paint. The exposure/DMEL ratio listed is 0.980. This qualifies for ‘acceptable’ low risk. For this scenario, the respirable fraction is set at 12%, limiting the risk even further. The contributing scenario listed in chapter 9.1.21 describes the testing of pigment paste by brushing and rolling. Inputs selected were conservative, especially for the concentration of pigment in the mixture which was set over 3 times the average concentration in paint. The exposure/DMEL ratio listed is 0.980. This qualifies for ‘acceptable’ low risk. For this scenario, the respirable fraction is set at 12%, limiting the risk even further. The value of 12% is obtained from literature for spraying of paint scenarios and may be deemed a gross overestimation of the actual value. Although literature on particle size of paint and brushing is scarce, the British Health and Safety laboratory (2005) reported on measurements during brushing and roller applications of isocyanate-based 2-pack paints that showed no aerosol exposure19.Reference number and date:


nameEC Number

CAS Number



Ref.No: 248Date: 2014/04/06

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:OtherName of org/company:Allgemeine Unfallversicherungsanstalt

Risk Management Measures


18 The art of occupational exposure modelling – development and evaluation of generic inhalation exposure models J.M. Schinkel, 2013, Thesis Utrecht University ISBN: 978-90-393-6009-519 Measured Airborne Isocyanate from Mixing and Brush and Roller Application of Isocyanate based 2-pack PaintsResults - February 2005, Matthew Coldwell and John White,HSL/2005/60

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Country:Austria

Applicants’ response:Applicants reply to Comments 248 - 259Contributing third party: Algemeine Unfallversicherungs Anstalt, AustriaECHA Consultation numbers: 0012-01 to 0012-12Comment AUA: RAC has established a Reference Dose Response Relationship for the carcinogenicity of hexavalent chromium. This relationship indicates an excess lung cancer risk for workers exposed during work lifetime of 4:100,000 (1 EE –6 per year) if the airborne exposure concentration is not higher than 0,01 µg Cr(VI)/m³ = 10 ng Cr(VI)/m³.Pigment Yellow 34 consists of ~70% PbCrO4 and ~30% PbSO4. The content of Cr(VI) in this mixture is 11,26 %.Therefore an airborne exposure concentration of 0,089 µg PY34/m³ is associated with a work lifetime cancer risk of 4:100,000.

Pigment Red 104 consists of ~81% PbCrO4, ~13% PbSO4, ~6% PbMoO4. The content of Cr(VI) in this mixture is approximately 13,03 %.Therefore an airborne exposure concentration of 0,077 µg PR104/m³ is associated with a work lifetime cancer risk of 4:100,000.

Reply applicant: In the current registration dossiers for PY.34 and PR.104 a DMELworker, long term, systemic, inhalation was derived for carcinogenicity of Cr(VI). For the cancer risk after inhalation exposure only the respirable fraction was considered in the Chemical Safety Assessment. The lung cancer risk of the two pigments was assessed, using the Occupational Exposure Limit for hexavalent chromium compounds as described by Seidler et al. (2012) and as recommended by the RAC. Based on a maximum chromium level of 15% in PY.34 and PR.104, this value corresponds to a Cr (VI) exposure for both pigments of 0.0667 µg/m3. The SCOEL (2004) definition for poorly soluble Cr(VI) compounds and the bioelution study in simulated interstitial fluid from the REACH registration dossier were used to justify an Assessment Factor of 44.4 for poor solubility of the pigments. Thus arriving at a DMELworker, long term, systemic, inhalation of 2.96 µg/m3 for both PY.34 and PR.104.The DMEL for inhalation was set at such a level that if a worker is continuously exposed for 40 hours per week, 40 weeks per year and for 40 year the additional cancer risk resulting from this exposure is 4:100,000. This is in accordance with societal and political consent to be deemed “acceptable” low. An employer has met his minimisation20 burden which is laid down in the EU worker protection directives. An exposure/DMEL ratio in our CSR below 1 shows that this risk level is achieved, assuming that all pigment is deposited in the lungs. Therefore we are able to conclude that for any individual worker, using the pigments in the manner described in our CSR the risk can be deemed “acceptable” low.In order to calculate the additional cancer risk for monetisation in the socio-economic analysis the respirable fraction was used to calculate the additional lung cancer risk for the EU working population. The non-respirable fraction is assumed to be ingested through mucociliary clearance. The intestinal cancer risk has also been taken into account in our original submission by comparison to a DNEL, as in line with the RAC’s draft risk analysis of the pigments. Subsequently, we related the intestinal cancer risk to the non-threshold dose-response curve the RAC concluded upon in

20 The directives on the protection of workers clearly stipulate that an employer shall first determine the necessity of the use of a CMR substance. If the CMR is needed, the employer needs to determine if the risk is acceptable low. Based on societal and political consensus a use is not allowed if the additional lifetime cancer risk (based on 40 hours per week, 40 weeks per year and 40 years per career) exceeds 4:1000. If the additional risk of CMR is lower than 4:1000 the employer needs to minimise exposure until the acceptable” low cancer risk of 4:100000 has been achieved. The results of exposure and risk assessment need to be documented, added to the personal files of the workers exposed and kept until 40 years after cessation of the exposure.

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their final risk assessment. When taking the DMELs for both lung cancer and intestinal cancer into account, the addition to the overall cancer risk increases by approximately 10%.

