Committee for Risk Assessment (RAC)
Committee for Socio-economic Analysis (SEAC)
Opinion
on an Application for Authorisation for
Industrial use, of a qualified mixture of chromium trioxide by spraying or immersion, and of a qualified mixture of dichromium tris(chromate) by pen application, for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military use, and requiring a maintained electrical conductiv ity after severe climatic environments, atmospheric corrosion resistance and paint adhesion
ECHA/RAC/SEAC: Opinion N° AFA-O-0000006510-83-08/F
Consolidated version
Date: 06/09/2016
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Consolidated version of the
Opinion of the Committee for Risk Assessment and Opinion of the Committee for Socio-economic Analysis
on an Application for Authorisation
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restric tion of Chemic als (the REACH Regulation), and in partic ular Chapter 2 of Title VII thereof, the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) have adopted their opinions in accordance with Article 64(4)(a) and (b) respectively of the REACH Regulation with regard to an applic ation for authorisation for:
Chemical name(s): chromium trioxide; dichromium tris(chromate) EC No.: 215-607-8; 246-356-2 CAS No.: 1333-82-0; 24613-89-6 for the following use:
Industrial use, of a qualified mixture of chromium trioxide by spraying or immersion, and of a qualified mixture of dichromium tris(chromate) by pen application, for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military use, and requiring a maintained electrical conductivity after severe climatic environments, atmospheric corrosion resistance and paint adhesion
Intrinsic property referred to in Annex XIV:
Artic le 57 (a), (b) of the REACH Regulation for c hromium trioxide Artic le 57 (a) of the REACH Regulation for dic hromium tris(c hromate)
Applic ant:
Nexter Mechanics Nexter Systems
Reference number:
11-2120106012-82-0003
Rapporteur, appointed by the RAC: Lina DUNAUSKIENĖ Co-rapporteur, appointed by the RAC: Susana VIEGAS Rapporteur, appointed by the SEAC: Stavros GEORGIOU Co-rapporteur, appointed by the SEAC: Janez F URLAN
This document compiles the opinions adopted by RAC and SEAC.
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
PROCESS FOR ADOPTION OF THE OPINIONS
On 23/11/2015 Nexter Mechanics and Nexter Systems submitted an applic ation for authorisation inc luding information as stipulated in Artic les 62(4) and 62(5) of the REACH Regulation. On 01/02/2016 ECHA received the required fee in accordance with Fee Regulation (EC) No 340/2008. The broad information on uses of the application was made publicly available at http://echa.europa.eu/addressing-c hemic als-of- concern/authorisation/applications-for-authorisation on 10/02/2016. Interested parties were invited to submit comments and contributions by 06/04/2016.
The draft opinions of RAC and SEAC take into account the comments of interested parties provided in ac cordance with Article 64(2) of the REACH Regulation as well as the responses of the applic ant.
The draft opinions of RAC and SEAC take into account the responses of the applicant as well as third parties to the requests that the SEAC made according to Article 64(3) on additional information on possible alternative substances or technologies.
The draft opinions of RAC and SEAC were sent to the applicant on 29/07/2016.
The Applicant informed ECHA that they did not wish to comment on the opinions. The draft opinions of RAC and SEAC were therefore considered as final on 06/09/2016.
ADOPTION OF THE OPINION OF RAC
The draft opinion of RAC
The draft opinion of RAC, which assesses the risk to [human health] [and/or] [the environment] arising from the use of the substance – including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives – was reached in accordance with Article 64(4)(a) of the REACH Regulation on 03/06/2016.
The draft opinion of RAC was agreed by consensus.
The opinion of RAC
Based on the aforementioned draft opinion and in the absence of comments from the applic ant, the opinion of RAC was adopted as final on 06/09/2016.
ADOPTION OF THE OPINION OF SEAC
The draft opinion of SEAC
The draft opinion of SEAC, which assesses the socio-ec onomic fac tors and the availability, suitability and technical and economic feasibility of alternatives associated with the use of the substance as described in the application was reached in accordance with Article
2 64(4)(b) of the REACH Regulation on 09/06/2016.
The draft opinion of SEAC was agreed by consensus.
The opinion of SEAC
Based on the aforementioned draft opinion and in the absence of comments from the applicant, the opinion of SEAC was adopted as final on 06/09/2016.
3
THE OPINION OF RAC
The applic ation inc luded the nec essary information spec ified in Artic le 62 of the REACH Regulation that is relevant to the Committee’s remit.
RAC has formulated its opinion on: the risks arising from the use applied for, the appropriateness and effectiveness of the risk management measures described, the assessment of the risks related to the alternatives as documented in the application, the information submitted by interested third parties, as well as other available information.
RAC c onfirmed that it is not possible to determine a DNEL for the carcinogenic properties of the substance in accordance with Annex I of the REACH Regulation.
RAC c onfirmed that there appear not to be any suitable alternatives that further reduce the risk.
RAC confirmed that the operational conditions and risk management measures described in the application limit the risk, provided that they are adhered to as described in the application along with the suggested conditions and monitoring arrangements.
THE OPINION OF SEAC
The applic ation inc luded the nec essary information spec ified in Artic le 62 of the REACH Regulation that is relevant to the Committee’s remit.
SEAC has formulated its opinion on: the socio-economic factors and the availability, suitability and technical and economic feasibility of alternatives associated with the use of the substance as documented in the application, the information submitted by interested third parties, as well as other available information.
SEAC took note of RAC’s confirmation that it is not possible to determine a DNEL for the carcinogenic properties of the substance in accordance with Annex I of the REACH Regulation.
SEAC confirmed that there appear not to be suitable alternatives in terms of their tec hnical and ec onomic feasibility for the applic ant.
SEAC considered that the applicant's assessment of: (a) the potential socioeconomic benefits of the use, (b) the potential adverse effects to human health of the use and (c) the comparison of the two is based on acceptable methodology for socio-ec onomic analysis. Therefore, SEAC did not raise any reservations that would change the validity of the applicant’s conclusion that overall benefits of the use outweigh the risk to human health, whilst taking account of any uncertainties in the assessment.
4 SUGGEST ED CONDIT IONS AND MONIT ORING ARRANGEMENT S
The following conditions and monitoring arrangements are recommended in case the authorisation is granted: Additional conditions and monitoring arrangements for the authorisation:
The effectiveness of the current RMMs should be ensured by implementing appropriate preventative maintenance programmes which shall be described in the subsequent review report. Environmental emissions of Cr(VI) to air from the Roanne site shall be subject to measurements with the results of monitoring made available to enforcement bodies on request. Measurement campaigns shall be undertaken according to standard sampling and analytical methods, where available. Emissions data shall be presented in any subsequent review report. Additional c onditions for the review report:
For any subsequent authorisation review report, the applicant should provide additional occupational exposure measurements representative for all tasks with potential for exposure, the number of workers that are potentially exposed and sites to demonstrate that the RMMs and OCs are still appropriate and effec tive in limiting the risks.
REVIEW
Taking into account the information provided in the applic ation for authorisation prepared by the applicant and the comments received on the broad information on use(s) the duration of the review period for the use is recommended to be seven years.
5 JUSTIFICATIONS
The justific ations for the opinion are as follows:
1. The substance was included in Annex XIV due to the following property/properties: Carc inogenic (Artic le 57(a)) Mutagenic (Artic le 57(b)) Toxic to reproduc tion (Artic le 57(c )) Persistent, bioac c umulative and toxic (Article 57(d)) Very persistent and very bioaccumulative (Article 57(e)) Other properties in ac c ordanc e with Artic le 57(f):
2. Is the substance a threshold substance? YES NO
Justification:
Chromium trioxide has a harmonised classification as Carcinogen Cat. 1A and Mutagen Cat. 1B with H350 and H340 according to CLP.
Dichromium tris(chromate) has a harmonised classification as Carcinogen Cat. 1B with H350 according to CLP. Based on studies which show its genotoxic potential, the Risk Assessment Committee (RAC) has concluded that Chromium trioxide should be considered as non-threshold substance with respect to risk characterisation for carcinogenic effect of hexavalent chromium (reference to the studies examined are included in the RAC document RAC/27/2013/06 Rev. 1 Final).
3. Hazard assessment. Are appropriate reference values used?
Justification: RAC has established a reference dose response relationship for carcinogenicity of hexavalent chromium (RAC/27/2013/06 Rev.1 Final) which was used by the applicant. The molecular entity that drives the carcinogenicity of Chromium trioxide (Cr(VI)) is the Cr(VI) ion, whic h is released when the substanc es solubilise and dissoc iate. Cr(VI) causes lung tumours in humans and animals by the inhalation route and tumours of the gastrointestinal tract in animals by the oral route. These are both loc al, site-of- contact tumours– there is no evidence that Cr(VI) causes tumours elsewhere in the body.
Dose-response relationships were derived by linear extrapolation. Extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidenc e is suggestive of non-linearity, it is ac knowledged that the exc ess risks in the
6 low exposure range might be an overestimate.
In the socio-economic analysis (SEA) the remaining human health risks are evaluated based on the dose-response relationship for carcinogenicity of hexavalent chromium (RAC27/2013/06 Rev.1 agreed at RAC-27).
Are all appropriate and relevant endpoints addressed in the application? All endpoints identified in the Annex XIV entry are addressed in the applic ation.
4. Exposure assessment. To what extent is the exposure from the use described?
Description: Short description of the use Nexter Mechanics and Nexter Systems are downstream users of Cr(VI). This applic ation for authorisation relates to the use of a qualified mixture of c hromium trioxide by spraying or immersion, and of a qualified mixture of dichromium tris(chromate) by pen application, for conversion coating of mechanical structures of armoured vehicles and associated parts made of aluminium alloy for military use. The main functional properties sought are elec tric al c onduc tivity, c orrosion resistanc e and paint adhesion. These functional properties are directly related to the harsh conditions of use of the armament systems and the need to ground the elec tric al and elec tronic systems.
The only conversion treatment process c urrently qualified by the applic ant for aluminium alloys is Alodine 1200™ (subsequently referred to in this opinion simply as Alodine), a product of Henkel Surface Technology. This corrosion inhibitor contains hexavalent chromium and provides corrosion protection while also inhibiting the formation of electrical insulators such as hydroxyl-oxides of aluminium. The applic ant c laims that Alodine also assists paint adhesion.
