COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	Formaldehyde, oligomeric reaction products with aniline (technical MDA)	
CAS number:	25214-70-4	
EC number:	500-036-1	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: 

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
11	2011/10/13	International NGO
Health and Environment Alliance
Belgium	HEAL supports the placement of Formaldehyde...(Technical MDA) on the candidate list on the basis of the information in the Annex XV dossier.	Thank you for the supporting comment.	
10	2011/10/13	National Authority
RIVM
Netherlands	The Netherlands supports the proposal to include Formaldehyde, oligomeric reaction products with aniline in the candidate list of substances of very high concern. 	Thank you for the supporting comment.	
8	2011/10/13	Member State
Sweden	The Swedish CA agrees that technical MDA, being classified as Carc. 1B due to the high content of MDA, meets the criteria according to Article 57(a) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for the supporting comment.	
7	2011/10/13	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	Formaldehyde, oligomeric reaction products with aniline is a multisubstituent component containing high amounts (over 50&w/w) of the candidate substance 4,4’-diaminodiphenylmethane (MDA).
Thus it is obvious that Formaldehyde, oligomeric reaction products with aniline has to enter the authorisation process. Substituting MDA by an UVCB would contradict and misdirect authorisation according to the REACH regulation.
	We thank you for your support and your comment. We fully agree that substituting MDA by an UVCB would contradict and misdirect authorisation according to the REACH regulation. 	
5	2011/10/13	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this UVCB substance in the candidate list given that it meets the criteria for classification as carcinogenic in accordance with Article 57 (a) of REACH.	Thank you for the supporting comment.	
4	2011/10/12	Member State
Belgium	Belgium supports the identification of Formaldehyde, oligomeric reaction products with aniline (technical MDA) as SVHC according to article 57 (a) 	Thank you for the supporting comment.	
3	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of Formaldehyde, oligomeric reaction products with aniline (technical MDA) as SVHC.	Thank you for the supporting comment.	
2	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for the supporting comment.	
1	2011/10/06	Member State
Norway	The Norwegian CA supports that formaldehyde, oligomeric reaction products with aniline (technical MDA), should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for the supporting comment.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2011/10/13	Member State
Ireland	Formaldehyde, oligomeric reaction products with aniline (technical MDA) is classified as Carc. 1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) of REACH.	Thank you for the supporting comment.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
6	2011/10/13	Industry or trade association
EDF SA
France	1.	Synthesis

EDF has a specific use for Methylenedianiline Oligomers, which it considers to be of the upmost importance. Ion exchange resins are indispensable for nuclear power plants to operate. At present, they may only be conditioned by means of the MERCURE process which employs the hardening agent that contains Methylenedianiline Oligomers. 

Research into alternative products, which is actively conducted by the various stakeholders involved, is encouraging and should be concluded in the near future, but the regulatory constraints and requirements applicable to the validation of a new conditioning process create a considerable amount of uncertainty in relation to the date of use of the replacement product.

Measures to eliminate chemical risks are being implemented at every work sites. They are based on the protection of the health of operators involved (risk of cutaneous absorption and inhalation), and the environment (both within and outside the conditioning area).

The results of all the assessments carried out (urinalysis and swab samples) confirm that the measures in place are efficient. 

2.	Detail of the process and risk assessment
2.1	Use

Context : 

Ion exchange resins are used in the purification process of the primary coolant at the nuclear power plants (CNPE) of the EDF fleet.  This purification process performs a vital role in reducing the radiological activity of the primary coolant and, consequently, in protecting the parties involved from radiation. Moreover, the ion exchange resins retain corrosion products and are therefore able to protect the systems.

Once saturated, these spent resins are transferred to storage tanks at the nuclear power plants.  These resins are then conditioned in concrete containers, in preparation for removal and long term storage at the CSFMA (Storage Centre for Low and Intermediate Level Waste) which is operated by ANDRA (French national radioactive waste management agency).  
The conditioning process is made possible by two mobile machines called “MERCURE” (Machines for Encapsulating Resins in Containers Using Epoxide Resins), which are taken from site to site with a suitable schedule which allows that the storage tanks can be processed.

Principle of the MERCURE process :

The requirements set forth by ANDRA for storage containers at CSFMA specify that conditioning must guarantee the containment of ion exchange resins radioactivity, a good resistance to compression and a low leaching of the matrix, among other things.  These requirements are also constraints for the resin conditioning process. The MERCURE process is the only currently available process which satisfies all of these requirements and which is approved by ANDRA for ion exchange resin conditioning.