Comment AUA: An airborne exposure concentration of ~0,08 µg Pigment/m³ (as a TWA limit value) must not be exceeded to provide an „acceptable“ low cancer risk in accordance with societal and political consent reached in EU countries e.g. in Germany (work lifetime excess cancer risk not higher than 4:100.000). It should be emphasised that the submitted SEA documents explicitly confirm the risk of 4:100.000 as that work lifetime excess cancer risk which is aimed at. This intention is most welcome.In the SEA documents (chapter “Basic assumptions”), it is argued that the inhalatory DMEL (for lung cancer) is set at a level which warrants an additional individual lung cancer risk (work lifetime) of 4 EE–5 (i.e. 4:100.000), “taking into account the percentage of the pigments which is respirable”.In the SEA documents is stated that only a percentage of 2.2 to 12% of the pigments is respirable when handling the pigment powder or spraying pigment-containing paints. There is only poor scientific evidence for this prediction. Toxicity may be much higher because particles of larger size may be deposited in the upper respiratory tract and resorbed and/or ingested into the body.

Reply applicant: Indeed for this reason and in accordance with the RAC recommendation, the rest of the inhalable pigment dust is considered as oral exposure and the intestinal cancer risk is calculated for this fraction. The combined inhalation and oral cancer risks are considered in the Chemical Safety Assessment.

Comment AUA: The starting point of the risk characterisation that only 12% of the pigment is respirable – in other words: 88% of airborne particles do not cause toxicological concern – is doubtful und so far not adequately justified .

Reply applicant: this assumption of the Algemeine Unfallversicherungs Anstalt is not correct. The 88% is taken into account for oral cancer risk. In fact, the worst case was used in the majority of the exposure scenarios: considering 12% for inhalation exposure and 98% for oral exposure, leading to 110% coverage of the dose. The percentage of the substance that is respirable stems either from information in the registration dossiers of PY.34 and PR.104 or from published literature, for the spraying of paint. We have used the 12% value as a worst case estimate for the respirable fraction of all uses in which the pigments are not handled as powder. For the vast majority of uses we base our authorisation request on, it is safe to assume that the respirable fraction will be lower. As the lung cancer risk based on dose (µg) is larger than the risk of intestinal cancer we overestimate the

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additional cancer risk to individual workers and the EU working population.

Comment AUA: But even if one assumes that only 12% of the airborne pigments are respirable, a “DMEL” of 0,66 µg Pigment/m³ would be the maximum limit concentration in air (0,08 * [100/12]). In contrast to this, the exposure scenarios mostly rely on a DMEL of 3 µg Pigment/m³; already this implies a 5-fold higher cancer risk compared to the objective to warrant a work lifetime cancer risk not higher than 4:100.000, as declared by the submitted SEA document.

Reply applicant: the Algemeine Unfallversicherungs Anstalt has correctly deduced the DMEL of ca. 3 µg/m3, as described in our reply above. The Assessment Factor of 44.4 applies to the inhalable pigment dust containing 15% Cr(VI). The justification for this was given in the REACH registration dossiers for PY.34 and PR.104 and in our answers to the RAC/SEAC questions submitted on the 4th of April 2014. In short:

1. the chromates that were assessed for the derivation of the OEL by Seidler et al. (2012) were all highly soluble chromates. PY.34 and PR.104 have very limited bioavalability, which is highly dependent on solubility. The soluble chromates from which the cancer risk was derived, were 7,200x - 80,000x more soluble than PY.34 and PR.104.

2. As described by the RAC, a clear mode of action for Cr(VI)-induced tumours has not been established. The evidence indicates genotoxicity of Cr(VI) in vivo, but clear evidence of mutagenicity in vivo in the target tissues (lung and intestine) by relevant routes of exposure is lacking. Cr(VI) seems only weakly mutagenic in vivo and its mutagenicity, if any, is most likely to be only one contributory factor in the carcinogenic process, together with tissue injury, irritation, inflammation and cell proliferation. PY.34 and PR.104 are only mutagenic in vitro once they have been solubilized by nitrilotriacetic acid (NTA). In vivo the same relation between lack of chromate solubility and mutagenicity was observed. In vivo PY.34 and PR.104 were not genotoxic, while the water soluble sodium dichromate was.

3. The reductive capacity of the human lungs is more than sufficient to metabolize any solubilized Cr(VI) from PY.34 or PR.104 to Cr(III) and excrete this Cr(III) from the body.

The ample reductive capacity of the lungs, in combination with the low solubility and lack of mutagenicity of the pigments support the justification of the AF of 44.4, leading to the DMELworker, long term, systemic, inhalation of 2.96 µg/m3 (for more details see our answer to RAC/SEAC questions, submitted on 4th of April 2014).

Comment AUA: In each case, pursuant to European OSH legislation (Article 6 Paragraph 2 (h) of Directive 89/391/EEC) collective protective measures have to be given priority over individual protective measures.In any circumstance, the employer must ensure that the risk is reduced to a minimum by application of protection and prevention measures (Pursuant to Article 6 Paragraph 2 of Directive 98/24/EC = CAD). These must include, in order of priority:(1) design of appropriate work processes and engineering controls and use of adequate equipment and materials, so as to avoid or minimise the release of hazardous chemical agents which may present a risk to workers' safety and health at the place of work;

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(2) application of collective protection measures at the source of the risk, such as adequate ventilation and appropriate organizational measures;(3) where exposure cannot be prevented by other means, application of individual protection measures including personal protective equipment.