Conversion coating is either applied by spraying or immersion, depending on the typology of treated parts. Spraying and immersion uses take place at different sites. - Spraying treatment is c arried out by Nexter Mechanics at their site in Roanne, France. All operations relating to the chromium conversion coating take place in the same dedicated room, which contains a spraying cabin (Hafroy machine). T he Hafroy machine allows the coating of large parts (vehicles or turret bodies) up to 3.5 × 2 × 7.5 m weighing up to 15.5 tons. The applic ant states that, for ballistic reasons, body shells of armament systems have to undergo chromate conversion after assembly and welding. According to the applic ant this c onstitutes a signific ant difference to conversion coating applications in the aviation industry, where parts are treated and then assembled. The spraying treatment with the Hafroy Machine is performed by introducing an artic le into the c losed and c ompletely automatic system. Spraying does not involve any manual operations. After the article is contained within the system, it is rotated on a horizontal axis, and the content of several tanks (including an Alodine mixture) are automatically sprayed onto the article. At the end of the treatment, the article is rinsed with water. A complete treatment cycle takes approximately six minutes. There is no more than one
7 treatment cycle per day. The Hafroy Machine containment is in a depression and the air from the cabin is evacuated through a chimney located on the roof of the building. As Alodine is diluted to 1% with water before use in the Hafroy machine the concentration of chromium trioxide in the final mixture used for spraying is not greater than 0.6% (w/w). The Hafroy machine has a tank volume of 6,000 l. - Immersion treatment is c arried out by Nexter Systems in Tulle, France, and concerns auxiliary parts with shorter dimensions. The process consists of a single automatic treatment line comprising several baths, referred to as the “aluminium treatment line”. There is only a single Alodine-containing bath in the line, which is loc ated in the middle of the treatment line, followed by two baths containing rinsing water. Adjacent to the treatment line there is a restric ted area that allows appropriate workers to have access to the Alodine c ontaining treatment bath for sampling or other purposes. When the line is in operation, the armament parts are immersed into successive baths by an automated system. During the operation of the automated system no workers are located next to the bath. During the assembly of armament parts on the structure, at the beginning of treating aluminium, the parts have not been yet in contact with hexavalent chromium. Consequently, there is no possible exposure to hexavalent chromium due to this handling of the articles. Alodine is supplied to Nexter Systems (Roanne) in a liquid form and to Nexter Mechanics (Tulle) in solid form. Typic al concentrations are not prec isely known by the applicant as they are commercially confidential. The composition of liquid and solid forms of Alodine are summarised below:
Component Liquid (Roanne – Solid (Tulle – spraying) immersion)
c hromium trioxide 25 – 50 % 30 – 60 %
hydrogen fluoride 1 – 5 % -
dihydrogen 1 – 5 % 2.5 – 10 % hexafluorozirconate
tetrafluoroboric acid 1 – 5 % -
boric ac id 0.1 – 1 % -
tripotassium - <20 % hexacyanoferrate
potassium - 10 – 30 % tetrafluoroborate
sodium fluoride - 2.5 – 10 %
Dichromium tris(chromate) is also used at Roanne (under the brand name Alodine
8 1132™ Touch-n-prep), for the same purpose as Alodine. The typical c oncentration is not prec isely known as it c onfidential. The concentration range of dichromium tris(c hromate) provided in the Henkel safety data sheet is 0.25 - 1%. Dic hro mium (tris)c hromate is only used by pen applic ation when needed, for touching-up parts that have already been treated with Alodine by spraying (i.e. to treat parts of the structure that could not be sprayed). The applicant estimated the maximum annual tonnage that could be required over the requested review period based on use during previous years (2012, 2013 and 2014) and considerations of the production capacity. The maximum tonnage of c hromium trioxide for this use is estimated to be 0.562 tonnes per year in Roanne and 0.040 tonnes per year in Tulle. T he ma ximum use of dichromium tris(chromate) in Roanne is estimated to be 0.001 tonnes per year. The applic ant states that consumer exposure is not relevant sinc e military equipment are not intended to be used by consumers. According to the applicant only professional workers use the treated armament parts. The applic ant states that there is no liquid form of the mixture of Cr(VI) re ma ining on the article after treatment thus there is no possibility of exposure to Cr(VI) via inhalation. The applicant considers that de rma l exposure and corresponding c ancer risk to professional users due to Cr(VI) exposure is negligible for the following reasons:
• the remaining Cr(VI) on the article is included into a matrix composed of hydroxyl-oxides of aluminium; • the thickness of this matrix is in the order of a few mic ro me t e rs; • the remaining Cr(VI) c onc entration is lower than 0.1%; and • onc e treated, all the artic les are painted and the paint c oating is designed to form a physic al barrier and remain for all the lifetime of the artic le. The applic ant provided two exposure scenarios for the use applied for:
(1) Industrial use, by spraying, of a qualified mixture of chromic acids for chromate conversion coating and
(2) Industrial use, by immersion, of a qualified mixture of chromic acids for chromate conversion coating.
According to the applic ant, the exposure scenarios inc lude all relevant proc esses and tasks associated with the use of Cr(VI) that could result in either environmental or worker exposure. In both cases the exposure scenarios are comprised of six Worker Contributing Scenarios (WCS) and one Environmental Contributing scenario (ECS).
9 Worker exposure
Table 1: Summary of Worker Contributing Sc enarios (Exposure Scenario 1) Industrial use, by spraying, of a qualified mixture of c hromic ac ids for chromate conversion coating
Contributing ES Brief Description RMMs
WCS 2 Sampling of Alodine 1200© is -Technical: Good natural Sampling of tank (PROC 8a) performed by scooping with a ventilation; laboratory vessel above the -Organisational: General opened tank. Opened tank (≈0.8 housekeeping practices in place; m²) Manipulation performed by a Number of workers: 1 per dedicated operator. operation; 2 operators involved. - PPE: Half mask with FFGazX P3 Primary emission source is at or TH3 filter (EN 143 – APF 10); arm's length. Nitrile protective gloves wi th Chromium trioxide is dissolved breakthrough time >480 min in a liquid mixture. The weight (EN 374); Protective clothes (EN fraction of Cr(VI) - 0.6% (taking 13034 Type 6). into account the dilution of Alodine 1200©). Sample size: Less 20 ml per operation. Size of the work area is > 3,000 m3. Exposure duration: frequency: 1 per week; duration: 2 min WCS 3 Titration of hexavalent -Technical: Good natural Titration of the hexavalent chromium in the Alodine 1200 ventilation; chromium (PROC 15) contain in the tank of the Hafroy -Organisational: General Machine. housekeeping practices in place; Titration is performed in a Manipulation performed by a laboratory vessel with open dedicated operator. surface of < 0.1 m² maximum - PPE: Half mask with FFGazX P3 and is performed in a fume or TH3 filter (EN 143 – APF 10); cupboard. Nitrile protective gloves with Primary emission source is at breakthrough time >480 min arm's length. (EN 374); Protective clothes (EN Number of workers: 1 per 13034 Type 6). operation; 2 operators involved. Chromium trioxide is dissolved in a liquid mixture. The weight fraction of hexavalent chromium compound - <0.6% (taking into account the dilution of Alodine 1200© and then the dilution with lab reagent). Sample size: Less than 20 ml per operation. Size of the work area is > 3,000 m3. Exposure duration: frequency: once per week; duration: 3 min WCS 4 Number of workers: 1 per -Technical: Good natural
10 Drain of tank (PROC 8b) operation; 2 operators involved. ventilation; Partial segregation without ventilation. Chromium trioxide is dissolved in a liquid mixture. The weight -Organisational: General fraction of Cr(VI) - 0.6% (taking housekeeping practices in place. into account the dilution of - PPE: Half mask with FFGazX P3 © Alodine 1200 ). The source or TH3 filter (EN 143 – APF 10); © (Alodine 1200 transferred) is in Nitrile protective gloves with the basement of the workshop. breakthrough time >480 min The air of the workshop (EN 374); Protective clothes (EN communicates with the air from 13034 Type 6). the basement through a delimited area of the workshop with gridfloor. Annual amount: < 0.562 tonnes / year; Size of the work area is > 3,000 m3. Exposure duration: frequency: - twice per year; duration: 30min. WCS 5 Number of workers: 1 per -Technical: Good natural Addition of mixture to the tank operation; 2 operators involved. ventilation; Transfer of liquid is (PROC 8a) Chromium trioxide is dissolved performed through a small filling in a liquid mixture. The weight opening on the container of © fraction of Cr(VI) - 30 – 60%. Alodine 1200 ; Careful transfe r involves workers showing Annual amount: < 0.562 tonnes attention to potential danger of / year; splashing, and carrying out the Quantity used for addition after transfer in a very cautious drain of tank: 3.5 l per manner. operation. -Organisational: General Quantity used for supplement housekeeping practices in place. for the routine use: 60 l per - PPE: Half mask with FFGazX P3 operation. or TH3 filter (EN 143 – APF 10); Size of the work area is > 3,000 Nitrile protective gloves with 3 m . breakthrough time >480 min Exposure duration: frequency:- (EN 374); Protective clothes (EN After drain of tank: 2 per year; - 13034 Type 6). Routine supplement: 1 per week duration: -During addition after drain of tank: 6 to 10 min for one container; - During supplement for the routine use: 1 to 4 min for 3.5 l WCS 6 Chromium trioxide is dissolved -Technical: Good natural Spraying of article in contained in a liquid mixture. The weight ventilation; Medium level system (PROC 7) fraction of Cr(VI) - 0.6% (taking containment (spraying in a into account the dilution of watertight containment with a Alodine 1200©). completely automatic system); Spraying in Hafroy Machine. A Enclosing hoods, fume cupboard complete cycle for this (The air in Hafroy Machine treatment takes approximately 6 containment is in depression and minutes. For spraying on all the the air from the cabin is surface of large parts up to evacuated through a chimney. 3.5×2×7.5m, 10m3 tank of The design of both enclosure mixture is used. and ventilation system is such as the source is encased Estimated that 3.5 l of Alodine because no air flow can be 1200© is used per operation. directed from the enclosure to This mixture contained in the the workshop); The automatic tank is reused for each
11 operation (the circuit is closed). spraying treatment is launched Number of workers: 1 per and controlled by a work er from operation; 2 operators involved. a steering console; Annual amount: < 0.562 tonnes -Organisational: General / year; housekeeping practices in place; traine d work e rs; The Hafroy Size of the work area is > 3,000 Machine is regularly monitored. m3. - PPE Nitrile protective gloves Exposure duration: frequency: - with breakthrough time >480 once per day; duration: 6 min. m in (EN 374); Protective clothes (EN 13034 Type 6). WCS 7 Dichromium tris(chromate) is -Technical: Good natural Pen application (PROC 10) dissolved in a liquid mixture, ventilation. contained in a pen (Alodine -Organisational: General © Touch-N-Prep ). The weight housekeeping practices in place; fraction - 0.25 - <1%. traine d work e rs; Number of workers: 1 per - PPE: Half mask with FFGazX P3 operation; 2 operators involved. or TH3 filter (EN 143 – APF 10); Pen application. Surface Nitrile protective gloves with considered: maximum 2,000 breakthrough time >480 min cm² in 45 minutes; (EN 374); Protective clothes (EN Annual amount: < 0.001 tonnes 13034 Type 6). / year; Primary emission source proximity - at an arm's length. Size of the work area is > 3,000 m3. Exposure duration: frequency: every day; duration: 45 min. No te 1: The Applicant states that work e rs are sk ille d ope rators re ce iving re gular training with re gard to chemical risk management and prope r use of personal protective equipment. Note 2: Monitoring measurement will be performed yearly to validate the exposure estimated in this CSR. No te 3: Table compiled by RAC with information from the application.
(Exposure Scenario 2) Industrial use, by immersion, of a qualified mixture of c hromic acids for chromate conversion coating
Contributing ES Brief Description RMMs
WCS 2 Chromium trioxide is dissolved -Technical: Good natural Sampling of bath (PROC 8a) in a liquid mixture. Alodine ventilation; © 1200 diluted in bath. The -Organisational: General weight fraction of Cr(VI) - housekeeping practices in place; diluted in bath (≈0.37%). Manipulation performed by a Sampling of bath is performed dedicated operator; by transferring the mixture in a - PPE: Nitrile protective gloves vessel. with breakthrough time >480 Primary emission source m in (EN 374); Protective clothes proximity is at arm's length. (EN 13034 Type 6). Number of workers: 1 operator involved in sampling. Primary emission source proximity is at arm's length. Sample size: Less than 200 ml per operation. Size of the work area is > 3,000 m3.
12 Exposure duration: frequency: 1 per week, 44 weeks per year; duration: 2 min
WCS 3 Alodine 1200© diluted in the -Technical: enclosing hood, Titration of the hexavalent bath treatment (≈0.37%) and fume cupboard; chromium (PROC 15) then with lab reagents. -Organisational: General Titration is performed in a housekeeping practices in place; laboratory vessel with open Manipulation performed by a surface of approximately 0.1 m² dedicated operator; maximum and is performed in a - PPE: Nitrile protective gloves fume cupboard. with breakthrough time >480 Number of workers: 1 per m in (EN 374); Protective clothes operation; 1 operator involved (EN 13034 Type 6). (laboratory worker). Primary emission source proximity is at arm's length. Sample size: Less than 20 ml per operation. Size of the work area is < 300 m3. Exposure duration: frequency: 1 per week, 44 weeks per year; duration: 5 min. WCS 4 Chromium trioxide is dissolved -Technical: Good natural Operation next to the bath in a liquid mixture. Alodine ventilation; © (drain of bath and maintenance 1200 diluted in bath. The -Organisational: General operations) (PROC 8b) weight fraction of Cr(VI) - housekeeping practices in place; diluted in bath (≈0.37%). traine d work e rs; Number of workers: 1 worker - PPE: Nitrile protective gloves per operation; 2 workers with breakthrough time >480 involved. min (EN 374); Protective clothes The substance is not directly (EN 13034 Type 6). used. Operations performed next to the chromium bath, such as: drain of bath, visual control or maintenance operations. Size of the work area is > 3,000 m3. Exposure duration: frequency: - - For maintenance or visual control: once a week; - For drain of bath: 3 per year; duration: - For maintenance or visual control: 45 min; - For drain of bath: 120 min. WCS 5 Chromium trioxide flakes are -Technical: Good natural © Addition of mixture to the bath used. Alodine 1200 (30-60%). ventilation; The powder fall in © (PROC 8a) Transfer of Alodine 1200 into the liquid content of bath. The the bath is performed by pouring is pe rform e d in a ve ry pouring the container directly cautious manner in order to into the bath. avoid splashes from the bath; Number of workers: 1 worker Container with small opening; per operation; 2 workers -Organisational: General involved; housekeeping practices in place; Annual amount: ≤ 40 kg per traine d work e rs; year; - PPE: Half mask with P3 filter Size of the work area is > 3,000 (EN 143 – APF 10); Nitrile
13 m3. protective gloves with Exposure duration: frequency: breakthrough time >480 min monthly; duration: 30 min. (EN 374); Protective clothes (EN 13034 Type 6). WCS 6 Number of workers: 2 workers -Technical: Good natural Dismantling of armament parts involved. ventilation; No liquid remains on (PROC 21) Activity class - handling of the article; articles. There is no liquid from -Organisational: General of the mixture of hexavalent housekeeping practices in place; chromium remaining on the traine d work e rs; article (they have been rinsed, - PPE: Nitrile protective gloves further treated without with breakthrough time >480 hexavalent chromium and then min (EN 374); Protective clothes dried). The remaining (EN 13034 Type 6). hexavalent chromium on the article is included into a matrix. The remaining hexavalent chromium concentration is lower than 0.1% for each article (The cutaneous route of exposure is considered negligible). Size of the work area is > 3,000 m3. Exposure duration: frequency: - every day. WCS 7 Chromium trioxide is dissolved -Technical: Good natural Dipping of article in baths in a liquid mixture. Alodine ventilation; All the operations © tre atm e nt in the work e rs’ far 1200 diluted in bath. The are far from the chromium bath, field (PROC 13) weight fraction of Cr(VI) - the emission source of diluted in bath (≈0.37%). hexavalent chromium (several Number of workers: Maximum of meters); 2 workers involved. -Organisational: General Annual amount: ≤ 40kg per housekeeping practices in place; year; traine d work e rs; Open bath treatment in the worker’s far field (it includes - PPE: Nitrile protective gloves operations performed outside with breakthrough time >480 the restricted area, such as min (EN 374) (Protective gloves operations in the mounting and are not worn during the dismantling area or at the ope ration at the steering control steering control of the treatment as no possible dermal line). All the operations exposure); Protective clothes performed outside the restricted (EN 13034 Type 6). area are far from the chromium bath. Open surface - <3 m²; Size of the work area is > 3,000 m3. Exposure duration: frequency: every day; duration: 420 min per day. No te 1: The ap plica nt states that work ers are skilled operators re ceiving re gular training with re gard to chemical risk management and proper use of personal protective equipment. Note 2: Monitoring measurement will be performed yearly to validate the exposure estimated in this CSR. No te 3: Table compiled by RAC with information from the application.
