PUBLIC VERSION - Europa VERSION Legal name of ... Formulation of an epoxy resin hardener containing...

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ANALYSIS OF ALTERNATIVES and SOCIO-ECONOMIC ANALYSIS PUBLIC VERSION Legal name of applicant(s): POLYNT COMPOSITES FRANCE Submitted by: POLYNT COMPOSITES FRANCE Prepared by: BUREAU VERITAS Substance Name: Formaldehyde, oligomeric reaction products with aniline, also known as poly[aminophenyl)methyl]aniline, polymeric MDA, PMDA or technical MDA EC Number: 500-036-1 CAS Number: 25214-70-4 Uses applied for: Use 1: Formulation of an epoxy resin hardener containing technical MDA Use 2: Industrial use of an epoxy resin hardener containing technical MDA aimed at immobilising spent ion exchange resins in a high containment matrix Uses number: 1 & 2

Transcript of PUBLIC VERSION - Europa VERSION Legal name of ... Formulation of an epoxy resin hardener containing...

ANALYSIS OF ALTERNATIVES

and

SOCIO-ECONOMIC ANALYSIS

PUBLIC VERSION

Legal name of applicant(s): POLYNT COMPOSITES FRANCE

Submitted by: POLYNT COMPOSITES FRANCE

Prepared by: BUREAU VERITAS

Substance Name: Formaldehyde, oligomeric reaction products with aniline, also known

as poly[aminophenyl)methyl]aniline, polymeric MDA, PMDA or

technical MDA

EC Number: 500-036-1

CAS Number: 25214-70-4

Uses applied for: Use 1: Formulation of an epoxy resin hardener containing technical

MDA

Use 2: Industrial use of an epoxy resin hardener containing technical

MDA aimed at immobilising spent ion exchange resins in a high

containment matrix

Uses number: 1 & 2

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 2

TABLE OF CONTENTS

DECLARATION ................................................................................................................................................... 5

LIST OF ACRONYMS ......................................................................................................................................... 6

1 SUMMARY .............................................................................................................................................. 7

2 AIMS AND SCOPE OF THE ANALYSIS ............................................................................................ 9

2.1 Aim of the analysis..................................................................................................................................... 9

2.2 Scope of the analysis .................................................................................................................................. 9

3 APPLIED FOR “USE” SCENARIO FOR BOTH USES ................................................................... 10

3.1 Analysis of substance function ................................................................................................................. 10

3.1.1 Spent ion exchange resin source .............................................................................................................. 11

3.1.2 Radioactive waste management overview and specific regulation context .............................................. 15

3.1.3 Near surface storage facility concept and its specific rules for waste acceptance and the technical

approval process ....................................................................................................................................... 19

3.1.4 M.E.R.C.U.R.E. process to pack spent IER ............................................................................................. 26

3.1.5 Conclusion of substance function for Use 1 ............................................................................................. 32

3.1.6 Conclusion of substance function for Use 2 ............................................................................................. 33

3.2 Market and business trends including the use of the substance in both uses ............................................ 38

3.2.1 Supply chain of the Annex XIV substance, tMDA for both uses ............................................................. 38

3.2.2 Annual tonnage ........................................................................................................................................ 41

3.2.3 Electricity production by Nuclear Power Plants in France ....................................................................... 42

3.3 Remaining risk of the “applied for use” scenarios for both uses .............................................................. 44

3.4 Human health and environmental impacts of both “applied for use” scenarios ....................................... 44

3.4.1 Number of people exposed ....................................................................................................................... 44

3.4.2 Results of estimated excess cancer risks for workers for both uses ......................................................... 44

3.5 Monetised damage of human health and environmental impacts for both uses ....................................... 46

3.5.1 Liver Cancer: Incidence, prevalence, mortality. ...................................................................................... 46

3.5.2 The economic assessment for the cases of cancer .................................................................................... 47

4 SELECTION OF THE “NON-USE” SCENARIO FOR USE 1 ......................................................... 51

4.1 Research and identification of alternatives for use 1 ................................................................................ 51

4.2 The most likely non-use scenario for use 1 .............................................................................................. 51

5 SELECTION OF THE “NON-USE” SCENARIO FOR USE 2 ......................................................... 52

5.1 Research on alternative process to M.E.R.C.U.R.E. process ................................................................... 53

5.1.1 Efforts made to identify alternatives to M.E.R.C.U.R.E. process (research & development and data

searches) ................................................................................................................................................... 53

5.1.2 Identification of alternative process to M.E.R.C.U.R.E. process ............................................................. 53

5.1.3 Conclusion of the identification of known alternative process to M.E.R.C.U.R.E. ................................. 57

5.2 Research on a new containment matrix without tMDA, to be used in the present M.E.R.C.U.R.E.

process ...................................................................................................................................................... 59

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 3

5.2.1 Efforts made to identify and develop a new containment matrix without tMDA (research &

development and data searches) ............................................................................................................... 59

5.2.2 Identification of known alternatives for a new containment matrix without tMDA ................................ 60

5.3 Assessment of shortlisted technique alternatives ..................................................................................... 61

5.3.1 Alternative 1: new hardener, D8M2 ......................................................................................................... 61

5.4 The most likely non-use scenario for use 2 .............................................................................................. 78

5.4.1 Could the production of spent IER be stopped? ....................................................................................... 79

5.4.2 Is it possible to temporary store spent IER on NPP in order to wait an available alternative? ................ 82

5.4.3 Could the M.E.R.C.U.R.E process carry out of the European Union? ..................................................... 83

5.4.4 It is possible to use an alternative? ........................................................................................................... 84

5.4.5 Conclusion of the non-use scenario for use 2 ........................................................................................... 84

5.4.6 Non-use of Use 1 ...................................................................................................................................... 84

6 IMPACTS OF GRANTING AUTHORISATION ............................................................................... 85

6.1 Impacts of a granting authorisation for use 2 ........................................................................................... 85

6.1.1 Economic impacts for use 2 ..................................................................................................................... 86

6.1.2 Human Health or Environmental Impact for use 2 .................................................................................. 89

6.1.3 Social impacts for use 2 ........................................................................................................................... 90

6.1.4 Wider economic impacts for use 2 ........................................................................................................... 90

6.1.5 Distributional impacts for use 2 ............................................................................................................... 90

6.2 Impacts of granting authorisation for use 1 .............................................................................................. 91

6.2.1 Economic impacts for use 1 ..................................................................................................................... 91

6.2.2 Human Health or Environmental Impact for use 1 .................................................................................. 91

6.2.3 Social impacts for use 1 ........................................................................................................................... 91

6.2.4 Wider economic impacts for use 1 ........................................................................................................... 91

6.2.5 Distributional impacts for use 1 ............................................................................................................... 91

6.3 Uncertainty analysis ................................................................................................................................. 91

7 CONCLUSION ....................................................................................................................................... 92

7.1 Comparison of the benefits and risk for Use 1 ......................................................................................... 92

7.2 Comparison of the benefits and risk for Use 2 ......................................................................................... 92

7.3 Information for the length of the review period ....................................................................................... 93

7.4 Substitution effort taken by the applicant if an authorisation is granted .................................................. 93

8 REFERENCES ....................................................................................................................................... 94

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 4

TABLES OF FIGURES

Figure 3-1: Articulation of both uses and main actors ......................................................................................... 10

Figure 3-2: Operating principle of a nuclear power plant with a cooling barrier .............................................. 11

Figure 3-3: Ion exchange resin chemistry (cationic resin on the left and anionic resin on the right) ................. 12

Figure 3-4: French radioactive waste classification. Circle red indicates spent IER category. .......................... 17

Figure 3-5: photos of the final disposal facility of ANDRA .................................................................................. 19

Figure 3-6: Technical approval process .............................................................................................................. 24

Figure 3-7: M.E.R.C.U.R.E. process picture and illustration .............................................................................. 26

Figure 3-8: Illustration of a concrete container (=waste package) ..................................................................... 27

Figure 3-9: Chemical structure of the epoxy resin and the tMDA and the reaction between those 2 components

which is an example of one typical reaction between amine & epoxy .................................................................. 28

Figure 3-10: Schematic representation of the reaction between those 2 components .......................................... 28

Figure 3-11: Cross-linked polymer network......................................................................................................... 28

Figure 3-12: xxxxxxxx xx xxx xxxxxxxx xx xxx xxx xxxxxxxxxxxxxx. xxxxxx xx xxx xxxx xxx x xxxxx xxxxxxx xxxx

xxx xxxx) ............................................................................................................................................................... 30

Figure 3-13: Supply chain of tMDA which is used to pack spent IER in confined immobilized waste package. . 38

Figure 3-14: Scheme of use 1 ............................................................................................................................... 39

Figure 3-15: Scheme of use 2 ............................................................................................................................... 40

Figure 3-16: Distribution of French NPP ............................................................................................................ 41

Figure 3-17: Electricity production mix in France in 2014 (source: EDF) ......................................................... 42

Figure 3-18 Incidence and mortality of the top 15 cancers in EU28 ................................................................... 46

Figure 3-19: Reference values for chemicals related mortality and morbidity .................................................... 47

Figure 3-20: Resulting excess risk, mortality costs and morbidity in groups of exposed workers for use 1 and

use 2 ...................................................................................................................................................................... 48

Figure 3-21: Discounted economic cost of the health impact for both uses. ........................................................ 49

Figure 3-22: Reference value for the sensitivity analysis ..................................................................................... 49

Figure 3-23: Mortality and morbidity costs by groups of workers exposed (upper bound) ................................. 50

Figure 3-24: Economic Costs of health impact discounted for both uses (upper bound) ..................................... 50

Figure 5-1: Main advantages and disadvantages of direct immobilization processes ......................................... 56

Figure 5-2: Progress for approval with new hardener D8M2: current situation at the time of this present

authorization application...................................................................................................................................... 65

Figure 5-3: Successive steps required to fully implement D8M2 hardener in M.E.R.C.U.R.E process ............... 69

Figure 5-4: Main question to choose a non-use for use 2 with a NPP normal operating .................................... 78

Blank #2

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 5

DECLARATION

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 6

LIST OF ACRONYMS

ANDRA « Agence Nationale pour la gestion des déchets radioactifs », in English “the French

National Agency for Radioactive Waste Management”

CEA “Commissariat à l'énergie atomique et aux énergies alternatives”, in English “French

Alternative Energies and Atomic Energy Commission”

EDF “Electricité de France” is the national company producing electricity in France

IER Ion Exchange Resin

M.E.R.C.U.R.E. « Machine d'Enrobage de Résine dans un Conteneur Utilisant des Résines Epoxy », in

English the « Equipment to Coat IER in a Container with Using Epoxy Resins »

NPP Nuclear Power Plant

NSA Nuclear Safety Authority, in French the ASN “Autorité de Sureté nucléaire”

POLYNT POLYNT Composites France is the applicant of this authorization apply

PWR Pressurised Water Reactor

tMDA Technical MDA or Formaldehyde, oligomeric reaction products with aniline, (CAS

number 25214-70-4. EC number: 500-036-1)

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 7

1 SUMMARY

Two uses are considered together for this AoA-SEA because they are very interlinked. The two main

actors of the supply chain have worked closely for the research of alternatives for many years. One

document for both uses avoids repetition of the discussion and analysis.

The use 1 is the formulation of an epoxy resin hardener, which is called “D7M6”, containing

approximately 36% of technical MDA (tMDA). Use 1 takes place at POLYNT Composites France

facility and the formulation follows the requirements of their client, SOCODEI.

The use 2 is the industrial use of the epoxy resin hardener containing tMDA aimed at immobilizing

radioactive wastes in a high containment matrix with the M.E.R.C.U.R.E process operated by

SOCODEI. SOCODEI is a subsidiary of EDF specialized in the radioactive waste management. The

radioactive wastes considered here are ion exchange resins (IER) which are spent during water

treatment of Nuclear Power Plant (NPP). The water treatment with IER enables the chemical control

of the process water in all NPP operated by EDF (which is the national company producing electricity

in France). This water treatment ensures the complete integrity of the NPP primary circuits and limits

the radioactivity discharged via the authorized releases.

Radioactive wastes need a specific management that has been developed since the design of the NPP

in France, with a dedicated French regulatory framework while fulfilling international standards.

According to the French radioactive waste regulation, spent IER have to be sent to the near surface

disposal of ANDRA (French national radioactive waste management Agency). ANDRA have strict

specifications to accept wastes because radiation emissions have to be assessed and controlled over a

long period of time (i.e. 300 years). The disposal facility must isolate radioactive wastes from the

environment for the time needed for the radioactivity removal. The physicochemical form of the

waste package is the first safety barrier at near surface disposal facility. Therefore, several strict

interlinked properties are required for the final immobilized waste as a set of acceptance criteria.

Those wastes must indeed resist to various degradation processes which are cumulative and which

may interact in numerous combinations because of their long period of storage.

A specific treatment was developed with the M.E.R.C.U.R.E. process (direct immobilization

treatment) which involves the substance tMDA. To date, ANDRA only accept French radioactive

spent IER which are confined and immobilized in the polymer matrix produced by this process. This

confined immobilized waste package has been validated by a technical approval. The substance

tMDA is crucial to obtain a cross-linked polymer network meeting the required durability and

resistance requirements, as compulsory requested by ANDRA.

The polymerization of the epoxy matrix is an irreversible reaction within which tMDA is cross-linked

in a three-dimensional solid and insoluble polymer, which is then placed in a concrete container.

Consequently, following the polymerization, the hazardous character of tMDA is no longer expressed

in the immobilized end waste. Furthermore, the waste packages are resistant to leaching and they are

stored in closed disposal facilities.

For more than a decade, the 2 main actors of the present dossier, POLYNT Composites France and

SOCODEI, have worked closely to substitute carcinogenic substances in their products. The research

of a new containment matrix without CMR substances, as tMDA, has begun in 2003 for a total cost of

more than 1 million € (euros value in 2014 without discounting) for both actors.

Since then, two carcinogenic substances have been successfully removed but not the tMDA this alone

capable of meeting all ANDRA’s requirements.

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 8

A new hardener formulation has been developed in 2012 but all technical tests required by ANDRA

have not been finalised yet. Moreover, a technical approval must be requested to ANDRA for any

process modification or adjustment before using new products, as it has been the case with other

carcinogenic substances previously removed. However, even without full technical results, the

technical approval process has been launched in the purpose of implementing the new hardener,

without carcinogenic substances, as soon as possible. As we write these lines, the technical process is

still ongoing and the present authorization request aims at having time to end up this procedure in

order to hopefully validate the new matrix and then to implement the new hardener.

If SOCODEI could no longer use tMDA, they would no more be able to pack spent IER on each NPP

after the sunset date until an alternative is available (i.e until the new hardener is approved by

ANDRA) while those NPP would continue producing their radioactive wastes.

Indeed, French NPP provide around 75% of electricity in France. Stopping NPP production is

therefore not an option. NPP will still be operating and then they will still produce spent IER which

could not be stored anymore in discharge tanks. There will still be spent IER to treat in one way or

another.

Although EDF would face a dead-end at the sunset date, the less non-realistic non-use scenario has

been developed, for the sake of the present dossier submission completeness only. This would consist

in using the aforementioned not yet available alternative, i.e. the new hardener, while its use has not

been yet approved by French Competent Authority.

Because the waste packages in their new form could not be sent to the near surface disposal of

ANDRA, EDF would have to request lots of specific dispensations and to adapt transitional technical

measures for each of their 19 NPP sites with a lot of expensive studies. The total monetized impact is

a cost of several tens of millions €. Other risks, as economic impacts if the new hardener is never

approved by ANDRA, have not been monetized but should also be considered.

The main benefit of the non-use scenario would be to reduce exposure to a carcinogenic substance.

According to the data available and the results of exposure modelling, risk for man via environment is

considered as very low with this use of tMDA. It was not necessary to estimate an exposed general

population.

For the health impact on workers related to the use of tMDA, the resulting excess risks calculated

with several worst case assumptions are, at the highest, in the 10-7

order of magnitude (for Use 1) and

in the 10-6

order of magnitude (for Use 2). Those impacts are also monetized. However, those impacts

are evaluated to be less than ten euros considering the limited number of people exposed (6 workers

for use 1 and 50 workers for use 2) and the mentioned above resulting excess risks.

The report concludes that the benefits of both continued uses of tMDA are substantial and

considerably outweigh the risks. Even with all efforts made by the applicant and SOCODEI, it has not

been possible to remove the last carcinogenic substance as soon as wanted and it will not be possible

before the sunset date anyway. The present authorization request aims to have the time necessary to

end up the technical approval process and hopefully implement the “carcinogenic free” new hardener.

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 9

2 AIMS AND SCOPE OF THE ANALYSIS

2.1 Aim of the analysis

The applicant of this dossier is using technical MDA (EC 500-036-1; CAS 25214-70-4) in the

formulation of an epoxy resin hardener which is then industrially used for immobilizing radioactive

wastes in a high containment matrix. Technical MDA is classified as carcinogenic (category 1B).

The adequate control of risks arising from the applied for uses of the substance cannot be

demonstrated in accordance with Annex I, section 6.4 of Regulation (EC) No 1907/2006 as tMDA is

not considered as a threshold substance.

This dossier contains an analysis of alternatives which has the purpose to demonstrate that no

technically or economically feasible alternative technologies are yet available to replace the tMDA in

the above mentioned uses. Then, the aim of the socio-economic analysis is to assess whether the

socio-economic benefits of the continued applied for uses of tMDA outweigh the risks to human

health and the environment.

2.2 Scope of the analysis

Geographic scope

The companies covered by this application are described in this dossier and are all located in France.

The second use of the substance tMDA is linked to the use of ion exchange resin (IER) in French

Nuclear Power Plants (NPP) and to the radioactive waste management regulation which is a strict and

specific French regulatory framework. Studied impacts of the non-use are located in France.

The geographical scope of this study is EU and more specifically France.

Temporal scope

The temporal scope is set as the length of the requested review period, which is 12 years.

Indeed, the impacts of a non-granted authorisation would last until the forecasted alternative is

available (see calculation of the availability estimate in §7.3).

As regards the exposure to tMDA:

The impacts on the environment have not been addressed as the substance was not identified as of

very high concern to the environment;

According to the data available and the results of exposure modeling (developed in the CSR), the risk

for “man via environment” is considered as very low for the 2 uses of tMDA. Therefore, no impacts

will be triggered after the use of the tMDA has ceased. The polymerisation of the epoxy matrix is an

irreversible process following which tMDA is cross-linked in a three-dimensional solid and insoluble

polymer surrounded by a concrete container. Therefore, the hazardous character of the substance is no

longer expressed in the confined immobilized end waste which is resistant to leaching and is stored in

a closed disposal facility.

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 10

3 APPLIED FOR “USE” SCENARIO FOR BOTH USES

3.1 Analysis of substance function

Both uses are very interlinked. The substance function is therefore explained in this section for both

uses.

The use 1 is the formulation of an epoxy resin hardener containing technical MDA (tMDA) which is

called “D7M6 hardener”. It takes places at POLYNT Composites France facility and the formulation

follows the requirements of their client, SOCODEI.

The use 2 is the industrial use of the epoxy resin hardener containing tMDA which aims at

immobilizing spent ion exchange resins in a high containment matrix, operated by SOCODEI1. Ion

exchange resins are used for process liquids treatment of primary circuit water of EDF2 Nuclear

Power Plant (NPP) and they are treated as radioactive wastes when they are spent. The “D7M6

hardener” containing tMDA is used by SOCODEI in the M.E.R.C.U.R.E. process to immobilize those

radioactive wastes.

The following diagram represents main actors in this dossier (see more explanations in the supply

chain description in section 3.2.1):

Figure 3-1: Articulation of both uses and main actors

To understand the critical function of tMDA, it is important to understand those following points

which are developed in following sections:

1. The production of spent ion exchange resins (radioactive waste) resulting of NPP operation;

2. The radioactive waste management overview and the specific regulation context;

3. The near surface storage facility concept, its specific rules for waste acceptance and the

technical approval process;

4. The M.E.R.C.U.R.E. process to pack spent IER, which uses tMDA.

1 SOCODEI is a subsidiary of EDF and they are specialized in the radioactive waste management.

2 EDF is the national company producing electricity in France.

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 11

3.1.1 Spent ion exchange resin source

3.1.1.1 Principles of ion exchange processes

Ion exchange is a treatment process aiming at extracting mobile ions from a solution. The solution

goes through a solid matrix that contains functional groups. Those functional groups capture the

mobile ions which are then bound to the matrix. The resulting solution which has gone through the

matrix is free of these ions. The selection of an appropriate ion exchange medium depends on the

liquid to be treated.

Note: the process is named “exchange” as it is reversible in the majority of cases but this reversibility

is not relevant in the process subject of this authorisation dossier (as it will be explained in section

5.4.1.).

3.1.1.2 Brief overview of the operation of a Nuclear Power Plant (NPP)

This section gives a brief overview of the operation of a PWR (Pressurised Water Reactor) in order to

understand why ion exchange processes are used at Nuclear Power Plant (NPP), operated by EDF.

The operation of a PWR is based on three independent circuits filled with water:

- The primary circuit, a closed pressurised water circuit which transmits the heat released in

the reactor core by the fission reaction produced by the fuel rods and transported to steam

generators.

- The secondary circuit is a closed circuit which takes the steam produced by the steam

generators to the turbine. The thermodynamical energy released by the steam allows the

turbo-generator unit to turn and produce electricity which is sent to the network. The steam is

then transformed completely into water by the tertiary cooling circuit.

- The tertiary cooling circuit supplies cold water taken from a river or from the sea. This

circuit can be either open (water taken directly from the source and sent back returned to it)

or it can pass through a cooling tower (see figure 3-2).

Figure 3-2: Operating principle of a nuclear power plant with a cooling barrier

The containment requirement is crucial for a NPP: this is the rule of non-dispersion of radioactive

materials or fluids. Three physical barriers ensure this containment:

TERTIARY CIRCUITSECONDARY CIRCUITPRIMARY CIRCUIT

Tank

reactor

Turbine

Alternator

Pump

Building reactor(Nuclear zone)

Engine room(Non-nuclear zone)

Condenser

Dry cooler

Steam

water

Steam

generator

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 12

- the casing around the fuel,

- the primary circuit,

- and the reactor building containment enclosure.