Reply applicant: The modelled uses were based on a large number of visits of European facilities handling the substance, our vast experience in the field of Industrial Hygiene for both the paint and the plastic sector, and the information from relevant OECD publications. For several activities we list more than 1 manner of handling the substance, all resulting in an exposure that can be deemed ‘acceptable’ low. An example is the dosing of the substance, which can be performed semi-automated or manually. Another example is the spraying of paint, which is listed as an automated activity and a manual activity.

The exposure estimations that are included in the chemical safety report were modelled in the Advanced REACH Tool. The exposure estimate selected is the 90th percentile, providing robustness to the assessment. It is safe to assume that the average exposure will be below this 90th percentile and the average exposure is directly linked to the additional cancer risk. In building the exposure estimations we first included the process and technical controls, and then selected the appropriate collective technical risk management measures. The ART result does not take into account respiratory protection. This was added to the exposure scenario only if it is used in practice or if control of exposure to other substances present in the mixture in which the pigments are present requires their use. This is for instance required in the contributing scenario of spraying of paint, were respiratory protection is needed on order to limit exposure to volatile organic substances. In none of the modelled contributing scenarios were risk management applied which we have not seen in practice or have not found in literature.

Based upon the above we think that the abovementioned hierarchy of control is implemented in our risk assessment. It is the responsibility of every individual employer to select the different sets of contributing scenarios, to match the use patterns of the individual companies.

The Algemeine Unfallversicherungs Anstalt has copy pasted this section into at least one other response to an authorisation request by another applicant. In that submission the comment is not explained either. Directive 89/391 is a cornerstone of EU Health and Safety legislation and is broadly implemented in all the member States. There are at least two relatively recent implementation reports21 which do not point to specific problems of relevance to the current authorisation dossier. The only issue that has been raised is that in SME’s worker participation is sometimes substandard in the implementation of the safety measures. The use of PY.34 and PR.104 has already been considerably reduced and is now limited to specific applications for which the uses are absolutely essential. In the downstream user survey that was performed the applicant interviewed both management and workers and all professed awareness and involvement in the measures required to safely handle the substances. In fact the authorisation process and the survey added to the positive awareness on safety and security that directive 89/291 attempts to foster. Furthermore

21 2007: http://europa.eu/legislation_summaries/employment_and_social_policy/health_hygiene_safety_at_work/c11149_en.htm2004: https://osha.europa.eu/en/legislation/directives/the-osh-framework-directive/the-osh-framework-directive-introduction

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https://osha.europa.eu/en/legislation/directives/the-osh-framework-directive/the-osh-framework-directive-introduction

http://europa.eu/legislation_summaries/employment_and_social_policy/health_hygiene_safety_at_work/c11149_en.htm

formulation and use of the pigments was increasingly done by specialised companies through tolling arrangements or by dedicated employees who are specially trained for the handling of the pigments. All of this involves measures that are in harmony with 89/391 and 98/24 but in reality often much further reaching practices are implemented based on national law, guidance and voluntary OHSE systems implemented by the users of the substance.

Comment AUA: However, the DMELs in fact used in the exposure scenarios are not disclosed – nor are their derivation steps.

Reply applicant: in our reply to the RAC/SEAC questions submitted on 4th of April 2014 we have provided all necessary information to ECHA to reconstruct the whole process, including detailed ART reports and excel files that show all calculations and modelling. The derivation is also part of the Chemical Safety Report, which is included in our updated registration dossiers for PY.34 and PR.104.

Comment AUA: The lack of explicitly specified exposure limit values (e.g. DMELs, DNELs) and the used data, methods and steps of their derivation should not be accepted in applications for authorisation.

Reply applicant: all relevant information has been made available to ECHA and is part the REACH registration dossiers for PY.34 and PR.104.

Comment AUA: In a large number of contributing scenarios, there is a considerable risk of inhalation of pigment powder, pigment dust, pigment abrasion or pigment aerosol.The dustiness of the powder is specified with 1006 mg inhalable dust/kg PY34 and 2363 mg inhalable dust/kg PR104 respectively. (No data are given for the respirable fraction [fraction which enters the alveolar region] and the thoracic fraction.)The referring Exposure Scenarios indicate that the exposure levels applied for risk characterisation had been calculated under the precondition that the workers have to use respiratory protection. (This allows, if desired, to postulate a “mask effectiveness of 99,5%” and simply to divide the expected air concentration by 200! E.g. PR104-chapter 9.1.21.) In reality, it is absolutely impracticable to reliably distinguish between respiratory protection effectiveness of 90% – 97,5% – 99% – 99,5% – 99,75% (e.g. in chapter 9.2.12) – 99,9% (e.g. in chapter 9.3.6)! On the contrary: Work practice demands a sufficient margin of safety.However, the precondition that worker have to use respiratory protection as a main RMM would be a severe violation of EU OHS legislation (see above); this cannot be accepted.

Reply applicant: As indicated above, by modelling exposure in the Advanced REACH tool we first included the process and technical controls, and

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then selected the appropriate collective technical risk management measures. The ART result does not take into account respiratory protection. This was added to the exposure scenario only if it is used in practice or if control of exposure to other substances that are present in the mixture of the pigments formulation requires their use. This is for instance required in the contributing scenario of spraying of paint, were respiratory protection is needed on order to limit exposure to volatile organic substances. In none of the modelled contributing scenarios were risk management applied which we have not seen in practice of have not found in literature. In none of the exposure scenarios can RMM be seen as the main RMM.