14 Table 2: The overall number of workers that could be directly exposed to Cr(VI) at applic ant’s sites
Legal entity Type of process Site Number of workers involved
Nexter Systems spraying Roanne 4
Nexter Mechanics immersion Tulle 3
The overall number of workers that could be directly exposed to Cr(VI) in Roanne via inhalation and/or via the dermal route is four (two main workers and two substitute workers). According to the information provided by the applic ant, two main workers perform the tasks described in WCS 2 to 5 and 80 % of operations associated with WCS 6 and 7. The two substitute workers are only involved in spraying (WCS 6) and in application of Touch’N prep (WCS 7) and carry out about 20% of tasks related to those WCS, usually in case of departure or vacation of main workers. It is explained by the applic ant that after visual c ontrol of the spraying treatment, workers sometimes use the Touch-n-prep pen in the case of incomplete treatment during spraying. The overall number of workers that could be directly exposed to Cr(VI) in Tulle via the inhalation and/or via the dermal route is three (one laboratory worker) and two ma in workers in the plating shop. Between the two main workers, except for the presence of workers in the plating shop near the treatment line (WCS 7), ac tivities are distributed equally. It should be also mentioned that operations related to Use 4 that take place at the Tulle site create combined exposures. This combined exposure relates to the same laboratory worker that is involved in sampling (WCS 2) and titration (WCS 3) in Uses 1, 2 and 3 as well.
Methodology used by the applicant Worker exposure Inhalation exposure:
For inhalation exposure assessment the applicant uses a combination of modelling data (ART model, version 1.5) and air monitoring data (personal and stationary measurements). The approach used by the applicant to determine the inhalation exposure levels is as follows: for each of the activities, the exposure levels were modelled (90th percentile for inhalation exposure), all exposure levels of the different activities per specific worker are aggregated to arrive to a total exposure for each worker, inc luding all his ac tivities of the day. The applicant claims that the inputs used for the modelling cannot be strictly representative of the realistic use performed on site. They state that all the inputs for each contributing scenario presented in the CSR have been chosen in order not to under estimate the exposures. Furthermore, the duration and the frequencies of the tasks were considered by taking into account the maximum possible increase of activity presented in accordance with the tonnage estimation. The applic ant suggests that the
15 chosen frequencies most probably do not reflect the exact frequencies and task durations, however the applicant consciously chose to present the maximal estimations in order to c over potential future ac tivities. Exposure sc enario 1: Industrial use, by spraying, of a qualified mixture of c hromic ac ids for chromate conversion coating. Modelled as well as measured data (personal and stationary measurements) are available for this exposure sc enario. According to the applicant the measured data was obtained during campaigns in 2013 (two personal measurement values) and 2015 (six personal and two stationary measurement values). T he measured data was provided by the applic ant to c orroborate a modelling-based exposure assessment. In 2015 the applicant performed two measurement campaigns in order to determine both short term and long term exposures. Most of the personal measurements were performed when workers were undertaking their usual activities. Short term and long term personal measurement data was compared with the modelled data f o r t he s a me activities. Short term personal measurement data was provided for four tasks: combined WCS2 & 3, WCS5 (separate measurements were provided for the ac tivities after the drain of Alodine in the tank and for ac tivities related to the addition of Alodine to the tank to supplement current use) and for WCS7. According to the applicant all the measured exposures were < 0.5 μg/m3 and were lower than the modelled short term exposure estimates. The long term measurement campaign provided average measured exposures for the workers performing tasks related to (1) WCS 2, 3 and 5 (activities related to the addition of Alodine to the tank to supplement current use), 6 and 7, and (2) for workers performing tasks related to WCS 4 and 5 (ac tivities after the drain of Alodine in the tank). According to the applicant in both cases measured average exposures were below the detection limit <0.02 μg/m3. Modelled exposures (90th percentile for inhalation exposure) were 0.5 µg/m3 and 0.81 µg/m3 (without RPE), respectively. In 2015 the applicant also performed ambie nt air measurements (stationary). These measurements were performed at fixed points next to the Hafroy Machine and on the gridfloor and next to the STEP. According to the applicant in both cases measured average exposures were below the detection limit of <0.02 μg/m3. The applic ant also measured total c hromium in order to dete rmine eight hour exposures, and found that measurement results did not exceed 1 μg/m3. The applic ant also obtained personal measurement data during a 2013 measurement campaign. Only long-t e rm personal measurements were performed and the averaged measured exposures were provided for (1) workers performing tasks related to WCS2, 3, 5 (ac tivities related to the addition of Alodine to the tank to supplement current use) and (2) for workers performing tasks related to WCS6 and 7. According to the applic ant in both cases measured average exposures were below a detec tion limit of 0.02 μg/m3. Modelled average exposures for the same WCS (90th percentile for inhalation exposure) were 0.33 µg/m3 and 0.17 µg/m3 (without RPE), respectively. T he applicant notes that in both 2013 and 2015 average measured exposures were lower than corresponding modelling estimates and therefore consider that modelled exposure estimates would result in a more conservative assessment of workplace exposure. Therefore the applicant based their exposure and risk characterisation solely on modelled data, corroborated by the available measurement data. RAC considers that the modelled
16 estimates of exposure appear reliable and more conservative than measurements, but would have preferred that the applicant’s exposure assessment for all WCS had been based on representative measured exposure data.
For workers, exposure and risks were estimated per individual WCS and also after considering combined exposure of workers across different WCS. It should be noted that the applicant chose to use an APF of 10 for the RPE (based on the recommendation of INRS, Institut National de Recherche at de Securite). RAC notes that an APF of 10 used in Franc e is less than the APF values applied in some other EU Member States (e.g. APF 20-30, observed in UK, Germany and Italy).
Table 3: Operational Conditions, Frequency and c alculated exposure levels for industrial use, by spraying, of a qualified mixture of chromic acids for chromate conversion c oating
Contributing Duration ART Calculated Calculated scenario and modelling exposures per exposures per frequency (90th year without RPE year with RPE of exposure percentile) (APF = 10) (µg/m3) (µg/m3) (µg/m3)
WCS 2 2 min/day 0.18 6.82 × 10-5 6.82 × 10-6 Sampling of tank 1 /week (PROC 8a)
WCS 3 3 min/day 0.18 1.02 × 10-4 1.02 × 10-5 Titration of the 1/week hexavalent chrom ium (PROC 15)
WCS 4 30 min 0.0084 2.39 × 10-6 2.39 × 10-6 Drain of tank (PROC 8b) 2/year
WCS 5 After Drain: 39 3.32 × 10-2 3.32 × 10-3 Addition of mixture 10 min to the tank (PROC 8a) 2/year
To supplement current use:
4 min
1/week
40 weeks/year
WCS 6 6 min 0.011 Main Worker: Main Worker: Spraying of article
17 in contained system 5/week 5.00 × 10-5 5.00 × 10-5 (PROC 7) 40 Substitute Worker: Substitute Worker: weeks/year 1.25 × 10-5 1.25 × 10-5
WCS 7 45 min 1.8 Main Worker: Main Worker: Pen application 5/week 6.14 × 10-2 6.14 × 10-3 (PROC 10) 40 Substitute Worker: Substitute Worker: weeks/year 1.53 × 10-2 2.60 × 10-2
Exposure scenario 2: Industrial use, by immersion, of a qualified mixture of c hromic acids for chromate conversion c oating.
Modelled as well as measured exposure data (one stationary measurement) are available for this exposure scenario. According to the applicant measured data were obtained during a campaign in 2015. The quantity of measured data is limited and was provided by the applicant to corroborate a modelling-based exposure assessment. According to the applic ant during the measurement campaign in 2015, the a mbie nt air concentration in the restricted area next to the chromium bath was measured (WCS4). During the time when the measurement was taken an addition of Alodine to the bath (WCS-5) was performed. Thus the applicant assumes that the data obtained represents the highest concentration that could be measured at those workplaces. Average measured exposure was compared with average mo de lled exposure e s t ima t e (90th percentile for inhalation exposure) yielding values of 0.143 μg/m3 and 0.693 μg/m3 (without RPE), respectively. The applicant considers that average measured exposure concentrations were lower than modelled estimate and therefore c onsider that modelled exposure estimates would result in a more conservative assessment of workplace exposure. Therefore the applicant based their exposure and risk characterisation solely on modelled data, corroborated by the available measurement data. RAC considers that the modelled estimates of exposure appear reliable and more conservative than measurements, but would have preferred that the applicant’s exposure assessment for all WCS had been based on representative measured exposure data.
Similar to ES1, exposure and risks to workers were estimated per individual WCS and also after considering combined exposure of workers across different WCS. It should be noted that the applicant chose to use an APF of 10 for the RPE (based on the re c o mme nda t io n o f INRS, Institut National de Recherche at de Securite). RAC notes that an APF of 10 used in France is less than the APF values applied in some other EU Member States (e.g. APF 20-30, observed in UK, Germany, Italy).
18 Table 4: Operational Conditions, Frequency and c alculated exposure levels for industrial use, by immersion, of a qualified mixture of chromic acids for chromate conversion c oating
Contributing Duration and ART Calculated Calculated scenario frequency of modelling exposures per exposures per exposure (90th year without RPE y e ar with RPE percentile) (APF = 10) (µg/m3) (µg/m3) (µg/m3)
WCS 2 2 min/day 0.22 1.83 × 10-4 1.83 × 10-4 Sampling of bath 1 /week (PROC 8a)
WCS 3 3 min/day 0.0019 2.38 × 10-6 2.38 × 10-6 Titration of the 1 /week hexavalent chrom ium (PROC 15)
WCS 4 Drain: 0.073 8.09 × 10-4 8.09 × 10-4 Operation next to the bath (drain of 120 min/ day bath and 3/ year maintenance o p e ra tions) (PROC 8b) Visual control & maintenance
45 min/ day
1/week
WCS 5 30 min/ day 10 1.70 × 10-2 1.70 × 10-3 Addition of 1/month mixture to the b a th ( P ROC 8 a)
WCS 7 420 min/ day 0.0048 4.20 × 10-3 4.20 × 10-3 Dipping of article 5 days/week in baths treatment in the work e rs’ far 44 field (PROC 13) weeks/year/worker
After the Trialogue the applicant informed RAC that biomonitoring had not been carried out at the of Tulle site sinc e 2012 but provided reassuranc e that biomonitoring will be performed again by the occupational doctor. The applicant was not able to obtain the biomonitoring data requested by RAC due to me dic a l confidentiality reasons. However, the applicant assured RAC that Nexter has never received any occupational doctors’ alert or information on partic ularly high exposures or any alarming trends. RAC acknowledges that the interpretation of biomonitoring data for chromium can be complex, but considers that biomonitoring data remains an important source of
19 information for a risk assessment, particularly in terms of monitoring trends over time. As such, RAC would welcome suitably anonymised biomonitoring data in a review report for this use. Dermal exposure:
The applicant has not assessed dermal exposure in accordance with the RAC reference document which states that there are no data to indicate that dermal exposure to Cr(VI) compounds presents a potential cancer risk to humans (RAC27/2013/06 Rev. 1). Combined exposure The applicant reports combined exposure for the different types of workers. This is done by adding up the time weighted exposure levels of the different tasks for a specific type of worker. It is reported in the CSR whic h tasks (WCS) a spec ific type of worker has to perform. At Roanne two main workers performing all the tasks desc ribed in WCS 2 to 7 whilst two substitute workers are mostly involved in spraying (WCS 6) and in applic ation of Touch’N prep (WCS 7). At Tulle a main worker performs tasks associated with WCS 4, 5 and 7. The laboratory worker performs tasks assoc iated with WCS 2 and 3.
Table 5: Calculated combined exposure levels for each of the different type of workers
Calculated combined exposures (µg/m3) per one year
Function Without RPE With RPE (APF = 10)
Roanne
Main worker 9.48 × 10-2 9.53 × 10-3
Substitute worker 1.54 × 10-2 1.55 × 10-3
Tulle
Laboratory worker 1.86 × 10-4 1.86 × 10-4
Main worker 2.21 × 10-2 6.71 × 10-3
It should be noted that at Roanne the highest exposure was observed for main worker and is 9.48 × 10-2 µg/m3 without, and 9.48 × 10-3 µg/m3 with RPE respectively. In Tulle the highest exposure is also observed for main worker and is 2.21 × 10-2 µg/m3 without and 2.21 × 10-3 µg/m3 with RPE respec tively. The laboratory worker who performs the sampling and titration of the chromium baths in Use 4 is the same laboratory worker who performs the same tasks for the Uses 1, 2, 3 at the site of Tulle. Consequently, this laboratory worker is subject to combined exposure for all these tasks.
20 Table 6: Calc ulated c ombined exposure levels for laboratory worker for Uses 1, 2, 3 and 4 at the site of Tulle.
Calculated combined exposures (µg/m 3) per one year
Laboratory worker (at the site of Without RPE With RPE (A PF = 10) Tulle)
Use 1: hard chromium plating of 1.82 × 10-3 1.29 × 10-4 military armament steels parts which are thermomechanically stressed and in contact with oxidizing gas at high temperature, so as to ensure a thermal barrier with high melting point, resistance to wear and oxidation associated with weapons as well as resistance to impact and atmospheric corrosion
Use 2: hard chromium plating of 1.82 × 10-3 1.82 × 10-4 military armament parts in order to ensure surface hardness, resistance to atmospheric corrosion, abrasive wear resistance and friction coefficient for parts in relative movement
Use 3: use of a mixture of chromium 1.21 × 10-3 1.21 × 10-4 trioxide for the black colour hard chromium plating of exterior surface of steel weapon barrel designed for military use, to ensure, during the whole gun barrel service life, stealth, erosion, corrosion and high temperature resistances in the condition of uses
Use 4: use, of a qualified mixture of 1.86 × 10-4 1.86 × 10-4 chromium trioxide by immersion for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military use, and requiring a maintained electrical conductivity after severe climatic environments, atmospheric corrosion resistance and paint adhesion
Total 5.04 × 10-3 6.71 × 10-4
Uncertainties related to the exposure assessment:
RAC considers that the number of personal and stationary measurements provided by the applicant should be increased (particularly for the Tulle site) to provide a more representative picture of exposure. RAC notes that the applicant has already committed to undertake further exposure monitoring in the future. RAC notes that personal measurements are preferred to stationary measurements in this c ase and a suitable
21 limit of detec tion should be used as c riteria for dec iding how sampling is performed.
Finally, suitably anonymised biomonitoring data (historical and c urrent) should be ma de available to allow a more detailed exposure assessment and to identify a possible trend in workers exposure and could be included in any subsequent authorisation review report submitted.
Environmental releases / Indirect exposure to humans via the environment Releases to the environment The applic ant considered that “industrial use resulting in inclusion onto a matrix” (ERC 5) is the most appropriate Environmental Contributing Scenario. The Applicant states that strict emission control measures to avoid Cr(VI) emissions towards all compartments are in place. According to the Applic ant, Cr(VI) emissions into the air are considered to be very low but relevant and releases of Cr(VI) to the wastewater ma y be considered negligible. Release of Cr(VI), from any source, is expected to be reduced to Cr(III) under normal environmental c onditions, resulting in the impac ts of Cr(VI) being limited to the area around the source of release. Thus the applic ant c onsidered only loc al emissions from the site.
Exposure scenario 1: Industrial use, by spraying, of a qualified mixture of chromic ac ids for chromate conversion coating. According to the applicant the spraying process is performed in a closed system for which no release is expected except for: (1) air extraction during the spraying phase and (2) waste production during the treatment of liquid effluents.
An air extraction system is fitted to the Hafroy mac hine. Air is extracted and released to the atmosphere by two evacuation chimneys. It should be noted that during the Trialogue the applic ant c ommitted to apply additional risk management measures in order to reduce potential atmospheric emissions as much as possible should this be considered necessary. As for releases of Cr(VI) to wastewater, the applic ant c onsiders that wastewater treatment is highly effective. A waste treatment plant (WTP) is spec ific ally used for rec yc ling all the liquid effluents from the Hafroy Machine. This WTP is an installation with no liquid effluent which permits to recycle the water contaminated by producing demineralised water, and to treat the used mixture containing hexavalent chromium. Two types of treatment are performed in this WTP, depending on the potential concentration of hexavalent chromium and on whether the waste comes from used demineralised water or used Alodine. Some demineralised water is used in each process cycle of the Hafroy Machine for rinsing the aluminium structure treated. This water is collected and treated using active carbon and ionic resins to be recycled. Alodine used and drained from the tank is collected in a dedicated container in the WTP where treatment is performed (with sodium bisulfite). During this treatment, hexavalent chromium is reduced in trivalent chromium. Then, neutralisation with soda and a flocculation followed by a filtration on filter press and evapoconcentration are performed. Sludge produced is disposed of to specialised waste treatment. The distillate produced is channelled to the treatment line as for demineralised water (active carbon
22 and ionic resins). According to the applic ant the integrity of the process circuit and efficiency of the waste treatment plant (WTP) is regularly monitored. The applicant claims that at the end of the process all wastes are managed by a specialised waste manageme nt c o mpa ny .
Exposure sc enario 2: Industrial use, by immersion, of a qualified mixture of c hromic acids for chromate conversion coating According to the applicant no release is expected from the immersion process except for: (1) air extrac tion from the bath treatment line and (2) waste production during the treatment of liquid effluents. A waste treatment plant (WTP) on the site of Tulle is spec ific ally used for rec yc ling all the liquid effluents from the treatment line. Water used for rinsing the armament parts is recycled. Alodine used and drained from the tank is treated with a specific treatment. The integrity of the process circuit and efficiency of the waste treatment plant (WTP) is regularly monitored. The applicant claims that at the end of the process all wastes are managed by a specialised waste management company. According to the applicant, the atmospheric releases are considered low as the air from local extraction of the baths on aluminium treatment line is directed through a specific proc ess for air treatment (ac ido-basic scrubber). It should be noted that in the site of Tulle Uses 1, 2 and 3 are performed as well. The applicant states that for those uses wastewater treatment is highly effective. All the liquid effluents containing chromic ac ids on the site of Tulle are c ollec ted in a spec ific wastewater pipe and treated in the sewage treatment plant (STP) of the site. Water used in the two rinsing baths is recycled by using a treatment with active carbon. This treatment produces demineralized water from which consequently chromium is eliminated. Mixture drained from the used baths treatment is collected and specifically treated. Cr(VI) is reduc ed with soda. Then a floc culation, followed by a filtration on filter is performed. The water produced during this process is then recycled to produce demineralised water using active carbon as described above. The integrity of the process and efficiency of the sewage treatment plant is regularly monitored. The applicant claims that at the end of the process all wastes are managed by a spec ialised waste management company. Air emissions from local extraction of the baths in the plating shop is collected through a spec ific system and treated via a mist eliminator. The air is then evac uated through a chimney on the roof of the plating shop. The applicant states that releases of Cr(VI) to wastewater do not occur as aqueous wastes are either recycled within the plating line, or disposed of as hazardous waste. (for details, see Table 7). The applicant considers that releases to wastewater from the Tulle site are zero.
The applicant claims that at the end of the process all wastes are managed by a specialised waste management company.
23 Table 7a: Releases to the environment from the Roanne site
Release estimation method and Release Release rate details
All wastewater rec ycled within plating Water Final release fac tor: 0% process or disposed as hazardous waste Release factor from NONS/ESR TGD (2003) - IC 16 (Industrial category: Final release factor: 0.001% engineering industry), MC=3 (Main Air Local release rate: 28.15 mg per c ategory: Non-dispersive use), day mg/day Intrinsic properties of the substance (solubility > 1 g/l and vapour pressure < 10 Pa) Soil Final release fac tor: 0% Expert judgment
Table 7b: Releases to the environment from the Tulle site
Release estimation method and Release Release rate details All wastewater rec ycled within plating Water Final release fac tor: 0% process or disposed as hazardous waste Release factor from NONS/ESR TGD (2003) - IC 16 (Industrial category: Final release factor: 0.001% engineering industry), MC=3 (Main Air Local release rate: 1.81 mg per category: Non-dispersive use), day mg/day Intrinsic properties of the substance (solubility > 1 g/l and vapour pressure < 10 Pa) Soil Final release fac tor: 0% Expert judgment
Methodology used by the Applicant Indirect exposure to humans via the environment The applicant considered two exposure routes - inhalation and oral intake (ingestion of drinking water via air deposition) - for exposure of general population (10,000 residents and workers) at the local scale (4 km around the source of emission). The applicant chose not to use the EUSES software to estimate environmental exposure on the basis that EUSES input parameters are not fully adapted for inorganic substances like hexavalent chromium (some inputs such as boiling point, vapour pressure, octanol/water partition coefficient are not relevant). RAC notes that EUSES can be used to assess inorganic substances by adapting the input parameters used (ECHA R16 Guidance).
24 In order to c alc ulate the dispersion of Cr(VI) in the atmosphere around the Tulle site the applic ant used the “Doury Abacus” (Doury et al, 1980), a non-standard model. The applicant notes that the use of Doury Abacus is recommended in the compendium of the methodologies for the calculation of atmospheric dispersion made by the French National Institute for Industrial Environment and Risks (INERIS, Ω-12 Dispersion atmosphérique (Méc anismes et outils de c alc ul), 2012). Using the Doury abacus, the applicant calculated the exposure concentration that would occur 300, from the Roanne site and 100 m from the Tulle site (which was consistent with the actual distance from the site to the nearest residence). The applicant considers that the site is loc ated in a non-urban area. To c alc ulate exposure via the oral route the applicant used the equations for deposition from the TGD and assumed that all Cr(VI) deposited within the 4 km radius from the site would be transferred to drinking water (after ac c ounting for dilution using default fac tors). The applic ant states that there are no release measurements available for the Tulle site. During the Trialogue the applicant informed RAC that at the Roanne site, one measurement of total chromium (all forms of chromium, not only hexavalent chromium) released to the atmosphere was performed in 2015 and the measured concentration was found to be 0.45 μg/m3. The total emission of chromium per day, taking into account duration of the emission (~ 6 min/ day) and the volume of emitted air (275.5 m3) was calculated by the applic ant to be 123.975 μg per day. The applicant notes that that this value is much lower than t he ma ximum amount (28.15 mg per day) considered in the environmental contributing sc enario.
