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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): Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road markingConsultation number: 0012-12Applicant name: DCC Maastricht B.V. ORConsultation period: 12/02/2014 - 09/04/2014

Reference number and date:

Submitter: Alternative: Attachments:Type Generic

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Description of technical alternative

Classification and Labelling

Ref.No: 547Date: 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_547_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:


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Ref.No: 535Date: 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:


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Ref.No: 520Date: 2014/04/09

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Member State Competent Authority

The national legislation on road markings in Sweden requires white paint. Red markings are not normally used.

Comment_520_Attachment.pdf

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Name of org/company:Swedish Chemicals AgencyCountry:Sweden

Applicants’ response:Applicants reply to comments 519 and 520Contributing third party: KEMI (Swedish Chemical Agency)ECHA consultation numbers: 0012-11 and 0012-12

Reply applicant:It can be a corporate choice to use less performing pigments instead of PY.34 /PR.104 on airports, but the clear bright colours that can be made with these pigments will contribute to safety. Moreover, the longevity of the road marking is certainly a plus, especially on airports. It may be true that in Sweden only white permanent and yellow temporary road marking is used. However, other EU countries like UK and the Netherlands definitely use yellow road marking for long-duration road construction (which may last well over 1 year) or permanent yellow road marking (e.g. to indicate no parking zones). Therefore, longevity of the road marking is an issue.

For airfield road markings in the UK specific regulations exist regarding permanent yellow marking. For example, the Runway 08L-26R Rehabilitation Regulation for Gatwick airport prescribes: “The pigment for yellow permanent marking shall be Lead Chromate or a suitable light fast alternative…….”

In the Guide to Airfields Pavement Maintenance from the British (Defence Works Functional Standards), Ministry of Defense (page 134) it is stated that in replacing airfield markings in a similar colour as the original one, Requirements of MOD Specification TS10080 should be followed and “…..yellow paint shall contain at least 27% by mass of lead chromate”.Reference number and date:


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Ref.No: 468Date: 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"


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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. The applicant

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

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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.



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Ref.No: 375Date: 2014/04/08

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

Mixtures of organic and inorganic pigments



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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 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

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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 sector3. 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 users4. 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-CIBA5. 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 20096. 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 PR.104.

Colour matching industry

3 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..4 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.5 http://ec.europa.eu/competition/mergers/cases/decisions/m5355_20090312_20212_en.pdf PP. 19-306 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

BASF 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/a7. 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 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

7 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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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 Bismuth

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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 reality8 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 pigments9 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 colorants10. 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 most11 of these statements and has received a large response that BASF has quoted them without their authorization and that the statements themselves are not correct and do 8 We refer to our response to ETAD where we have given extensive links to the issue of PCB pollution of organicpigments.9 Presentation at Chemcon Istanbul 1st April 2014.10 http://www.crtib.lu/Leitfaden/content/FR/134/C602/

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

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.

11 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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12

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

12 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 required

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

PY.128 Dis-azo condensation Good solvent resistance

Poor shade functionality

Unknown by applicant Only two known

Unknown by applicant

Synthesis typically requires handling

No known concerns

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High colour strengthGood durability

Lower chromaMetamerismMore transparentLower dispersibility

suppliers – BASF and Synthesia

of chlorinated solvents




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

AABD – only available from Asia.3 known sources.

Available but limited to <10 significant ones

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 dispersibility

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

PY.65 Azo Limited chroma Poor shade functionalityPoor durabilityMetamerismMore transparent

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


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Poor solvent resistanceLower dispersibility

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 resistance





PO.67 Pyrazolo Chroma Poor shade functionality Coupling component Global volumes None known Solvent handling No known

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quinazolone Poor durabilityMetamerismMore transparentPoorer solvent resistanceLower dispersibility

only manufactured by BASF

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

requirements 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








PO.36 Benzimidazolone Solvent Poor shade functionality PCONA limited in Available but PCONA, 2- Handling of PCONA No known

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resistantDurability

MetamerismLower chroma/dirtyLower opacityLower dispersibility

supplyAABD limited number of suppliers. <5 good suppliers

limited to <10 significant ones

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

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

No known issues Available Requires poly phosphoric acid and para toluidine both hazardous chemicals

Significant amounts of phosphate waste that must be handledSolvent handling requirements needed too

No known concerns

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

Pigment Performance Availabilities Hazard Profile

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CI No. Class Strengths Weaknesses Raw material Pigment Raw material Pigment manufacturing

Pigment

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;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 mix13;

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

13 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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compared on their relative merits regardless of the mix they end up being used in.



nameEC Number

CAS Number



Ref.No: 369Date: 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



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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 mentioned

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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: 267Date: 2014/04/07