Comment AUA: Furthermore, often the expected air concentration has been “corrected” for the “short” duration of a work task e.g. by a factor 0,4 for 2 days/week.As a feature of safety – and as a requirement of EU OSH legislation –, distinct workplaces should not represent a lower level of RMMs. The reason for this is: (a) cancer risk must be put down as far as technical feasible and (b) the frequency of working cycles can change unexpectedly.Another pawn in a game seems to be the effectiveness of local exhaust ventilation. This effectiveness is fed into the calculation with a value of 50%, of 90% or of 99%, merely to achieve an apparent RCR below 1.The exposure scenarios sometimes give the impression that the RMM and protective measures had been chosen arbitrarily — far from occupational reality, feasibility and innovative alternatives — to pretend “adequate control”, merely as a matter of formality.

Reply applicant: As indicated above, by modelling exposure in the Advanced REACH tool we first included the process and technical controls, and then selected the appropriate collective technical risk management measures. During our extensive site visits to downstream users we witnessed different types of local exhaust ventilation. This is reflected in our modelled exposure, as we tried to be as true to real life as possible. The cancer risk of a linear non-threshold substance is related to the average exposure. In those cases were our site visits clearly showed that an activity is performed for less than 40 hours per week, a time reduction was included in the risk assessment. In selecting the sets of OC and RMM any individual employer is obliged, based on the national implementation of the EU protection of workers directive, to select those relevant to his particular use pattern. The minimisation requirement, and the necessity of use determination, applies here. However, based on the aforementioned societal and political consent, further minimisation is no longer required, if the exposure can be deemed “acceptable” low. This is the case in every exposure scenario in our exposure assessment.

Comment AUA:The application No. 0012-01 does not specify the inhalative exposure limit value (“DMEL”) on which the risk characterisation has been based on. The retrospective calculation shows that in most scenarios a “DMEL” of 3 µg Pigment/m³ (in few scenarios 3,5 µg Pigment/m³) was used as the limit value.As explained above, a DMEL of 3 µg Pigment/m³ (or even higher) is unacceptable high in terms of associated cancer risk. An approximately 40-fold

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lower exposure concentration (~0,08 µg Pigment/m³) is indispensable to provide an acceptable low cancer risk not higher than 4:100.000.In the long run, a substitution by non-carcinogenic pigments is deemed necessary.Technical alternatives such as enhanced RMMs (e.g. fully closed systems, local exhaust ventilation, inherent safe container systems…) have to be implemented without delay.

In a couple of scenarios respiratory protection is to be used up to 8 hours/day. Such an exposure scenario cannot be accepted because this is an infringement of EU OHS legislation. (In the same scenario often only poor technical RMM are envisaged.)

Reply applicant: Most of the uses were modelled based on an 8 hour use pattern in order to allow a downstream user to combine tasks. Looking at the uses listed, we do not recognize and do not agree to the remark on poor technical RMM envisaged, as we built our exposure estimation starting with technical measures that minimise emission, followed by the risk management measures aimed at reducing emission and finally personal protection. In assigning tasks to a function or a worker, the employer needs to select the task appropriately, given the OC and RMM present and needed to protect the health of the worker.

Comment AUA: It should be noted that in contributing scenario 17 (chapter 9.1.18) the DMEL used for risk characterisation obviously was 29 µg Pigment/m³ (!).

Reply applicant: Contributing scenario 17, listed in chapter 9.1.18 lists an exposure estimation of 0.001 mg/m3 and an Exposure/DMEL ratio of 0.023. This leads to an apparent DMEL of 29 µg Pigment/m³ (0.001/0.023). In the remarks it is stated that the predicted 90th percentile long-term exposure is 0.001 mg/m3, the result of which is corrected by applying respiratory protection. In Table 75, this correction was erroneously not included. The exposure value that should have been listed is 0.0001 mg/m3. The RCR listed is correct and therefore the DMEL in this scenario for pigment is 2.96 µg Pigment/m³, corresponding to the correct DMEL value listed. The error has probably occurred because for “inhalation, long term, systemic”, two reference values were used, a DNEL to account for the health effects of Lead and a DMEL to account for the health effects of Cr(VI). CHESAR only allows for one reference value to be included, so all values listed were entered manually. The Excel spreadsheet that was used listed the correct values, so the proper value was used in calculating the health benefits of the non-use scenario in the socio-economic analysis.

Comment AUA: No margin of safety exists in some contributing scenarios, because the RCR is very close to 1 (eg. chapter 9.1.4, chapter 9.1.16, chapter 9.1.22) – not yet taking into account the confidence interval of exposure assessment and the fact that the used DMEL is too high by a factor of ~40.

Reply Applicant: As stated above, the value of ~40 corresponds to an Assessment Factor to account for the extremely low solubility of PY.34 and PR.104 and is very conservative.All exposure estimations presented are the 90th percentile of the exposure estimation. The 90th percentile ensures a conservative estimating of individual worker exposure, allowing for compliance testing22. As the DMEL is set at such a level that the individual worker risk resulting from such