Table 8: Summary of indirect exposure to humans via the environment (inhalation route)
Exposure estimate, local scale Protection target Site Amount used, Estimates tonnes/year Man via Environment – Tulle: 0.040 (chromium 2.37 × 10-5 Inhalation (Use 4), trioxide) (µg/m3) Man via Environment – Tulle: 0. 5 ( c hro mium 2.96 × 10-4 Inhalation (Uses 1 and trioxide) 2), (µg/m3) Man via Environment – Tulle: 0. 3 ( c hro mium 1.78 × 10-4 Inhalation (Use 3), trioxide) (µg/m3) Total (Uses 1, 2, 3 & 4) Tulle: 0.84 4.98 × 10-4 (chromium trioxide) Man via Environment – Roanne: 0.562 5.3 × 10-5 Inhalation (Use 4), (chromium (µg/m3) trioxide);
25
0.001 (dichromium tris(chromate))
Table 9: Summary of indirect exposure to humans via the environment (oral route)
Exposure estimate, local scale Protection target Site Amount used, Estimates tonnes/ year Man via Environment – Tulle: 0.040 (chromium 2.35 × 10-7 Oral (Use 4), (µg/kg trioxide) bw/day) Man via Environment – Tulle: 0. 5 ( c hro mium 2.94 × 10-6 Oral (Uses 1 and 2), trioxide) (µg/kg bw/day) Man via Environment – Tulle: 0. 3 ( c hro mium 1.77 × 10-6 Oral (Use 3), (µg/kg trioxide) bw/day) Total (Uses 1, 2, 3 & 4) Tulle: 0.84 4.94 × 10-6 (chromium trioxide) Man via Environment – Roanne: 0.562 3.31 × 10-6 Oral (Use 4), (µg/kg (chromium bw/day) trioxide);
0.001 (dichromium tris(chromate))
Note: Cr(VI) was not considered to be eliminated or reduced during the transfers from the atmospheric emission to drinking water, despite the fact that it is very reactive in the environment.
Table 10: Measures for environmental exposure reduction
Reduction of emissions Risk management measure Water Roanne: A waste treatment plant (WTP) is specifically used for recycling all the liquid effluents from the Hafroy Machine. This WTP is an installation with no liquid effluent which permits to recycle the water contaminated by producing demineralised water, and to treat the used mixture containing hexavalent chromium. Tulle: Use 4: Alodine 1200© used and drained from the bath treatment is treated with a specific treatment. Hexavalent
26 chromium is reduced with soda. Then, a flocculation, followed by a filtration on filter is performed. The water produced with this process is then recycled to produce demineralised water through the process described below. Water used for rinsing the armament parts is rec yc led by using a treatment with active carbon. This treatment produces demineralized water. Chromium is consequently eliminated from water. With this treatment, there is no liquid effluent from the immersing proc ess.
Air Roanne: The Hafroy Machine containment is in depression and atmospheric emission can be considered from the releases through the two chimneys. Tulle: Use 4: During the Trialogue the applicant confirmed that there is no LEV for the Alodine bath at the Tulle site.
Uncertainties related to the environmental releases exposure / assessment of exposure to humans via the environment:
RAC notes the efforts made by the applic ant to c alc ulate the indirect exposure of humans via the environment. RAC initially considered that the environmental exposure assessment was uncertain, and could have been underestimated, because of the use of a generic release factor (0.00001) f ro m t he superseded ESR/NONS TGD that was not spec ifically linked to operating c onditions and risk management measures (i.e. the type and efficiently of air abatement equipment). RAC was spec ific ally c onc erned that the generic release factor was for a substance with a low vapour pressure which, whilst true for inorganic solutions of Cr(VI), is not a relevant consideration where spraying deliberately creates a fine mist of particulates that contain Cr(VI), and which are subsequently removed from the workplac e and released to the environment by the LEV. However, after the Trialogue the applicant provided additional measured data of releases from the Hafroy machine (single sample) that supports the release factor used in the exposure assessment. RAC considers that the additional data provided by the applic ant, for the Roanne site, provides some reassuranc e about the magnitude of environmental releases. However, the uncertainty associated with releases to the air compartment could be further addressed by the applicant undertaking further measurements. For the Tulle site, the emission factor from the TGD is considered reasonable as the use is conducted at ambient temperature and no aerosols are generated (no electric current is applied). Therefore the assumptions regarding low potential for releases based on vapour pressure c onsiderations are more valid. RAC acknowledges that Cr(VI) will transform in the environment to Cr(III), which has been previously described in the EU RAR for chromate substances (EU RAR 2005). This will reduce the potential for indirect exposure to humans via the environment after release. Regarding air emissions and exposure of general population, the assessment is based on a non-standard approach. According to the Applicant, highly effective systems to control air emissions are in use. In addition, reduc tion of Cr(VI) to Cr(III) in the air is also likely
27 to further reduce the general population exposure. However, RAC notes that the certainty of presented data would be increased by providing measurements of loc al emissions to air. Taking the uncertainties mentioned above into account, RAC considers that the indirect exposure calculated by the applicant is acceptable for risk characterisation and impact assessment.
Conclusion RAC c onsiders that: - the desc ription of use provided allows c onc lusions to be drawn related to exposure situations. - the methodology used to derive exposure levels is suitable. RAC notes that the exposure assessment provided by the applic ant is princ ipally based on the results of modelling. However, the available monitoring data, whilst limited, corroborates this approach. - the number of stationary and personal measurements provided by the applicant is rather low. - the information provided, related to exposure resulting from the use applied for, is considered to be sufficient to use in the risk assessment and in the risk characterisation. - the indirec t exposure c alculated by the applic ant is acceptable for risk characterisation and impact assessment, but contains uncertainties related to the lack of measurements of emissions to the air.
5. If considered a threshold substance, has adequate control been demonstrated? YES NO NOT RELEVANT, NON THRESHOLD SUBSTANCE
Justification: RAC has concluded that chromium trioxide (Cr(VI)) should be considered as a non- threshold carcinogen with respect to risk characterisation.
6. If adequate control is not demonstrated, are the operational conditions and risk management measures described in the application appropriate and effective in limiting the risk? YES NO
Justification:
28 Workers
The applicant has estimated cancer risk according to the RAC reference dose-response relationship for carcinogenicity of hexavalent chromium (RAC 27/2013/06 Rev. 1, agreed at RAC 27). The applic ant has c onservatively assumed that all inhaled c hromium trioxide particles are in respirable range and contribute to the lung cancer risk. Thus, the excess life-time lung cancer risk is 4 × 10-3 per µg Cr(VI)/m3 for 40 years of exposure (8 h/day, 5 d/week).
Evaluation of the Risk Management Measures
The applicant states that risk management measures (RMMs) that minimise exposure to chromium trioxide are already implemented. The applic ant explains that at Tulle, exc ept for titration of hexavalent chromium, all the operations relating to the chromium plating take place in a dedicated room. The laboratory were the samples are analysed is a separate room from the workshop. In Roanne all the operations relating to the chromium plating take place in a dedicated room. The operational conditions (OCs) and RMM have been described only at a general level. The Applic ant has listed these RMMs typic ally used on site to decrease the exposure: closed system (in Roanne), automated process, general housekeeping and the use of PPE (such as RPE, special clothing and gloves). In the CSR the applicant states that specific organisational measures (such as supervision of eac h operator involved, regular workplace measurements performed by external and independent experts and periodic control of effectiveness of equipment) are implemented to ensure RMM efficiency, c omplianc e with OELs and the low levels of exposure described in t he CSR. The applic ant notes that both the Roanne and Tulle sites are ISO 14001, ISO 9001, AS9100C/JIS Q 9100 / EN9100 certified and these certifications involve regular control of all the risk management measures implemented. Furthermore, the applicant states that in the future the compliance with the OC described in the CSR will be periodic ally c ontrolled and the effic ienc y of RMM (mainly ventilations and RPE) will be regularly verified. All workers involved will be made aware of the best practices at the workplace in order to ensure that the level of exposure is as low as possible. The applic ant is also planning to perform measurements adapted to the contributing scenarios presented in the CSR in order to verify the main raw exposures estimated with the modelling approach. The applicant states that measurements of atmospheric emissions will be performed yearly as well. The applic ant also stated that in order to improve the risk management system at the site of Roanne, a protocol on how to check ventilations and air extractions before each treatment will be implemented. A complementary procedure for preventive and curative maintenanc e operations will be implemented as well. The applicant is also planning to harmonise risk management prac tic es at both sites (Tulle and Roanne) in the future. RAC notes that effectiveness of implemented RMM could be improved by replacing natural ventilation with general mechanical ventilation and by introduction of more automation (if possible) into the proc ess and LEV could be also introduced in Tulle.
29
Risk characterisation The risk c harac terisation was performed by the applic ant by calculating the average inhalation exposure levels per spec ific worker per year and, based on these calculations, by deriving the average excess risk levels for each of the worker (see table 10).
Table 11: Summary of exposures per worker per year without and with RPE (44 weeks per year)
Calculated combined exposures (µg/m3) per year
Function Without RPE With RPE (APF = 10) Roanne
Main worker 9.48 × 10-2 9.53 × 10-3 Substitute worker 1.54 × 10-2 1.55 × 10-3 Tulle
Laboratory worker 1.86 × 10-4 1.86 × 10-4 Main worker 2.21 × 10-2 6.71 × 10-3
Table 12: Exc ess c ancer risk estimates for 40 years exposure per type of operator with and without RPE. Lung cancer risks for individual worker Function Without RPE With RPE (APF = 10)
Roanne Main worker 3.79 × 10-4 3.81 × 10-5 Substitute worker 6.14 × 10-5 6.19 × 10-6 Total per Use 4.41 × 10-4 4.43 × 10-5 Tulle
Laboratory 7.43 × 10-7 7.43 × 10-7 worker Main worker 8.82 × 10-5 2.69 × 10-5 Total per Use 8.90 × 10-5 2.76 × 10-5
It should be noted that the laboratory worker who performs the sampling and titration of hexavalent chromium is the same operator who performs the operation of sampling and titration of the chromium bath described for the Uses 1, 2, 3 and 4 at the site of Tulle. Consequently, this operator is subject to combined exposure and exposure risk estimation for these tasks.
30
Table 13: Exc ess risk estimates for 40 years exposure for laboratory worker with and without RPE for all 4 Uses performed in Tulle.
Lung cancer risks per individual worker
Laboratory worker (at the site of Tulle) With RPE Without RPE (A PF = 10)
Use 1: hard chromium plating of military armament steels parts which are thermomechanically stressed and in contact with oxidizing gas at high temperature, so as to ensure a thermal barrier 7.28 × 10-6 7.28 × 10-7 with high melting point, resistance to wear and oxidation associated with weapons as well as resistance to impact and atmospheric corrosion
Use 2: hard chromium plating of military armament parts in order to ensure surface hardness, resistance to atmospheric corrosion, 7.28 × 10-6 7.28 × 10-7 abrasive wear resistance and friction coefficient for parts in relative movement
Use 3: use of a mixture of chromium trioxide for the black colour hard chromium plating of exterior surface of steel weapon barrel designed for military use, to ensure, during the whole gun barrel 4.85 × 10-6 4.85 × 10-7 service life, stealth, erosion, corrosion and high temperature resistances in the condition of uses
Use 4: use, of a qualified mixture of chromium trioxide by immersion for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military 7.43 × 10-7 7.43 × 10-7 use, and requiring a maintained electrical conductivity after severe climatic environments, atmospheric corrosion resistance and paint adhesion
Total 2.01 × 10-5 2.68 × 10-6
Indirect exposure Exposure to humans via the environment was based on modelled data. The risk characterisation was performed by taking into account the risk for the general population (10,000 residents and workers) in the vic inity of Cr(VI) industrial settings. For the general population the sum of the risk due to inhalation and water intake was taken into account by the applicant. Indirect exposure/local and regional The applicant has estimated cancer risk for general population on the basis of the inhalation exposure and also on the basis of water intake. The risk assessment has been performed according to the RAC reference dose-response relationship for carcinogenicity of hexavalent chromium (RAC 27/2013/06 Rev. 1). The applic ant has conservatively assumed that all inhaled chromium trioxide particles are in respirable range and contribute to the lung cancer risk. Thus, an excess life-time lung c ancer risk is 2.9 × 10-
31 2 per µg Cr(VI)/m3 for 70 years of exposure (24 h/day, 7 d/week).
Table 14: Excess risk estimates for 70 years exposure for the inhalation route
Excess risk Site level
Inhalation Tulle Roanne
Use 4 6.88 × 10-7 1.54 × 10-6
Note: values calculated by RA C
Table 15: Excess risk estimates for 70 years exposure for oral intake
Excess risk Site level
Oral intake Tulle Roanne
Use 4 1.88 × 10-10 2.65 × 10-9
Note: values calculated by RA C
Table 16: Excess risk estimates for 70 years combined route
Excess risk Site level
Total excess Tulle Roanne risk all routes per site
Use 4 6.88 × 10-7 1.54 × 10-6
Note: values calculated by RA C The applic ant has not calculated the risk related to regional exposure. However, Cr(VI) is effectively reduced to Cr(III) in the environment, which is why EU RAR concluded that the regional exposure may not be relevant. RAC c onsiders this c onc lusion as reliable. According to the applic ant, releases to the wastewater are minimal/ no existent and no exposure assessment or risk assessment on the basis of this source of exposure was performed.
Conclusion RAC considers that the RMMs and OCs described in the application are appropriate and effective in limiting the risk to workers and the general population. However, RAC notes that the applic ant’s strategy for monitoring of exposure for workers and releases to the
32 atmosphere is not yet sufficiently developed. In addition, the on-going effectiveness of the current RMM (LEV equipment, scrubbers, waste water treatment) should be ensured by implementing appropriate preventative maintenance programmes.
7. Justification of the suitability and availability of alternatives
7.1 To what extent is the technical and economic feasibility of alternatives described and compared with the Annex XIV substance? Description:
Under Use-4, chromium trioxide is used by Nexter Systems and Nexter Mechanics in the form of a mixture for the chromate conversion coating of structural and auxiliary aluminium parts of armoured vehicles. The mixture used, is a trademark of the supplier and is applied by spraying or immersion. A slightly different mixture c ontaining also a small amount of dic hromium tris(c hromate) is applied by pen applic ation. Chromate conversion coating ensures electrical conductivity, atmospheric corrosion resistance and paint adhesion to the parts of the armoured vehicles. The required levels of performance come from the DGA’s requirements that are specified during the development of the concerned armament systems, according to foreseen field use needs and Maintenance in Operating Conditions needs all along their operational deployment.
It has to be stressed that the majority of aluminium alloys parts treated by Nexter for its armament parts are 7000 series alloys. The 7000 family alloys are among the best performers in terms of mechanical and ballistic properties. They are, however very sensitive to corrosion. Well-known Cr(VI)-free conversion processes used in other industries (e.g. in the building sector) cannot be used for Use-4 applic ations, sinc e these industries mainly use 5000 and 6000 series alloys, which show lower sensitivity to corrosion than 7000 series.
Given the importance of Use-4 for Nexter’s and its c ustomers’ ac tivities, a signific ant work of research, testing and benchmarking of potential alternatives was carried out by Nexter Mechanics and Nexter Systems over the last 15 years. As of today, Nexter relies on a joint workgroup with CETIM dedicated to identify Cr(VI)-free alternative surface treatment solutions. Data searches were based on bibliographic research, benchmarking and laboratory testing. This work resulted in a short list of 5 alternatives to Use-4: Alternative 1, Alternative 2, Alternative 3, Alternative 4 and Alternative 5 (all alternatives are identified by the trade names of the relative suppliers of chemicals whic h will not be used in this opinion).
The actual mixture used by NEXTER is currently widely used in armament and aeronautical industries; the network of subcontracting is thus well developed. The c hoic e of an alternative will thus be indirec tly c onditioned by the aeronautical industry qualification choices and the evolution of the industry toward one solution. Nexter constitutes a niche market for the treatment mixtures formulators, which may not legitimate a specific development of products specifically adapted to those spec ific needs in case standard solutions do not appear to be appropriate. It is unlikely that 3 or 4 conversion treatments will be implanted in the subcontracting network. Nexter has therefore to be vigilant about which solution will be qualified by the aeronautical
33 industry, due to their leadership on this market. For this reason, Nexter pursues the studies of four alternatives and one as backup option.
Technical feasibility
As mentioned above, the short listed have undergone laboratory resting for c ruc ial performanc e parameters with the following results:
ELECTRICAL CORROSION PAINT CONDUCTIVITY RESISTANCE ADHESION Alternative 1 OK(1) OK(1) OK Alternative 2 Assessment in Assessment in Assessment in progress progress progress Alternative 3 OK(2) OK(2) Assessment in progress Alternative 4 OK(2) OK(2) Assessment in progress Alternative 5 OK(2) OK(2) Assessment in progress (1): with reproduc ibility issues; (2): at laboratory scale Further assessment of individual alternatives is summarised as follows:
Alternative 1 is at an industrial stabilisation stage. Preliminary assessment showed a strong dependency of the functional performance of Alternative 1 with application mode. Testing does not currently show an acceptable reproducibility of results with aspersion and immersion processes. As stated in section 3.1, consistency between immersion and spraying processes is a critical parameter, as parts treated with these two processes may be functionally assembled.
Alternative 2: Preliminary laboratory assessments have been carried out for. This treatment is c ompliant with immersion and spraying proc esses.
Alternative 3 has been tested at laboratory scale. No further studies are planned on this process and it is kept as a backup solution for two main reasons: - Performance levels are lower than those offered by Alternatives 4 and 5; - Alternative 3 is a two-step process, which induces the need for a second tank to be installed in the Nexter Mec hanic s plant.
Alternative 4: First tests have been carried out at laboratory scale. Since the results appeared very promising, a second study was carried out in spraying conditions confirming the results of the first study. An in-depth assessment is currently performed at laboratory scale to demonstrate the performanc e reproduc ibility of both immersion and spraying processes with selected subcontractors or laboratories as well as the painting capabilities.
Alternative 5: First tests have been carried out at laboratory scale. Since the results appeared very promising, a second study was carried out in spraying conditions confirming the results of the first study. An in-depth assessment is currently performed
34 at laboratory sc ale to demonstrate the performanc e reproduc ibility of both immersion and spraying processes with selected subcontractors or laboratories as well as the painting capabilities.
The overall process leading to the implementation of all the above mentioned alternatives with the exc eption of alternative 3 (only bac k-up alternative) is summarised as follows:
Ec onomic feasibility
The preliminary assessment of costs by the applicant shows, that the costs for alternatives 1, 4 and 5 should be in line with the costs of the current process while the costs for alternative 2 should be somewhat higher. Alternative 3 was not assessed with regard to the ec onomic feasibility
Conc lusion
SEAC notes that the applicant has performed a thorough search for alternative processes as part of continuous improvement, long before the phasing out of Cr(VI) was imposed by REACH. Five alternatives were short listed in view of the fact, that an alternative will be indirectly conditioned by the aeronautical industry, who has leadership in this field, and the of the subcontracting network is expected to go toward one solution. Nexter has therefore to be vigilant about which solution will be qualified by the aeronautical industry and for this reason pursues the studies of four alternatives and one as backup option. The applicant did present an elaborated plan for substitution activities for the R&D work and implementation of the alternative processes requiring 3 years with which SEAC concurs. Their explanation, why internal and external qualifications (including necessary R&D, military testing and industrialisation) would take up to 7 years is, that their customer, DGA, will consider this switch to a new process a major change requiring an in-depth qualific ation (military testing approval) to ensure the proper functioning and required military capability of the gun or its auxiliary equipment. SEAC understands that military use does not necessarily require ‘formal type approval’ qualification (akin to airworthiness certification) in all cases but cannot ascertain or evaluate if the proposed length of 7 years is always required, espec ially since the customers military approval requirements are confidential for reasons of national sec urity. Economic feasibility was not assessed in detail, but preliminary assessment by the applic ant is, that c osts of alternatives 1, 4 and 5 should be in line with the current costs while the costs for alternative 2 would involve some additional costs. However, though not explic itly stated, the approac h by the applic ant transpiring from the applic ation is the same as in Use-1: the unfeasibility of the alternatives before the sunset date is a
35 technical feasibility issue and not an economic feasibility one. SEAC agrees and commends this approach. The applicant has not assessed the technical and economic feasibility of outsourcing of Cr(VI) plating services or relocating outside the EU considering that this would not be ac c eptable for their main c lient, the French armed forc es, sinc e this would c ompro mis e the integrity of French sovereignty and the field operation capacity of the armed forces through the release of c ritical military know-how. SEAC cannot assess these statements, since they are not scientific arguments but rather socio-politic al (see also sec tion 8 for further discussion on this). During the Trialogue meeting, the applicant also stressed out, that even in case of the outsourcing of the chrome plating process, their customer, DGA, would consider their switch to an outsourced sub-contractor a sufficient change in manufacturing provenance so as to require requalification, such that authorisation for continued use of Cr(VI) in the hard chromium plating process would still be needed during the period required for requalification, and expected to require a review period of 7 years. 7.2 Are the alternatives technically and economically feasible before the sunset date? YES NO
Justification: The applicant presented a plan for substitution activities which shows that none of the two eventually feasible alternatives, can be implemented before the sunset date, in particular due to extensive qualification required by their customer, the armed forces. Conc lusion SEAC concurs with the assessment by the applicant that no alternative is technically feasible before the sunset date.
7.3 To what extent are the risks of alternatives described and compared with the Annex XIV substance? Description: The Applicant has considered a variety of different alternatives for the purpose of replac ing the use of c hromium trioxide in the industrial use, of a qualified mixture of c hromium trioxide by spraying or immersion, and of a qualified mixture of dic hromium tris(chromate) by pen application, for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military use. According to the applicant significant R&D was and is being carried out by the Applicant in order to develop alternatives. Several potential alternatives are subject to ongoing R&D, but do not currently support the necessary combination of key functionalities to be considered as technically feasible alternatives to the use of Cr(VI) in the use applied for. All of the identified potential alternatives are assessed by the applic ant in terms of their: tec hnical feasibility, economic feasibility, and availability. A detailed risk assessment of the alternatives to facilitate a c omparison with chromium trioxide has not been conducted. The alternative assessments do not provide an overview of general information on the
36 substances used within the alternatives and alternative processes as well as the risk to human health and environment. The applic ant presented potential alternative solutions for the two main processes (by spraying or immersion) whic h involve the use of c hromium trioxide. Sinc e dic hromium (tris)chromate is used for adjustments, as part of the spraying process, the application of alternatives solutions presented for chromium trioxide will also substitute the use of dic hromium (tris)c hromate linked to this proc ess (alternative solutions would have to be formulated for pen applications). Thus, the alternatives solutions are presented for the whole process and concern both Cr(VI) compounds. The applic ant states that well-known Cr(VI)-free conversion processes used in other industries (e.g. in the building sector) cannot be used for these applic ations, sinc e these industries mainly use alloys, whic h show lower sensitivity to c orrosion than the alloys used by the Applicant. These possible alternatives are shortlisted and c onsidered in more detail as it is judged to be more promising for future development: SurTec 650 (Alternative 1), BONDERIT E 6500 (Alternative 2), Gardobond C4749 + Ardrox 1768 (Alternative 3), INTERLOX 338 (Alternative 4) and LANTHANE 613.3 (Alternative 5). According to the applic ant the 5 alternatives mentioned above show different maturity levels: Alternative 1 has entered industrial stabilisation stage whereas Alternatives 3 to 5 are relatively new formulations and alternative 2 was for the first time presented in February 2015. Applic ant c laims that these solutions have yet to be thoroughly in-depth tested, validated and implemented and, due to certification delays, will not be industrially operational before 2024 and therefore not available for the Applicant after the chromium trioxide sunset date.
• Alternative 1: SurTec 650 This is a new treatment, qualified for some industrial applications, but currently under assessment for 7000 and 2000 aluminium series alloys in the aeronautical and armament industries. According to the Applicant who relies on information provided in the Safety Data Sheet, SURTEC 650 contains no hazardous substances. No further information is available. This treatment is based on Cr(III) and zirc onium salts as c orrosion inhibitors. In general, conclusion can be made, that, the transition from chromium trioxide to SurTec 650 might constitute a shift to less hazardous substances. • Alternative 2: BONDERITE 65000 The applicant informs that BONDERITE 65000 was presented at the Henkel Surface Technologies “Innovative Day” in February 2015. According to the Applicant the hazards and the risks of Alternative 2 are not yet known. • Alternative 3: Gardobond C4749 + Ardrox 1768 Gardobond C4749 + Ardrox 1768 have only been tested at laboratory scale. According to the Applicant who relies on information provided in the Safety Data Sheet, Gardobond C4749 + Ardrox 1768 contain no hazardous substances. No further information is available.
37 • Alternative 4: INTERLOX 338 INTERLOX 338 is a conversion developed by ATOTECH. This treatment is based on Cr(III) and zirc onium salts as c orrosion inhibitors. Ac cording to the Applicant who relies on information provided in the Safety Data Sheet, INTERLOX 338 contains no hazardous substances. No further information is available. • Alternative 5: LANTHANE 613.3 LANTHANE 613.3 is a conversion process developed by COVENTYA. This treatment is based on Cr(III) and organic additives as c orrosion inhibitors. No lanthanum salts are used in the formulation. According to the Applicant who relies on information provided in the Safety Data Sheet, LANTHANE 613.3 contains no hazardous substances. No further information is available. Evaluation of the hazard of alternatives is hampered by lack of information; although the suppliers MSDS state in four cases that the alternatives contain no hazardous substances, RAC was unable to verify this.
