01 June 2009

“Responses to comments” document for 4,4’– Diaminodiphenylmethane (MDA) (EC number: 202-974-4)

This document provides ECHA’s responses to the comments received during the public consultation on the draft recommendation for inclusion of substances in Annex XIV of REACH which took place between 14 January and 14 April 2009.   

I - Comments and responses to comments on the prioritisation

General comments on the prioritisation
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090115	Individual, Hungary	MDA has no other use than intermediary use. The file of priorioritisation_mda.pdf contains contradictory information about it as well. 1. on page 5 the first sentence is unclear: "The first two uses (intermediate in the manufacture of high performance polymers and processing to 4-4’methylenebis(cyclohexaneamine) used as a hardener in epoxy resins) are intermediate uses." There is no statement about the fourth use of MDA as hardener in adhesives if it is intermediary or not intermediary use. On the following page, 6, however, both the epoxy resin and adhesives uses are considered as non-intermediary use. This is the contradiction in the text. It is clear for every chemist that a hardener use in general means a use where the hardener itself, in this case MDA, chemically react with the other component of the system. E.g. MDA reacts with epoxy resins and this means the hardening effect. The same is valid for adhesives: they work only in cases when MDA chemically reacts with other component resulting in a crosslinked chemical structure which is hard and serves to connect the two parts to be adhered to each other. All these mean intermadiary use which is exempted from authorization. All the known uses of MDA are intermediary uses.	We thank you for your comment. 

Your comment on the clarity of the text will be considered when preparing the final recommendation and its supporting documents to be sent to the Commission as part of ECHA’s first recommendation to be sent to the European Commission by 01 June 2009. However, we believe there is no contradiction between the two sentences you mention in your comment.

As for your comment that all the uses of MDA are intermediate uses, in accordance with Article 3(15) of the REACH Regulation an intermediate means a substance that is manufactured for and consumed in or used for chemical processing (synthesis) in order to be transformed into another substance. 

The use of MDA in the manufacture of high performance polymers and processing to 4-4’methylenebis(cyclohexamine) is considered to be an intermediate use because in these cases MDA is the starting material which is transformed during synthesis (manufacture of polymers and 4-4’methylenebis(cyclohexamine)) into other substances, which are then further used. These further uses include also the use of 4-4’ methylenebis(cyclohexamine) as a hardener in epoxy resins, which is not considered to be an intermediate use. 
The direct use of MDA as hardener in epoxy resins and adhesives results in a chemical reaction between the MDA and the resin or adhesive. This use is not considered as a use of an intermediate in a manufacturing process of another substance but as an end use of the substance. The use of MDA as hardener in epoxy resins and adhesives does not result in another substance which is manufactured/imported or placed on the market as such or in a preparation (although an article including the hardened resin may be placed on the market). 	
20090226	MSCA, United Kingdom	The major exposure situation to methylene dianiline (MDA) seems to be occupational. MDA is a category 2 carcinogen, and therefore is covered by the stipulations of the Carcinogens Directive. In principle, what additional regulatory benefit is offered by Authorisation? 
	We thank you for your comment. 

The work under the ESR concluded that there is a need for further risk management. The Carcinogens Directive or other existing Community legislation was not considered to ensure high enough certainty on the level of protection, in particular with regard to workers in skilled trade. It should be noted that the Carcinogens Directive does not cover self-employed persons although some MSs may have covered self-employed in their national legislation.	
20090313	Germany, company 	Proposal: To exempt from the authorisation requirement the placing on the market of SVHC in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Justification: Defined substance samples are required to calibrate analytical instruments to identify and quantify the substance (e.g. for measurement solutions used by enforcement agencies). The applications are laboratory use by professional users (minimal risk to consumers and the environment, controlled professional use and disposal). The volumes required for calibration samples (analytical standards) are minimal, typically a solution in the range of millilitres. The concentration of the chemical standard substance is normally low - in the range of 0.1%-2% and often lower according to the sensitivity of the measuring technique. For existing or future development of new highly sensitive analytical test solutions (e.g. using mass spectroscopy, chromatography, optical spectroscopy, etc.), the use of analytical standards for calibration purposes is indispensable and is required for deployment of technical verification instruments for operational enforcement of environmental policies. A substitution of the substance of concern is technically not possible due to the calibration purpose of the usage. Comment on Terminology: Analytical standards are sometimes also named chemical standards, calibration standards or samples or test samples. 
	We thank you for your comment.

According to Art. 56(3) of the REACH Regulation, the obligations of Art. 56(1) and 56(2) “shall not apply to the use of substances in scientific research and development”.
Hence, as defined in Art. 3(23) of REACH the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year does not require authorisation.

ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use does not require an authorisation	
20090324	MSCA, The Netherlands	In general, the background documents and justification provided by ECHA are well prepared. On one important aspect NL disagree with the proposal from ECHA: according to us the fact that a substance can easily replaced by a an other substance in same group (in the case of diarsenic trioxide and sodium dichromate), is not an argument to de-prioritize the substance, because it other wise will be very hard to take care of problematic groups of substances. According to NL prioritisation of one of the substances in the group is a signal to industry that also these kind compounds are subject to the authorisation regime.   NL used a ranking system to analyse the available information on hazard properties, manufacture, uses and releases:  Aspect      Points 1. PBT/vPvB  no      0  yes      1 2. Volume    low (10000 t/yr)   5 3. Use (number of point sources, potential for worker exposure, potential for consumer exposure)  small/low     1   medium      2  many/high/widespread   3 4. Release  non-diffuse/controlled insignificant 1  medium      2  diffuse/uncontrolled/significant  3      Following this analysis, HBCDD, DEHP, Musk xylene, SCCP, BBP and DBP are considered to have high priority for inclusion in Annex XIV because they fulfill indisputable one or more of the prioritisation criteria in REACH article 58(3).   Because the production volume, the use and consequently the potential exposure will not result in significant risks for human or environment, the following substances are not fulfilling the criteria for prioritisation: anthracene, TBTO, cobalt dichloride, diarsenic pentaoxide, lead hydrogen arsenate and triethyl arsenate.    For the three remaining substances, MDA, sodium dichromate and diarsenic trioxide, there are some doubts. Finally, NL concluded that MDA and sodium dichromate should be given priority for inclusion in Annex XIV. For diarsenic trioxide NL concluded that the substance is of low priority. More details are given at substance specific comments.	We thank you for your comment.

However we would like to clarify that prioritisation of the 7 selected substances for ECHA’s recommendation of candidate substances to be included in Annex XIV is the result of the application of a coherent priority setting approach, which has been presented to and discussed with the MSC. Many members of the MSC expressed support to ECHA’s priority setting approach and in general it was positively received.
However, if there are elements in the prioritisation approach that are not supported, these may be discussed in forthcoming MSC meetings with the objective to further develop the approach so that it gets as broad as possible agreement.

As regards NL’s disagreement with ECHA’s stance on the pertinence of subjecting substances to authorisation that could be easily replaced by other substances with the same/similar hazard profile: NL deem prioritisation of one of the substances in a group of substances with similar hazard potential to be a sufficient signal to industry that also these other compounds of the group are subject to the authorisation regime. We believe however that this view has no legal foundation in the REACH Regulation since only substances whose ID is explicitly specified in an Annex XIV entry are subject to authorisation. Hence similar substances are not subject to this requirement, unless they are listed in Annex XIV. Prerequisite for inclusion of a substance in Annex XIV is the explicit identification as candidate substance. This requires specification of its ID and properties in an Annex XV dossier and a formal identification of its SVHC properties by the procedure laid down in Article 59 of the REACH Regulation.
	
20090408	MSCA, Ireland	IE would like to support the work that ECHA has done in prioritising and recommending the following 7 substances for inclusion in Annex XIV of the REACH Regulation. 
•	5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 
•	4,4’-Diaminodiphenylmethane (MDA) 
•	Alkanes, C10-13, chloro (SCCPs) 
•	Hexabromocyclododecane (HBCDD) (and all major diastereoisomers identified, i.e. α, β and γ-HBCDD) 
•	Bis(2-ethylhexyl) phthalate (DEHP) 
•	Benzyl butyl phthalate (BBP) 
•	Dibutyl phthalate (DBP)

Based on the information given in ECHA’s prioritisation and justification documents and following consultation with other relevant national authorities in Ireland, IE would have no objection to the inclusion of these 7 substances in Annex XIV. We can support the proposed transitional arrangements, proposed review periods for certain uses (where applicable) and the proposed exempted (categories of) uses (where applicable).
	We thank you for your support.	
20090409	MSCA, Poland	We support recommendation of 4,4’ – Diaminodiphenylmethane (MDA) as a priority for inclusion in Annex XIV. We agree that MDA meets criteria 'high volumes' and 'wide dispersive uses' to its prioritisation for inclusion in Annex XIV.
	We thank you for your support.	
20090414	Allgemeine Unfallversicherungsanstalt, Austria national authority
 	We welcome the inclusion of MDA in Annex XIV because due to Directive 67/548 MDA is also classified as R43 may cause sensitization by skin contact. 
	We thank you for your support.	
20090414	Instituto Sindical de Trabajo, Ambiente y Salud (ISTAS), Spain, national NGO 	ETUC General comments: The prioritisation proposed by ECHA has been developed on the basis of the available information on intrinsic properties, uses, releases and volumes of the substances of very high concern on the Candidate List . According to article 58(3) priority for inclusion in Annex XIV shall normally be given to substances with: a) PBT or vPvB properties; or b) wide dispersive use; or c) high volumes. ECHA states that: “Given that the listing of the criteria is connected by the term ‘or’, this means that meeting one criterion could in principle be sufficient to prioritise a substance for inclusion in Annex XIV. However, in order to allow further differentiation the approach actually followed for prioritising the candidate substances for inclusion in Annex XIV also considers how many of these three criteria are met by the candidate substance concerned and to what degree”. However, in ETUC's opinion ECHA has not followed a clear and comprehensive methodology for prioritizing substances and the justification that has been given in some cases is not in accordance with the announced criteria. For example, ECHA has justified not to prioritize several substances due to the lack of information on releases (sodium dichromate, cobalt dichloride, diarsenic pentaoxide) or to the lack of information on safer alternatives (cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide and sodium dichromate). These reasons for non prioritization are also not in accordance with the Precautionary Principle stated in the REACH recital (69): “To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention.” In ETUC's view, complete information on alternatives and releases shall be generated by the company asking for authorization for a certain use, and should not be a criteria for not including a SVHC in the Authorization list. In addition, we consider that the Prioritization criteria used by ECHA do not take into account workers health when considering human exposure. Only consumer exposure has been considered and used as justification not to prioritize several HPV substances (triethyl arsenate, anthracene, diarsenic pentaoxide, diarsenic trioxide, sodium dichromate and lead hydrogen arsenate). However, these susbstances are of high importance for workers health and are known to cause recognized work-related diseases at Community level (Commission Recommendation of 19 September 2003 concerning the European schedule of occupational diseases (notified under document number C(2003) 3297) (Text with EEA relevance) (2003/670/EC) ANNEX I). In order to better take into consideration worker's health and given that in Article 58(3) the term "normally" implies that the criteria mentioned do not need to be seen as exclusive, ETUC suggests that ECHA should take into account an additional criterion for prioritising SVHC in the Annex XIV. This criterion should be the existence of recognised occupational diseases linked to the SVHCs. ETUC has recently proposed a methodology to prioritise SVHC taking into account this specific criterion (see attached document). The Trade Union Priority List for REACH Authorisation includes 306 HPVC entries also ordered by score by reference to their intinsic eco-toxicological properties. We believe that if those chemicals are included in the candidate list and subsequently prioritised in the Annex XIV, it would surely promote the development of safer alternatives and cut both the incidence of chemical-related occupational diseases and the attendant costs for the Community, workers and industry itself. 	We thank you for your comment. 