Compliance with this requirement is mainly due to strict treatment and chemical monitoring of the

water in the primary and secondary circuits in order to ensure the complete integrity of the primary

circuit as well as the integrity of the various adjacent circuits.

3.1.1.3 Use of ion exchange processes in Nuclear Power Plant (NPP)

The use of ion exchange resin (IER) is the most common treatment methods for aqueous liquids in

both nuclear industry and in other industries.

Ion exchange technology has been applied for many years in nuclear fuel cycle operations and other

activities involving the treatment of radioactive liquids.

In order to ensure the strict treatment and chemical monitoring of the water and ensure the

containment requirement, IER treat the following aqueous liquids:

- The primary coolant (water) purification;

- The primary effluents;

Ion exchangers have proved to be reliable and effective for the control of both the chemistry and

radiochemistry of primary coolant system. French NPP processes have been designed with a primary

water treatment, which includes IER to minimize the degradation of system components by removing

ions responsible of these adverse effects like corrosion and to remove radioactive contaminants

(fission and activation products).

The ion exchange process is very effective for this decontamination by transferring the radioactive

content of a large volume of liquid into a small volume of solid. It ensures a high quality of

decontamination for the liquids.

This decontamination of the NPP aqueous liquids is essential for their operation. Moreover, this

decontamination is essential to limit the radioactivity discharged via authorized releases.

3.1.1.4 Definition of Ion Exchange Resin (IER)

Nuclear grade ion exchangers are resins that are similar to regular grade resins but that have tighter

strict specifications for particle size and composition.

In the scope of this authorisation dossier, IER are small polystyrene beads with a diameter ranging

between 0.3 and 1.2 mm. They are made of carbon chains bridged by divinylbenzene component, on

which acidic or basic functions are attached, allowing capturing anions or cations.

Figure 3-3: Ion exchange resin chemistry (cationic resin on the left and anionic resin on the right)

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 13

“Ion exchange capacity” is intended to describe the total available exchange capacity of an IER. The

value is constant for a given ion exchange material and depends on different parameters (ions

concentration, flow, temperature…). In a column system this generally refers to the volume of the

solution that can be treated before the ion exchange medium is considered to be spent.

Over time, IER must be replaced when one of the following criteria is overtaking: radiological,

chemical, pressure variance or expiration date. These IER cannot be regenerated as will be explained

afterwards (as explained in § 5.4.1.3.). Those spent IER must therefore be treated as radioactive waste

due to their radiochemical characteristics.

3.1.1.5 Spent IER temporary storage

On each NPP, spent IER are collected and warehouse in dedicated discharge tanks while waiting for

the appropriate treatment with the M.E.R.C.U.R.E. process which involves the tMDA substance.

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In the discharge tanks, spend IER are mixed in water to avoid their clogging between two campaigns

of treatment.

3.1.1.6 Radioactivity of spent IER

IER processes treat various aqueous liquids which carry activated corrosion products and fission

products. By nature, those products are radioactive because they are in relation with the primary

coolant of the plant reactor (made radioactive by neutron activation).

IER capture those products in order to control the chemistry and radioactivity parameters of primary

coolant. IER become therefore radioactive.

Radioactivity is a phenomenon during which unstable atomic nuclei (=radionucleides) are

transformed in stable atomic nuclei after series of radioactive disintegration. During those

disintegrations, some ionizing radiation emissions are produced.

Major radionuclides are: Mn54

, Co58

, Co60

, Ag110m

, Sb124

, Sb125

, Cs134

, Cs137

, Ni63

in those radioactive

spent IER. This term will be simplified with spent IER in the rest of the present report.

The radioactivity of the nuclear wastes is characterized by two properties. It is important to

understand those properties to understand following reasoning, in section 3.1.2.3:

- The “activity” is a rate that corresponds to the number of disintegrations of radionuclides per

unit of time (i.e. second). It is expressed in Becquerel (or Giga Becquerel (109 Bq)). In other

words, it is the radioactivity level.

The concentration of radionuclides is high in spent IER. Thus, activity concentration of spent

IER is high: the average activity concentration is 2,000 GBq/m3 and the highest activity can

be 10,000 GBq/m3). .

- The “half-life” or « radioactive period » of all radionucleides in the waste. The half-life is

the amount of time required for the activity to be reduced by half. Otherwise, the half-life is

the time needed to lose the half of his potential to produce ionizing radiation emissions,

therefore of his harm.

This half-life depends on each type of radionucleide. Radionucleides of spent IER have

mainly “short” half-lives, i.e. half-lives of less than 31 years. From a safety point of view, it is

considered that the waste has lost its potential for harm after 10 periods, i.e. after less than

310 years.

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3.1.1.7 Conclusion

The use of ion exchange media is crucial for the Nuclear Power Plant (NPP) operated by EDF. The

use of ion exchange resin (IER) ensures the strict treatment and chemical control of the water in the

primary circuit. This water treatment ensures the complete integrity of the primary circuit, which is

one of three physical barriers of the crucial containment requirement for a NPP.

Over time, IER must be replaced. Consequently spent IER become radioactive wastes, which need a

very specific waste management owing to their radioactive nature. This specific treatment was

developed with the M.E.R.C.U.R.E. process which involves the tMDA substance and it is operated by

SOCODEI. This process meets radioactive waste management regulation which is developed is the

following section.

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3.1.2 Radioactive waste management overview and specific regulation context

The radioactive waste management is very strict and depends on each country framework regulation

while fulfilling international standards.

The radioactive waste treatment choice is a combination of technical factors and national standards of

waste acceptance criteria for disposal. The final waste package must meet all applicable regulatory

and waste acceptance requirements of the final disposal facility.

The selection of a waste treatment is an integral part of the overall French waste management system

design, which has been developed for several dozens of years. This waste management takes care of

each operation for all kind of radioactive wastes.

3.1.2.1 International context of radioactive waste

This French regulation is part of an international context.

At European level, the radioactive waste management is governed by the Directive of the 19th of July

2011. It established especially the responsibility of Member States in this management.

At international level, the International Atomic Energy Agency (IAEA) establishes safety standards to

protect health and minimize danger to life and property of nuclear activities. On 29 September 1997,

France signed the Joint Convention on the Safety of Spent Fuel Management and on the Safety of

Radioactive Waste Management3, established under the IAEA constitute, which is the first legal

instrument to directly address these issues on a global scale.

The obligations of the Contracting Parties are based to a large extent on the principles contained in the

IAEA Safety Fundamentals document "The Principles of Radioactive Waste Management", published

in 1995.

Each Contracting Party has the obligation to establish and maintain a legislative and regulatory

framework to govern the safety of radioactive waste management. Each contracting Party has also the

obligation to ensure that individuals, society and the environment are adequately protected against

radiological and other hazards, by appropriate siting, design and construction of facilities and by

making provisions for ensuring the safety of facilities both during their operation and after the closure

of the facilities.

Several IAEA requirements are also available4.

3.1.2.2 French legal and regulatory principles of radioactive waste management

Regulating safety of radioactive waste is therefore a national responsibility.

For more than thirty years, radioactive waste management is a major industrial challenge and the

French regulation is regularly strengthened. Two founding laws have set the roadmap in 1991 (Act

91-1381 of the 30th of December 1991) and in 2006 (Act 2006-739 of the 28

th of June 2006) and many

others texts regulates this context. Each management step is governed by the regulation.

3 Information available on : https://www.iaea.org/publications/documents/conventions/joint-convention-safety-spent-fuel-management-and-

safety-radioactive-waste

4 For example: IAEA (2009), Predisposal management of radioactive waste – General safety requirements part 5 - n° GSR part 5; IAEA

(2009), Disposal approaches for long lived low and intermediate level radioactive waste – IAEA Nuclear Energy Series - Technical Reports - No. NW-T-1.20. Available on: http://www-pub.iaea.org/books

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The important points to underline our report are explained below:

► Article 13 in Act 91-13815

Historically, the French national radioactive waste management Agency (ANDRA) was created

within the French Atomic Energy Commission (French acronym CEA) by 7 November 1979 order.

ANDRA acquired its independence from the CEA and became a public industrial and commercial

establishment (French acronym EPIC) responsible for long term management of radioactive waste,

under the authority of the French Ministries for Energy, Research and Environment.

► Article 2 in Act 2006-739

One of the most important principles is “the sustainable management of all kinds of radioactive

materials and waste has to be ensured in compliance with the protection of human health, safety and

environment”. This article also stipulates that "research and implementation of the necessary means

for the final safety implementation of radioactive waste has to be taken to prevent or limit the charges

by future generations."

► Article L.542-1-2 of the Environment Code

A National Plan for the Management of Radioactive Materials and Waste (PNGMDR in French) has

been drawn up after more than 15 years of research and it is updated every 3 years.

This plan is based on the national inventory of radioactive wastes6 and on the perspectives to link

wastes production and storage capacity needs. It highlights the needs to develop global industrial

management schemes, to improve existing management methods and to take into account the

significant management feedback.

It is considered as an important tool to improve radioactive waste management.

► Order of the 7th February 2012 about general rules of Basic Nuclear Installation (with

title 6)

This regulation involves that waste producers are responsible for the management and the

conditioning of their radioactive wastes (article 6.7). They must ensure the compatibility between the

radioactive wastes treatment choice (and therefore the final waste package) with their subsequent

management, especially with acceptance specifications (article 6.7). The operators have to take into

account interdependencies among the different radioactive waste management steps.

3.1.2.3 Radioactive waste classification

The French regulation has also framed the radioactive waste classification which is based on main

international concepts (see The Safety Requirements publication, Predisposal Management of

Radioactive Waste of IAEA7).

Radioactive wastes are very diverse in terms of hazards and compositions. Wastes are sorted into

categories with similar characteristics in order to enable the safest management. French radioactive

waste classification classifies wastes with 2 features which have been explained in section 3.1.1.6

above:

5 Available on: http://www.andra.fr/international/pages/en/menu21/andra/regulatory-texts-1585.html

6 ANDRA (2012), National inventory of radioactive wastes published by ANDRA in June 2012. Available on:

http://www.andra.fr/index.php?id=edition_1_5_2&recherche_thematique=all

7 IAEA (2009), Predisposal management of radioactive waste – General safety requirements part 5 - n° GSR part 5. Available on:

http://www-pub.iaea.org/books/IAEABooks/8004/Predisposal-Management-of-Radioactive-Waste

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- The “activity” which is expressed in Bq/g or Bq/Kg. The radioactive wastes could be

classified in 4 different levels: very low, low, intermediate or high level waste;

- The “half-life” of all radionuclides in the waste. It is distinguished waste with a short half

time (< or = 31 years) from those with a long half time (31> years) It is considered for waste

with short half-life that radioactivity is very dimed after ten period (around 300 years).

Those 2 features determine several categories of radioactive waste and a treatment solution is defined

for each class8.

<- - - - - - - - - - - - - - - - - - - - - - - - - - - HALF - LIFE - - - - - - - - - - - - - - - - - - - - - - - - >

<-

- -

- -

- -

- -

- A

CT

IVIT

Y -

- -

- -

- -

- -

- -

>

Very short-lived

Half-life < 100 days

Short-lived

Half-life < 31 years

Long-lived

Half-life > 31 years

Very low level

(VLL)

Radioactive decrease

on production site

then disposed of

adopting conventional

solutions

Surface disposal facility

(very-low-level radioactive waste disposal facility

in the Aube district)

Low level

(LL)

Near surface disposal

facility

(low and intermediate-

level waste disposal

facility in the Aube

district)

Shallow disposal

facility

(studied in accordance

with the Act of 28 June

2006)

Intermediate

level

(IL)

High level

(HL)

Reversible deep geological disposal facility

(studied in accordance with the Act of 28 June

2006)

Figure 3-4: French radioactive waste classification. Circle red indicates spent IER category.

3.1.2.4 Waste management strategies

This radioactive waste classification and the management strategy cover all categories of radioactive

waste. This involves setting up specific waste management systems, taking into account not only

radiological risks, but also chemical and sometimes biological hazards incurred by that waste.

Waste management begins with the nuclear plant design, proceeds during the operating life of the

installation through concern for limitation of the volume, the noxiousness of waste produced, and the

quantity of residual radioactive materials it contains. It ends up with waste elimination (recycling or

final disposal) via the intervening stages of identification, sorting, treatment, packaging, transport and

storage. All operations associated with management of a category of waste, from production to

disposal facility, constitute a waste management route, each of which must be adapted to the type of

waste concerned.

The operations within each route are interlinked and all the routes are interdependent. These

operations and routes form a system which has to be optimized in the context of an overall approach

to radioactive waste management encompassing safety, traceability and volume reduction issues.

It has to be noted that long-term management solutions exist in France (repositories) for the

categories of radioactive waste which represents the major volumes (but with a low radioactive

8 This radioactive waste categories classification table is a simple way to know the waste treatment solution category. There are more

parameters which have to be considered to define the final waste category, as the waste stability or the presence of some toxic chemicals.

See more explanations on : http://www.andra.fr/international/pages/en/menu21/waste-management/waste-management-strategies-1612.html

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content): the very-low-level waste (VLL waste) and the low and intermediate-level short-lived

waste (LIL-SL waste).

The French government had chosen industrial disposal to manage those wastes in a safe and

sustainable way, by isolating them from human and environment.

Near surface disposal facilities meet safety requirements. To date, for LIL-SL waste category there

is only one French near surface disposal facilities in the city of Soulaines9 and it is managed by

ANDRA.

In addition, others disposal facilities are under studies but not yet built for other categories.

3.1.2.5 Classification of spent IER

As explained in section 3.1.1.6, spent IER have mainly short half-life radionuclides and a low and

intermediate level of activity with their radionuclides concentration (2,000 GBq/m3 in average and

maximum of 10,000 GBq/m3).

Spent IER package are therefore in the “Low and intermediate level short-lived waste” (LIL-SL)

category (see the red circle on the table 3-1 above). It is also important to note that spent IER are in

the high bracket of the LIL-SL waste category which can be accepted by ANDRA’s facility.

Moreover the French ordinance of the 27th December 2013 (with the article 11.2) indicates clearly that

“low and intermediate level short-lived waste” category have to be sent to the only near surface

disposal facility of ANDRA, within their conditions of acceptance specifications.

Therefore the compulsory treatment for spent IER is to send wastes at the ANDRA’s near surface

disposal facility in Soulaines, by following specific and strict compulsory rules.

3.1.2.6 Conclusion

Radioactive wastes need a specific waste management that is developed since the design of the NPP

in France and with a dedicated regulatory framework. The management waste strategy covers all

categories of radioactive waste.

Radioactive spent IER are low and intermediate level short-lived waste (LIL-SL) category. This

category has a final disposal facility and it is compulsory to send them in the only French near

surface disposal facility operated by ANDRA. However ANDRA have strict specifications to

accept those wastes which are explained in the following section.

9 There is a former near surface disposal facility in the North of France but it is no longer operated.

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3.1.3 Near surface storage facility concept and its specific rules for waste acceptance

and the technical approval process

3.1.3.1 The near surface disposal facility in France

The near surface disposal facility have been designed for very low level (VLL) and low and

intermediate-level (LIL) waste category with short lived radionuclides. In the ANDRA’s near surface

disposal facility in Soulaines for LIL-SL waste category, waste package are set in several reinforced

concrete structure of 25 meters-long and 8 meters high. A full-box is sealed with a concrete slab with

an impermeable liner. A final several meters high cover will provide rain and intrusion protection.

According to the international requirements and national regulation, radiation emissions have to be

assessed and controlled over a long period of time. It raised complex issues concerning the need to

anticipate the preservation and transmission of long-term memory, beyond the closure of disposal

facilities.

Figure 3-5: photos of the final disposal facility of ANDRA

The multi-barrier concept

The disposal facilities must isolate radioactive wastes from the environment for the time needed to the

radioactivity removal. Any transmission or dissemination of radioactive materials must be avoided.

Disposal safety is based on 3 building blocks:

1. The waste package with the physico-chemical form;

2. Disposal facility where waste packages are stored;

3. And the natural barrier with the geology of the location.

All these rules are enacted in the Basic Rules of Safety of NSA10

. ANDRA has great experience in

design and operating of this kind of facilities by following these rules.

10French reference: RFS-I.2. of the 08/11/1982 and RFS-III.2.e of the 31/10/1986 which are available on :

http://www.asn.fr/Reglementer/Regles-fondamentales-de-surete-et-guides-ASN/Guides-de-l-ASN-et-RFS-relatifs-aux-INB-autres-que-REP

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3.1.3.2 Definition of the confined immobilized waste package

The waste package is the first barrier of the disposal safety. Waste producer has to produce waste

packages with a correct physico-chemical form to ensure the first barrier of the near surface disposal

facility safety.

A very effective technique is to package wastes into an unalterable form. This form should prevent

the migration of radionuclides from the waste package into the environment, especially under the

action of water. This form should also protect people and environment from radiation emissions of the

radioactive waste.

The waste package is constituted by the "containment media11" that traps radioactive elements (e.g.

radioactive spent IER) into “the container” which is placed around. The initial radioactive waste is

then immobilized in the entire waste package. Those strong and stable packages are easy to handle

and to transport, then ready for disposal.

ANDRA are defined specific activity limits12 of the whole waste package in order to guaranty the

storage safety. In the case of radioactive spent IER concerning by this authorization dossier, waste

packages have also to be confined in order to respect those limits.

Confined immobilized waste package13 has therefore more criteria than only immobilized waste

package. All those criteria are required in order to retain the structural integrity of the waste package

over long periods and they are described below.

Therefore, SOCODEI have to pack spent IER in “confined immobilized waste packages”, this term

will be used in the rest of the present report. SOCODEI

In order to produce those kinds of waste packages, SOCODEI have developed M.E.R.C.U.R.E.

process with the use of tMDA. This process is explained in the section 3.1.4 below.

3.1.3.3 Properties of confinement immobilized waste forms: difficulty to obtain immobilized

waste forms fulfilled waste acceptance criteria

The purpose of SOCODEI is to pack spent IER in confined immobilized waste packages. Those waste

packages must be durable and resistant14 over a long period of time in order to ensure the first

barrier of the disposal safety, as required by ANDRA.

The effects of various degradation processes are cumulative and they may interact in various

combinations. Those degradation processes have to be taken into account to define this confinement

immobilized waste package. For example, irradiation of a waste form and radiolytic gas generation

may lead to a reduction in mechanical strength and a subsequent formation of cracks, which could

allow water to contact the interior of the waste form and increase the leach rate. If this infiltrated

water were to freeze it could cause a further cracking of the waste form15.

11 The media used to trap radionuclides are varied: cement, bitumen, thermosetting resins, glass, ceramics, etc.

12 ANDRA’s specific activity limits are the Maximum Limit of Acceptability (MLA) and the Threshold Immobilization Limit (TIL), which

are defined in ANDRA’s document, Specific evaluation and reporting of radioactive characteristic, ACO SP ASRE 99.002. Available on:

http://www.andra.fr/index.php?id=itemmenu_article_484_1681_8_1&itemracine=462

13 According French reference RFS-III.2.e (see website link above)

14 According §4.7 of the French reference RFS-I.2 (see website link above)

15 IAEA (2002), Technical reports series no. 408, Application of ion exchange processes for the treatment of radioactive waste and management of spent ion exchangers, page 84. Available on: http://www-pub.iaea.org/MTCD/publications/PDF/TRS408_scr.pdf

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In the aim to avoid those degradation processes, several strict interlinked properties are required for

the final confinement immobilized waste form.

3.1.3.3.1 Mechanical properties

The mechanical properties of the waste package are an important requirement. The waste form must

undergo a series of tests, such as a determination of its compressive strength, to demonstrate that it

will maintain its integrity over the required period of time.

3.1.3.3.2 Thermal stability

There are two main considerations for thermal stability: the production of heat during the

solidification process and the effect of exposure to heat (or cold) after the solidification of the waste

form.

In M.E.R.CU.R.E. process, the polymerization is an exothermic reaction. If peak temperatures reach

more than 100°C any water presented in the waste package will boil off and the steam generated can

produce cavities and cracks in the final product.

3.1.3.3.3 Leaching behaviour

A key property of a matrix containing radioactive waste is its leaching resistance. The leaching

resistance determines how well the radionuclides of concern are retained within the waste form

when it is subjected to wet conditions.

It should be noted that this behavior depends on the waste form and the radionuclides in the waste. It

can be altered by the chemistry of the waste material, the formulation of the immobilization matrix

and the chemistry of the leaching water.

3.1.3.3.4 Difficulty of long term chemical and radiological stability criteria16

It is well known that subjecting organic materials to radiation fields can alter their physical properties.

The containment matrix is difficult to formulate in order to limit radiolysis or chemical degradation

processes, which can further influence the radiological, chemical and physical properties of the waste

form.

Radiolytic effects

The associated radiation fields of spent IER can be high. When integrated over long time periods, this

may result in radiolytic damage to the matrix.

Damage to the ion exchange medium may reduce its capability to retain radioactive ions, while

damage to the immobilization matrix will reduce the mechanical integrity and physical durability of

the waste form. This could, for example, increase susceptibility to leaching by water. The radiolysis

process may also produce combustible or explosive gas mixtures (e.g. hydrogen, methane and

oxygen), as well as corrosive liquids (e.g. sulphuric acid and nitric acid).

16 IAEA (2002), Technical reports series no. 408, Application of ion exchange processes for the treatment of radioactive waste and management of spent ion exchangers, page 92 (see website link above)

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Chemical and biological effects

The chemical and biological degradation of organic ion exchange media has also been known to

occur. The results of such degradations are generally similar to those of the radiolytic effects.

The degradation of organic materials by any of the above processes can also lead to the formation of

water soluble degradation products, which are able to chelate the absorbed radionuclides and thereby

increase the mobility of these radionuclides in the repository.

Since the strength of the matrix is based on covalent bonds of the polymer network, the matrix must

be kept away from materials that could break the bond, such as the calcium or sodium ions contained

in many groundwaters or cement materials.