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exposure is below 4:100,000 and thus deemed ‘acceptable’ low, an RCR of below 1 suffices and no further margin of safety is required. This holds true, even if the entire exposure corresponding to the DMEL was in the respirable fraction and available for absorption in the lungs.The contributing scenario listed in chapter 9.1.4 is the manual dosing of powder. In this scenario worst case estimates were used, the exposure/DMEL ratio listed is 0.919. This qualifies for ‘acceptable’ low risk, as noted above. For this scenario, the respirable fraction is 2.2%, limiting the risk even further. Other contributing scenarios for similar activities result in lower exposure/DMEL ratios. It is the individual employer’s responsibility to account for the selected set of operational conditions and risk management measures listed in each of those contributing scenarios, based on the responsibility ensuing from the Member States implementation of EU protection of workers directives.The contributing scenario listed in chapter 9.1.16 describes the mixing of colour paste into paint in closed mixing vessels. Inputs selected were conservative, especially for the concentration of pigment in the mixture which was set over 3 times the average concentration in paint. The exposure/DMEL ratio listed is 0.980. This qualifies for ‘acceptable’ low risk. For this scenario, the respirable fraction is set at 12%, limiting the risk even further. The contributing scenario listed in chapter 9.1.21 describes the testing of pigment paste by brushing and rolling. Inputs selected were conservative, especially for the concentration of pigment in the mixture which was set over 3 times the average concentration in paint. The exposure/DMEL ratio listed is 0.980. This qualifies for ‘acceptable’ low risk. For this scenario, the respirable fraction is set at 12%, limiting the risk even further. The value of 12% is obtained from literature for spraying of paint scenarios and may be deemed a gross overestimation of the actual value. Although literature on particle size of paint and brushing is scarce, the British Health and Safety laboratory (2005) reported on measurements during brushing and roller applications of isocyanate-based 2-pack paints that showed no aerosol exposure23.Reference number and date:


nameEC Number

CAS Number



Ref.No: 239Date: 2014/04/04

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Industry or trade associationName of org/company:British Coatings FederationCountry:United Kingdom

There are a range of alternative pigments available, which although not direct equivalents due to the unique physical and chemical characteristics of lead chromates, can be used in the manufacture of paint and powder coatings to give end-user equivalent products.


Applicants’ response:Applicants reply to Comments 238-243Contributing third party: British Coatings Federation, UK22 The art of occupational exposure modelling – development and evaluation of generic inhalation exposure models J.M. Schinkel, 2013, Thesis Utrecht University ISBN: 978-90-393-6009-523 Measured Airborne Isocyanate from Mixing and Brush and Roller Application of Isocyanate based 2-pack PaintsResults - February 2005, Matthew Coldwell and John White,HSL/2005/60

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ECHA Consultation numbers: 0012-01 to 0012-12

Comment BCF:ALTERNATIVE ID AND PROPERTIESLead Chromate Pigments (PY34 and PR104) undoubtedly have certain cost and performance advantages over other pigments. Reply Applicant: we agree to this statement.

There are no direct (weight for weight) alternatives for lead chromate pigments due to their chemical composition. Reply Applicant: we agree to this statement.

This is not a rare situation for a substance as most have unique properties. From the perspective of the paint and powder coating manufacturer it is not the chemical composition of a pigment that is of primary importance rather it is its performance in terms of:- resistance to degradation (lightfastness, blooming, heat stability, acids and alkalis, solvents)- colour properties (opacity, tint strength and colour)- physical properties that aid use (oil absorption, density)Reply Applicant: we agree to these statements.

Paint and powder coating manufacturers select pigments to meet the balance of properties appropriate to the intended end use of the coating. The withdrawal of lead chromates in the EU would reduce the range of options open to paint and powder coating manufacturers but we do not believe it to be insurmountable. Reply Applicant: we agree to this statement. As we have made clear in our AoA, every alternative will result in some compromise in performance and a 1:1 substitution of PY.34 and PR104 is impossible.

There are a wide range of lead-free alternatives that have and are currently used within the paint industry, Appendix I sets out a brief summary of a small selection of these. We have only considered those that are similar in colour to the lead chromate pigments and have consulted our members to get their approximate costing information. In the time allowed us to make this representation it has not been possible to produce sample panels but we have relied on commercially available pattern cards from the major pigment manufacturers. Many of these alternatives have been covered in detail in the DCC Application for Authorisation, but we disagree with their conclusion that lead chromate pigments are irreplaceable. Many of our members have already replaced them in their industrial coatings ranges.Reply Applicant: “Many” does not indicate ALL members. As has been clearly shown by the overwhelming supporting comments from downstream users PY.34 and PR.104 remain irreplaceable. The pattern cards used by the BCF are outdated and are marketing literature rather than true technical literature. They do not adequately give a technical comparison of the potential alternatives versus the significantly superior PY.34 and PR.104.

TECHNICAL FEASIBILITYAlternatives to lead chromate pigments have been used for many years in products for customers that have requested lead-free materials. See Appendix for comparison with alternative pigments.

ECONOMIC FEASIBILITYLead chromate alternatives are, in most cases, more expensive as substances and lead to more expensive products. See Appendix for comparison with alternative pigments. Reply Applicant: we agree to this statement.

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HAZARDS AND RISKS OF THE ALTERNATIVEMost alternatives are not hazardous. See Appendix for comparison with alternativepigments. Reply Applicant: It is true that most alternatives are not classified as CMR. However, this doesn’t mean that the alternatives and/or their metabolites or precursors don’t possess hazardous properties. Some of them clearly do, as we have shown in our AoA.

AVAILABILITYAll the pigments listed in the attached appendix are commercially available in the EU.

CONCLUSION ON SUITABILITY AND AVAILABILITY OF THE ALTERNATIVEDespite efforts by pigment manufactures over many years, pigments identical to lead chromates (PY 34 and PR104) have not been developed. Moreover, it is unlikely that this will ever be possible due to the unique nature of substances. Reply Applicant: we agree to this statement. This BCF statement confirms the virtually impossibility of development of 1: 1 alternatives for PY.34 and PR.104, due to their unique properties. It at least confirms our notion that the development of new pigments that are equally good performing as PY.34 and PR.104 will be extremely costly and extremely time consuming, given the wide range of high technical, high safety and high economical standards such pigments will have to meet.