However, we do not agree with the statement that in developing/applying ECHA’s prioritisation approach the precautionary principle and/or worker’s health were not taken into consideration. From the published description of the prioritisation approach (‘General Approach for Prioritisation of Substances of Very High Concern for Inclusion in the List of Substances Subject to Authorisation’, one of the documents used by ECHA for preparation of its Recommendation) it should be concluded that information on occupational health has been taken into account.
It further seems to be a misunderstanding of ECHA’s explanations regarding the priority of particular candidate substances to claim that ECHA had justified not to prioritise several substances with lack of information on releases (sodium dichromate, cobalt dichloride, diarsenic pentaoxide) or with lack of information on safer alternatives (cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide and sodium dichromate), and by doing so had violated the precautionary principle. Decisive factor for non-prioritisation of all above mentioned metal salts and oxides was not uncertainty about exposure or alternatives but the possibility that these substances could be easily replaced by other salts or forms of the metal with the same or a similar hazard potential, which would render any authorisation measures imposed solely on the mentioned substances ineffective unless the closely related compounds could as well be subjected to the authorisation requirement in a grouping approach. This requires however first the development of Annex XV dossiers for the similar metal compounds and their identification as SVHC in accordance with Article 57 of REACH Regulation.

Your proposal on consideration of further prioritisation criteria and the supplementary information on ETUC’s prioritisation will be taken into account in the further development of the prioritisation approach developed by ECHA.

Substance specific comments related to prioritisation
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090217	MSCA, Luxembourg	We support the prioritisation of MDA for inclusion in Annex XIV.
	We thank you for your support.	
20090324	MSCA, The Netherlands	MDA NL agrees with ECHA’s opinion to prioritize this substance, in our ranking the substance scored in between (7).  1) no PBT/vPvB (score 0) 2) although that manufacture volume amounts to 1,400,000 t/yr, only 350 t/y is relevant for authorization (i.e. non-intermediate use as hardener in epoxy resins and adhesives) (volume: score 3 - relatively high) 3) The use in epoxy resins and adhesives is intended for industrial use, however, open use in the skilled trade area can not be excluded. Also consumer exposure (from azodye Cartasol Yellow) and polyurethane medical devices can not be excluded (use: score 2 - potentially widespread use) 4) For open use in the skilled trade area, both release and worker exposure can not be excluded (release: score 2 - potentially not insignificant)
	We thank you for your support and for the additional information provided.	
20090402	MSCA, Norway	Even though the information on the volumes of MDA used as hardener in adhesives and epoxy resins is limited, we support the assumption of a potentially high number of professional and industrial actors in the supply chain exposed across the entire EU (and EEA) and the description of MDA in non-intermediate uses as wide dispersive use . We support the prioritation of MDA which is in accordance with article 58 (3) (b). In section 8 in the prioritisation background document MDA is described as toxic to reproduction. This should be corrected to carcinogenic, in line with section 3 (intrinsic properties). The concentration limit should be adjusted to 0.1%. 	Thank you for your support and your comment. It will be taken into account together with any other contributions when preparing the final recommendation and its supporting documents to be sent to the Commission by 01 June 2009.
	
20090414	Allgemeine Unfallversicherungsanstalt, Austria, national authority 	p23 technical report If the framework of worker protection was efficient for the control of MDA in the workplace (as stated p23, last paragraph) there won’t be exceedings of OELs (as cited in Table 3.2). Thus we cannot accept the statement “The German competent authority (…) note in their Annex XV dossier that, with respect to inhalative exposure, most scenarios in these sectors showed ONLY NEGLIGIBLE concern according to the criteria used under Directive 793/93. For those scenarios that indicated a need for additional measures, the framework of worker protection was REGARDED SUFFICIENT for adequate control of inhalative exposure.” p24, technical report It has to be emphasized that the use of protective gloves at the workplace only can be the measure of lowest priority, in accordance with Chemical Agents Directive (98/24/EC). The argument that “gloves will eliminate 90% of dermal exposure” therefore cannot be accepted. p25, Table 3.2 technical report Some of the measured and estimated values (cited p25, Table 3.2) of inhalative exposure at the workplace within the report exceed the Austrian OELs either for short term or long term exposure in the work place (MAK, Maximale Arbeitsplatzkonzentration). The Austrian OELs for MDA do not contrast with those in EU member states with good practices in occupational health. p26 There are reasonable doubts that hardener in epoxy resins only are applied by certified personnel. Referring to the use of PPE see comment on p24. 
	We thank you for your support and for the additional information provided. This information will be taken into account together with any other contributions when preparing the final recommendation and supporting documents to be sent to the Commission by 01 June 2009.