The MERCURE process is based on a polymerisation reaction between the waste (the spent ion exchange resins) and two chemical products: an epoxide resin and a hardening agent. These two products are supplied by the company CCP Composites (formerly Cray Valley), which makes preparations using substances supplied by an upstream manufacturer.

The hardening agent contains the substance covered in this document, i.e., the "Methylenedianiline Oligomer" (see the appended Safety Data Sheet).  The matrix which results from this reaction fulfils the particular requirements set forth by ANDRA in relation to the quality of the waste (resistance to compression, radioactivity containment, etc.)  

The MERCURE process is the only process currently approved by ANDRA for ion exchange resins conditioning and is therefore the only existing solution for the removal of ion exchange resins of the power plants.

Process implementation :

The mobile conditioning facility includes two fundamental components: the tank containing the products required for the process, including the "Methylenedianiline Oligomers", which is located outside the resin storage area, and the machine itself, which is located inside this area.  Hoses are used to connect the tank containing the necessary chemical products to the machine.  

The three components of the die (spent resins, epoxide resin and hardening agent) are placed in a concrete container which includes Internal Radiation Protection, in which a mixing cycle is carried out by a rotor located within the container. 

As soon as the container is conditioned, a steel lid is welded on to the internal radiation protection and a concrete cap is then cast onto the upper section of the container.  At the end of this process, the container is transported to the ANDRA storage centre. 

2.2	Amounts

Approximately 500 concrete containers of this kind are produced in a year at the EDF fleet of power plants, which represents a yearly consumption of about 45 tons of hardening agent.  According to the Safety Data Sheet, the hardening agent comprises less than 26% of "Methylenedianiline Oligomers" and the annual consumption of this substance is approximately 12 tons. 

Each of the concrete containers includes between 79 and 98kg of the hardening agent, (therefore between 20 and 26kg of "Methylenedianiline Oligomers").

A conditioning "campaign" at a nuclear power plant may give rise to a production of between 50 and 200 concrete containers. There is an average of 6 campaigns a year.

Chemical products, including "Methylenedianiline Oligomers", are taken to the various sites inside a double compartment tank with a capacity of 15m3 of epoxide resin and 9m3 of hardening agent (the average density of which totals 1.08). This amount is therefore the maximum amount which may be found on a site at any given time.

2.3	Replacement

Since the chemical risks related to the substances in use during the process were brought to light, studies have been undertaken, upon the request of the EDF operator, by EDF's department for studies and research, in collaboration with SOCODEI, the operator of the MERCURE machine, as well as the supplier CCP Composites. These studies have led to the replacement of two dangerous chemical substances which were initially employed during the process. The aim of the studies currently being conducted is to find a replacement for the "Methylenedianiline Oligomers". 

The research in progress has recently identified a hardening agent which could satisfy the numerous requirements applicable to the process. An initial pilot test was conducted for the purpose of validating the suitability of this substance in the process specifications booklet. Tests are underway on the matrix resulting from this test in order to verify the suitability of the new substance in relation to the process.

The current replacement schedule is expected to be carried out over a number of years (3-7 years). It is important to note that many constraints, external to EDF, create an air of uncertainty in relation to EDF's proposed replacement plan.  
In particular, the replacement is dependent upon ANDRA agreeing to the new hardening agent. The tests to be conducted in the context of validating this new hardening agent will last for a period of about 2 years. The results of these tests must be concluded so that the replacement may be implemented. 

2.4	Risk management

The work site risk management is in keeping with regulations in force.

Design 

For the production stages, the entire process is automated; thus the operator does not come into contact with the chemical products during normal operation. 
For the other stages (installation, fall back, maintenance, etc.), various improvements have been made to the work site so as to minimise the chemical risk. For example, concerning the hoses cleaning stage, a scraping system has been set up to clean the products which are left in the hoses at the end of the process in the best possible manner. 

Area designation 

Two CMR (chemicals classified as Carcinogenic, Mutagenic or toxic to Reproduction) risk areas are designated on the work site:

·	The first corresponds to the tank storage location. This tank is located inside the conditioning building. Wire mesh is used to outline the area. The tank may only be accessed through a cabin where all safety equipment required for the work in that area is kept. 

·	The second corresponds to the area within the immediate vicinity of the conditioning machine. This machine is located inside the building in which the connections with the spent resin storage tanks are made. 