Lead Chromates enable clean bright colours of paint and powder coatings to be made, however, they are essentially used to impart colour and are not truly functional pigments. Reply Applicant: we agree to the statement that PY.34 and PR.104 enable clean bright colours of paint and powder coatings.

For instance, they do not impart corrosion protection, film preservation or adhesion properties to coatings. There is an adequate available supply of suitable pigments in the EU with which to replace the use of lead chromate pigments although some compromise in performance and or cost will be required in many instances. The balance of compromise will vary with product type and area of end use.

OTHER COMMENTSThe British Coatings Federation, which represents 90% of the UK Coatings Industry, does not support this application to continue the use of lead chromate pigments in industrial coatings. At a BCF council meeting in April 2013, the BCF's Industrial Coatings Council supported legislating to create a global ban on the manufacture of all lead chromate pigments as, for the paint industry, we believe there are suitable alternatives available. Under the REACH Authorisation, lead chromate pigments will be banned in Europe from 2015, which will make a level playing field for all manufacturers within Europe.

Global Alliance to Eliminate Lead PaintIn 2009 2013 the International Paint and Printing Inks Council (IPPIC) which is a member of the UN/WHO Global Alliance to Eliminate Lead Paint (GAELP), established the following policy: “IPPIC supports the long-standing effectiveness of lead-use restrictions that are already in place in certain jurisdictions and recommends their widespread adoption by authorities not currently regulating the use of lead in paint and printing ink. Such restrictions may be accomplished through specific legislation or regulation, formal voluntary agreements, or by other means that ensure widespread and verifiable compliance.”

Whilst it may be practical to continue to regulate the controlled use of lead chromate containing paints in the EU this may perpetuate a global market in the trade in lead chromate pigments including in territories where regulation is less effective. We believe that the EU should be taking a lead on this issue and enforcing a prohibition on the use of lead chromate in paints.

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Reply Applicant:1. Basic Facts about the Lead in Paint WorldwideBased on actual numbers for LC and the Paint Industry (industry estimates 2012 and Orr & Boss Survey 2009)

lead in LC in paints worldwide accounts for only 0.02% of the total volume of paint produced and sold worldwide ie extremely small part of the world paint industry;

lead in LC in paints in the EU accounts for only 0.02% of the total volume of paint produced and sold in the EU ie an extremely small part of the EU paint industry

Decorative paint production worldwide is the largest single segment of the paint industry with 51% of the total volumes produced and sold.

Reference to the WHO/GAELP number of 1.0 million tons for lead used in paint worldwide if this number is true (which we do not believe it is) then lead in LC used in the paint industry worldwide contributes only 0.8% of lead used in

paint worldwide; we believe the figure used by the WHO/GAELP for lead used in paint is grossly overstated and politically motivated.

2. Focus of the WHO/GAELP/IPPICThe World Health Organization, International Programme on Chemical Safety published the "Business Plan of the Global Alliance to Eliminate Lead in Paint" , UNEP/WHO 24 August 2012.

http://www.who.int/ipcs/assessment/public_health/gaelp/en/http://www.who.int/ipcs/assessment/public_health/business_plan_en.pdf?ua=1

In our view the focus from the documentation is clearly to eliminate lead used in decorative coatings in the home and schools ie where children can be exposed.

Goals and objectives of the Global AlliancePage 2, Section 4: ".............. the primary focus of the Alliance is to prevent children's exposure to paints containing lead ................. "

i.e. in homes and at schools

Page 3. Section 7: " ...................... the elimination of lead paint applied to surfaces in and around the home and schools ...................... is therefore a priority focus for the efforts of the Global Alliance"

the Alliance does not mention anything about specific industrial uses of lead in any of its objectives - they are very general about everything other than homes and schools

Monitoring and Evaluation of the Business PlanPage 8. Section 18 (b) : " number of paint companies that have committed to the work of the Global Alliance and have eliminated the use of added lead compounds in all of the decorative paints that they manufacture'.................................. by 2020 : all paint manufacturers have eliminated the use of added lead compounds in primary (decorative) areas

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http://www.who.int/ipcs/assessment/public_health/business_plan_en.pdf?ua=1

http://www.who.int/ipcs/assessment/public_health/gaelp/en/

so the focus is once again on the priority (decorative) uses of lead in paint (not industrial i.e. the uses applied for by the applicant) also REACH and WHO are out of sync on their deadlines

3. IPPIC POSITION- IPPIC has adopted the strategy that the focus is on eliminating lead in decorative paints, not industrial applications.

4. AKZO/BASF/BCFAlthough these entities say they support the WHO/GAELP initiative, they as the dominant players in their industries (Akzo and BASF) are pushing the agenda and focus of the WHO/GAELP and even IPPIC to suite their own political agendas without due regard to the SME's in the business that do not have the resources to compete. They should by all means do what they as individual companies believe in, but they should not be forcing other industry entities especially on a worldwide basis to follow suite.