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

SubsInMixture

see non confidential attachment

CLPsee attachment

Comment_267_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 mentioned

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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: 259Date: 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 minimisation14 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.14 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 32(51)

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 reports15 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 protection

15 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

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:The application No. 0012-01 does not specify the inhalative exposure limit value (“DMEL”) on which the risk characterisation has been based on. The

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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 testing16. 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 exposure17.Reference number and date:


nameEC Number

CAS Number



Ref.No: 237Date: 2014/04/04

Affiliation:BehalfOfAnOrganisationType/Role in the supply chain:Non-governmental organisation (NGO)

With regard to the described hazards of the alternative substances we have a different view. International producers submitted to REACh on most organic pigments discussed as alternatives. Based on public available information such


16 The art of occupational exposure modelling – development and evaluation of generic inhalation exposure models J.M. Schinkel, 2013, Thesis Utrecht University ISBN: 978-90-393-6009-517 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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Name of org/company:ETADCountry:Switzerland

alternatives have a less problematic toxicological profile compared to lead chromates.

Applicants’ response:Applicants reply to comments 232 -237Contributing third party: ETADECHA consultation numbers 0012-03 to 0012-12

ETAD’s comments do not debate the performance attributes of the lead free alternatives. They focus on our statements regarding the hazards and risks of the alternatives. In general it seems that ETAD has an issue with the fact the applicant pointed to hazard data that is outside of their submission in the registration files. The applicant contends that registration CSR data is not exclusively of relevance in an authorization application where both the production and the final use of the substance must be taken into account for the purposes of assessing hazards and risks. There have been many cases where chemicals that ‘can’ be used safely in practice were not used safely and so despite efforts by good companies to work safely have been the subject of restrictions.

Hazards and risks of the alternativeWith regard to the described hazards of the alternative substances we have a different view. Colorant producers present on the international market and with manufacturing sites worldwide already submitted REACH dossiers on most organic pigments discussed as alternatives to ECHA. Based on the current knowledge of the substances and of the manufacturing processes such alternative colorants have a less problematic toxicological profile compared to lead chromates.The comments can be found in various similar documents (0012-05, 0012-06, 0012-09, 0012-10, 0012-11, 0012-12). The page numbers may vary.

4.1 Diarylide pigments – DIARYLIDES – ALTERNATIVE 3No. Page No. Quote Comment Reply Applicant

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Production of semi-products is very dangerous and pollutive. When breaking down into constituent parts the pigments yield dangerous classified substances. Limitations for these releases have already been set in European legislation for example for food packaging.

The production can take place mainly in closed systems, i.e. occupational exposure can be excluded. Additionally, through appropriate waste treatment, these organic semi-products can be decomposed to toxicological harmless compounds.The thermal degradation of azo diarylide pigments in polymers is a long known issue. A corresponding publication from ETAD clarified already in 1990 under which conditions the breakdown occurs, with specific references to the different applications. The document is a well-known reference also outside the association.

ETAD talks about the fact that the production of semi products CAN take place mainly in closed systems, i.e. occupational exposure CAN be excluded. The operative word here is CAN….: DCB – suspect human carcinogen produced mainly in India,

China and Japan. It is widely known that production in India and China CAN place workers at higher risk.

Acetoacetarylides – the coupling components are produced using a diketene process which is explosive by its very nature and must be strictly controlled.

Finally, DCC is not saying that the risk of production cannot be adequately controlled but rather there is an inherent risk that should be controlled. The same as it is felt there is an inherent risk in the production and use of PY.34 and PR.104. DCC is simply stating that the alternatives have inherent risk too that must be suitably controlled.

The European Legislation on food packaging sets a limitative list 38(51)

for substance that can be detected over 10ppm. The fact 3,3'-DCB is NOT on the list means its presence is not allowed (art 5 Regulation 10/2011). US sources also confirm no DCB food uses permitted.

The production of the pigment is not the only cause of the pollution by classified substances. Non-respect of the threshold of 200°C in plastic manufacturing will also cause DCB to leach out over acceptable limits. (Ref. Encyclopedia Of Polymer Science and Technology Ed. John Wiley and Sons, Inc.; Online ISBN: 9780471440260; DOI: 10.1002/0471440264)

The Danish Ministry of the environment confirms issues also in other areas with DCB in this they followed concerns on DCB first voiced by Germany. “The formation of carcinogenic amines is regarded to be the major causative factor of the carcinogenicity of a given dye. (...) Aromatic amines which may be considered carcinogenic are listed in Table 3.4 below. (...) and not all aromatic amines have been sufficiently tested to allow for an evaluation of carcinogenicity.”18