It is crucial for long term stability that complexing agents that could increase the mobility of

radiotoxic long lived radionuclides are excluded from waste packages that may come into contact

with water.

3.1.3.4 Waste acceptance criteria for confinement immobilized spent IER in France

ANDRA have defined the quality of waste package with a set of acceptance criteria in order to

receive durable and resistant waste package.

ANDRA disposal facility waste acceptance criteria are the set of rules reflecting a mix between the

technical considerations with all previous explained properties, economic criteria and the legal and

regulatory principles.

Those criteria are also a translation of Basic Rules of Safety of NSA.

The set of criteria are available in ANDRA’s document17.

For spent IER category, the main requirements for the durable and resistant confinement

immobilized waste package are:

- A limited exudation of water: the exudation of water has less than 3% by volume under a

compressive stress of 0.35 Mpa applied for one hour;

- A low exothermic reaction, which results in a heart mix maximum temperature under 90°C

during the polymerization step to avoid the production of steam18

- An homogeneity in the waste: the process should enable a homogeneous distribution of

spent IER into the matrix;

- A high mechanical compression strength of the package (>8MPa)

- A stability under ionizing radiations;

- A leaching resistance: a high resistance against leaching by water of the waste packages;

- The chemical compatibility of all components of the package;

- A maximum surface dose rate of the waste packages of 2 mSv/h but NSA has required a

maximum dose rate of 0,75 mSv/h;

- An inflammation resistance: resistance against fire of the waste packages.

Therefore those criteria define appropriate treatment options. M.E.R.C.U.R.E. process, which is

explained in the following 3.1.4 section, has taken into account those criteria about waste form and

17 ANDRA’s document: ACO.SP.ASRE.99.004/B. Available on:

http://www.andra.fr/index.php?id=itemmenu_article_484_1681_8_1&itemracine=462

18 The polymerization between the resin and the hardener could create water by polycondensation. This water would turn to steam If the

polymerization temperature exceeds 100°C and it could be damaged the package by swelling or its cracking.

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some specificity related to ion exchange waste forms, owing to the higher concentration of

radionuclides, their associated radiation emissions and the nature of the IER themselves.

3.1.3.5 Technical tests required by ANDRA

For each waste acceptance criteria, the waste producer has to ensure compliance of the waste package

properties with these criteria.

For some specific criteria, ANDRA requires technical tests. The methods to perform these tests are

defined by ANDRA (i.e. exudation, compression). Moreover some of them are especially complex to

implement (i.e. leaching resistance).

Technical tests may involve specific operational conditions such as: laboratory sample testing, test on

radioactive or non-radioactive full-scale waste package.

The overall experience below on a leaching test is a pertinent example to explain the complex

implementation of this kind of test. The leaching test measures the released speed of radiochemical

elements from a matrix19.

In order to carry out a control on the actual technical approval n°11BX (see next section for more

explanation about technical approval), SOCODEI decided to achieve a long leaching test in July

2009. The last answer of ANDRA has been received in August 2015.

- The first step was to produce a radioactive full-scale waste package (in real condition).

- In parallel, the second step consisted in requesting for availability in a special lab facility in

CEA20. Indeed the long leaching test is carried out in such specific dedicated room (the test

sample is radioactive). Those rooms are not always available.

- In November 2010, an order was finally concluded with CEA. Then the leaching test was

realized between February 2011 and May 2012 (the long leaching test takes 455 days in the

dedicated room).

- CEA send the test report 6 months later. In addition, SOCODEI took 3 more months to

analyze the results in order to check the accordance with ANDRA requirements.

- The results were sent to ANDRA in January 2013 and some discussions were necessary to

add some further technical details.

- Last ANDRA answer dates from August 2015, some discussions back and forth are still

ongoing.

3.1.3.6 Technical approval process of ANDRA

A waste producer has therefore to deal with ANDRA before sending waste package in order to ensure

that waste packages respond to ANDRA requirements qualities. This is set out in the technical

approval and technical tests which are explained above.

19 ANDRA’s document n°ACO.SP.ASRE.00-052. Available on:

http://www.andra.fr/index.php?id=itemmenu_article_484_1681_8_1&itemracine=462

20 CEA is the French Atomic Energy Commission.

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Therefore ANDRA developed a technical approval process to obtain this approval. ANDRA will

deliver 2 documents to obtain the full technical approval (as explained in ANDRA’s document

ACO.SP.ASRE.98.084):

- one approval document

- and one acceptance document.

This process has 4 major steps and it requires several exchanges back and forth between waste

producer and ANDRA. This process can take several years of discussion before approval.

It can also be noticed that the monitoring by ANDRA continues over the years after approval.

In the case of spent IER, only spent IER package produced with M.E.R.C.U.R.E. process using tMDA

can be sent to ANDRA disposal facility (the actual technical approval number is 11BX).

Figure 3-6: Technical approval process Abbreviation used: (WCM) Waste Compliance Matrix; (WCP) Waste Characterization Program ; (WCF) Waste

Characterization File ; (TP) Technical Provisions ; (OA) Organizational Arrangements.

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3.1.3.7 Conclusion

According to the French radioactive waste regulation, spent IER have to be sent to the near surface

disposal of ANDRA.

ANDRA have set up strict durability and resistance requirements for packages which are sent by

waste producers in order to ensure the multi-barrier concept, so the safety of the disposal over long

period of time.

To date, ANDRA only accept radioactive French spent IER which are confined and immobilized in

the polymer matrix produced by M.E.R.C.U.R.E. process, which uses tMDA. This confined

immobilized waste package has been previously validated by a technical approval (n°11BX).

This process enables to avoid the cumulative effects of various degradation processes and to have

the best compromise to concentrate enough waste in one package (compactness requirement) while

meeting French and European regulations and ANDRA’s requirements.

Any change on the confined immobilized waste package has to be approved and accepted by

ANDRA.

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3.1.4 M.E.R.C.U.R.E. process to pack spent IER

Spent IER produced by EDF have to be sent to the near surface waste disposal facility managed by

ANDRA in order to be disposed over 300 years, according to the French integrated radioactive waste

management system and French regulations, as explained in section 3.1.2 above.

Specific and strict rules have been set in order to control this disposal safety, as described in section

3.1.3 above. ANDRA requires confinement immobilized waste forms to ensure structural integrity

over long periods of time.

In the 90’s, SOCODEI therefore developed an immobilization treatment with the M.E.R.C.U.R.E.

process which involving a chemical reaction of polymerization between an epoxy resin and a mixture

containing tMDA, the Annex XIV listed substance, object of this authorisation dossier. It is a complex

process encompassing a detailed consideration of spent IER characteristics and the compatibility with

the near surface waste disposal facility requirements. M.E.R.C.U.R.E. process is explained below.

3.1.4.1 M.E.R.C.U.R.E. process is a direct immobilization treatment

M.E.R.C.U.R.E. is a direct immobilization treatment. The English translation of this acronym is

« Equipment to Coat IER in a Container with Using Epoxy Resins »21

.

Immobilization treatment is a process consisting in incorporating the waste into a matrix for

solidification which is then placed into a final disposal container to produce a stable end product or

confined immobilized waste package.

In our case, the matrix is a polymer obtained by reacting:

- a mixture (containing resin named 195RD09T, which will be named “epoxy resin” in the

report)

- with a hardener (a mixture named “D7M6 hardener” in the report) which contains tMDA,

- and spent IER.

The process consists in mixing those 3 products at an ambient temperature with a homogeneous

dispersion, in a concrete container (=waste package).

The mixing, achieved with a single-blade, triggers the polymerization. The substance tMDA enables

the formation of a cross-linked polymer network producing the “containment media”. The

polymerization is ended after 24 hours: the spent IER are then blocked in the matrix.

Figure 3-7: M.E.R.C.U.R.E. process picture and illustration

21 In French, M.E.R.C.U.R.E. means « Machine d'Enrobage de Résine dans un Conteneur Utilisant des Résines Epoxy »

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Use number: 1 & 2 POLYNT COMPOSITES FRANCE 27

SOCODEI operates M.E.R.C.U.R.E. process on EDF sites and POLYNT Composites FRANCE, which

is the applicant for this authorization apply, is the supplier of the epoxy resin and the D7M6

hardener, which contains the substance tMDA.

The concrete final disposal container is impervious, durable and confining. It is built with a layer of

steel ensuring radiological protection, integrated in the concrete. The single-blade is blocked in the

matrix at the end.

The final average weight of a waste package is approximatively between 5000 and 5700 kg 300 to

350 kg of IER.

Figure 3-8: Illustration of a concrete container (=waste package)

The stable end waste is the concrete final disposal container (=waste package) which contains

spent IER blocked in the cross-linked polymer network obtained by the polymerization of the

epoxy resin and the D7M6 hardener (containing tMDA).

Those confined immobilized waste packages are obtained with M.E.R.C.U.R.E. process meet

ANDRA and French regulation requirements. Those packages can be sent to the only one final

near surface disposal facility, as it was explained above.

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3.1.4.2 Crucial role of tMDA in the polymerization - Chemistry of epoxy resins

The mixture of the D7M6 hardener contains 36% of tMDA which is a diamine. The amine is the

reactive parts that enable the polymerization of the epoxy resin.

To understand the crucial role of tMDA in the cross-linked polymer network, it is important to

synthetically explain epoxy resins chemistry: a polymer thermoset network is created by the reaction

between the epoxy functions of the epoxy resin and the amine functions of the

tMDA.

Figure 3-9: Chemical structure of the epoxy resin and the tMDA and the reaction between those 2 components

which is an example of one typical reaction between amine & epoxy

Figure 3-10: Schematic representation of the reaction between those 2 components

When those 2 components are mixed, the following three-dimensional network is created. Spent IER

have also reactive chemical groups (see picture 3-5 above) that can be entrapped into this network.

Figure 3-11: Cross-linked polymer network

Epoxy resin

tMDA in the D7M6 hardener

(E.g. reaction of the 4-4’MDA

isomer):

D7M6

hardener

EPOXY RESIN

EPOXY RESIN

EPOXY RESIN

EPOXY RESIN

Epoxy resin

Spent IER

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The role of tMDA in the final waste properties is as follows:

- Homogeneity in the waste: the symmetrical position of the amine groups within tMDA

contributes to the cured polymer regularity.

- Resistance to high temperature variations & fire resistance : tMDA contributes to the

immobilized waste resistance both to freezing (once stored outside) or melting (in case of a

fire) thanks to the numerous carbone-nitrogen covalent bonds its creates with the

thermosetting resin epoxide groups, enabling a tridimensional infusible and insoluble solid

network.

- Limited exudation of water & high mechanical compression strength: tMDA's rigid

aromatic rings contribute to the polymer mechanical resistance. tMDA compacity and

reactive groups symmetry endow the cured polymer with a stiffness, a uniformity and a

network density not obtainable from other amine types

- Stability under ionizing radiations: the chemical group the more stable and the more

resistant to ionizing radiation is the 6 carbons aromatic ring. tMDA, which aromaticity rate is

very high, is thus a major actor of the final waste resistance to ionization

- Leaching & hydrolysis resistance: the 6 carbons aromatic ring is the less sensitive to water,

tMDA thus highly contributes to the polymer resistance to hydrolysis and leaching. This is

also enabled by the absence of water sensitive groups in it (amide, imide, ester or ether)

- Chemical reaction control: tMDA reacts with the epoxide groups of the epoxy resin with a

low exotherm avoiding the waste water content to be transformed into steam during the

polymerization. This enables the encapsulation of waste containing a high quantity of water

with no foaming phenomenon.

The cross-linked polymer network is the result of the polymerization and the substance tMDA is

crucial in this specific matrix in order to meet ANDRA requirements as explained in section

3.1.3.4.

3.1.4.3 The resulting tree-dimensional polymer entrapped the substance tMDA

The polymerisation of the epoxy matrix is an irreversible process and tMDA is therefore cross-linked

in the tree-dimensional solid and insoluble polymer.

There is an excess of epoxy resin compared to the hardener during the production of the package, so

that all tMDA functions have theoretically reacted with epoxy resin. As a consequence, no tMDA

should remain in the finally cured matrix. Indeed some measurements were performed and they

showed results of MDA22 below the limit of quantification (< 1 µg/m3) during the polymerisation end

phase (see CSR report, section 9.2.7.2 for more explanations).

Therefore the hazardous character is no longer expressed in the confinement immobilized end waste

in the final concrete container. Finally those waste packages are resistant to leaching and they are

store in closed disposal facility.

22 Measurements are expressed in MDA and not in tMDA. For more explanations, see the CSR report.

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3.1.4.5 Equipment and specific location of M.E.R.C.U.R.E. process

There is a specific location for the M.E.R.C.U.R.E. equipment on each NPP. Each M.E.R.C.U.R.E

equipment consists of:

- The M.E.R.C.U.R.E. machine itself where the mixing of the products takes place and the

concrete packs are produced. This machine set up indoor, in the power plant station building

in a controlled room.

- The operating tank containing the hardener set up outdoor, in a restricted CMR controlled

area next to the building of the nuclear plant station where the M.E.R.C.U.R.E machine is

located. A specific area is set up to access this operating tank.

- Flexible and rigid pipes, pumps and other appropriate equipment enable to connect the

operating tank outdoor and the machine indoor i.e. to supply the M.E.R.C.U.R.E machine

with the hardener.

- Specific mobile control room, workshop and shelters that enable to operate the equipment, to

put on and remove the protective equipment, to control the access to the area to the authorised

and trained people

Spent IER are directly transferred from the discharge tank in the M.E.R.C.U.R.E. machine without

inappropriate human exposure.

3.1.4.6 Development of M.E.R.C.U.R.E. process & cost development

The first M.E.R.C.U.R.E. equipment was put into operation in 1996.

Before M.E.R.C.U.R.E. process development, spent IER were already immobilized in a matrix with

another process, the PRECED process. However, this process had a too high fire hazard level (due to

the catalyzer) which is the crucial risk factor on a NPP.

The complex work needed to develop the M.E.R.C.U.R.E. process took 20 years of research and

development:

- In the 70’s and 80’s, the first step was to define the chemistry of the new polymer matrix (to

define the chemistry formula and the associated process). This work was performed by

CEA23. SOCODEI have purchased 10 patents which were filed by CEA for a cost of 3.5M€

(euros value without discounting).

- In the 90’s, the second step was to adapt this process with NPP requirements, the cost of

which as 2.5M€ (euros value without discounting).

- Then the manufacture of each of the two M.E.R.C.U.R.E. equipments led to a cost of 6M€ in

1996, then in 2002 (euros value without discounting).

3.1.4.7 Benefits of M.E.R.C.U.R.E. process

The development of this process was complex due to many requirements or obligations:

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- The machine itself had to be designed to be able to go in the specific controlled location in the

building, with all appropriate equipment enable to connect the operating tank outdoor and the

machine indoor, for every NPP which were built before the equipment development;

23 As remember, CEA is the Atomic Energy Commission

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- The equipment had to meet the safety and security requirements of NPP, especially the fire

hazard level which is the crucial risk factor on a NPP (The equipment had to resist to

radiation emissions;

The M.E.R.C.U.R.E. process met all those requirements while the final confinement immobilized

waste form with tMDA met ANDRA’s requirements and the French regulation for the integrated

radioactive waste management system.

To date, only spent IER immobilized through this process are accepted in ANDRA’s disposal facility,

which have been approved by the technical approval.

3.1.5 Conclusion of substance function for Use 1

POLYNT Composites France uses tMDA to formulate the epoxy resin hardener as requested by their

client, SOCODEI. The substance tMDA has no specific function for the formulation itself during the

use 1. The tMDA characteristics are of interest for use 2 only.

Use 1 is a separate step that requires its own exposure scenario.

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3.1.6 Conclusion of substance function for Use 2

Function aspect Explanation

Task performed by

the Annex XIV

substance, tMDA

A mixture containing approximately 36% of the substance tMDA is used as a

hardener to immobilize radioactive wastes, which are spent ion exchange

resin (IER), in a containment matrix.

The substance tMDA in the D7M6 hardener is crucial to enable the formation

of the containment matrix which is a cross-linked polymer network. This

polymer is obtained by the polymerization of the epoxy resin and the D7M6

hardener which immobilizes spent IER into a final concrete waste package.

The confined immobilized waste packages are produced by the process called

M.E.R.CU.R.E.

M.E.R.C.U.R.E. process is operated by SOCODEI, which is specialized in the

radioactive waste management. This is the use 2.

POLYNT COMPOSITES FRANCE is the supplier of both epoxy resin and the

D7M6 hardener containing tMDA. The D7M6 manufacture is use 1. POLYNT

COMPOSITES FRANCE is the applicant for this authorization.

What critical

properties and

quality criteria

must the substance

fulfill?

The substance tMDA is crucial to obtain a cross-linked polymer network

having the required resistance properties, as compulsory requested by

ANDRA (see section “customer” requirements below): resistance to ionization,

mechanical stress, thermal variations effects, hydrolysis and leaching.

The tMDA reactive parts (i.e. amine groups) enable the polymerization of the

epoxy resin through the creation of strong carbon-nitrogen covalent bonds: this

result in a tree-dimensional solid and insoluble network in which spent IER

are blocked.

Reacted tMDA is trapped in the cured polymer: this is an irreversible process.

It is important to note that the non-reactive aromatic structure and aliphatic

parts of tMDA are also crucial for obtaining the final polymer required

properties. This waste will indeed be disposed over long period of time (more

than 300 years) and must resist to various degradation processes which are

cumulative and may interact in various combinations.

Several strict interlinked properties are required for the final immobilized

waste as a set of acceptance criteria. This set of criteria reflects a mix

between the technical considerations, economic criteria and the legal and

regulatory principles:

- A limited exudation of water;

- A low exothermic reaction to avoid the production of steam;

- An homogeneity of the waste;

- A high mechanical compression strength of the package;

- A stability under ionizing radiations;

- A leaching resistance;

- The chemical compatibility of all components of the package;

- A maximum surface dose rate of the waste packages of 0,75 mSv/h;

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- An inflammation resistance.

The role of tMDA in the final waste properties is as follows :

- Homogeneity in the waste: the symmetrical position of the amine

groups within tMDA contributes to the cured polymer regularity.

- Resistance to high temperature variations & fire resistance : tMDA

contributes to the immobilized waste resistance both to freezing (once

stored outside) or melting (in case of a fire) thanks to the numerous

carbone-nitrogen covalent bonds it creates with the thermosetting resin

epoxide groups, enabling a tridimensional infusible and insoluble solid

network.

- Limited exudation of water & high mechanical compression

strength: tMDA's rigid aromatic rings contribute to the polymer

mechanical resistance. tMDA compacity and reactive groups symmetry

endow the cured polymer with a stiffness, a uniformity and a network

density not obtainable from other amine types

- Stability under ionizing radiations: the chemical group the more

stable and the more resistant to ionizing radiation is the 6 carbons

aromatic ring. tMDA, which aromaticity rate is very high, is thus a

major actor of the final waste resistance to ionization

- Leaching & hydrolysis resistance: the 6 carbons aromatic ring is the

less sensitive to water, tMDA thus highly contributes to the polymer

resistance to hydrolysis and leaching. This is also enabled by the

absence of water sensitive groups in it (amide, imide, ester or ether)

- Chemical reaction control: tMDA reacts with the epoxide groups of

the epoxy resin with a low exotherm avoiding the waste water content

to be transformed into steam during the polymerization. This enables

the encapsulation of waste containing a high quantity of water with no

foaming phenomenon.

Thus, confined immobilized waste package which are produced with the

substance tMDA have achieved all required technical tests and justification

to fulfill the set of properties.

Function

conditions

The substance tMDA is used in the M.E.R.C.U.R.E. process which is a direct

immobilization treatment. The English translation of this acronym is

« Equipment to Coat IER in a Container with Using Epoxy Resins ».

An immobilization treatment is a process consisting in incorporating the waste

into a matrix for solidification (i.e. the polymer) which is placed into a

concrete final disposal container to produce the confined immobilized waste

package.

The M.E.R.C.U.R.E. process consists in mixing 3 products at an ambient

temperature with a homogeneous dispersion, in the concrete container:

- an epoxy resin

- with the D7M6 hardener which contains tMDA,

- and spent IER.

The polymerization is ended after several hours. The spent IER are then

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blocked in the matrix and the final average weight of a waste package is

approximatively between 5000 and 5700 kg.

M.E.R.C.U.R.E. process is operated by SOCODEI (i.e. USE 2) which is

specialized in the radioactive waste management.

POLYNT COMPOSITES FRANCE is the supplier of both epoxy resin and the

D7M6 hardener containing tMDA (USE 1). POLYNT COMPOSITES

FRANCE is the entity who applies for this authorisation.

The maximum annual tonnage used is 28.8 tons per year.

The 2 M.E.R.C.U.R.E processes produce a maximum of 442 confined

immobilized waste packages per year and per machine, i.e. 884 waste packages

in total.

Is the function

associated with

another process

that could be

altered so that the

use of the

substance is

limited or

eliminated?

The use of the substance tMDA is linked to the use of ion exchange resin (IER)

on Nuclear Power Plants (NPP) which are operated by EDF. EDF is the

national company producing electricity in France.

The use of IER is crucial for the NPP operation. The use of IER ensures the

strict treatment and chemical monitoring of the water in the primary circuit.

This water treatment ensures the complete integrity of the primary circuit,

which is one of three physical barriers of the crucial containment

requirement for a NPP.

Over time, IER must be replaced. Consequently spent IER become radioactive

wastes, which need a very specific waste management owing to their

radioactive nature. This specific treatment was developed with the

M.E.R.C.U.R.E. process which includes the substance tMDA.

On each NPP, spent IER are raised on discharge tank for waiting a

M.E.R.C.U.R.E. process campaign.

Process and

performance

constraints

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Design of the M.E.R.C.U.R.E. process

The machine itself had to be designed to be able to go in the specific controlled

location in each building, with all appropriate equipment enable to connect the

operating tank outdoor and the machine indoor, for every NPP which were

built before the equipment development;

The equipment had to meet the safety and security requirements of NPP,

especially the fire hazard level which is the crucial risk factor on a NPP (The

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equipment had to resist to radiation emissions).