Note however that the technical report on “Data on Manufacture, Import, Export, Uses and Releases of as well as information on potential alternatives to its use” will not be updated.	
20090414	MSCA, Sweden	We support the prioritisation of MDA for inclusion in Annex XIV. The substance fulfils two of the criteria for prioritisation mentioned in REACH Art. 58.3 –wide dispersive use and (relatively) high volume.
	We thank you for your support.	
20090414	Instituto Sindical de Trabajo, Ambiente y Salud (ISTAS), Spain, national NGO 	The ISTAS do agree with the prioritisation stated by ECHA for this substance.
	We thank you for your support.	

II - comments and responses to comments on the draft Annex XIV entries 

General comments on the justification
Date 	Submitted by (name, Organisation/MSCA)	Comment	Response	
20090402	MSCA, Norway	Even though the information on the volumes of MDA used as hardener in adhesives and epoxy resins is limited, we support the assumption of a potentially high number of professional and industrial actors in the supply chain exposed across the entire EU (and EEA) and the description of MDA in non-intermediate uses as wide dispersive use . We support the prioritation of MDA which is in accordance with article 58 (3) (b).We support the inclusion of MDA in the draft recommendation of inclusion in Annex XIV with the justification for an authorisation scheme for MDA in non-intermediate use. 
	We thank you for your support.	
20090406	MSCA, United Kingdom	The UK REACH CA sent in comments by the end of February, as requested by the MSC secretariat. Within the UK there has also been consultation across all relevant governments departments and devolved administrations within the UK. As a result, some additional comments have been collected. These are indicated below – along with repeating the earlier comments from the CA, so as to keep everything together. The additional comments do not change the previous “UK” position on MDA.
		
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, international NGO 	CHEM Trust, Greenpeace, HEAL and WWF support the prioritisation for inclusion in Annex XIV due to its relatively high volume and wide dispersive uses.
	We thank you for your support.	
20090409	MSCA, Austria	The Austrian CA supports the inclusion in Annex XIV on the basis of the comments on the justification paper.
	We thank you for your support.	
20090409	MSCA, Germany	The German CA supports the justification document. MDA clearly fulfills the criteria of REACH article 58(3) to be recommended with priority for inclusion in Annex XIV.
	We thank you for your support.	
20090414	Allgemeine Unfallversicherungsanstalt, Austria, national authority 	The prioritisation is strongly supported, in particular from the viewpoint of occupational health. Regarding the exemptions of uses we demand: Artists’ paints only should be exempted from the authorisation requirement in the case 1) of being evident that the substance is used in artists’ paints 2) there is no alternative substance available. 
	We thank you for your support and your comment.

We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions Article 58(2) could be used to exempt that specific use. We see two such situations: 

i)	Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply
ii)	Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.  	
20090414	Belgium, company 	In their original submission on MDA under the REACH Annex XV procedure (see: http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp), the German Competent Authorities proposed that, inter alia, "mixing and handling formulations containing MDA in the industrial area" should be exempted from authorisation requirements (see p. 21 of the report). This proposal was justified on the basis of elimination of 90% of dermal exposure, and the fact that residual dermal exposure can be tolerated except for scenarios in skilled trades. Since the German authorities were the official rapporteurs for the EU risk assessment conducted on MDA, and have in-depth knowledge of MDA, its hazards, uses, exposures and releases we consider that their proposal should be accepted. Unfortunately, this proposal is not reflected in the official ECHA report. We therefore request that the proposal from the German authorities to exempt industrial uses of MDA from authorisation requirements should be reinstated and and accepted.
	We thank you for your comment. 

However, we would like to clarify that the Authorisation procedure does not foresee a possibility to exempt uses from the authorisation requirement on the basis of low level of risks. Uses can only be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled (Article 58(2)of the REACH Regulation). Therefore, we would like to stress that the information on the low level of risks cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.

This information, however, may be part of the applications for authorisation to be submitted to ECHA (art. 62(4) (d) – Chemical Safety Report), and may be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include. 

Please note that the German CA agrees with the recommendation as proposed by ECHA (see comment of the German CA in section “Uses (or categories of uses) exempted: comments on the uses proposed to be exempted”)
	
20090414	MSCA, The Netherlands	The Netherlands CA has submitted their comments on the justification already as part of the webforms for prioritisation. The Netherlands CA agrees with the recommendation for inclusion in Annex XIV of 4,4’– Diaminodiphenylmethane (MDA)
	We thank you for your support.

Transitional arrangements: comments on the proposal and conclusion
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090402	MSCA, Norway	We support the proposed latest application date and sunset date in this rather short supply chain that involves a high number of professional and industrial actors. 
	We thank you for your support.
	