In their Notice #6 of 2008 (available on etad.com19) ETAD says the same thing and explains why it is important to know the amine content of your pigments and that the 3,3'-DCB can escape under unexpected circumstances. This contradicts ETAD’s bold statement that production can always be safe. In a much earlier publication ETAD also confirmed the problems related to Nordic Council of Ministers that the downstream use of the pigments at excessive temperatures (Chloro-organic Used as Pigments- pp.54-55 – ISBN 92-9120-785-2) is problematic.Finally see also: Dewald RAzB, Schnaitmann D. Pigment decomposition in polymers in applications at elevated temperatures. Dyes Pigments 1991;15:1–14

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In Appendix 1 we have given an overview of warnings from market suppliers (excluding the applicant) regarding the various alternatives. These warnings and independent research generally support the views below which are the summarised opinion of the applicant regarding the risks of the alternatives in this group.…- Some of the pigments in the group are classified as carcinogenic due to impurities (PO.34), or have MSDS warnings of being

Non-classified pigment grades of PO. 34, PY. 13 and PY. 83 are available on the market.Experimental data on all four pigments has been collected and generated for the purpose of registration under REACH at the tonnage band of > 1000 tpa (PY. 13 and PY. 13) and 100/1000 tpa (PO. 34, PO. 13).In general, all four pigments are not toxic upon acute ingestion, not irritating to skin and eyes and do not cause skin sensitization in experimental animals. No adverse effect

It must be emphasized that the quotes selected by ETAD represent the SUMMARIZED OPINION OF THE APPLICANT, as also explicitly mentioned in the quote to the left.PO.34: we note that obviously some PO.34 products show CMR hazards on their MSDS' and other references show sensitizing properties of PO.34 (Acta Derm Venereol Suppl (Stockh). 1987;134:95-7)PY.13: PY 13 is toxic when heated to decomposition level emitting chlorine and nitrogen oxides and this is most likely true for all the family of pigments.PO.13: we admit our typo concerning sensitization vs irritation

18 http://www.statensnet.dk/pligtarkiv/fremvis.pl?vaerkid=624&reprid=0&filid=24&iarkiv=119 http://www.etad.com/documents/Downloads/publications/notice_no_6_rev_2008.pdf

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http://www.etad.com/documents/Downloads/publications/notice_no_6_rev_2008.pdf

http://www.statensnet.dk/pligtarkiv/fremvis.pl?vaerkid=624&reprid=0&filid=24&iarkiv=1

sensitisers (PO. 13, PO. 34) or causing other toxic effects (PY.13, PY.83);

after repeated exposure, no genotoxicity or reproductive toxicity was observed. The pigments are not considered to be carcinogenic and no hazard for the environment was identified. As regards the specific warnings:(PO34): Carcinogenic due to impurities - This description is based on a MSDS from CHEMTREC, as written on P110.These impurities are described as carbon black and ethylbenzene. These impurities are not mentioned in the entries for PO34 REACH-registration, and no corresponding classification is triggered for the registered products.(PO 13, PO 34): warning of being sensitisers - This description is based on MSDS from Lansco Colour (PO 13) and from CHEMTREC, as written on P 109 and 110, respectively. See general comment above.Additionally, concerning PO34 the above mentioned MSDS says “May cause silicosis due to crystalline silica presence.” This implies that the toxic effect is caused by silica and not by PO34.(PY13, PY83): causing other toxic effectsConcerning PY13, there are no such descriptions in Annex 1 P109-117. It might be a typo.Concerning PY83, the MSDS from CHEMTREC, P 116, says “May be fatal to swallow and long term exposure may cause permanent brain and nervous system damage + may cause corrosion / irritation.” This MSDS contradicts the above information submitted for REACH, a CHEMTREC product-specific classification is a possible explanation.In particular, PY83 showed no specific target organ toxicity, either by single or by repeated exposure.

for PO.13, although there is an MSDS claiming it is a sensitizer. The irritation on the other hand is amply reported on i.a. by the Australian EPA.ETAD states that the pigments are non-toxic, and then refer to our comments on the various MSDS’ which state they potentially are toxic. The issue here is that whilst, the pigments may indeed be non-toxic, the formulated products often are potentially hazardous. For example the Lansco MSDS refers to a PO.13 being a sensitizer. Often this relates to the use of Colophony or other additives in the formulation of the pigment product on the market. Hence the need to label it.