“Customer”

requirements

USE 1: POLYNT has to formulate epoxy resin and the D7M6 hardener by

following SOCODEI’s conditions.

USE 2: SOCODEI has to produce waste package by following ANDRA’s

requirement and they had to deal with ANDRA to obtain a technical approval

for wastes produced with M.E.R.C.U.R.E. process.

According to the French radioactive waste regulation, spent IER have to be

sent to the near surface disposal of ANDRA.

ANDRA is the French national radioactive waste management Agency.

ANDRA have set up strict durability and resistance requirements for

packages which are sent by waste producers in order to ensure the multi-

barrier concept, so the safety of the disposal over long period of time (i.e. 300

years).

To date, ANDRA only accept French radioactive spent IER which are confined

and immobilized in the polymer matrix produced by M.E.R.C.U.R.E. process,

which uses tMDA. This confined immobilized waste package has been

previously validated by a technical approval (n°11BX).

This process enables to have the best compromise to concentrate enough waste

in one package (compactness requirement) while meeting French and European

regulations and ANDRA’s requirements.

Any change on the confined immobilized waste package has to be approved

and accepted by ANDRA.

Industry sector

requirements or

legal requirements

for technical

acceptability

The use of the substance tMDA is linked to the radioactive waste management

regulation.

Radioactive wastes need a specific waste management that is developed since

the design of the NPP in France and with a dedicated regulatory framework

Radioactive waste management is a major industrial challenge for more than

thirty years and it is a national responsibility. This management is very strict

and depends on each country framework regulation while fulfilling

international standards.

The radioactive waste treatment choice is a combination of technical factors

and national standards of waste acceptance criteria for disposal.

The French government had chosen industrial disposal to manage those

wastes in a safe and sustainable way, by isolating them from human and

environment.

Radioactive spent IER are low and intermediate level short-lived waste (LIL-

SL) category. This category has a final disposal facility and it is compulsory to

send them in the only French near surface disposal facility operated by

ANDRA (see French ordinance of the 27th December 2013 with the article

11.2).

The near surface disposal facility must isolate radioactive wastes from the

environment for the time needed to the radioactivity removal. The waste

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package with its physico-chemical form is the first barrier of the disposal

safety of the near surface disposal facility. ANDRA have therefore strict

specifications to accept wastes because radiation emissions have to be

assessed and controlled over a long period of time (i.e. 300 years).

Therefore the substance tMDA allow obtaining confined immobilized waste

packages with M.E.R.C.U.R.E. process. Those waste packages meet ANDRA

and French regulation requirements and they can be sent to the only one final

near surface disposal facility.

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3.2 Market and business trends including the use of the substance in both uses

3.2.1 Supply chain of the Annex XIV substance, tMDA for both uses

The supply chain of tMDA is unique and in this specific case, the use of the substance tMDA doesn’t

lead to the production of some goods.

The high quality of the 2 components of the epoxy resins is highly important to produce durable and

resistant over time waste package, as required by legal and regulatory principles, as explained in

previous section 3.1. And the substance tMDA is a crucial component of the hardener enabling it to

fulfill its function and obtain the final matrix.

SOCODEI and POLYNT work therefore closely for many years for the current production.

The supply chain of the substance tMDA is in the following scheme.

Figure 3-13: Supply chain of tMDA which is used to pack spent IER in confined immobilized waste

package.

The part of the supply chain concerned by REACH scope is indicated by the blue frame. EDF is not

legally concerned by the authorization process, but D7M6 containing tMDA is crucial for their

activity. Air Products has no use in the authorization scope.

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Use 1: Formulation of an epoxy resin hardener containing technical MDA

The two components of the matrix (the epoxy resin and the resin hardener which contains tMDA)

have always and only been produced by only POLYNT Composites France24 (named POLYNT in the

report) since the development of M.E.R.C.U.R.E.

POLYNT is supplied by AIR PRODUCTS for tMDA. AIR PRODUCTS is the only company to have

registered tMDA under REACH regulation for non-intermediate uses.

Figure 3-14: Scheme of use 1

Use 2: Industrial use of an epoxy resin hardener containing technical MDA aimed at

immobilizing spent ion exchange resins in a high containment matrix

The hardener D7M6 with tMDA is used in the M.E.R.C.U.R.E. process, which is operated by

SOCODEI to pack spent IER. The wastes are a consequence of the liquid process treatment on

Nuclear Power Plant (NPP), managed by EDF.

EDF is the national company producing electricity in France (see more details in following section

3.2.3.).

SOCODEI is a subsidiary of EDF which has been created in 1990. SOCODEI was assigned the task

of designing, financing, building, and operating facilities for low and intermediate-level radioactive

waste.

SOCODEI has therefore developed the M.E.R.C.U.R.E. process (as explained in section 3.1.4) and

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24 POLYNT Composites France has experienced different legal entities over the years (SPADO, then Cray Valley, then CCP Composites France and now POLYNT Composites France) but D7M6 has always been produced in the same workshop.

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Figure 3-15: Scheme of use 2

Other subcontractors are involved to provide the concrete package used in M.E.R.C.U.R.E. process.

AFTER the USE (out of authorisation scope)

Immobilized waste packages obtained with M.E.R.C.U.R.E. process are sent to ANDRA, which is the

French national radioactive waste management Agency and they are responsible for long term

management of radioactive waste, under the authority of the French Ministries for Energy, Research

and Environment.

ANDRA approved the M.E.R.C.U.R.E. process with the technical approval 11BX with the current

epoxy resin formulation and D7M6 hardener which contains tMDA.

Moreover, the polymerisation of the epoxy matrix is an irreversible process and tMDA is entrapped in

the cured polymer. Its hazardous properties are therefore no longer a danger in the confined

immobilized waste in the final disposal container.

SOCODEI and POLYNT have worked closely for the research and development of a new

alternative, as it will be further explained in following section 5.1.

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3.2.2 Annual tonnage

3.2.2.1 Amount of spent IER to pack in use 2

EDF operated 58 reactors operating at 19 sites in France. All of which are producing spent IER to be

treated with M.E.R.C.U.R.E. process, in quantities more or less important.

Figure 3-16: Distribution of French NPP

Since the development of M.E.R.C.U.R.E. process, following quantities of spent IER have been

treated:

- From 1996 to 2014, M.E.R.C.U.R.E. n°1 has packed 1843 m3 of spent IER ;

- From 2002 to 2014, M.E.R.C.U.R.E. n°225

has packed 1429 m3 of spent IER.

This represents 3272 m3

or more than 8,500 waste packages which have been sent to ANDRA since

1996.

The quantities of spent IER to treat vary within a range of 220 m3 up to a maximum of 340 m3 by

year. Each NPP is treated every 18 to 72 months whether all NPP are roughly treated over 4 years

with 2 M.E.R.C.U.R.E. process, and then again.

For example:

- 2014 : 220 m3

- 2015 : 330 m3

- 2016 : 254 m3 (estimation)

- 2017 : 265 m3 (estimation)

25 The second M.E.R.C.U.R.E. equipment has only been built in 2002

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3.2.2.2 Annual tonnage of tMDA in use 1

Therefore, the amount of tMDA depends on quantities of IER to be treated, according to the schedule

of intervention.

For the last 5 years, the average tonnage of tMDA purchased by POLYNT is 18 tons per year.

Year Quantity of tMDA

purchased (tons)

2009 18.3

2010 18.5

2011 20.2

2012 16.3

2013 20.7

2014 15.8

For the next years, the maximum tonnage of tMDA that could be reached is evaluated at 28.8 tons

per year.

3.2.3 Electricity production by Nuclear Power Plants in France

The substance tMDA is used to pack spent IER over 58 reactors operating at 19 sites in France.

In order to understand the critical use of those reactors in France, it is very important to note that

those 58 reactors produce 77% of the electricity used in France, as represented in the flowing scheme.

Figure 3-17: Electricity production mix in France in 2014 (source: EDF)

Nuclear power77%

Hydraulic8%

Other renewable energy

2%

Combined cycle gas &

cogeneration

6%

Fossil thermal (not including

gas)

7%

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Some information about the importance of the nuclear industry in France are available in a report of

PwC26

: “France is one of a few big countries to have taken advantage of the major advances in

nuclear physics in the second half of the 20th century to equip itself with a nuclear power generation

industry. Beginning in the 1970s, the nuclear power facility development program in France led to the

development of a major industry, one that is active on both the national and international levels. With

78% of its electricity generated by nuclear power today, France has made a technological choice

fundamental to its economy.”

Socio-economic impact of this particular power industry in France is also used in section 6.2 below.

Morover, it could be noticed that nuclear power contributes controlling greenhouse gas emissions,

which is a core concern nowadays. In France, this nuclear production of electricity with the other

renewable energies means (hydraulic electricity, wind electricity, solar electricity…) could reach to a

98% of carbon-free electricity.

26 “The socio-economic impact of the nuclear power in France” by PwC, available on: http://www.pwc.fr/le-poids-socio-economique-de-electronucleaire-en-france-125-000-emplois-directs-et-une-contribution-au-pib-de-071.html

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3.3 Remaining risk of the “applied for use” scenarios for both uses

The substance tMDA was included in Annex XIV of REACH “list of substances subject to

authorisation” due to its carcinogenic properties.

Remaining risks for both uses are related to those properties.

The excess cancer risk levels are evaluated in the CSR and are summarized below.

3.4 Human health and environmental impacts of both “applied for use”

scenarios

3.4.1 Number of people exposed

General population:

According to the data available and the results of exposure modelling, risk for man via environment is

considered as very low with this use of tMDA. It was not necessary to estimate an exposed general

population.

Workers:

The remaining risks of the applied for use scenarios are consequently only related to the exposure of

the workers concerned by these two uses:

- For the use 1: 6 workers

o Group 1: the formulation operators. There are two trained and authorised

formulation operators and one of them is likely to perform all formulation tasks.

o Group 2: the quality technicians who attend the test of the formulation and perform

the analytical lab work and storage of samples. There are two trained and authorised

formulation operators and one of them is likely to perform all analytical lab work.

o Group 3: the maintenance workers who perform the maintenance tasks. There are

two trained and authorised formulation operators and one of them is likely to perform

all maintenance tasks.

- For the use 2: 50 workers with 40 people in total which are trained, qualified and authorised

to perform the M.E.R.C.U.R.E process and 10 more people likely to participate in the

maintenance work.

3.4.2 Results of estimated excess cancer risks for workers for both uses

- For the use 1:

The resulting excess risks calculated with several worst case assumptions are, at the highest, in the

10-7

order of magnitude and respectively:

Formulation operators (group 1)

Excess individual cancer risk for a professional life time exposure: 2.22. 10-7

Excess cancer risk for a professional life time exposure for this population of 2 workers: 4.44 10-7

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Quality Technician (group 2)

Excess individual cancer risk for a professional life time exposure: 7.14. 10-8

Excess cancer risk for a professional life time exposure for this population of 2 workers: 1.43 10-7

Maintenance worker (group 3)

Excess individual cancer risk for a professional life time exposure: 3.26. 10-9

Excess cancer risk for a professional life time exposure for this population of 2 workers: 6.52 10-9

- For the use 2:

The resulting excess risks calculated with several worst case assumptions are, at the highest, in the

10-6

order of magnitude (M.E.R.C.U.R.E operators):

Excess individual cancer risk for a professional life time exposure: 8.97. 10-8

Excess cancer risk for a professional life time exposure for this population of 50 workers: 4.49 10-6

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3.5 Monetised damage of human health and environmental impacts for both

uses

3.5.1 Liver Cancer: Incidence, prevalence, mortality.

Liver cancer is the 6th most common cancer worldwide, with over 782,000 new cases diagnosed in

2012 (6% of total). In Europe, it is the 13th most common cancer with approximately 63,500 new

cases diagnosed in 2012 (2% of total)27

. A number of 8200 new cases of liver cancer was estimated in

2011 in France, including almost 80 % for men.

Figure 3-18 Incidence and mortality of the top 15 cancers in EU28

Hepatocellular carcinoma (HCC or liver cancer) represents 70 to 90 % of primary liver cancers. There

are four types of liver cancer treatment: partial ablation, liver transplantation, percutaneous tumor

destruction and chemotherapy.

According to the World Health Organization, liver cancer is responsible for over 47,000 deaths in the

European Union each year.

According to the latest publication of the European Association for the Study of the Liver (EASL),

liver cancer is the third leading cause of death from cancer worldwide28

. As with most cancers,

survival prognosis of liver cancer increases when it is detected at an early stage.

Without any treatment, the liver cancer is rapidly fatal, with a survival rate at 5 years of the order of

5%. When liver resection with curative intent is carried out, the survival rate at 5 years reached 26-40

27 Ferlay J, et al. (2013). Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer.

Apr;49(6):1374-403.

28 Blachier M1, Leleu H, Peck-Radosavljevic M, Valla DC, Roudot-Thoraval F. (2012) The burden of liver disease in Europe: a review of available epidemiological data. EASL.

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%. Unlike other cancers, liver cancer mortality rate is very close to the incidence rate due to the very

low survival rate.

The total cost of cancer in the European Union was estimated at 126 billion euros in 2009, including

health care represent 51.0 billion (40%). In the case of France, the total cost of cancer in 2009

amounted to 17 billion euros29

.

The dealing cost of HCC is global in France and also includes any additional care and support during

and after treatments such as psychological support for the patient and his family and social support30

.

3.5.2 The economic assessment for the cases of cancer

The objective of this section is to estimate the total economic cost of excess cancers associated with

exposure to tMDA

3.5.2.1 The costs of mortality and morbidity

The economic assessment of health impacts takes into account two important components, namely the

costs associated with mortality and morbidity:

- The first component (mortality costs) can be measured in two ways, either by the value of

statistical life (VSL) and by the value of a life year lost (VOLY). For this analysis, the

estimation of VSL provides the study from the University of Prague and recommended by

ECHA, will be used. An average VSL value of € 5 million in 2014 prices has been approved

for the monetization of impacts related to cancer31

.

- The second component (cost of morbidity) is measured by the statistical value of a case of

cancer (VSCC). Following the recommendations of the same study of University of Prague

and recommended by ECHA, a VSCC32

estimate of € 396,000 in 2014 prices will be used.

The values were converted to 2015 prices based on the price index harmonized consumer from

Eurostat database33

:

REFERENCE VALUES

Value (€) Value 2015 (€)

Mortality (VSL) 5 000 000 5 043 196

Morbidity (VSCC) 396 000 399 114

Figure 3-19: Reference values for chemicals related mortality and morbidity

29 Luengo-Fernandez, R et al. (2013) Economic burden of cancer across the European Union a population-based cost analysis

30 Inca, available at: http://www.e-cancer.fr/

31 Anna Alberini, Milan Ščasny (2014) Stated-preference study to examine the economic value of benefits of avoiding selected adverse

human health outcomes due to exposure to chemicals in the European Union – Part3. Charles University in Prague.

32 Nevertheless, some methodological issues have been identified during a NeRSAP workshop organized by ECHA. Source: Expanscience

Socio-Economic Analysis (non-confidential report), page 7

33 Available at: http://ec.europa.eu/eurostat/tgm/table.do?tab=table&init=1&language=fr&pcode=teicp060&plugin=1 with a value of deflator GDP of 1.00786392

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3.5.2.2 Monetization of health impacts for both uses

Following calculation formula have been used to estimate the costs of mortality and morbidity for

each group of exposed workers for both uses.

Following tables below summarize the CSR results for the resulting excess risks associated with

exposure to the tMDA for both uses and the costs of mortality and morbidity for each group of

exposed workers.

Use 1: Formulation of an epoxy resin hardener containing tMDA

Excess risk of cancer Mortality (€) Morbidity (€)

Group 1 (2 workers) 4.44E-07 0.055979476 0.004430165

Group 2 (2 workers) 1.43E-07 0.018029426 0.001426833

Group 3 (2 workers) 6.52E-09 0.000822041 6.50556E-05

TOTAL 0.080

Use 2: Industrial use of an epoxy resin hardener containing tMDA aimed at immobilizing spent ion exchange

resins in a high containment matrix

Excess risk of cancer Mortality (€) Morbidity (€)

Group 1 (50 workers) 4.49E-06 0.566227352 0.044810724

TOTAL 0.611

Figure 3-20: Resulting excess risk, mortality costs and morbidity in groups of exposed workers for use 1 and

use 2

The total cost of excess cancer risk for use 1 is 0.080 € for one year of exposure and total cost of

excess cancer risk to use 2 is 0.61 € for one year of exposure.

The resulting excess risks calculated with several worst case assumptions are, at the highest, in the 10-

7 order of magnitude (for Use 1) and in the 10

-6 order of magnitude (for Use 2) and the limited number

of workers cause a very limited economic cost for the human health impact in this specific case.

Calculation formula used in this analysis:

VSL: 5 043 196 et VSCC : 399 114

REC : resulting excess risks

𝑚𝑜𝑟𝑡𝑎𝑙𝑖𝑡é = 𝑉𝑆𝐿 × 𝑅𝐸𝐶40

𝑚𝑜𝑟𝑏𝑖𝑑𝑖𝑡é = 𝑉𝑆𝐶𝐶 × 𝑅𝐸𝐶40

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𝐶𝑡 = REC, s=4% et n=12 years

with Excel : =VA (4%; 7 ; REC)

𝑉𝐴 =∑𝐶𝑡

(1 + 𝑠)𝑡

𝑛

1

3.5.2.3 Results

Following ECHA’s recommendations, all monetized impacts need to be discounted. Based on the

recommendation of the ECHA’s guide, a 4% discount rate was applied to the monetary value of the

excess cancers associated with exposure to tMDA for a period of 12 years, which is the review period

pursued in this present report (see section 7.3).

Cost associated with excess risk of cancer by the use of the

substance Present value (12 years)

Use 1 < 1€

Use 2 5.6€

Figure 3-21: Discounted economic cost of the health impact for both uses.

3.5.2.4 Sensitivity analysis

In the sensitivity analysis, an upper bound will be established to take into account possible existing

uncertainties related to the estimation of CSR values and monetary values associated with mortality

and morbidity of cancer. The lower bound won’t be estimated due to the results obtained are low

enough.

Economic values estimated as upper bound in the study of the University of Prague will be considered

to achieve the sensitivity analysis. These estimates correspond to the VSL and VSCC values with an

income elasticity of 1.034

.

Values are expressed in 2015 prices based on the price index for consumption extracted from the

Eurostat database.

Reference values

Upper bound2015

Mortality (VSL) 5 558 291

Morbidity (VSCC) 436 174

Figure 3-22: Reference value for the sensitivity analysis

Using the new reference values, the following results are obtained:

34 Namely, the recommended core values were estimated with an elasticity of 0.7

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Use 1: Formulation of an epoxy resin hardener containing tMDA

Excès de risque de

cancer Mortality Morbidity

Group 1 (2 workers) 4,44E-07 0,06169703 0,004841531

Group 2 (2 workers) 1,43E-07 0,01987089 0,001559322

Group 3 (2 workers) 6,52E-09 0,000906001 7,10964E-05

TOTAL 0.088

Use 2: Industrial use of an epoxy resin hardener containing tMDA aimed at immobilizing spent ion exchange

resins in a high containment matrix

Mortality Morbidity

Group 1 (50 workers) 4,49E-06 0,624059901 0,048971654

TOTAL 0.673

Figure 3-23: Mortality and morbidity costs by groups of workers exposed (upper bound)

With this sensitivity analysis, results do not really change with the total cost of excess cancer risk for

use 1 is 0.088 € for one year of exposure and total cost of excess cancer risk to use 2 is 0.67 € for one

year of exposure.

Cost associated with excess risk of cancer by the

use of the substance (upper bound) Present value (12 years)

Usage 1 < 1€

Usage 2 6.3€

Figure 3-24: Economic Costs of health impact discounted for both uses (upper bound)

A monetized has been studied for those human health impacts for workers for both uses.

However those impacts are evaluated to less than 10 euros with the limited number of people

exposed (6 workers for use 1 and 50 workers for use 2) and the mentioned above resulting

excess risks.

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4 SELECTION OF THE “NON-USE” SCENARIO FOR USE 1

4.1 Research and identification of alternatives for use 1

The substance tMDA has no specific function for the formulation itself during the stage of the use 1

and it is a pre-requisite stage for use 2.

In consequence, it could not be carried out an analysis of alternative. The reader shall refer to the

analysis of alternatives for use 2, which will cover all possible options for alternatives to tMDA.

However, POLYNT have worked closely with SOCODEI for the research and development of a

hardener alternative. Efforts of both actors are described in the same section 5.2.1 below. Moreover

hazard and risk evaluation of the promised alternative for use 2 which is developed thereafter,

considered both uses, use 1 and use 2 (see section 5.4).

4.2 The most likely non-use scenario for use 1

The non-use of use 1 is determined by the non-use of use 2. There is more information at the end of

section 5.

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5 SELECTION OF THE “NON-USE” SCENARIO FOR USE 2

To search a suitable alternative, the first key requirement to be remembered is that spent IER have to

be sent to the near surface disposal of ANDRA according to the French radioactive waste

regulation35

. However, ANDRA have set up strict durability and resistance requirements for

packages which are sent by waste producers in order to ensure the safety of their disposal over long

period of time (i.e. more than 300 years).

Those wastes must therefore resist to various degradation processes which are cumulative and may

interact in various combinations because they are disposed over long period of time: resistance to

ionization, mechanical stress, thermal variations effects, hydrolysis, inflammation and leaching.

To date, ANDRA only accept French radioactive spent IER which are confined and immobilized in

the polymer matrix produced by M.E.R.C.U.R.E. process, which uses tMDA. This confined

immobilized waste package has been previously validated by a technical approval (n°11BX).

As explained above, tMDA in the D7M6 hardener is crucial to enable the formation of the

containment matrix to block radioactive wastes into a final concrete waste package with a cross-

linked polymer network. The substance tMDA is crucial to fulfill strict durability and resistance

requirements of ANDRA.

Therefore SOCODEI had two ways for searching an alternative of tMDA:

- Either to look for an alternative process to the M.E.R.C.U.R.E. process, which is explained in

the first following section 5.1;

- Or to search a new containment matrix without tMDA, to be used in the present

M.E.R.C.U.R.E. process, which is explained in the following section 5.2.

By searching the suitable alternative, SOCODEI have kept in mind those following key points,

as explained above in this report:

- The future final waste form, with a totally new process or with a new hardener in the

M.E.R.C.U.R.E. process will need to achieve all technical tests. And this new final waste

form will need to go through the entire technical approval process to be approved.

- Process and performance constraints fulfilled by the actual M.E.R.C.U.R.E. process:

o The limited autonomy of each NPP before discharge tanks of spent IER are full

(between 18 to 72 months);

o Spent IER have to be treated on each site;

o The specific design of the M.E.R.C.U.R.E. process to be able to go in the specific

controlled location in each building.

The assumption of this analysis of alternative (section 5.1 to 5.3) is the normal operating of NPP and

the need to continue to treat spent IER. Other kind of assumptions as regeneration of spent IER or the

change of aqueous liquid treatment of NPP have been studied at the end of the section 5 (see section

5.4).

35 According to the French ordinance of the 27th December 2013. See section 3.1.2.5.

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5.1 Research on alternative process to M.E.R.C.U.R.E. process

5.1.1 Efforts made to identify alternatives to M.E.R.C.U.R.E. process (research &

development and data searches)

The historical selection and development of M.E.R.C.U.R.E. process was the best strategic

compromise in order to pack spent IER according to all the legal and technical requirements (as

explained in previous section 3.1). Thus, the analysis of every alternative process was carried out

before to develop and choosing M.E.R.C.U.R.E. process in early 90’.

Moreover, this analysis of worldwide processes has been recently reviewed for two reasons: when the

development of a hardener without tMDA was difficult and for the development of the new

generation NPP (i.e. European Pressurized Reactor) to verify the best available technique.

This analysis was between 2006 and 2013, it included research literature on the alternative processes

and some contacts had also been made in several countries.

To achieve this research, it is estimated that 0.2 FTE36 of research staff was needed between 2006 and

2009 and then between 2011 and 2013.

5.1.2 Identification of alternative process to M.E.R.C.U.R.E. process

The conclusion of the worldwide processes analysis was that there are numerous alternative processes

already used in the world or studied but there is no worldwide consensus on a particular process.

This is mainly due to a variety of regulations in the different countries. Each country has its own

radioactive management system with its own requirements, while fulfilling international standards, as

explained in section 3.1.2 above.

The selection of a treatment for spent IER must consider their physical and chemical characteristics.

Basically, there are two main methods for the treatment of spent organic ion exchange materials:

(1) The destruction of the organic compounds to produce an inorganic intermediate product that

may or may not be further conditioned for storage and/or disposal;

(2) Or direct immobilization, producing a stable end product, as M.E.R.C.U.R.E. process.

A brief summary of all those worldwide technological alternatives is developed thereafter.

Lots of following information has been extracted of the well explained document of the International

Atomic Energy Agency (IAEA), Technical reports series no.40837.

5.1.2.1 Destructive methods for spent resin treatments

Destructive methods for the treatment of spent ion exchange materials are intended to alter the

chemical, radiological and/or physical characteristics of the spent ion exchange materials in

preparation for their final disposal. These processes include thermal and non-thermal treatments:

- Thermal processes : pyrolysis, incineration, multicomponent particle combustion, catalytic

extraction, hot pressing, vitrification and plasma techniques

- Other treatment methods (chemical treatment methods developed initially for hazardous

chemical waste): acid digestion, wet oxidation, molten salt oxidation, electrochemical

oxidation, barix process38, thermochemical treatment.

36 FTE : Full Time Equivalent

37 IAEA (2002), Technical reports series no. 408, Application of ion exchange processes for the treatment of radioactive waste and management of spent ion exchangers. Available at: http://www-pub.iaea.org/MTCD/publications/PDF/TRS408_scr.pdf

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- Processes under development but not yet industrial developed, as Microwave drying for

plasma arc incineration, Biological degradation or Cold crucible melting.

It was considered irrelevant to develop detailed explanations about all those destructive methods in

this report because they are well explained in IAEA’s document, Technical reports series no.408, in

pages 49 to 6537.

Several constraints of destructive methods have leaded to exclude this kind of treatment in the

legal framework waste management system in France. Those constraints are quickly

summarized below.

Considerations for secondary waste resulting from destruction processes

With all those destruction processes, secondary waste is produced, which could be of a nature similar

to primary waste or could be different (e.g. incineration ash). Therefore, it may require a specific

treatment and conditioning.

An evaluation of the secondary waste quantities and characteristics, as well as the choice of their

treatment and conditioning methods, is an essential step to choose first treatment.

The results of this evaluation could significantly affect the overall volume reduction factor, the

economics of operation or even the selection of the primary treatment process itself.

Anyway the dry or wet residues resulting from the secondary treatment of ion exchange materials

generally require immobilization prior to their final disposal, as direct immobilization, as

M.E.R.C.U.R.E. process.

Incinerator ash

The main conditioning processes employed for ash are compaction, pelletization, immobilization in a

cement matrix, placement into high integrity containers, sintering and melting. The choice of the

process is governed by the activity level, the chemical characteristics of the ash and the storage and/or

disposal options contemplated for the conditioned product. In some cases ash may be subjected to

grinding or a recovery of radionuclides before conditioning.

Wet residues

In some treatment processes, such as wet oxidation, the bulk of the activity is retained in the bottoms

as a wet residue. This can be treated further by dewatering. The final wet residue will require

immobilization in a suitable matrix, as M.E.R.C.U.R.E. process.

The selection of matrix materials and the evaluation of the waste forms is carried out in a similar way

to that for the direct immobilization technique.

Concentration of activity

Moreover, destructive methods will not destroy radioactivity levels. This radioactivity level will

therefore be concentrated. As explained above (see section 3.1.2.5), spent IER is already in the high

bracket of the LIL-SL waste category which can be accepted by ANDRA’s facility. If the

radioactivity level increases, the waste could change of radioactive waste category and not be

anymore accepted by ANDRA’s facility (see figure 5-1 above).

Gas production

38 Thermal destruction method under inert conditions for resins.

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Most of thermal processes produce gases which could contain some radioactive elements. Those

processes need to be treating before to be released according to a strict regulation. Treatment of this

kind of gases could be very complex and therefore not be mobile and very costly.

Considerations of radioactive waste transportation

Some of those destructive methods could not be carrying from one NPP to another. However spent

IER cannot be moved out of a NPP without treatment due to their radioactivity characteristics. If a

destructive method is built somewhere, some research and development will be also necessary to

design suitable temporary waste package, according to transport regulations.

5.1.2.2 Direct immobilization and encapsulation of spent IER

The second kind of treatment is the direct immobilization and it is the M.E.R.C.U.R.E. process

treatment category.

Immobilization is the process of incorporating waste into a matrix material for solidification or

directly into a storage and/or final disposal container. The immobilization matrices usually used for

spent ion exchangers are cement, bitumen and some polymers.

Most of the processes using the above matrices are performed on an industrial scale and they are

many details in many publications39.

Each immobilization matrices has their own advantages and their own limitations, as well summarizes

in the following table of the IAEA’s document40.

Matrix Advantages Disadvantages

Cement

Material is readily available and not expensive

Compatible with a wide range of materials

Excellent radiation stability

Non-flammable product

High pH results in a good chemical retention of

most radionuclides

Swelling of organic bead resins may cause cracking

of the matrix

Waste loading can be low, the volume of the final

waste form is greater than the original waste

volume

Moderate leach resistance for many radionuclides,

for example caesium

Bitumen

Good leach resistance

All the water in the waste is removed by the

process, resulting in good waste loadings

The waste form will soften at moderate

temperatures

Requires a container to maintain structural stability

Organic bead resins may swell and compromise the

waste form if there is a prolonged contact with

water

The organic waste form may be flammable and

subject to biodegradation

Has a lower radiation stability than cement

Polymer

(M.E.R.C.U.R.E

process category)

Wide variety of polymers are available

Good leach resistance for many polymers

Generally more expensive than bitumen or cement

Polymerization reactions can be affected by trace

materials in the waste

Has a lower radiation stability than cement

High integrity Simple and inexpensive to operate and handle Relies entirely on the container integrity

39 See reference [105–110] of the IAEA’s document (2002), Technical reports series no. 408. Available at: http://www-

pub.iaea.org/MTCD/publications/PDF/TRS408_scr.pdf

40 Table IX page 67 of the document of IAEA (2002), Technical reports series no. 408, Application of ion exchange processes for the treatment of radioactive waste and management of spent ion exchangers.

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Matrix Advantages Disadvantages

container

Steel containers have excellent radiation

stability

Not accepted in all jurisdictions

Polymer containers can have a low radiation

stability

Vitrification

The glass waste form has an excellent radiation

stability and leach resistance

Substantially reduces the volume of waste

Is a high temperature process

Is expensive to operate

Figure 5-1: Main advantages and disadvantages of direct immobilization processes

5.1.2.2.1 Cement immobilization

The technique of immobilizing radioactive waste (other wastes but not specifically spent IER) in

cement has been used in the nuclear industry and at nuclear research centers for more than 40 years.

Cement has many characteristics in its favour (see figure 5.1 above).

The main disadvantage of the cementation of spent IER is that the final waste volume is high

compared with the initial volume, owing to the low waste loadings that are achievable. Another

disadvantage of cementation for organic ion exchange materials is that a swelling of resin beads after

contact with water may occur in some disposal repositories. The swelling can result in micro cracks in

the cement or even in the overall cracking of the cement structure. This does not respect the

compactness requirement and the durability of the waste package concept.

Moreover, there would have some chemicals releases with cement immobilization of spent IER.

Although this process is used in some countries, the specific research and development works carried

out by EDF could not validate the feasibility of spent IER cement immobilization at an industrial

scale. This treatment would require 10 more years of development for an industrialization use.

5.1.2.2.2 Bitumen immobilization

Like cement, bitumen has been used for many years as an immobilization matrix for radioactive waste

(other wastes but not specifically spent IER).

Bitumen is a generic term used to cover a wide range of high molecular weight hydrocarbons.

It should be noted that the low melting temperature and the possibility of combustion in the case of an

accidental fire has lead in some countries to restrictions on the use of bitumen as a solidification

matrix, as in France.

5.1.2.2.3 Polymer immobilization processes

The immobilization of spent IER in polymers is utilized at many installations worldwide and it is the

M.E.R.C.U.R.E. process category.

Different types of polymers are used and further studies to improve cost effectiveness, process

simplicity and product quality are being carried out in many countries. Among the many polymers

used are epoxy resins, polyesters, polyethylene, polystyrene and copolymers, urea formaldehyde,

polyurethane, phenol-formaldehyde and polystyrene. Not all polymers are suitable for immobilizing

ion exchange resins.

Among the various polymer fixation processes developed, the most widely used are the polyester and

epoxy processes, as the one used in M.E.R.C.U.R.E. process in France. Both of these are ambient

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temperature processes and are comparatively simple considering the equipment and operations

involved.

5.1.2.2.4 Immobilization in high integrity containers

Dried spent ion exchange resins can be encapsulated in high integrity containers for storage and/or

disposal without immobilization in an additional matrix in a process in which dewatered or dried

resins are transferred directly into the final storage casks. The water is removed from the resins by

evaporation with a vacuum drying system in conjunction with a jacket heating system for the cask.

The waste casks can be made of ductile cast iron, high density polyethylene, fibers reinforced

concrete or steel.

This process is different of the other immobilization process because there is not “immobilization in

an additional matrix”. This is totally incompatible with ANDRA’s requirements of unalterable waste

form package which be durable and resistant with correct physico-chemical form (see full explanation

in section 3.1.3).

5.1.3 Conclusion of the identification of known alternative process to M.E.R.C.U.R.E.

This worldwide processes analysis has been carried out from a technical point of view between 2006

and 2013 to look for an alternative to M.E.R.C.U.R.E. process.

Nevertheless, the economic criterion could not be included in this analysis because it appeared too

difficult to obtain comparable data due to the use of inhomogeneous evaluation methods.

The technical analysis concluded there was a wide range of treatments to treat spent IER, which

could be very different from M.E.R.C.U.R.E. process such as destructive methods or direct

immobilization with several kind of matrix. However there is no technique better than another.

Each country has its own radioactive management system with its own requirements.

The first kind of treatment (destructive methods) have main constraints (secondary waste resulting

from destruction processes, concentration of activity, gas production …) which led to exclude this

treatment of the legal framework waste management system in France.

French actors have therefore developed a process in the second treatment category, the direct

immobilization.

The IAEA’s document stresses that the specific application of a matrix for a given waste must be

evaluated on an individual basis. Pilot level studies may be required to determine the optimum waste

loading and matrix composition. That is what has been done for the matrix of M.E.R.C.U.R.E.

process during its development 30 years ago and what is studied with the technical approval by

ANDRA. Therefore the M.E.R.C.U.R.E. process has met all French requirements, technical and

economic constraints.

Today the M.E.R.C.U.R.E. process meets all strict requirements of ANDRA with the technical

approval and there has been more than 8500 compliant waste packages sent to storage facility since

1996.

Among all kind of matrix, this analysis has determined that it was more relevant to find a new epoxy

resin matrix without CMR substance by keeping the M.E.R.C.U.R.E. process rather than to develop a

new complete process with all constraints explained above.

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- Technical constraints:

Spent IER cannot be moved out of the NPP because there is no available and suitable equipment to

carry out those wastes.

Therefore the new alternative process has to meet each implementation constraints. The

M.E.R.C.U.R.E processes are already designed to fit those implementation constraints.

- Approval process by ANDRA:

The approval process of ANDRA is a complex, costly and very long process with a lot of technical

tests to be achieved. If the process doesn’t change completely, some parts of the previous approval

could be used. The technical approval process with ANDRA will be more complex for a complete

new alternative process.

For example, for the step 3 of the approval process, the waste producer has to establish a methodology

to measure the activity of the waste (see explanation about radioactivity in section 3.1.1.6) that has to

be validated by ANDRA. The qualification process of this methodology has to be carried out for each

specific end waste and it is technically difficult and long.

- Modification in NPP procedures (specific authorisation):

For each modification on a NPP, lots of regulatory studies have to be carried out and lots of specific

application of authorisation would have to be requested to several French authorities. This regulatory

step is well explained in section 5.4.1.4 below.

If the M.E.R.C.U.R.E. process is kept by only changing products used, there would be still have some

safety and qualification studies. However, those studies and application for authorisation would only

need to be updated and they could be quicker than total new studies.

- Economic criterion:

The economic criterion could not be included in this analysis because it appeared it was too difficult

to obtain comparable data due to the use of inhomogeneous evaluation methods. However, it could be

easily understandable that a complete new process development would be also difficult and costly

than M.E.R.C.U.R.E development, as explained in section 3.1.4.6. As explained above, the

M.E.R.C.U.R.E. process development took 20 years and the cost rose more than 10M€.

Moreover, a complete new alternative process will require the definition of a new supply chain and

the training of the dedicated staff.

In addition the research and development of a hardener alternative without tMDA have been

carried out since 2003. It can be noticed that this research to remove all CMR substances has

begun before the entrance of the substance in Annex XIV.

This analysis of worldwide processes has been carried out between 2006 and 2013 when the

development of a hardener without tMDA was difficult and for the development of the new

generation NPP (i.e. European Pressurized Reactor).

This analysis has reinforced that it was more relevant to find a new epoxy resin matrix without

CMR substance by keeping the M.E.R.C.U.R.E. process. Therefore SOCODEI focused their

efforts to the research and development of the new hardener alternative without tMDA.

This research has led to a promising alternative with the new composition (i.e. the “D8M2

hardener”) as explained in the following section. This hardener alternative is the best option to

date but it is not yet validated by ANDRA, as it will be explained below.

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5.2 Research on a new containment matrix without tMDA, to be used in the

present M.E.R.C.U.R.E. process

5.2.1 Efforts made to identify and develop a new containment matrix without tMDA

(research & development and data searches)

The research of a new containment matrix without tMDA has begun before the beginning of the

REACH regulation in 2003. EDF enforced in his policy as required by European directives that all

CMR substances which are used on NPP must be substituted if possible. At this stage, there were 3

different CMR substances in the M.E.R.C.U.R.E. process (2 CMR substances in the hardener,

including tMDA and 1 CMR substance in the inhibitor agent).

Therefore, SOCODEI has been working on the substitution of CMR substances since 2003. Since

then, SOCODEI, with the help of Research & Development department of EDF41 and their

supplier POLYNT have been working closely.

This intense work has enabled substituting 2 of those 3 CMR substances:

- September 2004: substitution of a first substance (dibutyl phthalate)

- June 2006: substitution of the inhibitor agent (benzyl phthalate and n-butyl phthalate)

Those substitutions enabled to eliminate the risk for reproduction linked to the toxic properties of

these phthalates in this hazard class.

Before those substitutions, the hardener was called D7M5. With the new composition (called D7M6)

which is the current formulation, a new technical approval had been requested by ANDRA according

the explained technical approval process (technical approval 11AX => 11BX).

Major steps of the research and development to remove tMDA:

As explained in section 3.1.4.2. tMDA is the crucial element to obtain the cross-linked polymer

network in order to meet all ANDRA’s requirements.

Since the end of 2003, research has been carried out on tMDA substitution. A new formulation is on

the right track after 10 years of research:

- 2003-2006: research by changing the hardener as little as possible, while following all

the requirements

o Fundamental research on more than 100 molecules with the same electronic structure

of tMDA, because the aromatic character is the best resistance to radiation). Only one

is selected but finally it is not chosen because of difficulty of implementation.

o Then a research has been carried out with industrial chemicals suppliers of POLYNT.

A dozen of molecules have been studied from aromatic polyamines / cycloaliphatic /

aliphatic / polyamidoamides molecules.

Conclusion: The substitution of tMDA while changing nothing else in the formulation was

impossible. The substitution of the tMDA will require changing other components of the hardener, or

even a part of the 195RD09T mixture.

- 2006-2008 : research with another formulation

Another formulation, part of the family of the polyamidoamine PAA, which is a reaction product of

an aliphatic polyamine and fatty mono-acid, was investigated.

41 This department has been working in support for their subsidiary, SOCODEI.

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Some tests have been carried out on this new formulation. The irradiation resistance results were

good. However the temperature rose too high for the exothermic limit and the mechanical

compression strength resistance was 25% below the requirement.

At this stage, this new formulation reached some expectations of requirements specifications but it did

not meet all of them.

- 2009: research to improve the previous formulation to meet all requirements without

using aromatic amines

Modifications of several components did not optimize the formulation.

- 2010-2012 : research to improve the previous formulation by accepting aromatic amines

Previously, SOCODEI and POLYNT did not want to use aromatic amines, due to the potential CMR

properties of those substances.

With REACH regulation since 2006 knowledge has gradually increased about chemicals substances.

In the resulting impasse, a research has been carried out on aromatic amines because those substances

allow the reaction kinetic reduction, the improvement of mechanical strength and the contribution of

radiation resistance.

The knowledge improvement with REACH regulation lead to exclude CMR risks of diamines

substances, which have therefore been selected.

The best compromise was obtained with a formulation of 3 substances named A, B and C and this

new formulation was called D8M2. This alternative is developed in section 5.3 below.

In order to protect POLYNT Composites France Research and Development work and results

and to avoid potential harm to the company commercial interests, the composition of D8M2 is

not detailed and its components are anonymized hereafter.

Cost of the research and development to remove tMDA for POLYNT: the research cost of tMDA

removal could be assessed to 325,000€ from 2003 to 2014. This cost includes costs for technical trials

and costs of day worked.

Cost of the research and development to remove tMDA for SOCODEI: from 2003, the research

cost in order to remove tMDA in the hardener composition could be assessed to 870,000€ for

SOCODEI (including R&D works).

5.2.2 Identification of known alternatives for a new containment matrix without

tMDA

The intense work collaboration between SOCODEI, with the help of R&D department of EDF and

their supplier POLYNT from 2003 has led to find a new alternative hardener, called D8M2, without

CMR substance.

For the time being, it is the best solution to meet all strict legacy and technical requirements while

keeping M.E.R.C.U.R.E. process. The properties of the new hardener D8M2, their technical and

economic feasibilities, its availability and its hazard and risk characteristics are developed in the

following section 5.3.

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5.3 Assessment of shortlisted technique alternatives

5.3.1 Alternative 1: new hardener, D8M2

5.3.1.1 Substance ID, properties, and availability

The development of a new hardener formulation, the D8M2 took more than ten years of research to

meet all strict regulatory and technical requirements. As explained above, the whole hardener

formulation had to be replaced.

In order to protect POLYNT Composites France Research and Development work and results

and to avoid potential harm to the company commercial interests, the composition of D8M2 is

not detailed and its components are anonymized hereafter.

The classification of D8M2 is provided hereafter. Details on the approach to check the hazard profiles

of the substances of the formulation are provided in section 5.3.1.5.

Classification and labelling of D8M2 according to the criteria of the CLP regulation 1272/2008:

Hazard classes; categories and statement

Acute Tox. 4 - H302: Harmful if swallowed

Skin Corr. 1B - H314: Causes severe skin burns and eye damage

Skin Sens. 1 - H317: May cause an allergic skin reaction

Eye Dam. 1 - H318: Causes serious eye damage

STOT RE 2 - H373: May cause damage to organs through prolonged or repeated exposure

Aquatic Acute 1 - H400: Very toxic to aquatic life

Aquatic Chronic 1 - H410 : Very toxic to aquatic life with long lasting effects)

Label element:

Signal word

Danger

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Anonymised composition of D8M2 and classification of its components: D8M2 contains 3 substances

named A, B and C.

Chemical name Classification (Reg. 1272/2008)

A

Skin Corr. 1C (H314)

Skin Sens. 1 (H317)

Aquatic Acute 1 (H400)

Aquatic Chronic 1 (H410)

B

Acute Tox. 4 (H302)

Acute Tox. 4 (H312)

Eye Irrit. 2 (H319)

STOT RE 2 (H373)

Aquatic Acute 1 (H400)

Aquatic Chronic 1 (H410)

C

Acute Tox. 4 (H302)

Acute Tox. 4 (H312)

Skin Corr. 1B (H314)

Skin Sens. 1 (H317)

Aquatic Chronic 2 (H411)

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5.3.1.2 Technical feasibility of Alternative 1

ANDRA have set up strict waste requirements in order to receive confined, durable and resistant

immobilized waste packages. Those requirements are controlled with strict technical tests, as

explained in section 3.1.3.5.

SOCODEI, with the help of POLYNT, have led those technical tests between 2010 and 2014 and

some good results have been obtained with this new formulation of hardener. The formulation of the

new D8M2 hardener has been retained from 2012 onwards.

However, one test is missing at this point. The leaching test has not been totally carried out yet.

Leaching behavior test

As explained in section 3.1.3.3, a key property of a matrix containing radioactive waste is its leaching

resistance. The leaching resistance determines how well the radionuclides are retained within the

waste form when it is subjected to wet conditions. This property is complex and difficult to obtain.

Strict leaching behavior results are required by ANDRA. The leaching test measures the released

speed of radiochemical elements from a matrix42.

This leaching test requires significant resources and time. An example of the complexity of this

specific technical test process has been fully explained in section 3.1.3.5. It is the last time than

SOCODEI has carried out this specific test, and it took 6 years between 2009 and 2015.

This leaching test is time consuming. For example:

- this test has to be carried out on samples from a representative waste package produced in real

conditions, according to ANDRA test specifications. Thus SOCODEI has to produce the

representative waste package with radioactive spent IER immobilized with the new hardener

D8M2. However the production of waste packages using D8M2 hardener does not have

technical approval yet from ANDRA. SOCODEI has therefore to request a specific

authorization from ANDRA to produce this waste (in order to be able to send it to the near

surface storage facility afterwards) and needs also to inform NSA. All those specific

authorisation are time consuming;

- the long leaching test has to be carrying out in CEA in a laboratory specific dedicated room,

which is not always available;

- the only step in the laboratory is 455 days of test.

- discussion back and forth between SOCODEI and ANDRA at each step of validation could

also be long.

This leaching test is also very costly (230,000€). This test will be named “long leaching test” in the

rest of the report.

In 2012 (before the substance tMDA was included in Annex XIV of REACH regulation), SOCODEI

would ensure the leaching behavior of the new containment matrix and they would launch the

technical approval process before doing this long and costly leaching test. Therefore SOCODEI have

considered a “short leaching test”.

A shorter leaching test is available in the protocol CEN/TC/351/TS2 with a test on a monolith for 36

days. This protocol was adjusted to be able to compare cross-linked polymer network with former

42 ANDRA’s document n°ACO.SP.ASRE.00-052. Available on:

http://www.andra.fr/index.php?id=itemmenu_article_484_1681_8_1&itemracine=462

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D7M6 hardener and new D8M2 hardener. This short leaching test has been carrying out in 2013 in an

independent laboratory.

According to the results of this laboratory, the short leaching test had a successful outcome. The new

cross-linked polymer network with new D8M2 hardener would have a good leaching behavior.

Conclusion about technically feasibility and technical approval process launching

As explained before, SOCODEI have to request a new technical approval from ANDRA to use the

new D8M2 hardener. With all goods results, the D8M2 hardener was retained and SOCODEI have

chosen to launch the technical approval process in 2012 (see details of this process in section 3.1.3.6).

Then, with the good laboratory results of the short leaching test, SOCODEI has chosen to continue

this approval process by asking for a delay exemption for the long leaching test (this test would be

carried out later).

The purpose of this exemption was to implement the D8M2 hardener quicker on site and thus

removing all CMR substances of the M.E.R.C.U.R.E. process.

The new D8M2 hardener was technically held in 2012 by SOCODEI with a lot of technical tests.

The technical approval process has already been launched in the purpose of implementing on

site the new D8M2 hardener, without CMR substances, as soon as possible.

However, ANDRA have not still given their full validation about the short leaching test

exemption at the time of this present authorization application.

Therefore, the technical approval of the new D8M2 hardener has not been issued yet by the

French authorities. SOCODEI cannot implement this new solution without a technical

approval by ANDRA for the new confinement immobilized waste package.

5.3.1.3 Economic feasibility and economic impacts of Alternative 1

Research and development of a hardener alternative took several years and have involved technical

and financial resources, as explained in section 5.1 above.

The new D8M2 hardener will be produced by POLYNT. There will be some costs to adapt the

production process but those costs will be fairly limited.

There will also be some costs for the new technical approval process with ANDRA.

However, the development of such alternative by keeping M.E.R.C.U.R.E. process minimizes costs

than a new different process development.

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5.3.1.4 Availability of Alternative 1

The solution of the waste packages with the new D8M2 hardener was technically held in 2012 by

SOCODEI with a lot of technical tests. However, SOCODEI cannot implement this new solution

without requesting a new technical approval of ANDRA for the new matrix.

The technical approval process has 4 major steps and it requires several back and forth between waste

producer and ANDRA, for several years of discussion, as explained in section 3.1.3.6 above. At the

end, ANDRA will deliver one approval document and one acceptance document for a complete

technical approval.

SOCODEI have launched this process for D8M2 hardener in 2012, before the substance tMDA was

included in Annex XIV of REACH regulation (in August 2014).

Moreover, SOCODEI have request an exemption about the long leaching test on short leaching tests

results in order to remove all CMR substances as quick as possible.

Technical approval process Progress for approval with new hardener D8M2

(new technical approval number: 11CX)

1. Definition of the applicable

reference

September 2012: Request for a new technical approval – Kick-off

meeting

2. Admissibility stage Juillet 2013: Waste compliance matrix n°0 (WCM 0) sent from

ANDRA to SOCODEI.

3. Inquiry stage with 4 steps for the

approval document

Step 1:

October 2013: Waste compliance matrix n°1 sent from SOCODEI to

ANDRA with the exemption request about short leaching test.

November 2014: Waste compliance matrix n°1 accepted by ANDRA

without position statement of short leaching test

Step 2: 2015

Waste Characterization Program is accepted

But ANDRA have not yet validated the exception request about short

leaching behavior test

Step3 : N/A

Step4 : N/A

4. Acceptance stage N/A

Figure 5-2: Progress for approval with new hardener D8M2: current situation at the time of this present

authorization application.

In 2015, this technical approval process has been launched for 3 years but this process is not finished

yet and it is suspended pending the decision about short leaching test.

If the exception request about leaching test is not granted from ANDRA, SOCODEI must then carry

out the long leaching test.

Thus, this granted authorization is requested to have time to end up the technical approval

process in order to hopefully validate the new matrix and then to implement the new D8M2

hardener. Moreover it cannot be bet that ANDRA will accept the exemption request, the granted time

for authorization takes into account the time to carry out the long leaching test.

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It is noticed that if steps of the technical approval process are set up, their duration are not framed

by regulation. Otherwise regulation doesn’t enforce any delay to obtain the final technical approval.

This schedule has been built using the return of experience of SOCODEI and EDF about this specific

process.

Thus the schedule is planned by taking into account:

1. The time to carry out the short leaching test;

2. The time to carry out the long leaching test;

3. The time to end up the technical approval process;

4. And the time to do the technical transition between D7M6 hardener and the new D8M2

hardener.

5.3.1.4.1 The time to carry out the short leaching test (orange line on the Figure 5-3)

In October 2015, SOCODEI had some exchanges with ANDRA about the previous short leaching

test. ANDRA asked SOCODEI to do the short leaching test again but with a new protocol to be

validate with ANDRA.

The time to carry out this short leaching test is estimated at 2 years, from November 2015 to

December 2017.

- From November 2015 to March 2016: exchanges between SOCODEI and ANDRA about the

new short leaching test protocol;

- April 2016 to September 2016: preparation of samples to carry out the leaching test;

- October 2016 to March 2017: realization of the short leaching test in laboratory (180 days of

real test);

- April 2017 to December 2017: results analysis and exchanges with ANDRA in order to carry

out further approval process steps.

5.3.1.4.2 The time to carry out the long leaching test (blue line on the Figure 5-3)

As explained above, it cannot be bet that ANDRA will accept the exemption request about short

leaching test, the granted time for authorization takes into account the time to carry out the long

leaching test.

The long leaching test period has 2 main steps:

- The first step is the preparation of the operational conditions with:

- the request to NSA: SOCODEI will have to produce a representative waste package

with radioactive spent IER and immobilized with the new hardener D8M2 in order to

achieve the long leaching test. However this waste package doesn’t have a technical

approval yet. SOCODEI has to request a specific authorisation to NSA to do it.

- to prepare the realization of this representative waste package with the new hardener

D8M2, SOCODEI has to find a NPP able to do this specific representative waste

package according the schedule of conditioning campaigns (see section 3.1.4.4).

Moreover POLYNT has to do the new hardener D8M2, which is not yet

industrialized.

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- the long leaching test has to be carried out in specific dedicated room of CEA. Those

rooms are not always available. SOCODEI and EDF have some return of experience

and it is usual to wait one year to have one available room.

- The consuming time for this first step of preparation is evaluated at 12 months. The

second step is the realization of the test itself. The long leaching test is the most important

technical test and the longest test. Some operating conditions issues may occur and some

discussions back and forth between SOCODEI and ANDRA could take a long time. In the

previous example, see section 3.1.3.5, the long leaching test began in February 2011

(beginning of the test in the CEA’s lab) and some discussions were still ongoing in August

2015. This second step took 54 months between February 2011 and August 2015.

Because the duration of steps is not framed by regulation, the time of this second step has been

evaluated based on SOCODEI’s return of experience. Between operating conditions and

discussions with the authorities, which could not be accelerated anyway, the time of the second

step is evaluated at 54 months. It has also been noticed that this time does not take time

potential changes in the authorities’ procedures.

Consequently, the time to carry out the long leaching test is evaluated at 66 months, which is 5

years and 6 months, from January 2018 to June 2023.

5.3.1.4.3 The time to end up the technical approval process (green line on the Figure 5-3)

According to table 5-2, it is necessary to end up 2 more steps in the inquiry stage and the acceptance

stage in order to obtain the technical approval.

See section 3.1.3.6 for explanation about the full technical approval process.

The time to obtain the entire technical approval is evaluated to 30 months (to July 2023 to

December 2025):

- Step 3 (of the approval process): to set the WCP (Waste characterization Program) and to

establish WCF (Waste Characterization File) with results of the long leaching test.

- Step 4 (of the approval process): identify and describe TP (Technical Provisions) in order to

establish Waste Compliance Matrix n°3.

Those steps lead to obtain the final approval. As explained above, they require several exchanges

back and forth between SOCODEI and ANDRA. Those steps are evaluated at 18 months.

- Acceptance stage. This step leads to obtain the final acceptance and it takes 12 months.

5.3.1.4.4 The time to do the technical transition between D7M6 hardener and the new D8M2

hardener (purple line on the Figure 5-3)

The time is evaluated to 18 months (from January 2025 to June 2027) by taking account 2 steps

in parallel:

- D8M2 production launched by POLYNT

POLYNT needs 2 months to stop the production of D7M6 and begin the production of the new D8M2

hardener (facilities cleaning and adjustments, raw materials supply…)

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- Preparation of M.E.R.C.U.R.E process

The ratio of epoxy resin and the hardener is not the same with the former D7M6 hardener and the new

D8M2 hardener. Cleaning and some modifications are necessary in the M.E.R.C.U.R.E. process,

which could only be done during a technical stop. This technical stop is planned every 2 years for

each M.E.R.C.U.R.E. equipment. It could not be envisaged to modify the tight schedule for the

xxxxxxxxxxxxxxx M.E.R.C.U.R.E. equipments xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.

Therefore, it is evaluated to 18 months to have time to adjust both M.E.R.C.U.R.E. process.

In conclusion, the new D8M2 hardener is not available yet. According to all above hypothesis,

the new hardener will be fully implemented in June 2027. After this date, or 9 years and 10

months after the sunset date of tMDA, tMDA will be not anymore used for the M.E.R.C.U.R.E.

process.

Blank #6 Blank #6

The following scheme shows successive steps to fully implement the new D8M2 hardener, in June 2017, by taking into account:

1. The time to carry out the short leaching test, from November 2015 to December 2017;

2. The time to carry out the long leaching test, from January 2018 to June 2023;

3. The time to end up the technical approval process of ANDRA, from July 2023 to December 2025;

4. And the time to do the technical transition between D7M6 hardener and the new D8M2 hardener from January 2025 to June 2027.

Figure 5-3: Successive steps required to fully implement D8M2 hardener in M.E.R.C.U.R.E process

5.3.1.5 Hazard and risk of Alternative 1

The formulation D8M2 itself was not tested. The hazard profile of D8M2 is derived from the data

available on the substances of the formulation.

5.3.1.5.1 Hazard evaluation approach

The relevant information available to assess the hazard profiles of the three substances present in the

D8M2 formulation was gathered as follows:

- In-house company data,

- Other data: Databanks / databases of compiled data, published literature, regulatory,

academic and international organisations relevant websites.

In house company data:

These data consisted in the applicant suppliers’ safety data sheets (SDS):

- The two substances A and C are supplied as a mixture to the applicant by another company.

The SDS of the mixture is available.

- The third substance B is supplied to the applicant by another company. The SDS is available.

Other data:

The most recent search was performed in the period July – September 2015 by using the CAS

numbers and chemical names of the substances and the main sources included in this search were:

EU: Annex VI of the CLP regulation 1272/2008,

EU: Notified classifications according to CLP 1272/2008 criteria on the ECHA website,

EU: registry of intentions for CLH (Classification and labelling harmonisation), SVHC

(substances of very high concern) and restrictions on the ECHA website,

EU: lists addressing substances of concern or potential substances of concern (Authorisation –

restriction – SVHC – CoRAP…) on the ECHA website,

The GESTIS database (including international limit values),

EU: Registered substances under REACH on the ECHA website,

The OECD existing chemicals data base and eChem portal,

The US-EPA HPV Information system,

The US-EPA databases including ACToR, Chemview,…

TOXNET including HSDB, TOXLINE, CHEMIDPLUS, IRIS, DART, ITER …

PubMed,

NTP (USA),

NICNAS (Australia),

Government of Canada: The priority substances list and toxic substances list,

JECDB (Japan existing chemical database),

J-CHECK (Japan),

ICCA HPV initiatives,

The ECETOC JACC Reports,

IPCS INCHEM (including IARC).

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The data identified and the resulting hazard profiles are detailed in the sections below for each of the

three substances.

5.3.1.5.2 Substance A

Identity of the substance

The substance is a UVCB substance (origin: organic).

Data available

1/ Supplier SDS

In the SDS from the supplier, the substance is classified:

Skin Corr. 1C (H314)

Skin Sens. 1 (H317)

Aquatic Acute 1 (H400)

Aquatic Chronic 1 (H410)

2/ Annex VI of CLP regulation

The substance is not included in Annex VI of the CLP regulation (no harmonised classification).

3/ Notified Classifications according to CLP criteria

The most recent checking of the notified classifications for this substance was done in September

2015 on the ECHA website and showed a total of 692 notifications. None of them raised additional

alert which would potentially categorise the substance as a substance of very high concern, as

compared to the SDS classification above.

4/ Registration under REACH

The substance is pre-registered but not registered under REACH.

Nonetheless, according to the supplier, the substance is covered by the REACH dossier of another

substance. This other substance is not classified according to Annex VI of the CLP regulation.

5) EU lists

Neither the substance A nor the other substance registered under REACH appears on the European

lists addressing substances of concern or potential substances of concern (Authorisation – restriction –

SVHC – CoRAP…).

6/ Other data

The search performed on the substance A did not show complementary reliable data that would result

in a more stringent hazard CLP classification of the substance.

Some relevant data were found on the US EPA HPVIS web site (http://www.epa.gov/hpvis/):

An HPV (High Production Volume) dossier covering a category to which the substance A belongs

was submitted by the American Chemistry Council (ACC) in the period 2001 to 2004 under the High

Production Volume Challenge Program.

The US EPA published a Screening-level Hazard Characterization assessing this dossier. The opinion

of the US EPA was that the read across approach among the substances was not supported by

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sufficiently solid data due to the variability in the structures of the substances and the lack of

information on the composition of the mixtures. No data were available in the dossier on the human

health hazard of the substance A and a few environmental hazard data were available on analogues of

the substance A. These data, a study on acute toxicity to fish and a study on acute toxicity to aquatic

invertebrates, were consistent with the current classification of the substance A as very toxic to

aquatic organisms.

Consequently these data did not raise additional concern on the classification of the substance.

5.3.1.5.3 Substance B

Identity of the substance

The substance is an organic multi constituent substance.

Data available:

1/ Supplier SDS

In the SDS from the supplier, the substance is classified:

Acute Tox. 4 (H302)

Acute Tox. 4 (H312)

Eye Irrit. 2 (H319)

STOT RE 2 (H373)

Aquatic Acute 1 (H400)

Aquatic Chronic 1 (H410)

2/ Annex VI of CLP regulation

The substance is included in Annex VI of the CLP regulation. The harmonised classification is:

Acute Tox. 4 (H302)

Acute Tox. 4 (H312)

Eye Irrit. 2 (H319)

STOT RE 2 (H373)

Aquatic Acute 1 (H400)

Aquatic Chronic 1 (H410)

Consequently the classification of the supplier is in accordance with this Annex VI classification.

3/ Notified Classifications according to CLP criteria

The most recent checking of the notified classifications for this substance was done in September

2015 on the ECHA website and showed a total of 489 notifications. None of them raised additional

alert which would potentially categorise the substance as a substance of very high concern, as

compared to the current Annex VI harmonised classification.

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4/ Registration under REACH

The substance was registered under REACH by the supplier.

5) EU lists

The substance does not appear on the European lists addressing substances of concern or potential

substances of concern (Authorisation – restriction – SVHC – CoRAP…).

6) Other data

The search performed as described in section 5.3.1.5.1 above did not show complementary reliable

data that would result in a more stringent hazard CLP classification of the substance.

5.3.1.5.4 Substance C

Identity of the substance

The substance is an organic substance.

Data available

1/ Supplier SDS

In the SDS from the supplier, the substance is classified:

Acute Tox. Derm 4 (H312)

Acute Tox. Oral 4 (H302)

Skin Corr. 1B (H314)

Skin Sens. 1 (H317)

Aquatic Chronic 2 (H411)

2/ Annex VI of CLP regulation

The substance is included in Annex VI of the CLP regulation. The harmonised classification is:

Acute Tox. 4 (H302)

Acute Tox. 4 (H312)

Skin Corr. 1B (H314)

Skin Sens. 1 (H317)

Aquatic Chronic 2 (H411)

Consequently the classification of the supplier is in accordance with this Annex VI classification.

3/ Notified Classifications according to CLP criteria

The most recent checking of the notified classifications for this substance was done in September

2015 on the ECHA website and showed a total of 1278 notifications. None of them raised additional

alert which would potentially categorise the substance as a substance of very high concern, compared

to the Annex VI harmonised classification.

4/ Registration under REACH

The substance is pre-registered but not registered under REACH.

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Nonetheless, according to the supplier, the substance is covered by the REACH dossier of another

substance. This other substance is not included in Annex VI of the CLP Regulation (no harmonised

classification).

5) EU lists

Neither the substance C nor the other substance registered under REACH appears on the European

lists addressing substances of concern or potential substances of concern (Authorisation – restriction –

SVHC – CoRAP…).

6/ Other data

The search performed on the substance C as described in section 5.3.1.5.1 above did not show

complementary reliable data that would result in a more stringent hazard CLP classification of the

substance.

- Some relevant data were found on the OECD existing chemicals data base:

(http://webnet.oecd.org/Hpv/UI/Search.aspx):

The substance C was volunteered for the U.S. HPV program and subsequently the ICCA program by

a Group of companies in the U.S. Another substance was used as an analogue of substance C in this

dossier.

The SIDS initial Assessment Report prepared by the sponsor country for the SIAM and the OECD

agreed conclusions from this meeting are available on the website.

Both documents concluded that the chemical is of low priority for further work and did not

recommend additional testing. These data did not raise additional alert which would potentially

categorise the substance as a substance of very high concern, as compared to the Annex VI

harmonised classification above.

- Some relevant results of ecotoxicity tests conducted with the substance in the existing chemicals

survey program conducted by the Japanese Government and the National Institute of Technology and

Evaluation in Japan were found on the J-CHECK (Japanese CHEmicals Collaborative Knowledge

database) website, http://www.safe.nite.go.jp/jcheck/top.action:

Results from five studies acute toxicity on fish, algae and daphnia, long term toxicity on daphnia and

biodegradability are available; the results lead to a more severe classification than the Annex VI one,

i.e. aquatic acute 1 and aquatic chronic 1. However the data are not assignable (no sufficient

experimental details).

- Some relevant data were found on the PubMed website (http://www.ncbi.nlm.nih.gov/pubmed):

A series of 6 substances including the substance C were evaluated for potential genotoxic activity

using a battery of in vitro and in vivo assays. The study concluded that substance C had a weak

mutagenic potential. However these data were evaluated in the HPV dossier cited above which

concluded that the positive results were probably indirect, due to the substance C ability to chelate

necessary metals (copper) thus causing deficiency in these elements and subsequent toxicity.

5.3.1.5.5 Hazard of the formulation D8M2 and risk of the use of this alternative 1

Hazard evaluation

According to data available on the three substances of the hardener D8M2, this alternative product

does not contain substances of very high concern (SVHC) or substances potentially meeting SVHC

criteria.

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When compared to the current hardener D7M6 containing the tMDA substance subject of this

authorisation dossier, the alternative hardener D8M2 presents a hazard profile with no substances of

very high concern and a hazard classification either identical or less severe depending on the end

point:

D7M6 hazard classification Alternative D8M2 hazard classification

Acute Tox. 4 - H302: Harmful if swallowed

Acute Tox 3 – H311 Toxic in contact with skin

Acute tox 2 – H330 Fatal if inhaled

Skin Corr. 1A - H314: Causes severe skin burns

and eye damage

Eye Dam. 1 - H318: Causes serious eye damage

Skin Sens. 1 - H317: May cause an allergic skin

reaction

Germ cell muta 2 H341 suspected of causing

genetic defects

Carcinogenicity 1BH350 May cause cancer

STOT SE 1 – H370 Causes damage to organs

STOT RE 2 - H373: May cause damage to

organs through prolonged or repeated exposure

Aquatic Acute 1 - H400: Very toxic to aquatic

life

Aquatic Chronic 1 - H410 : Very toxic to

aquatic life with long lasting effects)

Acute Tox. 4 - H302: Harmful if swallowed

Skin Corr. 1B - H314: Causes severe skin burns

and eye damage

Eye Dam. 1 - H318: Causes serious eye damage

Skin Sens. 1 - H317: May cause an allergic skin

reaction

STOT RE 2 - H373: May cause damage to

organs through prolonged or repeated exposure

Aquatic Acute 1 - H400: Very toxic to aquatic

life

Aquatic Chronic 1 - H410 : Very toxic to

aquatic life with long lasting effects)

Risk evaluation

As regards the Use 2 of the dossier, the hardener D8M2 will be used in exactly the same way as for

the current hardener D7M6 except that the ratio of hardener versus epoxy resin will be slightly

different:

- Current ratio D7M6 37.5% / epoxy resin 62.5%

- Future ratio D8M2 24% / epoxy resin 76%.

Apart from the fact that new two-compartments road tanks adapted to this new ratio will be needed,

the successive operations of Use 2 will remain the same as those described in the CSR of the AfA

dossier.

Consequently the operating conditions described in the CSR for the current hardener D7M6 will

remain mainly relevant for the alternative D8M2. The risk management measures will stay

appropriate with the new risk evaluation.

Moreover, as regards the Use 1 of the dossier, the formulation of the D8M2 will be done similarly as

the formulation of the D7M6, on the same site and in the same conditions. Even if the substances used

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for the D8M2 are different, the successive operations will remain the same as those described in the

CSR of the AfA dossier.

Consequently the operating conditions described in the CSR for the current hardener D7M6 will

remain mainly relevant for the alternative D8M2 (only the risk management measures could be

adapted in order to stay appropriate with the new risk evaluation).

Thus, as the uses 1 and 2 with the alternative D8M2 will be the same as with the hardener

D7M6 but with the D8M2 hazard profile (without substances of very high concern), the risk

presented by the use of the alternative D8M2 is considered low, with no specific identified

concern for the man or the environment.

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5.3.1.6 Conclusions on Alternative 1

As explained in the previous section, it was more relevant to find a new epoxy resin matrix without

CMR substance while keeping the M.E.R.C.U.R.E. process.

From 2003, SOCODEI and POLYNT focused their efforts to the research and development of a new

hardener alternative without carcinogenic substances, as tMDA. This research took more than ten

years to meet all strict regulatory and technical requirements of ANDRA. This research has led to a

promising alternative with a new mixture, i.e. the D8M2 hardener.

D8M2 contains 3 substances, none of which is a substance of very high concern and its classification

and labelling according to the criteria of the CLP regulation 1272/2008 is provided above. As the uses

1 and 2 with the alternative D8M2 will be the same as with the hardener D7M6 but with the D8M2

hazard profile (without substances of very high concern), the risk presented by the use of the

alternative D8M2 is considered low, with no specific identified concern for the man or the

environment.

The new D8M2 hardener was technically retained in 2012 by SOCODEI with a lot of technical tests.

However, one test is missing at this point which is the long leaching test.

SOCODEI cannot implement this new solution without requesting a new technical approval of

ANDRA for the new matrix. This technical approval has been launched in 2012, with an exemption

request (based on results of short leaching test and not the long one) in order to remove all CMR

substances as quick as possible.

However, ANDRA have not still given their full validation about this short leaching test exemption

and the whole technical approval process is not finished yet. Therefore, the technical approval of the

new D8M2 hardener has not been issued by the French authorities yet.

As a consequence, SOCODEI cannot implement this new solution for the confinement immobilized

waste package.

The present authorization request goal is to have time to end up the D8M2 technical approval process

in order to validate and implement the new matrix. The final acceptance from ANDRA is expected

in June 2027.

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5.4 The most likely non-use scenario for use 2

Use 1 and use 2 are very interlinked. Brainstorming sessions were carried out with the applicant,

POLYNT, and all relevant experts of SOCODEI and EDF.

Choices of both non-uses are mainly led by use 2 assumptions.

French NPP provide around 75% of electricity in France, as explained in section 3.2.3. The very first

scenario which came to mind was to stop spent IER waste treatment through the NPP breakdown.

Knowing this French electricity production context, it is quickly understandable (and unintended) that

this situation could not be a possible solution, nor a most realistic non-use scenario.

The main assumption of those brainstorming sessions was a normal operating of NPP. Therefore 4

main questions arose:

- Could the production of spent IER be stopped while NPP are still operated?

- Could it be possible to temporary store spent IER on NPP in order to wait an available

alternative?

- Could the M.E.R.C.U.R.E. process be carry out of the European Union?

- Could there be an available alternative treatment for spent IER?

Figure 5-4: Main question to choose a non-use for use 2 with a NPP normal operating

Normal operating NPP produce spent

IER

Could the production of spent IER stop?

Could NPP operate without IER process?

Could regeneration of IER be an option?

Could spent IER not be replaced in treatment columns?

Is it possible to temporary store spent IER on NPP to wait availability

of an alternative?

Could the M.E.R.CU.R.E process carry out of the European Union?

It is possible to use an alternative?

Could the aqueous liquid treatment be changed in NPP?

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5.4.1 Could the production of spent IER be stopped?

5.4.1.1 Could NPP operate without IER process?

French NPP have been designed with IER to treat various aqueous liquids in order to minimize

corrosion or the degradation of system components by removing ions responsible of these adverse

effects like corrosion and to remove radioactive contaminants.

This decontamination of the NPP aqueous liquids is essential for their operating in order to ensure the

strict treatment and chemical monitoring of the water in the primary circuit. This water treatment

ensures the complete integrity of the primary circuit, which is one of three physical barriers of the

crucial containment requirement for a NPP.

Moreover, this decontamination is essential to limit the radioactivity discharged via this authorized

releases.

Therefore, NPP could not operate without aqueous liquid treatment.

5.4.1.2 Could spent IER not be replaced in treatment columns?

It was also tried to imagine not replacing spent IER when the ion exchange capacity is reached.

However, as explained in section 3.1.1, if spent IER was not replaced after their ion exchange

capacity breakpoint, it would cause an undesirable downgrading of the reactor aqueous liquids system

or other aqueous liquids systems.

But this decontamination of the NPP aqueous liquids is crucial for their safe operating as explained

above (section 5.4.1.1).

Therefore, spent IER have to be replaced when one of the following criteria is overtaking:

radiological, chemical, pressure variance or expiration date.

5.4.1.3 Could regeneration of IER be an option?

The IAEA’s document, Technical reports series no.408 explains ion exchanger regeneration options

in page 3943:

“In theory, the ion exchange process is reversible. Most ion exchange media can be regenerated by

using an appropriate strong acid (such as HNO3) for cation media or alkali (such as NaOH) for

anion media to replace the bound contaminant ions on the medium and restore it to its original

chemical form. Media life can be extended by regeneration, which saves on the costs of the new

medium and the disposal of the old. It should be noted that the medium is typically not completely

regenerated, with restoration rates of up to 90% being typical. Even with optimal regeneration,

therefore, the life of the medium is limited, and it will eventually need to be replaced.

The fact that regeneration is not complete is an important factor for nuclear grade ion exchangers,

because nuclear grade quality is maintained only until the first regeneration.

[…] In many countries regeneration is not practiced for radioactive systems since the concentrated

acid and caustic regeneration solutions are often difficult and costly to treat and produce no benefits

over a lower media usage. In addition, the process system itself is complicated and requires

additional valving, piping, pumps and tanks to handle the regeneration chemicals. It is therefore

43 Source: IAEA (2002), Technical reports series no. 408, Application of ion exchange processes for the treatment of radioactive waste and management of spent ion exchangers Available at: http://www-pub.iaea.org/MTCD/publications/PDF/TRS408_scr.pdf

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generally more cost effective to use the media on a once through basis. However, in situations in

which replacing the spent media is more expensive than the treatment and disposal costs,

regenerating spent media remains a desirable practice. Regeneration of non-radioactive water

treatment systems (such as for secondary side boiler feed water or plant demineralized water), in

which much larger volumes of media are typically used to treat high flows of water, is also practised

in some nuclear power plants.”

The regeneration of resin is already used for some water treatment on NPP, as demineralized water

treatment. However, as explained above and based on EDF internal expertise, the regeneration of

resin for primary coolant purification (see section 3.1.1 above) has never been performed worldwide.

As explained above, the nuclear grade quality is not maintained and based on experts’ statement it

would be only up to 40% of yield.

Moreover, this regeneration would need aggressive products (strong acid and base products) which

could be an important risk of corrosion for installation. This aspect would request to settle such

regeneration installation outside of the close perimeter of the reactor. Moreover, those uses of strong

acid and base would have other important impacts on workers.

And finally, such regeneration would produce some radioactive effluents which would also need to be

treated.

This option is technically too difficult. Moreover if the ion exchange media regeneration

produces secondary waste of high activity, it has to be treated as well. Finally, the nuclear grade

quality is not maintained after the first regeneration. This option cannot therefore be selected.

5.4.1.4 Could the aqueous liquid treatment be changed in NPP in order to stop the production of

spent IER?

The question about changing the aqueous liquid treatment of NPP has also been raised. The first point

is that French NPP have been designed with IER to treat aqueous liquids

First step

In the case of changing overall treatment, the first step would be to find another liquids treatment

technologies which could fit to the current NPP design specifications: equivalent efficiency criteria

and processing speediness, available space around the facilities, matching with actual liquids pipes,

compliance with European and French regulatory (as REACH regulation…). Specific studies would

also be needed to ensure that a potential selected alternative treatment could be adapted for each of 58

reactors, without altering the safety of facilities.

Second step

If a potential alternative treatment would be finding, the second step would be a regulatory step.

Indeed, lots of regulatory studies have to be carried out and lots of specific application of

authorisation would have to be requested to several French authorities (NSA, French ministers which

are in charge nuclear safety matters, French local authorities …) before to implement those

modifications.

A specific study of French regulatory texts has to be done in order to know which studies and

authorizations would need to be performed, according to technical modification related to the

potential alternative treatment (unknown so far). The regulatory framework of Basic Nuclear

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Installation is very complex for the purpose of the fail-safe principal for the entire lifetime of the

facility.

The relevant texts are French Codes as Public Health Code and Environment Code, and in particular

the “TSN” act44, and other specific French texts as the act 2007-155745 which defines applicable

procedures and their details contents for Basic Nuclear Installation according to the degree of

modifications. The applicable procedure to follow will depend on the degree of modifications related

to the hypothetical, not yet known, suitable water treatment (especially articles 26, 31 or 57)46.

Therefore, it is not yet possible to summarize the studies and authorisations scope to be performed.

Nevertheless, because the treatment is related to the heart of NPP, it could be assumed that studies

would be complex to pursue.

Based on EDF return of experience, it can be assumed that this regulatory step would need at least 3

to 5 years, for a simple case. Moreover, it could be noticed than those studies have to be done for each

58 reactors which mean enough available internal and external resources to carry out all those studies

in the same time.

Third step

Finally, with a hypothetical suitable water treatment and all required authorizations, a third step with

major modifications would need to be operated on each NPP. Some specific tools would be

developing to do those modifications and some qualification tests would also be required. Moreover,

those modifications would be operated in radiation environment which involves radiation protection

for workers and specific trained workers. Such modifications would require expensive provisional and

temporary stop of electricity production (several millions euros by NPP). Finally, those modifications

would request specific internal and external resources which are limited.

It could be assumed than such modifications on 58 reactors would be cost hundreds of millions of

euros.

Such modifications are complex and it can be assumed that they would be spread on 15 years to

achieve all French NPP (based on return of experience). This time is not to mention the time need for

the first step of research which is difficult to estimate and the second one for the regulatory step. The

total time to change the aqueous liquid treatment of NPP could therefore be assumed between 20 to 30

years.

Great modifications have never been conducted on reactors for this type of case and a

hypothetical suitable water treatment is not yet known. Moreover the total time is estimated of

more than 20 years. This non-use scenario could never be ready at the sunset date (August 2017)

without stopping to operate NPP. The economic point of view has not been detailed but it seems

obvious that this solution would cost several hundred millions of euros.

Such modifications in terms of investment costs and implementation timelines have also to be

considered according to the whole NPP lifetime in France and all the work projects which are

already scheduled.

44 Act 2006-686 of the 13th of June 2006, act “TSN” for Transparency and Safety in the Nuclear field, available at:

http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=LEGITEXT000006053843&dateTexte=20081107

45 Act 2007-1557of the 2sd of November 2007, available at:

http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000000469544

46 For example, a specific application for authorisation according to “article 26” would include at least a safety analysis (fire prevention,

explosion, radiation protection, earthquake protection…), a risk assessment studies of the new technology, an environmental impact assessment, an health and safety conditions of workers, an organizational and human factors assessment…

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This option of non-use scenario could therefore not be retain in this study.

In conclusion, 4 assumptions in order to stop the spent IER production have been studied with

the operation of NPP without IER process, the stop of replacement of IER in treatment

columns, the regeneration of IER or the change of aqueous liquid treatment in NPP. All of them

would be both not technically and economically possible and could be implemented on time (at

the sunset date) in no way.

5.4.2 Is it possible to temporary store spent IER on NPP in order to wait an available

alternative?

As explained in section 3.1, radioactive waste management is a major industrial challenge for more

than thirty years. This management is very strict and depends on each country framework regulation

while fulfilling international standards. The radioactive waste treatment choice is a combination of

technical factors and national standards of waste acceptance criteria for disposal.

In France, radioactive spent IER are low and intermediate level short-lived waste (LIL-SL) category.

This category has a final disposal facility and it is compulsory to send them in the French near

surface disposal facility operated by ANDRA (see French ordinance of the 27th December 2013

with the article 11.2) with the appropriate treatment.

In this way, a question was if it would be possible to temporary store spent IER on NPP in order

to wait an available alternative, as the availability of D8M2?

As explained in section 3.1.1.5, spent IER are collected and warehouse in dedicated discharge tanks

while waiting the next packaging conditioning campaigns with M.E.R.C.U.R.E. Spend IER are stored

in those specific discharge tanks because they need to be mixed in water to avoid their clogging

between two campaigns of treatment.

If spent IER clogged, they could not be pump out of discharge tanks in order to pack with

ME.R.C.U.R.E process. Any new temporary other storage would need to take into account of this

specificity.

The campaigns frequency depends on each NPP characteristics because those discharge tanks are

different on each NPP: they have different volume capacities and they fill up at various speeds

depending on the reactor operation, the number of maintenance carried out on the NPP, etc Each NPP

has its own autonomy between 18 to 72 months.

If they are not adapted treatment after the sunset date, those actual discharge tanks would be not

emptied. Therefore some additional appropriated means would need to be set up for waiting an

available alternative. As the previous scenario (see section 5.4.1.4), this kind of modification has

never been studied and those three steps described above would need to be done: some research

would be required to find additional appropriated solutions on each NPP, then regulatory studies and

specific application of authorisation would have to be requested and finally those means would have

to be implemented on each NPP in France.

In this scenario, specificities in terms of space availability of each NPP would also need to be

considered.

Moreover, those additional appropriated means would also create new potential radiological risk areas

which would require specific protection to be implemented. This scenario would require more

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activities in such radiological risk areas which have to be limited as required by EDF internal policy

with the ALARA47 principle.

Moreover, it could be noticed that all those modifications would be only temporary storage for

waiting the availability of an alternative as the D8M2 hardener.

As the previous scenario of liquid treatment modification (see section 5.4.1.4) the time to

conduct all those research of additional appropriated means, regulatory studies and

modifications would take several years and it will cost several millions of euros.

Therefore it can be assumed that first additional appropriate means would not be ready when

the first discharge tanks would be full and it would require to be emptied.

This option of non-use scenario could therefore not be retained in this study.

5.4.3 Could the M.E.R.C.U.R.E process carry out of the European Union?

The delocalisation of the process out of the E.U. is a common question in the non-use scenario

identification.

However, this dossier is a very specific case and it is not only moving the process outside the

European Union.

As previously explained (see explanation in section 3.1.2), radioactive waste management has a very

specific framework.

- First, it is compulsory to send confined immobilized waste package of spent IER in the

French near surface disposal facility operated by ANDRA, wherever those final wastes could

be packaged, even it is outside of the European Union48

.

- The second point is transportation of radioactive waste through different countries is

regulated by different international texts as the Basel Convention49

, the Council Directive

2006/117/EURATOM50

. This regulatory framework complicates transportation of radioactive

substances through different countries.

With the assumption that the regulatory framework allows this transportation of radioactive waste and

knowing that fact to bring back final wastes, if this scenario is extended, a place to operate the process

outside of the E.U would need to be find.

If by any chance a country would allow this operation, its regulation framework would also to be

following.

Wherever this place would be finding, spent IER would therefore need to be send there from France

which is at the West of the E.U. This transportation would be by road or train through Europe or by

boat. This transportation would be over long distance anyway while EDF have always made all efforts

to treat their own waste in France, by developing appropriate technologies.

47 ALARA principle = “As Low As Reasonably Achievable”. The EDF internal policy establishes that the radiation protection is based on 3

main principles: the justification of the exposition with the benefits should outweigh the disadvantages, the optimization with the ALARA

principle, and the limit dose rate for operators.

48 According to the European Directive of the 19th of July 2011 (Chapter 1, article 4.2)

49 The Basel Convention is a convention about the Control of Transboundary Movements of Hazardous Wastes and Their Disposal

50 Directive 2006/117/EURATOM of the 20th of November 2006 on the supervision and control of shipments of radioactive waste and spent fuel

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This dossier is a very specific case and the scenario of the process delocalisation out of the E.U.

is not a technically and regulatory non-use scenario possible.

5.4.4 It is possible to use an alternative?

As explained in the entire section 5, there is currently no available alternative.

The best option for a future alternative is the new D8M2 hardener while keeping the M.E.R.C.U.R.E

process. This new D8M2 hardener was technically retained in 2012 by SOCODEI with a lot of

technical tests and the technical approval process has been launched at this time. However this new

hardener will not be available until it will be fully technically validated and then approved by the

Authorities.

It is estimated that this new alternative will be available in 2027 and none means are available to

accelerate the approval process.

5.4.5 Conclusion of the non-use scenario for use 2

Those brainstorming sessions have led to the following conclusion.

The very first scenario of stopping the production of spent IER by stopping NPP operation is not an

option because French NPP provide around 75% of electricity in France, as explained in section 3.2.3.

Therefore the non-use scenario has been studied with the assumption of a normal operating of NPP.

The main conclusion is that there will still be spent IER to treat in one way or another because:

- NPP have to continue being operated with the same aqueous liquid treatment which produce

spent IER.

- Those spent IER will still be stored in discharge tanks the capacities of which could not be

extended.

- The process will not be able to be operated outside of the E.U.

Each resulting solutions are not technically suitable, not economically possible, or not yet approved

by Competent Authorities.

After the sunset date, in case of the non-granting authorisation, when discharge tanks are full, spent

IER will have to be treated. But there will be no available alternative. Even the best option with the

D8M2 hardener will not be yet fully validated nor approved by the Competent Authorities.

By looking at all aspects of all those options, strictly speaking, there is no realistic non-use scenario

which could be operated at the sunset date. It is a dead end.

5.4.6 Non-use of Use 1

Use 1 and use 2 are highly interlinked.

For the supplier POLYNT Composites France, the non-use 1 is interlinked to the non-use 2 as they

will follow their customer’s requirement in any case.

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6 IMPACTS OF GRANTING AUTHORISATION

Preamble: two major actors were already involved in the dossier. Others actors have been asked

during the entire authorisation process profiting non-specific authorisation meetings but without

specific consultation.

6.1 Impacts of a granting authorisation for use 2

With a tMDA granting authorisation, SOCODEI would be able to continue using M.E.R.C.U.R.E.

process with D7M6 hardener to pack spent IER (use 2) on each NPP after the sunset date until an

alternative is available.

The radioactive wastes management road would not be disrupted allowing continuity of NPP

operations (reminder: NPP produce 75% of the French electricity).

Waste packages could continue being sent to the near surface disposal of ANDRA in accordance with

the French dedicated regulation (see French ordinance of the 27th December 2013).

Nevertheless there would have some remaining risks of the applied for use 2 which are related to the

exposure of the workers and which are detailed in section 3.4. But the resulting excess risks calculated

with several worst case assumptions are, at the highest, in the 10-6

order of magnitude (for

M.E.R.C.U.R.E operators).

Moreover, a tMDA authorisation granting would avoid non-realistic options to be considered. As

explained above in the selected non-use conclusion, there is no realistic non-use scenario which could

be put in place at the sunset date.

As explained, stopping NPP production is not an option. NPP will be still operated and then they will

still produce spent IER which could not be stored in more, not available, discharge tanks. There will

still be spent IER to treat in one way or another.

Although EDF would face a dead end at the sunset date in the case of a non-granting tMDA

authorisation, the less non-realistic non-use scenario is developed further theoretically for the sake of

the present dossier submission completeness only.

As reminder for non-specialist about the authorization methodology, the most likely non-use scenario

is what the applicant will do if they can no longer use the substance. SOCODEI wants to avoid this

situation at all costs and it is why they request this authorization. However this less non-realistic non-

use scenario selection was necessary for the authorization methodology in order to pursue the socio-

economic analysis.

Because EDF would still have spent IER to treat, the less non-realistic non-use scenario would consist

in using the non-available alternative, i.e. the D8M2 hardener which is not yet approved by

Competent Authority.

Indeed this new hardener would not be approved at the sunset date; consequently those waste

packages could not be sent to the near surface disposal of ANDRA.

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Therefore those waste packages would have to be disposed waiting for D8M2 approval by ANDRA,

expected in the end of 2025 (at the end of step 3, see section 5.3.1.4) in order to be finally sent to

ANDRA.

Those waste packages should be temporary stored on each NPP because no transitional disposal

facility exists to date. Such facilities would be considered as a Basic Nuclear Installation and its

building would depend on the complex regulatory framework, already well explained. Such new area

building would take more than a decade51 while waste packages need to be disposed at the sunset date.

Therefore, in this theoretical non-use choice, it will be assumed that those waste packages would be

disposed on each NPP.

As previously explained (see section 3.1.2), radioactive wastes management is specific and the French

regulation enforces responsible management for NPP operators52. Thus, EDF would need to adapt

transitional technical measures for this waste packages disposal53. Specific protected area will

therefore have to be built to dispose those waste packages for several years, on each NPP.

Consequent economic impacts of those theoretical temporary specific protected area for waste

packages are described in the following section 6.1.1.

Finally, in this theoretical non-use choice in order to do this impact assessment, it is reminded that

D8M2 hardener is not fully technically validated without the final approval of ANDRA. In the

theoretical case that this new composition will never be approved, lots of wastes packages would need

to be reconditioned.

This case would be a huge impact as described in section 6.1.1.

A granting authorisation would lead to avoid those important impacts of the less non-realistic

non-use scenario which are developed below.

6.1.1 Economic impacts for use 2

6.1.1.1 Regulatory studies and specific authorisation in order to build temporary specific

protected area for waste packages

As well previously explained in section 5.4.1, lots of regulatory studies and lots of specific

authorisation would first have to be requested to several French authorities for any change on NPP

perimeter.

A specific study of French regulatory texts have to be done in order to know which studies and

authorisations would need to be performed, according to technical modification needed. The

51 This assumption is made with the example of the new construction of the “Conditioning and Storage Facility for Activated Waste”

(ICEDA,) located in France which started around 2005 and not still operational in 2015. It should be also noticed that such facility has not

been designed for such immobilized confined waste packages as waste packages produced with M.E.R.C.U.R.E. process.

52 According to several articles (6 & 8) of the order of the 7th February 2012 about general rules of Basic Nuclear Installation as “the

operator is responsible for the management of the wastes produced in its installation, by respecting provisions defined in the French

Environmental Code, particularly in the Title IV of the book V, and that take in account the available or under investigation treatment facilities" and also “The operator takes all provisions, by design, to prevent and reduce, particularly from the source, the production and

harmfulness of the produced wastes by the facility”.

53 According to articles 6.3 of the order of the 7th February 2012 “the operator is responsible of the safe and controlled conditions waste management” and “the operator has to define the disposal characteristics for wastes produced by the facility”.

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regulatory framework of Basic Nuclear Installation is very complex for the purpose of the fail-safe

principal for the entire lifetime of the facility.

Temporary specific protected area will therefore have to be built to dispose those waste packages for

several years, on each NPP.

Those studies and authorisations would need to be performed for each NPP (58 reactors on 19 sites in

France) before building those specific areas, which will be needed very soon after the sunset date.

Those studies and authorisations would require several humans and financial resources.

6.1.1.2 Technical and economic dimensions of the building of temporary specific protected area

Temporary specific protected area would be built into each NPP limits. Each NPP are different.

Therefore the construction of those temporary specific protected area would be adapted to specificities

of each of 19 NPP.

Technical provisions for the safety of the specific storage

Those temporary specific protected area would be buildings with walls and roofs in order to protect

waste packages from weather conditions. Those buildings would have controlled access and they

would be built into controlled area and biological protection and on 3 meters high because waste

packages are irradiating. Moreover, buildings do not need ventilation because wastes packages do not

release radioactive gas54.

Those buildings should be built into no flood-risk area and they would have been designed by

following earthquake-resistant buildings rules at nuclear level55.

Finally, those buildings would have bridge cranes with specific clamps to carry waste packages

inside. The waste package weight is 6.5 tones.

Dimension of those specific buildings

In the aim to estimate order of magnitude costs of such buildings, following assumptions have been

chosen:

- Waste packages could be stacked up to three units high and one waste package takes 1 m².

- Each M.E.R.C.U.R.E. campaign produces, on average, 111 waste packages56.

- Each NPP has a campaign every 18 to 72 months. Between the sunset date until the foreseen

availability of D8M2 in 2025 (at the end of step 3, see section 5.3.1.4), 3 campaigns would be

occurred on average. The storage building would be designed to store 333 wastes packages.

- The final area has estimated to 200 m² by taking into account 120 m² of storage57, 40 m² for

trucks area, 20 m² for specific access entry, and 20 m² of free space.

Constraints

Such free space is not available on each site.

Feasibility studies would need to be conducted for each site in order to design such buildings.

Moreover expertise and technical means would not been available to carry out such studies on 19 NPP

on the same time.

54 Permanent contamination is considered at zero and incidental contamination is considered at negligible thus the containment level is C0

(If it is more than C0, a ventilation would be needed).

55 Building should respect strict nuclear building seism safety rules.

56 See also the CSR, section 9.0. 57 333 wastes packages would need 111 m² then rounded to 120 m²

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xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. Each year, 8 storage buildings would need to be

built and first buildings would need to be ready since the sunset date, in 2017.

Economic evaluation of specific storage buildings

A. Economic evaluation of the buildings

An economic evaluation has been carried out to evaluate the cost of such specific buildings, by taking

into account the return of experience of EDF.

Order of magnitude costs of specific storage buildings with the return of experience of EDF

Civil engineering for 200 m² (3.000 €/m²) 600.000 €

Additional cost of earthquake-resistant buildings 100.000 €

Bridge cranes with specific clamps 100.000 €

Spreader 30.000 €

Biological protection 50.000 €

Electricity 50.000 €

Radiation protection58

100.000 €

Roads & main networks with potential ground elevated 200.000€

Total: 1.230.000 €

+ engineering (30 % of the total) =

500.000 €

+ uncertainties (20 % of the total) =

240.000 €

This first evaluation leads to 1.970.000€ for each NPP. For 19 sites, the estimated cost is

37.430.000€ to build those temporary specific protected area which will be used for only few

years (until 2025).

This is an estimated average cost which needs to be adjusted of each specific NPP.

Such investments would need to be start as soon as the final decision of this non-granting

authorisation would be known while remembering that 8 NPP would need those specific areas

each year.

B. Economic evaluation of the project management

Such modifications on NPP would also require changing intern safety instructions procedures and a

national project management.

It has been estimated that such modifications would require 2 FTE on 6 months for each NPP and 1

FTE for 1 year at the national level. Such project management would be evaluated at 2,240,000€59.

C. Timing to build those protected area

Moreover, some time would need between the non-granting decision and the first built specific

storage.

58 An equipment to control radiation exposition for operators would be necessary (monitoring dosimetry system and markers)

59 This evaluation is based on 120,000€/FTE/year, thus 120,000€ x 0.5 x 19 x 2 = 2,280,000€ and 120,000€ x 1 = 120,000€.

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6.1.1.3 Economic impacts if D8M2 hardener is never approved by ANDRA

As explained above, in this theoretical non-use choice, it is reminded that D8M2 hardener is the best

option but it is not fully technically validated, without the final approval of ANDRA.

The final decision doesn’t belong to SOCODEI, not EDF, or the applicant POLYNT.

In the theoretical case that this new composition has never approved, lots of wastes packages would

need to be reconditioned.

EDF has never been in such position, so it is difficult to evaluate resulting impacts.

It could be considered that a total complete new research and development would be required to pack

those waste packages already packed.

The resulting waste packages of this new process would need to meet waste acceptance criteria for

confinement immobilized spent IER of ANDRA which is difficult to meet, as explained above in

section 3.1.

A total new approval process would also need to be carry out which could be very difficult and very

costly as the M.E.R.C.U.R.E. process development which took 20 years of development and several

millions of euros.

Moreover during such development NPP would still produce spent IER which would be still pack

with D8M2 hardener while waiting a final approval process.

In the theoretical case, it is very difficult to assess economic impacts but it would be a crisis situation.

6.1.1.4 Economic impacts for other actors of the supply chain

The “downstream user” of the use 2 is ANDRA. With this theoretical non-use choice, ANDRA will

not receive wastes packages during some years (between 2017 and 2025) but those waste packages

will be sent there when the technical approval will be approved. Economic impacts will only be

moved forward.

Economic impacts for upstream users will be studied in the following section with impacts for

POLYNT of Use 1.

6.1.1.5 Conclusion of economic impacts for use 2

A granting authorisation would lead to avoid those economic impacts of the theoretical less non-

realistic non-use scenario which have been evaluated for the purpose of this impact assessment

Indeed this assessment showed that in case of a non-granting authorisation, EDF would be forced to

use a non-available alternative, the D8M2 hardener, to treat spent IER which would be still produced.

This assessment has been pushed as far as possible with available means and the resulting economic

impacts have been evaluated in several tens of millions of euros for EDF with a large uncertainty.

6.1.2 Human Health or Environmental Impact for use 2

Human health and environmental impacts are analysed in section 3.3 to 3.5. The resulting excess risks

calculated with several worst case assumptions are, at the highest, in the 10-6

order of magnitude (for

M.E.R.C.U.R.E operators). Those impacts are also monetized. However those impacts are evaluated

to less than 10€ with the limited number of people exposed and the mentioned above resulting excess

risks

A granting authorisation would lead to avoid those theoretical temporary wastes packages disposed on

each NPP.

Those disposals would lead of waste packages handling by internal staff and works in restricted

controlled area. Those impacts would result of ambient dose rate of waste packages. There is no

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evaluated environmental impacts in the case of the non-granting authorisation unless the construction

of storage areas on NPP site.

6.1.3 Social impacts for use 2

In this specific case, while NPP will be still operated with the production of spent IER needed to be

treated and the assumption of the less non-realistic non-use scenario, no specific impacts would occur

on employment.

On each NPP, there would be more handling during each campaign that could give a temporary extra

work for internal workers. This would cause adjustment in internal workload schedule.

Nevertheless, in addition, here is some information about socio-economic impact of the nuclear power

industry in France from a report of PwC60 in order to understand the importance of the specific

industry:

“Nuclear industry employs 125,000 people in France directly. The distribution of this employment

between the various chain links from value is relatively homogeneous: each link employs directly at

least 20,000 people. They are employment in all the areas of France.

These 125,000 direct jobs account for almost 4% of the total industrial employment in France. More

than 450 French companies have developed a specialization in the nuclear industry. The

consideration of the indirect and induced effects results in estimating at 410,000 the number of total

employment depending from nuclear industry in 2009, which weights nearly 2% of all employment in

France.

The cumulated added-value of the nuclear specialized companies and the dedicated public institutions

are estimated to be 12.3 billion euro (Md€) in 2009 or 0.71% of the GDP. The total added-value of

the sector (direct, indirect and induced) is 33.5 Md€, which accounts for 2% of the GDP. The

development with the export of the specialized companies in the nuclear sector also provides for a

better position of their related services in other areas of the world. The network of establishment and

very specific competences necessary to the nuclear activities constitute an important instrument of

economic diversification. 4 public institutions in France are dedicated to the nuclear activity: the

ANDRA, the ASN, the CEA and the IRSN. They represent 7000 direct jobs.

Each EPR project in the world has socio-economic impacts in France.

The developmental perspectives of nuclear industry over the period 2009-2030 forecasts 70,000 to

115,000 direct and indirect additional jobs in France and between 107,000 and 150,000 jobs in

Europe.”

6.1.4 Wider economic impacts for use 2

Likewise social impacts, with the theoretical less non-realistic non-use scenario, NPP are still

operating. No wider economic impacts are identified.

Nevertheless, it should be underlined that France could also export some electricity towards its

European neighbors61.

6.1.5 Distributional impacts for use 2

No potential identified impacts.

60 “The socio-economic impact of the nuclear power in France” by PwC, available at: http://www.pwc.fr/le-poids-socio-economique-de-

electronucleaire-en-france-125-000-emplois-directs-et-une-contribution-au-pib-de-071.html 61 Source: http://www.rte-france.com/sites/default/files/2015_01_27_dp_bilan_electrique.pdf

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6.2 Impacts of granting authorisation for use 1

The use 1 is the formulation of the hardener by POLYNT Composites France.

In case of granting authorisation for Use 1, POLYNT will also continue to supply SOCODEI with the

D7M6 hardener.

In case of non-granting authorisation, POLYNT would follow their customer’s requirement and they

would replace the production of D7M6 by the production of D8M2.

6.2.1 Economic impacts for use 1

In case of an authorisation non-granting, economic impacts would be limited because the production

of D7M6 hardener would be replaced by the production of D8M2 hardener.

The time to move from one production to another is estimated at 2 months. The new hardener would

be produced in the same equipment through a close process. This time would be needed to pursue new

raw materials, to clean the vessels and to adapt the process.

6.2.2 Human Health or Environmental Impact for use 1

Human health and environmental impacts are analysed in section 3.3 to 3.5.

For POLYNT, the resulting excess risks calculated with several worst case assumptions are, at the

highest, in the 10-7

order of magnitude. Those impacts are also monetized. However those impacts are

evaluated to less than one euro with the limited number of people exposed and the mentioned above

resulting excess risks

6.2.3 Social impacts for use 1

No potential identified impacts.

6.2.4 Wider economic impacts for use 1

No potential identified impacts.

6.2.5 Distributional impacts for use 1

No potential identified impacts.

6.3 Uncertainty analysis

This present analysis is based on lots of assumptions. Uncertainties might affect the results of the

calculations.

A sensitivity analysis has been done for the monetized of health impacts (see section 3.5).

For the other economic calculation, the estimation has been done with all expert knowledge.

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7 CONCLUSION

This report has analysed the potential alternatives and whether the socio-economic benefits of the

continued use of tMDA outweigh the risks to human health and the environment for both uses.

The use 1 is the industrial step in order to formulate the epoxy resin hardener as requested for use 2.

The use 2 is fully described in order to understand the crucial role of tMDA at immobilizing

radioactive wastes in a high containment matrix with the M.E.R.C.U.R.E process. This substance is

crucial to obtain a cross-linked polymer network having the required durability and resistance

requirements in the final waste package, as compulsory requested by ANDRA and the French

regulation.

If tMDA could no longer be used, SOCODEI would not be able to pack radioactive waste on each

Nuclear Power Plant after the sunset date until an alternative is available while Nuclear Power Plant

would continue producing those radioactive wastes.

Although EDF would face a dead end at the sunset date in the case of a non-granting authorisation of

tMDA, the less non-realistic non-use scenario has been analyzed for the purpose of this impact

assessment. Because EDF would still have spent IER to treat, the less non-realistic non-use scenario

consists in using the non-available alternative, the D8M2 hardener.

The results of the less non-realistic non-use scenario analysis showed that the socio-economic benefits

outweigh the risks.

7.1 Comparison of the benefits and risk for Use 1

The use 1 is the industrial step in order to formulate the epoxy resin hardener as requested for use 2.

With the selected less non-realistic non-use scenario, in case of an authorisation non-granting, socio-

economic impacts would be limited because the production of D7M6 hardener would be replaced by

the production of D8M2 hardener.

In comparison, the main benefit of the non-use scenario is the reduced exposure to a carcinogenic

substance. For the health impact on workers related to the use of tMDA, the resulting excess risks

calculated with several worst case assumptions are, at the highest, in the 10-7

order of magnitude for

use 1. Those impacts are also monetized and they are evaluated to less than one euro with the limited

number of people exposed (6 workers for use 1) and the mentioned above resulting excess risks.

As remember, risk for man via environment is considered as very low with this use of tMDA,

according to the data available and the results of exposure modeling.

However, a non-granting authorisation for use 1 would have the same consequences and socio-

economic impacts than for use 2, which would be non-possible.

In conclusion, the continued use of tMDA for use 1 outweighs the risks.

7.2 Comparison of the benefits and risk for Use 2

The use 2 is the industrial use of the epoxy resin hardener containing tMDA.

With the selected less non-realistic non-use scenario, in case of an authorisation non-granting, socio-

economic impacts have been monetized whenever possible.

Economic impacts are mainly due to the fact that waste packages could not be sent to the near surface

disposal of ANDRA and temporary means would be needed.

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The only monetized economic impacts would be several tens of millions of euros without all the other

impacts as regulatory studies or the theoretical case that the new hardener composition would never

been approved.

In comparison, as well as for the use 1, the main benefit of the non-use scenario is the reduced

exposure to a carcinogenic substance. For the health impact on workers related to the use of tMDA,

the resulting excess risks calculated with several worst case assumptions are, at the highest, in the 10-6

order of magnitude for use 2. Those impacts are also monetized and they are evaluated to less than ten

euros with the limited number of people exposed (50 workers for use 1) and the mentioned above

resulting excess risks.

In conclusion, the continued use of tMDA for use 2 outweighs the risks.

7.3 Information for the length of the review period

The alternative analysis in this report has showed that the research led to a promise alternative with

the new composition, D8M2 hardener. The new D8M2 hardener was technically retained in 2012 by

SOCODEI with a lot of technical tests but it is not yet validated by the Competent Authorities.

This granted authorization is requested to have time to end up the technical approval process in order

to hopefully validate the new matrix and then to implement the new D8M2 hardener, in June 2027 (it

is almost 10 years after the sunset date).

A detailed timeline have been studied in order to evaluate the time needed. This schedule evaluation

has been built using the return of experience of SOCODEI and EDF about this specific process.

Indeed the technical approval process has several major steps and it requires several back and forth

between waste producer and ANDRA, for several years of discussion. It is noticed that if steps of the

technical approval process are set up, their duration are not framed by regulation. Otherwise

regulation doesn’t enforce any delay to obtain the final technical approval.

With all uncertainties about this specific application authorisation, a long review period of 12 years

is requested by the applicant.

7.4 Substitution effort taken by the applicant if an authorisation is granted

For more than a decade, both main actors of this present dossier, POLYNT Composites France and

SOCODEI, have worked closely for the remaining carcinogenic substances in their products. The

research of a new containment matrix without those substances, as tMDA, has begun in 2003 for a

total cost of more than 1 million of euros (euros value in 2014 without discounting) for both actors.

The granted authorization is requested to have time to end up the technical approval process in order

to hopefully validate the new matrix and then to implement the new D8M2 hardener.

The duration of the technical approval is not framed by regulation and there is no means to accelerate

the process. However, the actors of the dossier would do everything in place to not slow down the

approval process.

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 94

8 REFERENCES

ANDRA (2012), National inventory of radioactive wastes published by ANDRA in June 2012.

Available on: http://www.andra.fr/index.php?id=edition_1_5_2&recherche_thematique=all

ANDRA documents ACO.SP.ASRE.00-052; ACO SP ASRE 99.002 and ACO.SP.ASRE.99.004/B.

Available on: http://www.andra.fr/index.php?id=itemmenu_article_484_1681_8_1&itemracine=462

ASN Fundamental Safety Rule RFS-I.2. of 08/11/1982 (French document named « Objectifs de sûreté

et bases de conception pour les centres de surface destinés au stockage à long terme de déchets

radioactifs solides de période courte ou moyenne et de faible ou moyenne activité massique »).

Available on : http://www.asn.fr/Reglementer/Regles-fondamentales-de-surete-et-guides-

ASN/Guides-de-l-ASN-et-RFS-relatifs-aux-INB-autres-que-REP

ASN Fundamental Safety Rule RFS-III.2.e of 31/10/1986 (French document named « Conditions

préalables à l'agrément des colis de déchets solides enrobés destinés à être stockés en surface »).

Available on : http://www.asn.fr/Reglementer/Regles-fondamentales-de-surete-et-guides-

ASN/Guides-de-l-ASN-et-RFS-relatifs-aux-INB-autres-que-REP

IAEA (2002), Technical reports series no. 408, Application of ion exchange processes for the

treatment of radioactive waste and management of spent ion exchangers. Available on: http://www-

pub.iaea.org/MTCD/publications/PDF/TRS408_scr.pdf

IAEA (2009), Predisposal management of radioactive waste – General safety requirements part 5 - n°

GSR part 5. Available on: http://www-pub.iaea.org/books/IAEABooks/8004/Predisposal-

Management-of-Radioactive-Waste

IAEA (2009), Disposal approaches for long lived low and intermediate level radioactive waste –

IAEA Nuclear Energy Series - Technical Reports - No. NW-T-1.20. Available on: http://www-

pub.iaea.org/books/IAEABooks/8184/Disposal-Approaches-for-Long-Lived-Low-and-Intermediate-

Level-Radioactive-Waste

PricewaterhousCoopers (2011), The socio-economic impact of the nuclear power in France by PWC.

Available on: http://www.pwc.fr/le-poids-socio-economique-de-electronucleaire-en-france-125-000-

emplois-directs-et-une-contribution-au-pib-de-071.html

RTE (2014), Review of the French electricity production in 2014. Available on (only in French):

http://www.rte-france.com/sites/default/files/2015_01_27_dp_bilan_electrique.pdf

Websites

https://www.iaea.org/

http://www.andra.fr/international/

http://www.cea.fr/english-portal/cea/identity

http://www.legifrance.com/

EC number:

500-036-1

technical MDA

Analysis of Alternatives & Socio Economic Analysis

CAS number:

25214-70-4

Use number: 1 & 2 POLYNT COMPOSITES FRANCE 95

Specific Reference the monetization

Anna Alberini, Milan Ščasny (2014) Stated-preference study to examine the economic value of

benefits of avoiding selected adverse human health outcomes due to exposure to chemicals in the

European Union – Part3. Charles University in Prague.

Blachier M1, Leleu H, Peck-Radosavljevic M, Valla DC, Roudot-Thoraval F. (2012) The burden of

liver disease in Europe: a review of available epidemiological data. EASL.

Ferlay J, et al. (2013) Cancer incidence and mortality patterns in Europe: estimates for 40 countries

in 2012. Eur J Cancer. Apr;49(6):1374-403.

Luengo-Fernandez, R et al. (2013) Economic burden of cancer across the European Union a

population-based cost analysis.

Specific Websites for the monetization

http://www.e-cancer.fr/

http://ec.europa.eu/eurostat