An updated information sheet in relation to these areas is available at the entrance, and the following details are included at the very least: the Safety Data Sheet and instructions about how products are to be used, safety guidelines and a list of the staff members with authorisation to access the area. The industrial doctor issues a medical certificate of no contraindication to those working in these areas.
There is a register for signing in and out of each area. It is kept up to date and displays arrival and departure times as well as the reason for being present.

Protection of operators involved in the process

The necessary Personal Protective Equipment is available at the entrance to each area. This includes compatible gloves, antacid overalls, protective visors and outer boots as well as pre-impregnated cleaning wipes.
Further, showers and eye wash stations can be found at the entrance of each area for quick rinsing in the event of an accident.

Cutaneous contamination prevention

At the beginning of the campaign, a briefing takes place in the presence of staff to discuss any risks related to the use of these chemical products. The medical protocol is presented at these briefings.
The medical protocol is drafted taking into account that the main risk to consider is cutaneous contamination. In case of contamination, it may be detected via urine analysis. 
The protocol is outlined by the industrial doctor of the site where the campaign is being carried out. It generally involves at least a weekly sample, as well as samples targeted during high-risk stages (hose connection and disconnection, any possible maintenance related activity, etc.)
These urine samples are subsequently sent to a laboratory for analysis to identify any possible contamination.
Records show that no urinalysis has produced positive results.

Prevention of contamination by inhalation

Atmospheric measurements are recorded at least once a year in order to detect if any individuals are at risk of contamination by inhalation.  Records show that no significant MDA atmospheric contamination readings have been made. 
Despite these results, measures have been taken to ensure the safety of those involved.

·	As for the machine, a ventilated anti-contamination tenting has been secured by an air exhaust with a minimal flow of 100 Nm3/h.

·	The tank temperature control system means that products with a temperature measuring between 20 and 25°C, and with a maximum threshold of 30°C, can be controlled. The products and the tank are maintained at atmospheric pressure, and the tank has a device which protects against overpressure and negative pressure. 

Prevention of environmental pollution (outside of buildings at nuclear power plants)

The tank is located in an airtight retention. The hoses used to ensure that products are transferred to the machine are confined by heated cladding and kevlar blankets, which are, in turn, protected by a vinyl enclosure thereby preventing leakages into the environment.  
An anti-pollution kit is in close proximity to the tank containing the products so that swift action may be taken in the event of an accidental spillage.
Any waste arising from the implementation of the process (gloves, overalls, etc.) are to be treated as CMR risk waste. The waste is deposited in PEHD drums which are subsequently sent to an adapted subsidiary along with a file detailing the CMR nature of the products. 

Pollution prevention in the buildings at the nuclear power plants

The level of cleanliness of the machine reception area and of the various pieces of equipment is assessed as swab samples are regularly taken. The wipes are sent to be analysed. In the event that contamination is detected, a cleaning process is undertaken until acceptable levels of cleanliness are achieved.

Prevention of environmental pollution (outside nuclear power plants)

The whole set of equipment (machine, tank and other containers) is cleaned and then a swab sample is taken before it leaves the nuclear power plant.

Note: Companies involved in the supply of chemical products and quoted here have given their consent for this document to be circulated at the public consultation of ECHA.	The German CA thanks you for the detailed description of a specific use of Methylenedianiline Oligomers that has not been taken into account in the ANNEX XV Dossier.
The comment states that Methylenedianiline Oligomers are used as a hardener component in the conditioning process of ion exchange resin. These ion exchange resins are used in the purification process of the primary coolant at nuclear power plants. The German CA understands that during certain stages of the conditioning process (installation, fall back, maintenance cleaning) workers may come into contact with the hardening agent.
Therefore various risk management measure have been implemented to the work site in order to minimize the chemical risk.  Since the chemical risks related to the use of Methylenedianiline Oligomers during the process were brought to light studies are being conducted that aim to replace this substance. The German Competent Authority acknowledges the risk management measures taken and strongly supports the current efforts made regarding replacement of the substance.

Since the specific use of Methylenedianiline Oligomers in the conditioning process of ion exchange resins is not considered in the ANNEX XV Dossier The German CA suggests ECHA to take this into account in an updated version. A corresponding text proposal has been attached (see SVHC-Report Part II_track changes.doc). 	
			See also:
Comment 6 attachment (EDF SA. Answer to the public consultation. Methylenedianiline oligomers (MDA).pdf).pdf		

Attachments

Comment number	Public attachment	
6	
Comment 6 attachment (EDF SA. Answer to the public consultation. Methylenedianiline oligomers (MDA).pdf).pdf