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There is already primary legislation regarding the release Primary Aromatic Amines (3-3’ dichlorobenzidine) setting a limit in plastics that is already hard to meet but in coatings there is no residue over 10 ppb permitted

There are grades of PY 83 available which meet the requirements of Resolution AP (89) 1 on the use of colorants in plastic materials coming into contact with food. Among others this Resolution sets a limit for primary aromatic amines (including 3-3'dichlorbenzidine) of < 500 ppm for pigments. This requirement for the pigment

As regards the general issue on DCB we refer to our answer above. Furthermore this statement implicitly proves the point of the applicant in that it says there are ‘some grades’ that meet resolution AP 89. In other words some do and some don’t. Which grades are used in the production process is also not ascertained or controlled by ETAD. More fundamentally the process with which the plastic is transformed is critical to ensuring whether DCB will leach into the food contact material. ETAD is well aware

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will result in a negligible exposure through potential migration from the coloured plastic material.

that none of the organic pigments producers check whether the 200°C limit is respected.The applicant also refers to the vote on 17th April 201420 on the packaging and waste directive which introduced new limits to the use of CMR (precursor) molecules in food packaging materials and orders their phase-out.Lastly as per the presentation of 1 April 2014 by Szilvia Deim Head of the ECHA enforcement authorities group during the CHEMCON conference, it is known that France has executed a specific enforcement against azo pigment excesses in articles (and substances) responding to alarming incidental measurements of excesses due to the use of these pigments.Certainly the applicant agrees that if all safety measures are respected the pigment should be safe – the reality is that there are concerns known in the market. These concerns are real and deserve to be put in the perspective of the different concerns related to the applicant’s pigments.

485459

…The intermediate factory needs to be a so-called ATEX facility– ergo constructed to deal with explosives and considering how many accidents are still occurring, this problem is not theoretical and world-wide production of diarylide pigments causes much more immediate damage than PY.34 and PR.104.

The production can proceed safely by using suitable equipment and following safe handling procedures.Accidental explosions have been reported in the past, but, to the best of our knowledge, due to mistakes occurred during production.

This reply by ETAD confirms our statement that the production of diarylide pigments is hazardous as they admit mistakes have been made.

485459

…Due to the health hazards of the precursor DCB, the manufacture is mandatorily happening in closed systems with full PPE for personnel – of course in India and China (which are the main sources) this requirement is rarely fulfilled

Even in China or in India, safe production can be achieved by using suitable equipment and following safe handling procedures.

ETAD basically confirms our statement that the production process is hazardous. Of course safe production could be achieved in China or India, but this is more often not the case in these countries.“The Chinese government’s policy on environmental protection has led to the temporary or permanent closure of many DCB (3,3’ Dichlorobenzidine) supplier facilities,” said Mr. Westrom.21 DCB is a key amine component for Azo Yellows, such as Pigment Yellow 12, 13, 14, 17, 83, 126, 127, 174, 176, Pigment Orange 13, 34, and Pigment Red 38. In addition, the supply of nitrocellulose was

20 http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A7-2014-0174&language=EN#title121 http://www.inkworldmagazine.com/issues/2013-09/view_features/the-raw-material-report/

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http://www.inkworldmagazine.com/issues/2013-09/view_features/the-raw-material-report/

http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A7-2014-0174&language=EN%23title1

temporarily disrupted after a fire at TNC Industrial Co. plant in the first week of August. TNC is a major nitrocellulose producer in Taiwan.” 22

The applicants research shows that numerous factories in China have been closed in an attempt to reign in the excesses in DCB production and that a limited number of larger installations were being favoured for the continued production (source: Proprietary DCC research in China)

485459

…Azo substances are also known to degrade into the environment under slightly acidic conditions – the higher the acidity the faster the degradation.

Diarylides pigments do not show such tendency, as reported in many available publications and specifically addressed by the corresponding endpoints in their REACH registrations.

This is a debate in itself – see for example degradation in urine of humans and rats: Analysis, purification and stability: requirements for a metabolism study of an azo dye and pigment. J Anal Toxicol. 1980 Mar-Apr; 4(2):63-7. [Journal of analytical toxicology]. Degradation does not occur immediately but after 48 hours.As ETAD references PO. 16 below as a counterexample – we note that it is soluble in acid (rated 3 on a scale of 5)23.

485459

…There is already primary legislation regarding the release Primary Aromatic Amines (3-3’dichlorobenzidine) setting a limit in plastics that is already hard to meet but in coatings there is no residue over 10 ppb permitted.

The Resolution AP (89) 1 on the use of colorants in plastic materials coming into contact with food sets a limit for primary aromatic amines (including 3-3'dichlorbenzidine) of < 500 ppm for pigments. This requirement for the pigment will result in a negligible exposure through potential migration from the coloured plastic material.