20090406	MSCA, United Kingdom	Earlier UK REACH CA comments: The major exposure situation seems to be occupational. MDA is a category 2 carcinogen, and therefore is covered by the stipulations of the Carcinogens Directive. In principle, what additional regulatory benefit is offered by Authorisation, unless one envisages that for occupational use(s) Authorisation might well be refused. What is it about this particular category 2 carcinogen that justifies it standing out for particularly onerous regulatory action under REACH? Additional comments received: This is primarily a human health issue for workers in relatively small tonnage applications and therefore could a Restriction be a more appropriate control mechanism? We cannot comment on the substitutes since there is insufficient information, although it sounds as though they might have similar hazards to MDA (i.e. carcinogens). 
	We thank you for your comment.  

As already mentioned in the response to your comment above the work under the ESR concluded that there is a need for further risk management. The Carcinogens Directive or other existing Community legislation was not considered to ensure high enough certainty on the level of protection, in particular with regard to workers in skilled trade. It should be noted that the Carcinogens Directive does not cover self-employed persons although some MSs may have covered self-employed in their national legislation.

The current priority setting approach used to select substances for the (draft) recommendation to include substances in Annex XIV does not reflect whether or not authorisation is the most appropriate Community wide instrument to address possible concerns related to the substance.

As concluded by the Workshop on the Candidate list and Authorisation as Risk Management Instruments (21-22 January, 2009) in future it would be beneficial if the MS (or COM) would document the reasons for selecting one of the processes and there would be a possibility to discuss the selection before initiating or, at the latest before, finalising the work on an Annex XV dossier.
	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, international NGO 	Page 2 Given the high risks for workers, the timelines foreseen for transitional arrangements are too long and should be shortened to 18 months application date (sunset date 36 months) after the date of inclusion in Annex XIV, as foreseen in the Guidance on inclusion of substances in Annex XIV (p.35). 
	We thank you for your comment.

Note that among the substances prioritised, for MDA the shortest transitional arrangements (application and sunset dates) are proposed. The reasons for proposing as the earliest application date 24 months from the inclusion of the substance into Annex XIV are explained in Annex I of ECHA’s Recommendation (substance specific document B). On the basis of the information available, ECHA does not see grounds for proposing shortening the application and sunset dates for MDA.	
20090414	MSCA, Sweden	We agree to the proposal of 24/42 months application/sunset dates. The justification seems appropriate.	We thank you for your support.	
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the transitional arrangements as proposed by ECHA.	We thank you for your support.	

Transitional arrangements: comments on the justification
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090414	MSCA, Sweden	See comment above.		

Uses (or categories of uses) exempted: comments on the uses proposed to be exempted
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090406	UK, company	Proposal for the exemption of use from the authorization requirement We propose to exempt the use of technical grade 4,4'-Diaminodiphenyl methane (MDA) as a component in epoxy curing agents from the authorization requirement. Pure MDA (solid) and technical grade MDA (viscous liquid) are both on the market. The pure substance represents higher risk to exposure due to its potential to form dust. Technical grade MDA is a viscous liquid with low vapour pressure, which presents significantly lower risk to exposure when required control procedures are in place. We propose this exemption to be valid only for technical grade MDA. An alternative description for the technical grade of MDA is under name formaldehyde, oligomeric reaction products with aniline (CAS 25214-70-4, EC Num. 500-036-1) – This product contains 59-61% of 4,4´-MDA, 3,5% of 2,4´-MDA and the rest are mainly tri- and polynuclear amines. Justification of the proposal Use of MDA in epoxy curing agents is regulated by current EU legislation due to its classification as a carcinogen cat. 2 (1). Further, an extensive EU risk assessment on MDA was published in 2001 End users of MDA have made significant progress adopting the personal protective equipment and control procedures recommended in this risk assessment. During its life cycle, MDA, as part of the curing agent, is mostly handled in closed systems which meet the criteria of strictly controlled conditions. This requirement has been readily implemented for the preparation of the hardeners and formulation of the resin/hardener system prior to final application. End-users of MDA-containing hardeners rely on non-permeable gloves and clothing to prevent skin exposure. Due to its highly reactive nature, MDA is firmly chemically bound into the matrix of the products/materials in which it is used, and under normal conditions is not released. All this corresponds to conditions for the use exclusion as published in Guidance on the inclusion of substances in ANNEX XIX. An additional fact to take into consideration is that OECD SIDS evaluation program shows that MDA has very short lifetime in the atmosphere and EC Risk Assessment excludes possible other ways of environmental exposure from the considered application. This means that possible persistent properties will not play any role. (1) COUNCIL DIRECTIVE 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) 
	We thank you for your comment.

Please note that the entry 4,4’ Diaminodiphenylmethane (MDA), CAS: 101-77-9, EC: 202-974-4 in the candidate list does not cover the substance to which you are referring to in your comment - formaldehyde, oligomeric reaction products with aniline (CAS 25214-70-4, EC Num. 500-036-1). These two substances are considered to be two different substances. Therefore the draft recommendation for MDA will not be applicable to formaldehyde, oligomeric reaction products with aniline (CAS 25214-70-4, EC Num. 500-036-1).

	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF),  Belgium, international NGO 	The exemption should be deleted, as it is not appropriate to exempt the use of MDA in artists paints. It is not justified to automatically take over this general exemption from the previous legislation where the derogation for artists paints had been established for all CMRs. Moreover, it is questionable if the exemption is needed, given the fact that it is apparently not used in these paints anyway. 
	We thank you for your comment.