5. LEVEL PLAYING FIELDIn case authorization is granted, DCC will not be discriminatory amongst the customers that require the pigment except that they will need to show compliance with the handling measures that the applicant requires. For BCF members there is therefore a perfect level playing field and no discrimination. As the applicant has mentioned several times – the uses of PY.34 and PR.104 are already very limited and any company that does not truly need them (certainly in coatings) will try to work with alternatives. Therefore the playing field would not change from where it has been for decades. Insofar as BCF implies that companies choose to market coatings solutions unsuitable for purpose because lacking too many of the positive characteristics of PY.34 and PR.104 are at a disadvantage this is also untrue. After all, the coatings customers have the choice to produce outside of Europe and in many cases will do so – the decision by some companies no longer to use the pigments for coil coatings lead to a huge increase of productions of such coils in Turkey. The applicant would contend based on its socio-economic analysis that the European market BCF seems to imply exists – actually will disappear unless authorization is granted. In the absence of authorization BCF members would be at a real disadvantage because they could not supply non-EU companies with their coatings even when BCF member customers move their production out of the EU.

Comment BCF:

Australia

We understand that all use of lead chromate pigments in coatings has been banned in Australia, confirming that alternatives are available.

Reply applicant: Australia has probably less than 1% of the world paint production. It is not clear on what data Australia based their ban of the use of LC's24. The Australian ban seems predominantly politically motivated as the health and environmental basis is entirely cast on the dangers of lead with no regard to bio-availability, solubility, exposures etc… Interestingly the Australian ban also foresaw exemptions for industrial uses and further detailed implementation where required. Australia’s economy also has less than 10% in manufacturing of which over half would never involve any coatings. Equipment coated with PY.34 and PR.104 on the other hand is not restricted and routinely imported into Australia. It is easy to ban something you did not or hardly used in the first place. Lastly it should also be noted Australia DID NOT ban the use of the pigments in plastics and does not appear to have any plans to do so.

Support from SIEF

24 http://www.nicnas.gov.au/__data/assets/pdf_file/0016/4390/PEC_29_Lead-Compunds-in-Industrial-Surface-Coatings-and-Inks_Full_Report_PDF.pdf53(57)

http://www.nicnas.gov.au/__data/assets/pdf_file/0016/4390/PEC_29_Lead-Compunds-in-Industrial-Surface-Coatings-and-Inks_Full_Report_PDF.pdf

A REACH pre-registration SIEF was formed for lead chromate. We note that none of the other SIEF members, including the lead registrant, have been involved in this Application for Authorisation.

Reply applicant: We would like to emphasize that Lead chromate is not relevant for this application. If specifically PbCrO4 is meant, this is pre-registered, not registered and has no pigment properties so not relevant to consider in this application. The applicant is a member of the LC consortium therefore automatically a member of the LC SIEF. The applicant has contributed to the studies in the LC consortium.

Hazardous wasteThe use of lead chromate pigments generates hazardous waste such as containers and packaging, which needs to be treated and disposed of appropriately. This hidden cost can help towards offsetting the increased cost of the alternative pigments.

Manufacture of pigments within the EUWe understand that lead chromate pigments are no longer manufactured within the EU and we believe that the DCC pigments are manufactured in Canada. The increase in demand for alternative pigments may have a positive effect on European business.

Reply applicant: It is not correct that lead chromate pigments are no longer manufactured in the EU. The applicant has knowledge of at least two companies that are still manufacturing lead chromate pigments in the European Union and plan to continue to do so for export after the sunset date.

Employment within the EUConcerns have been raised that the unavailability of lead chromate containing paints would place the EU manufactures of articles at a disadvantage. In most cases paint accounts for a very small proportion of the overall cost of articles, typically less than 2%. Given this the overall impact on the cost of the article would be minimal.

Reply applicant: Whilst this is true the overall impact on the value (also for resale) of the article can be very substantial. Faded and worn off coatings on agricultural equipment negatively impact their resale price. EU industry is therefore encouraged to delocalize which is what we have shown in our SEA where a substantial drop in demand in the whole market is expected. This may include some companies abandoning their article production altogether but more likely they will look beyond the EU to make their article and reimport it. For a fuller response we refer to the extensive analysis we have made in our application which is fully public and devoid of opinion but instead supports the argumentation with facts and data based on recognized international studies.

Safety CriticalWe fail to see how lead chromates could be considered ‘safety critical’. Whilst the yellow colour offered by lead chromates is ecognized as a safety colour, the exact shade of paint is not that important.

Reply applicant: The applicant invites BCF to justify this statement with a real reference. The debate currently ongoing about the safety aspect of cadmium yellow totally contradicts the BCF statement. As we have shown in our AoA application the colours yellow and red are particularly noticeable to the human eye and also provide the best contrast in various environments. The shade certainly plays a role in that which is why the very hard to match vivid colours of the PY. 34 and PR.104 are so critical.

TimetableThe current proposal of a sunset date of 21 May 2015 gives clarity to all paint and powder coating manufacturers within the EU allowing clear

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communication with downstream users and enabling the paint and coating-supplying industry to plan elimination of their inventories to enable a smooth transition to alternative products.

Reply applicant: BCF should be aware that transitional measures are foreseen in the Regulation for applicants that have entered their authorization request in due time. As the applicant is the only company requesting authorization it has kept its own customer base completely informed of the progress and the likely deadlines so that they may plan in whatever way they deem the best for their business. Neither companies that can transition (not DCC clients) nor those that cannot (DCC clients) are therefore in any way hindered in their planning.

MonopolyWe note that, in the event of an Authorisation being granted, DCC would effectively establish a monopoly position for lead chromate pigment supply in the EU.

Reply applicant: The applicant is the only manufacturer that has consistently indicated he will maintain production of PY.34 and PR.104 as well as announced well in advance he would apply for authorization. The two other companies actually manufacturing the PY.34 and PR.104 in Europe (for export only as of the sunset date) as well as the other members of the (former) EMLC chose not to join this application. The (former) EMLC members – as evidenced by the fact even non applicants are still producing – felt that the candidate listing was politically motivated but that the size of the market for the pigments did not warrant the investment required to apply for authorization.BASF in particular but also some other pigment makers also saw an advantage because they are globally the only supplier of some of the more expensive and less performant alternatives (protected by proprietary technology and/or patents). From their perspective they have the ability to move from a competitive market with a smaller more agile manufacturer to one of real monopoly at higher prices. The applicant on the other hand would never be able to explain why it charges monopoly prices for PY.34 and PR.104 to its customers in Europe when it substantially different prices in other markets. The applicant does not only sell these two pigments and customers might well choose to punish the applicant by cancelling orders of other pigments if it attempted to abuse its position. Finally we underline that both coatings and plastics even more so – are price elastic products so that by raising prices the applicant would effectively undermine his own socio-economic analysis that shows the huge drops in demand that would follow. So whilst it is true that DCC would be the only supplier able to deliver in Europe this is by no means reprehensible. EU competition law does not forbid the fact that one is a monopolist – this situation exists in other areas – what it does punish is the abuse of dominant position (i.e. monopolies or near monopolies).

REFERENCESPattern cards from pigment manufacturers including DCC, BASF.

APPENDIXESTable of potential alternative pigments.

Reply applicant: where substitution has taken place this has been at a considerably higher cost i.e. relative to lead based pigments at an index of 100, other

single pigment costs (1:1 basis) would be PY.184: 450; PY.74: 250; PR.112: 250. It’s amazing that the paint industry can accept these step change cost increases whereas it is impossible to raise prices for single pigments of any sort unless there is a world shortage. DCC believes its socio-economic analysis adequately shows that the effects of substitution also in coatings are punishing to the detriment of the whole economy whilst the actual health and environmental cost is negligible.

We disagree that many/most UK customers have changed to lead free formulas : not all UK customers have /can make the change away from 55(57)

PY.34 and PR.104 in the short term. We refer to the many respondents in favour of our application in this respect and the statement made by PPG in response to the false allegations by BASF that it was terminating the production of PY.34 and PR.104 coatings in the UK. In other words BCF is not representing all its members.

PY.34 and PR. 104 are not irreplaceable: we disagree - there will always be a compromise in quality/properties at increased cost; for those customers that have made the switch, the associated costs and compromises have been passed on to the final user leading to inflation and increased CoL and lower quality/performance standards. We have made extensive representations regarding this in our AoA, answers to rapporteur questions and our responses to the various submissions. The statement by BCF is merely an opinion which we feel is not based on any real understanding, technical justification or the realities of the needs of the market.



nameEC Number

CAS Number



Ref.No: 220Date: 2014/04/04

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Non-governmental organisation (NGO)Name of org/company:ChemSecCountry:Sweden

water-based, lead-free traffic paint are readily available today


Applicants’ response:Applicants reply to Comments 220 -231Contributing third party: Chemsec, SwedenECHA consultation numbers 0012-01 to 0012-12

Comment by Chemsec:ChemSec consider the handling of these first authorisation application as test case for future submissions and therefore call upon ECHA to take all the necessary steps to ensure that the process will be as effective and transparent as possible in order to deliver on the REACH objectives to substitute SVHCs by safer alternatives.Lead chromate molybdate sulphate red (C.I. Pigment Red 104)is a classified CMR (Class I & II) according to Annex 1 of Directive 67/548/EEC. Lead interferes with a variety of body processes and is toxic to many organs and tissues including the heart, bones, intestines, kidneys, and reproductive and nervous systems. ChemSec believes that the use of lead-paints is an unnecessary source of toxic lead in the environment. E.g. alternatives such as water-based, lead-free traffic paint are readily available today (http://en.wikipedia.org/wiki/Lead_paint)

Applicants reply:- Dominion Colour Corporation fully agrees with Chemsec that the REACH processes should be as transparent and effective as possible. For

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this reason, DCC has made its Application for Authorisation (AfA) totally transparent by submitting all documents as non-confidential;- The classification for reproductive toxicity of lead is one of the reasons that PY.34 and PR.104 were placed on the Annex XIV list for

authorization. This RA approach was taken despite the absence of any proof for toxicity based on PY.34 and PR.104 as such. Indeed, the hazardous properties of lead as such are not disputed. In fact, in our Chemical Safety Assessment we have chosen neurodevelopmental toxicity (which is the most critical effect) for the hazard assessment of this endpoint. As we have shown in our hazard assessment in the REACH registration dossiers for PY.34 and PR.104, the maximum lead exposure for workers exposed to the DMEL for carcinogenicity is about 2x lower than the BMDL01 for neurodevelopmental toxicity. Therefore, the DMELworker, long term, systemic, inhalation for carcinogenicity will be equally valid in avoiding neurodevelopmental effects.

- Moreover, our Chemical Safety Assessment also demonstrates that the uses described in our AfA do not result in a hazard/risk for the environment.

- The possible alternatives are evaluated in our Analysis of Alternatives. This document demonstrates that every alternative has shortcomings that dismiss them as candidates for 1:1 substitution of PY.34 and/or PR.104.

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comments and response to comments on …echa.europa.eu/.../a4a_comment_response_79_0012-02_… ·...

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