See earlier response

485459

…The increased use of the xylene solvent is also an issue that contributes to the environmental and human exposure to

Production processes exist where very little xylene is used for diarylide pigments and in particular no xylene is used for the diarylides

ETAD has misunderstood the statement – the remark has nothing to do with the use of xylene in the synthesis of the diarylide. Instead the solvent (xylene or another) is used in the

22 http://www.inkworldmagazine.com/issues/2013-09/view_features/the-raw-material-report/#sthash.WCayyWz2.dpuf23 http://suncolorpigment.en.hisupplier.com/product-1362547-China-Pigment-Orange-16-PO16-Permanent-Orange-R-supplier.html

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http://suncolorpigment.en.hisupplier.com/product-1362547-China-Pigment-Orange-16-PO16-Permanent-Orange-R-supplier.html

http://www.inkworldmagazine.com/issues/2013-09/view_features/the-raw-material-report/%23sthash.WCayyWz2.dpuf

hazardous substances. This illustrates that shifting to diarylides is not benificial.

pigments used as lead chromium substitutes. manufacture of the coating and the use of the diarylide pigment requires larger concentrations of solvent.

485459

…Furthermore diarylides are known to generate carcinogenic by-products during their Decomposition.

The thermal degradation of azo diarylide pigments in polymers is a long known issue. A corresponding publication from ETAD clarified already in 1990 under which conditions the breakdown occurs, with specific references to the different applications. The document is a well-known reference also outside the association.

ETAD basically confirms our statement that thermal degradation of diarylides to carcinogenic metabolites can occur

ORGANIC PIGMENTS - DIANISIDINE – ALTERNATIVE 4No. Page

No.Quote Comment Reply Applicant

5461

…The intermediate used in the manufacture of these pigments is 3,3’-dianisidine is presumed to have carcinogenic potential for humans. The manufacture is mandatorily happening in closed systems with full PPE for personnel. In India and China (which are now almost the only sources) this requirement is rarely fulfilled.

Even in China or in India, production can be achieved safely by using suitable equipment and following safe handling procedures.

ETAD basically confirms our statement that the production process is hazardous. Of course safe production could be achieved in China or India, but this is more often not the case in these countries.

5561

…Azo substances are also known to degrade into the environment under slightly acidic conditions – the higher the acidity the faster the degradation; there is evidence that humans may metabolise the Azo substance to its carcinogenic parent compound.

Diarylide pigments do not show such tendency, as reported in various available publications and specifically addressed by the corresponding endpoints in REACH registrations dossiers of diarylide pigments. Organic pigments in general, due to their high insolubility, share the same lack of bioavailability.

See earlier remark

5561

…When the pigment degrades – which it does very easily due to its poor durability – it will release its carcinogenic molecules – unlike the PY.34 and PR.104 molecules that are poorly soluble these ones are soluble and very dangerous.

See comment above.Additionally, even if more soluble in comparison with lead chromates, PO16 still is a quite insoluble substance.

Quite insoluble is hardly a scientific term – ETAD states in its notice 6/200824:” However, some azo pigments are sufficiently soluble under the analytical test conditions to yield detectable amounts of a listed amine (i.e. greater than 30 mg/kg consumer good).” PO.16 is part of the list of pigments they reference this statement to.

24 Opcit43(51)

61x

…There is already primary legislation regarding the release Primary Aromatic Amines (3,3’-dichlorobenzidine ) setting a limit in plastics that is already hard to meet but in coatings there is no residue over 10 ppb permitted.

The Resolution AP (89) 1 on the use of colorants in plastic materials coming into contact with food sets a limit for primary aromatic amines (including 3-3'dichlorbenzidine) of < 500 ppm for pigments. This requirement for the pigment will result in a negligible exposure through potential migration from the coloured plastic material.

See earlier remark

5461

…PO. 16 is itself sometimes noted as a suspected human carcinogen;

PO 16:Experimental data on acute and subacute toxicity in rats as well as genotoxicity has been made public by MHLW Japan. The acute oral toxicity (OECD 401) was found to be greater than 2000 mg/kg bw and no mortality occurred. No adverse findings were observed in the subacute oral study at the limit dose (OECD 407). PO 16 did not cause genotoxicity in the Ames test with Prival modification for azo compounds (OECD 471) and in the chromosome aberration test in vitro (OECD 473). All studies were reported to be performed under GLP.

Since the third annual report on carcinogens25 PO.16 has been termed a suspected human carcinogen because of the carcinogenic precursor molecules.

Pigment Orange 16 was positive for mutagenicity in a preliminary study using Salmonella typhimurium strain TA98; however, further study showed that this was the result of contamination. A more purified form of Pigment Orange 16 was not mutagenic with or without activation in the Ames assay, nor was it mutagenic in a modified Ames assay in which preincubation with flavin mononucleotide (FMN) was employed to facilitate cleavage of the azo bond (BF Goodrich Co. 1992).

61x

…The increased use of the xylene or other solvent is also an issue that degrades the environment/health benefit of shifting to diasinides.

Production processes exist where xylene is not used in the PO 16 production.

ETAD misunderstood our submission – the additional solvent is used in the coating not the synthesis of the pigment.

ORGANIC PIGMENTS – AZO BENZIMIDAZOLONES – ALTERNATIVE 5ORGANIC PIGMENTS – MONOAZO – ALTERNATIVE 6ORGANIC PIGMENTS – SPECIALTY AZO – ALTERNATIVE 7ORGANIC PIGMENTS – OTHER ORGANICS – ALTERNATIVE 8

25 For example: 8th annual report on carcinogens 1998 – edited by Barry Leonard p. 10444(51)

No. Page No.

Quote Comment Reply Applicant

8094101

PY. 110 and PY. 138 both have extremely dangerous production with intermediate products required that are unstable or solvents that are toxic.In the case PY.110 it is the use of PCl inmanufacture and the need to use dangerous solvents dichlorobenzene (Carcinogen cat. 2), POCl3 ortrimethylbenzene (causes chronic solvent induced encephalopathy). Furthermore 1,4- Benzenediamine and Tetrachlorophthalic anhydride both substances dermal sensitiser and knowncause of occupational asthma are used as an intermediate in the production of PY.110…

Safe production can be achieved by using suitable equipment and following safe handling procedures.

ETAD basically confirms our statement that the production process is hazardous. Of course safe production could be achieved in China or India, but this is more often not the case in these countries.

DPP PR. 254 – ALTERNATIVE 9No. Page

No.Quote Comment Reply applicant

8297103

…The manufacture is done as follows:… The synthesis steps provided do not reflect a scientific sound manufacturing process for PR 254. A suitable reference can be found, e.g., in “Industrial Organic Pigments, W. Herbst, K. Hunger (Second Edition), VCH”.

It is acknowledged that several different manufacturing processes are possible and that other manufacturing seems possible without acids: one synthesis method DPP uses a strong base is described. However, the production of DPP has a risk profile still –use of sodium metal dissolved in alcohol – leads to production of hydrogen gas. The process also requires solvents which are flammable. It is not a “safe” aqueous process.

85101107

The production of DPP is very dangerous due to the acids needed in the production….

The production of DPP is mainly conducted under alkaline conditions. To our knowledge, acids are used only for neutralization and the process can be performed under controlled conditions.

ALTERNATIVES PROPOSED BY SWEDEN IN ITS RESTRICTION PROPOSAL – ALTERNATIVE 10

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No. Page No.

Quote Comment Reply applicant

86102109

There are no known toxicity studies for this substance but the MSDS sheet advises the use of respirators and personal protective equipment due to possible skin sensitisation97. Furthermore PR.2 is mainly manufactured in China – all known sources are heavily contaminated with PCBs and deemed so hazardous that no western manufacturers wishes to use the pigment.

PR 2 has been registered for REACH, and the pigment dossier contains key toxicity studies as well as supporting studies and read-across references. The skin sensitisation labelling is also based on the evaluation of existing data. No other toxicity is supported by the provided studies.Accordingly to its REACH dossier in the >1000 tpa range, the pigment was registered in Europe by seven companies, most of them present on the international market and with manufacturing sites worldwide. It is also manufactured by other companies with the same profile. Independently from the production site, PR 2 grades are available which will comply with Resolution AP(89)1.In general, non-classified pigment grades of PR 2 are commercially available; these grades show PCBs contents below 50 ppm; specific grades with PCBs contents below 25 ppm are available as well. PR 2 is widely used in Europe, mainly for printing ink applications.

We concur PR.2 is a printing ink pigment and for this reason unsuitable as a substitute for PY.34 and PR.104. As regards the PCB pollution of the pigment (and others of its family) this is unfortunately a matter of record and a huge issue at this time.We reference:

Japanese government intervention in contaminated PR.2 Meti Report26; US Study of 2014 regarding the presence of PCBs in

commercial paint pigments27

Evidence for unique and ubiquitous environmental sources of PCBs28

The presence of PCBs in yellow pigment products in china with emphasis on PCB 1129

2025 Safer Chemistry programme30

There is ample further evidence of problems with PCBs the Japanese study (and subsequent national ones around the world) examined several other organic pigments including PR.112, PY.165, PY.13, PY.83, PY.12, PO.13, PY.55, PY.14, PY.17, PO.34, PY.81 finding up to 2000ppm of PCBs. The problem is broadly recognized and certainly the applicant will concur that better control of chemistry will prevent the PCB formation. It is just a fact that the qualities in the market sometimes fail to meet these criteria.

88103111

…Pigment Red 57……The substance is a known respiratory and skin sensitizer according to the risk statements that accompany it.

PR57:1Experimental data has been collected and generated for the purpose of registration under REACH at the tonnage band of > 1000 tpa.Pigment Red 57:1 is not toxic upon acute ingestion, skin contact and inhalation. It is not irritating to skin and eyes and does not cause skin sensitization in experimental animals. A screening study for subacute toxicity and repeated dose and reproductive toxicity showed adverse effects on the kidney at high

The risk phrases associated with PR.57:1 are:R20/21/22: Harmful by inhalation, in contact with skin and if swallowed.R36/37/38: Irritating to eyes, respiratory system and skin.31

ETAD is exclusively referring to the registration dossier which is apparently not in accord with risk phrases commonly assigned to the product in the market32.

26 http://www.p2.org/wp-content/uploads/june-27-pcbs-webinar.pdf PP. 44; www.meti.go.jp/english/press/2013/0510_02.html ; https://fortress.wa.gov/ecy/publications/publications/1407005.pdf27 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853905/28 http://www.ncbi.nlm.nih.gov/pubmed/2038437529 http://www.ncbi.nlm.nih.gov/pubmed/2423104130 http://www.p2.org/wp-content/uploads/june-27-pcbs-webinar.pdf31 http://www.chemicalbook.com/CASEN_5281-04-9.htm#SafetyData32 Random MSDS: http://www.aarbor.com/MSDS/1405W.pdf

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http://www.chemicalbook.com/CASEN_5281-04-9.htm

http://www.p2.org/wp-content/uploads/june-27-pcbs-webinar.pdf

http://www.ncbi.nlm.nih.gov/pubmed/24231041

http://www.ncbi.nlm.nih.gov/pubmed/20384375

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853905/

https://fortress.wa.gov/ecy/publications/publications/1407005.pdf

http://www.meti.go.jp/english/press/2013/0510_02.html

http://www.p2.org/wp-content/uploads/june-27-pcbs-webinar.pdf

doses. The pigment is a complex between an organic acid and calcium and dissociates at extreme pH, such as present in the stomach. Therefore, solubility is higher than for other pigments and uptake after ingestion is observed. The analogue sodium salt (Pigment Red 57) did not cause adverse effects in a life-long feeding study starting with in utero exposure. The substance will undergo testing for teratogenicity and fertility in the near future. No genotoxicity was observed. No hazard for the environment was identified.

88103112

Pigment Red 122…The production of this pigment is also highly pollutive with 5-8 kg of phosphates emitted to surface waters for every 1 kg of pigment produced.

Current manufacturing processes exist which incorporate a recovery step in the production, allowing phosphates to be reused or recycled.

Literature and patents state that polyphosphoric acid is required in large quantities for synthesis 33 . This is also confirmed in EPA impact assessment for large volume facilities to produce the pigment34. Furthermore by its own statement ETAD admits there is an issue as their claim is merely that ‘processes exist that include a recovery step.’ This is certainly true – are they always implemented? – certainly not.

104 C.I. Pigment Yellow 12…The substance is dangerous when in the presence of strong oxidizing agents and explosive.

No autoflammability, flammability or explosive properties have been shown by the studies collected or generated for the REACH registration of PY 12.

The REACH registration studies have been performed with PY.12 as such. Our statement is about the incompatibility of PY.12 with strong oxidizing agents.

APPENDIX INo. Page

No.Quote Comment Reply applicant

102117125

…PY.168… PY168:Experimental data has been collected and generated for the purpose of registration under REACH at the tonnage band of 100 - 1000 tpa.Pigment Yellow 168 is not toxic upon acute ingestion. A structural analogue was nontoxic after single skin contact. It is not irritating to skin and eyes and does not cause skin sensitization in experimental animals. No adverse effects were observed after repeated exposure to a structural analogue in animal studies. There is also no indication of a fertility impairing effect or a developmental toxic / teratogenic effect after administration of the analogue. No genotoxicity was

PY.168: no reply required

33 http://www.google.com/patents/CN102942802A?cl=en&dq=pigment+red+122+synthesis+for+plastic+powder&source=uds34 http://www.epa.gov/chemrtk/pubs/summaries/ci19122d/c16303tc.htm

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http://www.epa.gov/chemrtk/pubs/summaries/ci19122d/c16303tc.htm

http://www.google.com/patents/CN102942802A?cl=en&dq=pigment+red+122+synthesis+for+plastic+powder&source=uds

observed. No hazard for the environment was identified.

102117125

…PY.183… PY183:Experimental data has been collected and generated for the purpose of registration under REACH at the tonnage band of 100 - 1000 tpa.Pigment Yellow 183 is not toxic upon acute ingestion, single skin contact and inhalation. It is not irritating to skin and eyes and does not cause skin sensitization in experimental animals. No adverse effects were observed after repeated exposure to an analogue structure in animal studies. There is also no indication of a fertility impairing effect or a developmental toxic / teratogenic effect after administration of the analogue. No genotoxicity was observed. No hazard for the environment was identified.

PY.183: according to the disseminated REACH registration dossier PY.183 is not classified, not mutagenic, not skin sensitizing, not toxic after single or repeated exposure and not toxic to reproduction. However, the key study for reproductive toxicity ( OECD 421 reproduction screening study with a structural analogue /surrogate) 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. However, this is at least questionable, because macro- and microscopically apparent atrophy of the prostate probably constitutes an adverse effect.

103118126

…PY.61… PY61:Experimental data has been collected and generated for the purpose of registration under REACH at the tonnage band of 10 - 100 tpa.A structural analogue of Pigment Yellow 61 is not toxic upon acute ingestion, Pigment Yellow 61 nontoxic after a single skin contact. The analogue is not irritating to skin and eyes. Pigment Yellow 61 does not cause skin sensitization in experimental animals. No adverse effects were observed after repeated exposure to a structural analogue in animal studies. There is also no indication of a fertility impairing effect or a developmental toxic / teratogenic effect after administration of the analogue. No genotoxicity was observed at analogue substances. No hazard for the environment was identified.


103118126

…PY.62… PY62:Experimental data has been collected and generated for the purpose of registration under REACH at the tonnage band of 100 - 1000 tpa.Pigment Yellow 62 is not toxic upon acute ingestion. A structural analogue was nontoxic after single skin contact. It is not irritating to skin and eyes and does not cause skin sensitization in experimental animals. No adverse effects were observed after repeated


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exposure in animal studies. There is also no indication of a fertility impairing effect or a developmental toxic / teratogenic effect. No genotoxicity was observed. No hazard for the environment was identified.



nameEC Number

CAS Number



Ref.No: 225Date: 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 this

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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.



nameEC Number

CAS Number



Ref.No: 202Date: 2014/03/28

Affiliation:BehalfOfACompanyType/Role in the supply chain:Downstream UserName of org/company:product markingsCountry:United Kingdom

SubsOnItsOwn

py183 65212-77-3

CLPnon toxic


Applicants’ response:Applicants reply to Comments 199, 200, 201 and 202Contributing third party: Confidential

Comment by third party: There are many viable safe alternatives to red, primrose and yellow lead chromates for roadmarkings.Product markings as a responsible manufacturer

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has ceased to use them for six months and experienced no problems. It is important these materials are banned from use because the users do not take proper care when using them and the damage to people`s health and the environment is unmeasured.eg E.P Bray site that can be seen on the internet and the widespread use of recycled road chippings for tracks.Plenty of time has been given to find alternatives and if that time has not been utilized then that is the fault of the companies involved .Red alternativePR170 Napthol red is used in preference to lead chromate by many companies at present.

Applicants reply:- A six-month period of manufacturing lead chromate-free products is hardly long enough to evaluate performance of the alternatives in

comparison to PY.34 and PR.104 containing products. Issues of reduced durability or other performance characteristics will show themselves within one to two years.

- Users should of course always take proper care when using hazardous substances. In the “uses applied for” in the authorization application for PY.34 and PR.104 the Chemical Safety Report describes the proper use of the pigments in the use scenarios, including road marking.

- Moreover, the Chemical Safety Assessment has demonstrated that the use of PY.34 and PR.104 will not result in a risk for the environment and will remain below the accepted risk for worker health, since no consumer uses are included in the authorization application.

- Indeed, 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.

- The ECHA overview indicates that the proposed alternative in Comment 199 is PY.183, whereas in the text PR.170 Naphthol red is mentioned. It is not clear which alternative is proposed by the third party.

Hazard- PR 170 (Naphthol red) is not classified. It is not mutagenic, not skin sensitizing, not acutely toxic.- PY.183: according to the disseminated REACH registration dossier PY.183 is not classified, not mutagenic, not skin sensitizing, not toxic after

single or repeated exposure and not toxic to reproduction. However, the key study for reproductive toxicity ( OECD 421 reproduction screening study with a structural analogue /surrogate) 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. However, this is at least questionable, because macro- and microscopically apparent atrophy of the prostate probably constitutes an adverse effect.

Performance- PR.170 does not have the required level of durability or opacity to be a long term alternative for PR.104;- PY.183 also does not have the required level of durability or opacity to be a long term alternative for PY.34.- Neither PR.170 or PY.183 are considered in the industry suitable long term alternatives to PY.34 or PR.104.

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