We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions Article 58(2) could be used to exempt that specific use. We see two such situations: 

iii)	Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply
iv)	Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.  
	
20090409	MSCA, Germany	In the original Annex XV Dossier the German CA proposed to exempt uses in industrial areas with negligible exposure. But because intermediates are exempted from authorisation anyway and because of difficulties to clearly distinguish between industrial uses with negligible exposure and relevant exposure and uses by skilled trade we support the draft recommendation as it is now.
	Thank you for your support.	
20090414	MSCA, Sweden	We have difficulties agreeing with the argumentation for the exemption for MDA in artists´ paint based solely on the fact that such use is permitted under the limitations directive. Directive 76/769/EEC stipulates prohibitions with exemptions while authorisation under REACH may or may not result in the granting of authorisation depending on e.g. the level of control of risks. Thus, any analysis of advantages and drawbacks, risks, alternatives etc. that was relevant in deciding not to ban MDA in artists´ paint under the limitations directive is not necessarily relevant in deciding whether the use of the substances should be exempted from authorisation. Furthermore, we have seen no data indicating that MDA is presently used or could technically be used in artists´ paint, potentially making the proposed exemption unnecessary. Furthermore, there is an error in ECHA´s justification for the proposed exemption. Since MDA is classified as a carcinogen category 2 with a concentration limit of 0.1% reference should not be made to entry 30 but instead to entry 28 of Annex I to Directive 76/769/EEC.
	We thank you for your comment.

We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions Article 58(2) could be used to exempt that specific use. We see two such situations: 

v)	Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply
vi)	Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.  	

Other uses (categories of uses) to be exempted and existing Community legislation imposing on this (category of) use of the substance minimum requirements relating to the protection of human health or the environment
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090217	Austria, company 	The original proposal for inclusion of MDA in the Candidate list, a precursor to Authorisation, was submitted by the German Competent Authority. The associated document, 'Proposal for Identification of a substance as a CMR cat 1 or 2, PBT, vPvB or a substance of an equivalent level of concern' (Version 2 26.06.2008), concluded that MDA should be included on the candidate list and hence possible requirement for Authorisation with focus on open systems in the skilled trade area; an area where more information was requested through the Risk Reduction Strategy submitted Feb 2000, but failed to materialise. On page 21 of the above mentioned document it is recommended that ‘Production and further use of MDA as an intermediate in the chemical industry, mixing and handling formulations containing MDA in the industrial area’ should be exempted from Authorisation. On page 3 of ‘Justification of the Draft Recommendation of Inclusion in Annex XIV’ no comment or reference is made regarding the recommended exemptions for Industrial use contained in the proposal document, even though handling of MDA in this circumstance was not viewed as a major concern in the Risk Assessment Report published by the ECB in November 2001. The lack of exemption for uses in a controlled industrial environment disregards the previous comments and conclusions derived from in-depth studies conducted by independent bodies on behalf of the EU commission and fails to deliver the original intent of the proposal put forward by the German Competent Authority. 

Use of MDA in the workplace is controlled by workplace exposure limits and biological monitoring guidance values. Risk assessment approach driven by Chemical Agents Directive.
		We thank you for your comment.

However, we would like to clarify that the Authorisation procedure does not foresee a possibility to exempt uses from the authorisation requirement on the basis of low level of risks. Uses can only be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled (Article 58(2) of the REACH Regulation). Therefore, we would like to stress that the information on the low level of risks cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (art. 62(4) (d) – Chemical Safety Report), and may be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include. 

Please note that the German CA agrees with the recommendation as proposed by ECHA (see comment of the German CA in the section “Uses (or categories of uses) exempted: comments on the uses proposed to be exempted”)

With respect to the specific legislation you mention in your comment, Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

On the basis of the available information, ECHA considers that the existing Community legislation mentioned in this comment appears not entirely to fulfil the above elements.

Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for MDA in accordance with Art. 58(2) of REACH.
	
20090217	France, company 	The original proposal for inclusion of MDA in the Candidate list, a precursor to Authorisation, was submitted by the German Competent Authority. The associated document, 'Proposal for Identification of a substance as a CMR cat 1 or 2, PBT, vPvB or a substance of an equivalent level of concern' (Version 2 26.06.2008), concluded that MDA should be included on the candidate list and hence possible requirement for Authorisation with focus on open systems in the skilled trade area; an area where more information was requested through the Risk Reduction Strategy submitted Feb 2000, but failed to materialise. On page 21 of the above mentioned document it is recommended that ‘Production and further use of MDA as an intermediate in the chemical industry, mixing and handling formulations containing MDA in the industrial area’ should be exempted from Authorisation. On page 3 of ‘Justification of the Draft Recommendation of Inclusion in Annex XIV’ no comment or reference is made regarding the recommended exemptions for Industrial use contained in the proposal document, even though handling of MDA in this circumstance was not viewed as a major concern in the Risk Assessment Report published by the ECB in November 2001. The lack of exemption for uses in a controlled industrial environment disregards the previous comments and conclusions derived from in-depth studies conducted by independent bodies on behalf of the EU commission and fails to deliver the original intent of the proposal put forward by the German Competent Authority. 

Use of MDA in the workplace is controlled by workplace exposure limits and biological monitoring guidance values. Risk assessment approach driven by Chemical Agents Directive.	We thank you for your comment.