7.4 Would the available information on alternatives appear to suggest that substitution with alternatives would lead to overall reduction of risk? YES NO NOT APPLICABLE
Justification:
With respect to the 5 alternatives for chromium trioxide included in the applicant’s analysis of alternatives the applicant informed that the most promising alternatives are SurTec 650 (Alternative 1), BONDERITE 6500 (Alternative 2), Gardobond C4749 + Ardrox 1768 (Alternative 3), INTERLOX 338 (Alternative 4) and LANTHANE 613.3 (Alternative 5). Transition from chromium trioxide – which is a non-threshold carcinogen – to Alternatives 1, 3, 4 or 5 might constitute a shift to less hazardous substances. As no information was provided on the hazards and risks of possible Alternative 2, at the moment the conclusion cannot be made, that, the transition from chromium trioxide to BONDERITE 65000 might constitute a shift to less hazardous substances.
Conclusion
The most promising alternatives are SurTec 650 (Alternative 1), BONDERITE 6500 (Alternative 2), Gardobond C4749 + Ardrox 1768 (Alternative 3), INTERLOX 338 (Alternative 4) and LANTHANE 613.3 (Alternative 5). Transition from chromium trioxide – which is a non-threshold carcinogen – to Alternatives 1, 3, 4 or 5 might constitute a shift to less hazardous substances but would need further investigation.
7.5 If alternatives are suitable (i.e. technically, economically feasible and lead to overall reduction of risk), are they available before the sunset date? YES NO
38 NOT RELEVANT
Justification:
No alternative feasible before the sunset date was identified.
8. For non-threshold substances, or if adequate control was not demonstrated, have the benefits of continued use been adequately demonstrated to exceed the risks of continued use? YES NO NOT RELEVANT , THRESHOLD SUBSTANCE
Justification: Additional statistical cancer cases estimated by RAC
The estimated number of additional statistical cancer cases has been calculated using the excess risk values presented in section 6 and the estimation of the number of exposed people provided by the Applicant. It reflects the expected statistical number of cancer cases for an exposure over the working life of workers and entire life for general population.
RAC notes that these c alculations are based on the estimation of exposed populations as provided by the applic ant.
Table 18: Estimated additional statistical c ancer c ases for workers (40 years exposure)
Excess lung cancer risk Number of Estimated statistical lung exposed cancer cases people
Without RPE With RPE Without RPE With RPE (APF = 10) (APF = 10)
Roanne
Main worker 3.79 × 10-4 3.81 × 10-5 2 7.59 × 10-4 7.62 × 10-5
Substitute 6.14 × 10-5 6.19 × 10-6 2 1.23 × 10-4 1.24 × 10-5 worker
Total 4.41 × 10-4 4.43 × 10-5 4 8.81 × 10-4 8.86 × 10-5
Tulle
Main worker 8.82 × 10-5 2.69 × 10-5 2 1.76 × 10-4 5.37 × 10-5
39 Laboratory 7.43 × 10-7 7.43 × 10-7 1 7.43 × 10-7 7.43 × 10-7 worker
Total 8.9 × 10-5 2.76 × 10-5 3 1.77 × 10-4 5.44 × 10-5
Table 19: Estimated additional statistical c ancer c ases for workers (7 years)
Excess lung cancer risk Number of Estimated statistical lung per worker exposed cancer cases people
Without RPE With RPE Without RPE With RPE (APF = 10) (APF = 10)
Roanne
Main worker 6.64 × 10-5 6.67 × 10-6 2 1.33 × 10-4 1.33 × 10-5
Substitute 1.07 × 10-5 1.08 × 10-6 2 2.15 × 10-5 2.17 × 10-6 worker
Total 7.71 × 10-5 7.75 × 10-6 4 1.54 × 10-4 1.55 × 10-5
Tulle
Main worker 1.54 × 10-5 4.7 × 10-6 2 3.09 × 10-5 1.3 × 10-7
Laboratory 1.3 × 10-7 1.3 × 10-7 1 1.3 × 10-7 9.4 × 10-6 worker
Total 1.56 × 10-5 4.83 × 10-6 3 3.1 × 10-5 9.53 × 10-6
Table 20: Estimated additional, fatal and non-fatal, statistical c ancer c ases for workers (7 years)
Estimated statistical lung cancer cases
Fatal cases 2.50 × 10-5
Non-fatal cases* 8.00 × 10-6
* The non-fatal c ases are c alculated by applying the ratio of survival (24%) to mortality (74%) rate for lung cancer in France (Institut National du Cancer, Incidence nationale du cancer du poumon, 2015).
40
Table 21: Estimated additional general population statistical cancer cases (70 years exposure)*
Excess risk level Site
Inhalation (lung cancer cases) General Tulle Roanne population (10,000 people) (Use 4) (Use 4)
Fatal cases 1.54 × 10-3 6.88 × 10-4
Non-fatal cases 4.91 × 10-4 2.19 × 10-4
Oral (small intestine cancer cases)1 Tulle (Use 4) General population (10,000people)
Fatal cases 8.71 × 10-8
Non-fatal cases 1.01 × 10-7
Total number of fatal cases 2.23 × 10-3 (inhalation and oral routes)
Total number of non-fatal cases 7.10 × 10-4 (inhalation and oral routes)
* The non-fatal c ases are c alculated by applying the ratio of survival (24%) to mortality (74%) rate for lung cancer in France (Institut National du Cancer, Incidence nationale du cancer du poumon, 2015). 1: The total number of fatal and non-fatal cancer cases was not estimated by the applic ant for the Roanne site. RAC notes that risks at the Roanne site were estimated to be one order of magnitude lower than at the Tulle site.
Assessment of Impacts
The Assessment of impacts associated with this authorisation application and which has been undertaken by the applicant includes a comparative quantitative assessment between the monetised impacts associated with the “applied for use” and the “non-use” of chro mium trioxide. The perspective of the analysis is such that it can be used to show that the benefits to society of continuing to use chro mium trioxide exceed the risks of continued use over the analytical timeframe considered in the applicant’s analysis. Although the assessment does not provide an overall “net benefit” (“net loss”) estimate for the applied for use (non-use) scenario, a comparison of the benefits and costs estimated by the applicant makes this straightforward. It should also be noted that the analytic al timeframe (temporal boundary) c onsidered in the applic ant’s analysis is based on a period of 7 years (post sunset date: 2018-2024), which is the period of authorisation being sought by the applic ant. There is no explic it justific ation of the 7 year analytic al boundary beyond the fact that it c oinc ides with the review period being sought. As such, whilst it covers the decision-making time horizon, it is unc lear the
41 extent to which all major impacts are appropriately covered. In this respect the applic ant does not convinc ingly explain the rationale for using an “impac t period” of 7 years, given that in the application they appear to suggest a more realistic timeframe of 20-30 years for the “applied for use” impac ts. Specifically, the inc lusion of latent cancer burden risk estimates (see benefits section below) is based on an exposure period of 40/70 years, whereas the health impacts associated with this latent cancer burden are all assumed to occur within the 7 year analytical boundary. As such, whilst the arguments for the 7 year analytical time horizon are not well founded, the approach is acceptable since any bias introduc ed will tend to induc e c onservatism (overestimation) in the economic burden of health impact estimates derived. T he disc ounting period used is consistent with assessing the present value of all impacts at the date of drafting the analysis. Overall, given the decision making time frame, the approach provides a consistent comparison of benefits and costs over the time period of analysis selec ted.
The assessment of impacts is based on impacts occurring mainly in France and which are incremental to the respective baselines under the “applied for use” and “non-use” scenarios considered by the applicant. Although the applicant does not therefore use a single analytical baseline (i.e. define the baseline in terms of either one of the scenarios), the comparison of benefits and risks of granting authorisation is such that whilst it is somewhat analytically circuitous, it nevertheless c ompares in a consistent way the positive and negative impacts across the ‘applied for use” and “non-use” scenarios. With respect to the “non-use” sc enario, the applic ant, in line with their analysis of alternatives (see earlier sections), posits that they will have to cease the manufacture and maintenance of the armament systems covered by use 4, with a consequence that Nexter Mechanics’ activity would cease and Nexter Systems (the parent company) would be severely endangered. Moreover, France’s armed forces would thus be unable to secure the supply of armament systems that constitute the backbone of their operational capability, such as to “jeopardise France’s national sovereignty”. SEAC considers this “non-use” scenario to be based on justifications outside the realm of its competence, given that it is largely related to socio-politic al considerations (see later). SEAC’s assessment of this authorisation application is thus based on a tacit acceptance that these socio-politic al arguments have legal standing. Given this, the applicant’s socioeconomic assessment of the “non-use” scenario c onsiders the direc t financial c osts to their operations (in terms of loss of profits) in the event of not being granted an authorisation, as well as impacts on loss of orders, investment, unemployment, and distributional impacts related to France’s national sovereignty being c ompromised. Whilst the analysis of ec onomic impac ts related to the loss of profits to the applic ant is based on a well-established methodological approach to societal costs assessment, the estimation and inclusion of some of the other socioeconomic impacts is questionable in a number of respects as far as generating a methodologically robust measure of the total net economic cost to society of the non- use scenario (see cost section for details). As a result, the exact magnitude of the net economic costs is considered by SEAC to be somewhat uncertain. The analysis of the economic burden of human health impacts is based on established proc edures for the calculation of economic welfare changes as a result of human health risk reductions, albeit with the proviso noted above about the time period regarding latent effects associated with cancer exposures. Overall, whilst an acceptable economic valuation methodology underpins the
42 assessment of health impacts, the overall methodological approach underpinning the assessment of economic and other impacts has some deficiencies but is nevertheless still suffic ient to indic ate that benefits do exc eed risks, in partic ular with respect to some key parameters considered in the applicant’s sensitivity analysis. Whilst SEAC thus identify some uncertainty relating to the exact magnitude by which benefits exceed risks, the analysis is proportionate given the likely magnitude of risks assessed by RAC.
Costs of continued use (HH)
The quantitative analysis of the costs of continued use is based on a human health impact assessment using a methodology following the SEA guidance. The applicant estimates the physical health impacts (disease burden) associated with the exposures as described in the CSR as a result of the “applied for use” scenario. The approach is based on linking quantitative relationships between exposure and the health impact of interest. This general procedure is widely used for the assessment of benefits related to pollutants and is considered to be an appropriate methodological approach. In this respect, the applicant makes use of the linear exposure-response relationships for lung cancer as a result of exposure to Cr(VI) compounds, as estimated by and in accordance with the related ECHA paper (ECHA 2013). Using this general approach to quantitative health impact assessment, the applicant then estimates the disease burden associated with lung cancer as a result of the exposure to Cr(VI) under the “applied for use” scenario using two separate, but complementary approaches. Under the first (considered as the primary) approach, the applicant calculates disease burden in terms of disability adjusted life years (DALYs) associated with the cancer mortality and morbidity from exposures to Cr(VI) under the “applied for use” scenario. Under the secondary complementary assessment, the applicant calculates disease burden in terms of the expected count of fatal and non-fatal cancer cases (i.e. people with disease) arising from exposures to Cr(VI) under the “applied for use” scenario. Whilst the general approach is in both cases appropriate and complementary, the applicant in their original estimation appears to have made some minor errors and been inconsistent in their execution of the approaches. Specifically, in the case of the assessment based on DALYs, the applicant used the linear exposure-response relationship for lung cancer mortality given in ECHA (2013) to assess the c ombined mortality and morbidity impac ts related to the excess lung cancer mortality cases. However, since the exposure response functions in ECHA (2013) are defined in terms of cancer mortality only, the excess risk of lung cancer is higher than the excess risk of lung cancer mortality estimated via the exposure response functions, such that for every fatal case of lung cancer, there are additional non-fatal c ases of lung c anc er, with assoc iated morbidity impac ts. Whilst these were not inc luded in the applic ant’s original analysis using this DALY approach (and hence the health impacts will have been underestimated), the applicant provided a revised analysis in which these additional impacts were included. Likewise, in the assessment based on the number of fatal and non-fatal lung cancer cases, the applicant originally assumed that the exposure response functions relate to the excess risk of lung cancer per se rather than lung cancer mortality, and hence divides the associated incidence between fatal and non-fatal cases rather than estimating the additional non-fatal cases. Again whilst this led to health impac ts being underestimated in the original analysis, the applic ant provided a revised analysis taking account of the additional non-fatal cases. Whilst SEAC thus have some concerns regarding the applicant’s original execution of both methodological approaches, the
43 subsequent analytical revisions render these concerns no longer relevant. Furthermore, it should be remembered that the estimates presented by the applicant are likely to be a conservative (overestimate) assessment of the cancer burden since they do not apply any discounting in order to account for latency effects related to the exposures. The number of cases of excess lung cancer has thus been estimated at 2.50 × 10-5 fatal and 8.00 × 10-6 non-fatal c ases per year for workers for the requested review period (7 years). It should be noted that the exposure response relationships are based on an exposure time period of 40 years, and hence the applicant treats exposures as ‘separable’ over time in order to derive annual cases. SEAC considers such an approach appropriate and c onsistent with existing prac tic e in authorisation applic ations. For exposures related to ‘Man via Environment’, these are considered by the applicant to be negligible. However in accordance with RAC’s evaluation of the CSR and subsequent recommendation, the applicant provided an updated assessment of impacts related to man via environment. The associated number of cases of excess lung and intestinal cancer has been estimated at 2.23 × 10-3 fatal and 7.10 × 10-4 non-fatal cases for the requested review period (7 years). Once again, in order to derive annual cases, it has been necessary to treat the exposures as ‘separable’, given that the exposure response function is based on an exposure time period of 70 years for residents. SEAC thus c onsiders the estimates to be appropriately c alc ulated and in ac c ordanc e with ECHA guidance. Although there are uncertainties then with the disease burden analysis, SEAC in its assessment considers the estimates are likely to provide an adequate order of magnitude estimate of the expected level of cancer impacts relevant to the length of review period sought by the applicant. Concerning the estimation of economic welfare losses associated with the disease burden estimated using the two approaches described above, the applicant assesses both the medical treatment and the ‘human’ welfare losses associated with morbidity and mortality. The spec ific assumptions, methodology and studies used to derive the medical costs of cancer treatment are clear, appropriate and proportionate. The valuation of the human welfare related morbidity and mortality effects estimated using the two disease burden approaches (mentioned earlier) follows the ECHA guidance on SEA and uses a value of life year lost of € 66,000 (and which is used to value a DALY 1), alongside a Willingness To Pay (WTP) value of € 1.25 million to avoid a fatality and € 0.43 million for a non-fatal cancer case (based on uprating for the current price level of the recommended values contained in ECHA guidance on SEA). Whilst the applicant’s derivation of some of these values is not entirely clear (and in some cases relate to fatalities generally and not cancer fatalities), they are broadly in line with the relevant literature. Irrespective, the applic ant applies an upper and lower bound sensitivity value for the value of a life year. This does not result in any change in the conclusions reached. It should also be noted that the applicant applies a discount rate of 3% to the assessment of health impacts. Whilst it is standard practice to use the same discount rate for both cost and benefits, the rationale for using a different discount rate for health impacts to that used for the economic impacts in this instance is only rather vaguely described by the applicant. Nevertheless, the approach is in line with practice
1 SEAC is aware that valuation of DALYs is not without c riticism in the valuation of life and health literature. Nevertheless, valuations of disease burden conducted on this basis are routinely undertaken by regulatory agencies and others (e.g. WHO).
44 and guidelines found elsewhere (e.g. WHO), though the practice of manipulating the discount rate in this way has been called into question by some commentators. Irrespective, and for the sake of consistency, the applicant undertakes a sensitivity check using a 4% discount rate, which again indicates no substantive change in the conclusions reached. Based on applying the value of life year lost and the WTP values for fatal and non-fatal cancer to the disease burden estimates described above, the applicant estimates that the central value estimate of the human health costs of the “applied for use” scenario are € 3,263 for workers and man via the environment combined. SEAC finds that the specific approaches and assumptions used to derive the health costs of the “applied for use” are on the whole clear, transparent and based on standard assessment practices, such that the estimates derived are robust and valid in terms of their order of magnitude.
Benefits of continued use (cost of non-use scenario)
The applicant’s analysis of the benefits of continued use is based on a “non-use” scenario in which Nexter ceases the manufacture and maintenance of the armament systems concerned by Use 4. In its assessment of this scenario, the applicant estimates the ec onomic impac ts in terms of the ec onomic c osts associated with loss of revenues, profits and orders. Soc ial impac ts of the non-use scenario are estimated in terms of the costs of unemployment arising from the ceasing of Nexter’s operations. The applicant also discusses what are termed “distributional impacts”, but which are essentially the impact of the loss of supply of the military equipment manufactured under Use 4 on the French States military capability and sovereignty, as well as some losses of “investments” for the French State and wider impacts to Nexter’s industrial partners. The “distributional impacts” are not quantified but only discussed in qualitative terms. SEAC considers the applicants approach to assessing the economic and social impacts to be only partly based on a sound methodological foundation, as discussed further below.
SEAC consider that the arguments put forward by the applicant to justify their ‘non-use’ scenario are largely outside of the realm of socioeconomic analysis per se, relying instead on politic al imperatives related to national security and defence. Essentially the credibility of the scenario rests on the fact that France’s strategic autonomy is based on national ownership of key capabilities for defence and security. Whilst such argument may be questioned, especially given the ac quisition strategy of other member states, as well as internal market c onsiderations, the applic ant desc ribes the politic al, legal and administrative constraints that apply in this case. As such, SEAC has to accept at face value the credibility of the “non-use” sc enario in so far as it describes the de facto situation faced by the applicant and the French State in the event of no authorisation being granted and there being no suitable alternatives (see section on analysis of alternatives). Further questioning and challenge on this issue during the Trialogue did not reveal any further insights in this regard.
Regarding the applicant’s calculation of economic costs, SEAC considers these to represent an acceptable order of magnitude estimate of the situation faced by the applicant. The applicant has included a mixture of net economic welfare relevant measures alongside some measures that are not relevant (i.e. transfers) in order to
45 arrive at an aggregate measure of impact. Discounting in order to derive present values has been undertaken correctly where relevant using a 4% discount rate.
The specific cost items are set out and included in a spreadsheet, though the rationale for their inclusion is not always clear, for example the value of capital assets made redundant (given that these are sunk costs). The loss of profits is estimated on the basis of lost revenues along with the average operating margin for Nexter Group. However, whilst it was not originally possible for SEAC to scrutinise the precise derivation of these calculations, further evidence provided by the applicant was suffic ient to establish the c redibility of their estimation. The applic ant uses the 3 year average of annual revenues over the period 2015-17 to estimate annual lost revenues over the review period, along with an assumption of a zero growth rate over the period. Although there is some variability across the 3 year period, the applicant also uses the maximum and minimum revenues observed during the period in order to perform a sensitivity check. SEAC is thus content that the loss of profits thus calculated is thus not influenced by any “outlier” observation. In addition to the loss of profits, the applic ant also assesses “losses of orders”, i.e., future sales orders. Although these are estimated quantitatively, the applicant does not include them in their aggregate measure of economic impacts. SEAC consider this appropriate since their relevance in the face of the existing inclusion of future profit streams is questionable. As already mentioned the applicant also assesses the value of lost investments (capital assets) in the period prior to the sunset date, which are then included in the aggregate measure of economic impac t. However, no rationale for their inc lusion is spec ified by the applic ant, suc h that SEAC have no grounds to deviate from the view that these are sunk costs and any losses associated with them are already reflected within the lost future profits of the applicant. As such SEAC do not include these investments as relevant to the comparison of benefits and risks.
In addition to ec onomic impac ts, the applic ant also assesses the expected social impacts of the “non-use” scenario. The primary impact assessed here is the loss of employment associated with redundancies resulting from the applicant ceasing to manufacture and maintain the armament systems concerned by Use 4. Whilst costs related to unemployment c an in princ iple be inc luded in a net ec onomic welfare analysis (CBA), this is not a straightforward matter and requires appropriate qualification and justification. So for example, only those costs related to the period of temporary unemployment and associated loss of economic output (usually represented by salary c osts) can typically be inc luded. In this respec t, it is not c lear that the applic ant has appropriately c onsidered the duration of temporary unemployment for the workers affected, and moreover has assessed the costs in terms of social welfare payments alongside other social contribution payments and taxation losses. Given that these are usually considered to be transfers in net economic welfare (CBA) analysis, SEAC c onsiders their inclusion in the present analysis to be inappropriately undertaken, and hence does not include them within the comparison of benefits and risks. Other indirect impacts on employment related to Nexter’s value chain are also noted by the applicant, but are not quantified. In any case, their relevance is again not appropriately demonstrated by the applicant.
The final set of impac ts c onsidered relate to what the applic ant terms “distributional impacts”. The impacts appear to be related to the implications of a disruption of supply
46 of Nexter’s equipment to the French armed forces and consequent endangerment of France’s national sovereignty. SEAC find that the characterisation of these impacts as “distributional” does not conform with accepted norms or guidance on such matters. Whilst endangerment of national sovereignty may well have societal welfare effects (and hence could in principle be included in a net welfare analysis), such impacts are hardly distributional in nature, and hence would more appropriately be considered as wider social impacts. Irrespective, these impacts are not quantified, but clearly have a qualitative importance to the overall argumentation provided by the applic ant in support of authorisation (bearing in mind the proviso that the arguments accepting the politic ally based “non-use scenario” are accepted). Such qualitative argument can be considered, if necessary, alongside the quantitative estimates of benefits and risks of authorisation.
Conclusion Overall, given the very small negative human health impacts associated with the applicants use of chromium trioxide, the benefits of the “non-use” scenario are negligible, whilst the additional c osts associated with the loss in profits from the c easing of manufacture of relevant armaments at the applicant’s facility are relatively substantial, such that the benefits of the “applied for use” of chromium trioxide exceed the corresponding risks. Any uncertainties are relatively inconsequential and would in any case tend to magnify the magnitude by which the benefits exceed the risks. The total net cost of the “non-use” scenario (and hence the net benefits from granting the authorisation) are estimated at around €100-1,000 million for a period of 7 years (the authorisation period being sought). The applic ant has inc luded a sensitivity analysis for some of the parameters used in the analysis. This indicates that for the range of values for the parameters used to assess the economic burden of health impacts, the conclusion that benefits outweigh the risks of continued use is robust. SEAC consider the conclusion that benefits outweigh the risks of continued use to be robust.
9. Do you propose additional conditions or monitoring arrangements YES NO
Description for additional conditions and monitoring arrangements for the authorisation: The effectiveness of the current RMMs should be ensured by implementing appropriate preventative maintenance programmes which shall be described in the subsequent review report. Environmental emissions of Cr(VI) to air from the Roanne site shall be subject to measurements with the results of monitoring made available to enforcement bodies on request. Measurement campaigns shall be undertaken according to standard sampling and analytical methods, where available. Emissions data shall be presented in any subsequent review report.
47
Additional c onditions for the review report
For any subsequent authorisation review report, the applicant should provide additional occupational exposure measurements representative for all tasks with potential for exposure, the number of workers that are potentially exposed and sites to demonstrate that the RMMs and OCs are still appropriate and effec tive in limiting the risks.
Justification: RAC considers that the number of personal and stationary workplace exposure measurements provided by the applicant are limited and should be increased (partic ularly for the Tulle site). RAC notes that personal measurements are preferred to stationary measurements in this c ase and a suitable limit of detection should be used as c riteria for dec iding how sampling is performed. RAC considers that the measurement data available provides reassurance about the magnitude of environmental releases from the Roanne site. However, the uncertainty associated with the releases to the air compartment remains high and could be addressed by the applicant undertaking further measurements. For the Tulle site the emission factor from the TGD is considered reasonable as the use is conducted at ambient temperature and no aerosols are generated (no electric current is applied). Therefore, additional data on releases to the environment from this site is not an uncertainty that requires immediate attention.
10. Proposed review period: No rma l (7 years) Long (12 years) Short (…. _years) Other:
Justification: In identifying the review period SEAC took note of the following c onsiderations:
RAC’s advice: RAC has no advice concerning the length of the review period.
Other socio economic considerations
In identifying the proposed review period SEAC took note of the following considerations:
- The level of risk associated with the “applied for use” are low, alongside the corresponding negligible costs of the “applied for use” of chromium trioxide by the applic ant;
48 - There is no technically and economic ally feasible alternative to implement by the sunset date. - The applic ant has been proac tive in developing alternatives. These attempts have shown conclusive positive results in respect of basic testing, though further implementation, testing and qualific ation is required. - The applicant has presented an elaborated substitution profile for the R&D work and implementation of the alternative processes (as discussed in section 7.1 above), indic ating that eventual substitution may be achieved within the normal review period time horizon. The applic ant is fully c ommitted to the substitution to the alternative. - The benefits of continued use outweigh the risks by a considerable degree (in the range between 10,000-100,000 times).
Although it is diffic ult to assess the precise time required for military qualification, given this is subjec t to national security c onfidentiality requirements, SEAC, having taken into account the above points, considers that realistic prospects for substitution should be possible within the timelines of a normal review period, in line with the applicants substitution timelines and keeping in mind that the internal development, testing and industrialisation have not yet been c ompleted.
As such, SEAC recommends a 7 year review period. 11. Did the applicant provide comments to the draft final opinion? YES NO
11a. Action/s taken resulting from the analysis of the Applicant’s comments: YES NO NOT APPLICABLE
Justification: Applicant did not provide comments to the draft final opinion.
49