However, we would like to clarify that the Authorisation procedure does not foresee a possibility to exempt uses from the authorisation requirement on the basis of low level of risks. Uses can only be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled (Article 58(2) of the REACH Regulation). Therefore, we would like to stress that the information on the low level of risks cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (art. 62(4) (d) – Chemical Safety Report), and may be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include. 

Please note that the German CA agrees with the recommendation as proposed by ECHA (see comment of the German CA in the section “Uses (or categories of uses) exempted: comments on the uses proposed to be exempted”)

With respect to the specific legislation you mention in your comment, Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

On the basis of the available information, ECHA considers that the existing Community legislation mentioned in this comment appears not entirely to fulfil the above elements.

Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for MDA in accordance with Art. 58(2) of REACH.	
20090326	Germany, company 	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_mda.pdf, page 3, section "5.Proposed exempted categories of use". Proposal: To exempt from the authorisation requirement the placing on the market of MDA in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Justification: Defined substance samples are required to calibrate analytical instruments to identify and quantify the substance (e.g. for measurement solutions used by enforcement agencies). The applications are laboratory use by professional users (minimal risk to consumers and the environment, controlled professional use and disposal). The volumes required for calibration samples (analytical standards) are minimal, typically a solution in the range of millilitres. The concentration of the chemical standard substance is normally low - in the range of 0.1%-2% and often lower according to the sensitivity of the measuring technique. For existing or future development of new highly sensitive analytical test solutions (e.g. using mass spectroscopy, chromatography, optical spectroscopy, etc.), the use of analytical standards for calibration purposes is indispensable and is required for deployment of technical verification instruments for operational enforcement of environmental policies. A substitution of the substance of concern is technically not possible due to the calibration purpose of the usage. Our company does currently not have industry data with respect to volumes or concentrations of MDA used in analytical standards, but is committed to provide a constant stream of new measurement solutions to the environmental measurement market place. Comment on Terminology: Analytical standards are sometimes also named chemical standards, calibration standards, reference standards or samples or test samples. 

Community legislation: unknown
	We thank you for your comment. 

Please see the response to comment in section “General comments on prioritisation”.	
20090406	UK, company 
	Use as component in the epoxy curing agents

(1) COUNCIL DIRECTIVE 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) 
	Based on your comment in section “Uses (or categories of uses) exempted: comments on the uses proposed to be exempted”, we understand that you are in this case referring to the use of the substance formaldehyde, oligomeric reaction products with aniline (CAS 25214-70-4, EC Num. 500-036-1) as a component in the epoxy and curing agents. As already mentioned in the response to the above-mentioned comment, the entry 4,4’ Diaminodiphenylmethane (MDA), CAS: 101-77-9, EC: 202-974-4 in the candidate list, does not cover the substance to which you are referring to in your comment - formaldehyde, oligomeric reaction products with aniline (CAS 25214-70-4, EC Num. 500-036-1). These two substances are considered to be two different substances. Therefore the draft recommendation for MDA will not be applicable to formaldehyde, oligomeric reaction products with aniline (CAS 25214-70-4, EC Num. 500-036-1).

20090410	EDF, France, company 	Use of MDA in the case of the process for encapsulating radioactive ion-exchange resins 

Directive 90/394/CE
	We thank you for your comment.

Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly, ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

From ECHA’s assessment of the available information, there appears to be no Community legislation regulating the use of MDA for encapsulating radioactive ion-exchange resins.

Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for that specific use in accordance with Art. 58(2) of REACH. ECHA will however in its recommendation suggest to the Commission to verify this point.
	
20090414	Belgium, company 	"Mixing and handling formulations containing MDA in the industrial area" should be added under section 5 (page 3) of the ECHA report

EU Directive 2004/37/EC on the protection of workers from exposure to carcinogens and mutagens in the workplace
	Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

On the basis of the available information, ECHA considers that the existing Community legislation mentioned in this comment appears not entirely to fulfil the above elements.

Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for MDA in accordance with Art. 58(2) of REACH.	

Information on the need to exempt PPORD from the authorisation requirement, including the maximum tonnage
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
200090410	EDF, France, company 	In application of the article 58, § 2 of the regulation REACH of December 18th, 2006, EDF solicits for the use of MDA described below, the exemption of the obligation of authorization and wishes to subject the following observations. Use In its operation of electricity-producing nuclear facilites (58 reactors), EDF uses ion-exchange resins for purifying the water that cools the reactors. After use, these very radioactive resins are stored in limited-capacity tanks. Packaging is done regularly to avoid any interruption in generation. Using two portable machines which are moved from site to site, the Mercure process (its name is taken from a French acronym which describes it) provides a means to encapsulate these resins in an epoxy matrix that itself is contained in a confining package of concrete fitted with steel radiation protection. This encapsulation is done with an epoxy resin and a hardener composed of 10-25% MDA: depending on the varying quantity of radioactive resins packaged each year, annual consumption can range from 30-50 tonnes. This process was the subject of a detailed instruction with the French nuclear safety authority (ASN), which is charged with monitoring this operation, including the security of personnel. The packaged materials have been designed to follow radiological, chemical, and mechanical requirements for eventual management by the low and medium radioactive waste storage center managed by ANDRA, the French National Radwaste Management Agency. These requirements ensure the durability and the containment of the packages for at least 300 years to guarantee human and environmental safety. EDF began a national effort to identify hazardous substances in 2003. This effort resulted in the launching of substitution studies and hazard evaluations which led to imposing protective measures adapted for the workplace. Substitution Studies Studies were commissioned by EDF in partnership with different organisations to substitute three components used in the Mercure process identified as Carcinogenic, Mutagenic or toxic to Reproduction (CMR). While substitutes were found for two phtalates toxic to reproduction, no substitute was found for the aromatic amine MDA. Several leads were explored using national and internal bibliographic research done by SOCODEI, the lead contractor for the project; the Research and Development of EDF, the formulator of the epoxy matrix, and the toxicology division of EDF’s central support office for health in the workplace. The molecules proposed as a substitute in thin-coat applications (epoxy paints) do not provide the performance necessary for this specific large-scale use which also induces very strong exothermicities. These leads resulted in the selection of several potential molecules that were eliminated in the end either because they did not conform technically (criteria linked to the characteristics of the package to be stored by ANDRA, including behaviour after irradiation) or because they were not validated from a toxicological standpoint. For all of these molecules, serious toxicological and technical studies were conducted beginning in May 2004 with the goal of optimising research. In the absence of any suitable product on the market, a material able to satisfy the technical and toxicological criteria was envisaged and its manufacturing process was studied: it is an oligomer of aminostyrene and styrene named PAS50. As a result of the feasability study of this synthesis conducted by Polymer Expert, the nitration/reduction track took priority in the studies. The manufacturing processs using nitration and réduction was launched with ISOCHEM (SNPE group), a specialist in the industry. For the nitration phase, approximately twenty tests were carried out between mid-March 2005 and mid 2006 leading to a reproducible process which results in nitration at the required rate. For the reduction phase, twenty tests have been carried since June 2005 resulting in a product whose stability has not yet been confirmed. In parallel, several tests were performed by EDF R&D with a hardener using PAS50. These formulation tests have shown a significant drop in performance in comparison with the current hardener. Because of the technical difficulties encountered, this important study phase was stopped in 2007. Since then, the program continues with a document watch involving commercial chemical products that can serve as substitutes for aromatic amines, and alternative processes for the Mercure process. In addition, the formulator has put in place a research program to find a substitute using significant resources. Lastly, SOCODEI with the assistance of an independent expert, is studying a completely different formulation based on polyaminoamides, cyclo-aliphatic-monocycliques and polyester amino molecules. Every new formulation must receive the approval of the French nuclear safety authority and ANDRA with guideline delays of at least two years. Preventive and Safety Measures Taken By regularly incorporating operating experience feedback, EDF promotes and updates preventive and safety measures at the various nuclear facilities using the Mercure process by verifying effectiveness with a follow-up medical protocol. In accordance with regulatory requirements, the following measures have been taken and traced. The number of individuals involved in a packaging operation is less than 10 and exposure times are limited. These data are traced and an exposure sheet is maintained for each employee. After evaluating the risks, collective and individual preventive measures are put in place. The personnel involved are informed of the risks incurred and they are trained in preventive measures. Potentially hazardous zones have been determined and marked, and hazardous CMR phases in the procedures have been identified and limited in number ; morover, the process is largely tele-operated. An individual will not be assigned to a position with CMR exposure until he has been examined by the company doctor and given a clearance slip. A special follow-up medical protocol has been set up; it systematically includes urinary MDA measurements (biometrology) that enable validation of the onsite preventive measures taken. Since 2003, such measures have brought risk under control and avoided any adverse trends. Conclusion Use of MDA in the Mercure process is quite specialised and provides, with complete safety for operators and the environment, a means to encapsulate and contain materials that are radioactive. EDF proposes that an exemption be made for the use of MDA in the case of the Mercure process for encapsulating radioactive ion-exchange resins given the current unavailability of a substitute and given that risks to human health linked to its use under these conditions have been brought under control. EDF is committed to making the substitution studies file available as well as the procedures put in place when MDA is used in this process.	We thank you for your comment. 

As already indicated in your comment under “Other uses (categories of uses) to be exempted and existing Community legislation imposing on this (category of) use of the substance minimum requirements relating to the protection of human health or the environment” section, Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”
In particular, this means that the requirement to follow instructions and technical requirements from national authorities cannot be considered as such as a reason to propose an exemption. 

Furthermore, we would like to stress that the information on both the low level of risks and the availability and suitability of alternatives cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (art. 62(4) (d) – Chemical Safety Report, (e) – analysis of alternatives and (f) –  substitution plan), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.	

Review periods
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090410	EDF, France, company 	4 years
	We thank you for your comment.

However we would like to clarify that the review period that we are referring to in this section is, according to Art. 58(1) (d) of the REACH Regulation, the time-limited review to which authorisations should be subject.
Therefore, a review period can only apply to substances included in the Annex XIV of REACH, and for the uses which are not exempted.
Please note that, as indicated in its “Justification for the Annex XIV recommendation – General approach” paper and substance-specific justification for MDA (both annexed to this recommendation) ECHA does not propose any substance specific review period according to Art 58(1)(d) provisions. However, it should be stressed that authorisation decisions will always include case specific (application specific) review periods as this is required by Art. 60(8) and Art. 60(9)(e) or REACH.	

Attachments

EDF:

Ireland, MSCA:

ISTAS: