01 June 2009

“Responses to comments” document for 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) (EC number: 201-329-4)

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	
20090226	MSCA, United Kingdom 	Musk xylene has recently gone through through the Existing Substances Regulation, including the agreement of risk assessments and, where deemed necessary, a risk reduction strategy. There is a need to reflect on how this recently-established EU regulatory position sits alongside a proposal that this substance should now be subject to Authorisation. 	Thank you for your comment. 
Commission communication (2008/C 34/01) on the results of risk evaluation and the risk reduction strategy for musk xylene concluded that ‘there is need for further information and/or testing. This conclusion is reached because the substance is considered a PBT candidate chemical. A further PBT-testing strategy is proposed.’ The PBT working group concluded that musk xylene is a vPvB chemical. In addition, the substance is considered to be borderline T. Because of this the Draft Addendum to the final report (2005) of the risk assessment (PBT assessment) concluded that there is a need for further risk management. The NL, acting also as rapporteur for musk xylene under the ESR, submitted an Annex XV SVHC dossier proposing to identify musk xylene as a SVHC for eventual inclusion into Annex XIV in accordance with Art 59. Subjecting musk xylene to authorisation can be regarded as a response to the need identified in Commission communication (2008/C 34/01) for further risk management. 
Musk xylene was prioritised for inclusion in Annex XIV on the basis of the prioritisation approach applied by ECHA for this first recommendation. 
	
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.	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.	Thank you for your comment.
The 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.
	
20090409	MSCA, Poland	We support recommendation of 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) as a priority for inclusion in Annex XIV. We agree that Musk xylene meets criteria ‘vPvB properties’ and ‘wide dispersive uses’ to its prioritisation for inclusion in Annex XIV.	Thank you for your support	
20090414	Allgemeine Unfallversicherungsanstalt, Austria, National Authority	We welcome the prioritisation also because the substance being classified due to directive 67/548 as carc. cat. 3.	Thank you for your support	
20090414	European Flavour & Fragrance Association, Belgium, Industry or trade association	EFFA (European Flavour and Fragrance and Association) and IFRA (International Fragrance Association) agree, in general terms, with the assumptions and the main conclusions from the reports. The fragrance industry, under the International Fragrance Association (IFRA) Code of Practice (CoP), which EFFA subscribes as a member association of IFRA, will soon prohibit musk xylene for use in fragrance compounds world wide. Publication of the 44th Amendment to the CoP is expected in summer 2009. The IFRA Code of Practice is a comprehensive document that supports the IFRA commitment to provide products that are safe for use by the consumer and to the environment. The Code of Practice applies to the manufacture and handling of all fragrance materials, for all types of applications and contains the full set of IFRA Standards. Abiding by the IFRA Code of Practice is a prerequisite for all fragrance supplier companies that are members of IFRA (either directly or through national associations). The majority of client companies (including producers of toiletries and household products) expect their fragrances to comply with IFRA Standards as set out in the Code” Moreover, IFRA, as the global regulatory authority of the fragrance industry (including Europe), implements a Compliance Program in order to ensure that its CoP and Standards are fully adhered to by its members and that consumer products containing fragrances can be safely used. The IFRA Compliance Program focuses on the safety of fragranced consumer products by ensuring that the IFRA Code of Practice is fully applied and adhered to. It involves the analysis of a variety of consumer products for the presence of fragrance ingredients regulated by IFRA Standards. The Compliance Policy was launched on 1 May 2006. Phase 1 started with the development and validation of an appropriate analytical method followed by the collection and analysis of randomly selected finished product samples by an independent third party laboratory. Full implementation of the Program of Compliance and respective actions in case of confirmed non-compliance started in May 2007. For more information please visit IFRA's website (http://www.ifraorg.org/)	Thank you for your support and the additional information.	
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.
See attachment.	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 had were not been 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.

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 musk xylene for inclusion in Annex XIV.	Thank you for your support	
20090313	Germany, company	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_musk_xylene.pdf,  page 3, section "5.Proposed exempted categories of use".  Proposal: To exempt from the authorisation requirement the placing on the market of musk xylene in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments.  Our company does currently not have industry data with respect to volumes or concentrations of musk xylene used in analytical standards, but is committed to provide a constant stream of new measurement solutions to the environmental measurement market place.	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	Musk xylene NL agrees with ECHA’s opinion to prioritize this substance, in our ranking the substance scored high priority (total score 9) based on the following criteria: 1) PBT/vPvB (score 1) 2) An estimated production of 25 tonnes per year results in a relatively low volume (score 2) 3) The use in consumer products like detergents and cosmetics results in widespread use (score 3) 4) Production and consumer use results in a 100% release and exposure of workers, consumers and the environment (score 3)	Thank you for your support	
20090402	MSCA, Norway	N agrees on the prioritisation of musk xylene for inclusion in Annex XIV. The substance has been identified as a vPvB substance. Furthermore the use in consumer products like detergents and cosmetics results in widespread use with a high potential for release of the substance. The prioritisation of musk xylene is in accordance with  Article 58 (3) (a) and (b).	Thank you for your support	
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).
	Thank you for your support	
20090414	MSCA, Sweden	We support the prioritisation of musk xylene for inclusion in Annex XIV. The substance fulfils at least two of the criteria for prioritisation mentioned in REACH Art. 58.3 – vPvB and wide dispersive use.	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.	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	
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 musk xylene.	Thank you for the additional information	
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 the vPvB properties and wide dispersive uses.	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.	Thank you for your support	
20090409	MSCA, Germany	The German CA supports the justification document. Musk-Xylene clearly fulfills the criteria of REACH article 58(3) to be recommended with priority for inclusion in Annex XIV.	Thank you for your support	
20090414	Individual, United Kingdom	MX and synthetix musks very potently inhibit the expulsion of toxins out of cells (via MD/XR, multi-drug/xenobiotic resistance transporters); increasing the degree of PBT of not just this class of endocrine disruptors, but of any other toxin whose ejection is inhibited by musks (a 2004 published paper available in full, doi: 10.1289/ehp.7301). Given this and other indications of strong toxicity for this class of compounds, and the musk family’s massive data gaps, in no way should MX be slowed from being phased out. But EChA must also both analyze and commission independent data on all fragrances to assess their risk as cumulatively as people are exposed to fragrances; at real-world doses, and during vulnerable development. --	Thank you for your comment.
We take note of the concerns raised regarding the potential additive or cumulative effects that may occur as a result of exposure of humans or the environment to different substances at the same time. The actual assessment of the magnitude of the potential risks that may occur through combined exposure is highly complex and needs substantial knowledge in terms of the exposure profile (which substances to take into account, at what level does the exposure occur and what is the spatial variability). In addition, in cases where the exposure profile would be known knowledge on the potential interactions that the different substances have in humans or environmental species needs to be known in order to be able to fully assess the potential effects of the combined exposure. 
Authorisations will be granted to specified actors (this can be manufacturers, importers or downstream users) who need to describe in their application the specific use or uses of the substance for which they request an authorisation. The Commission shall grant an authorisation if the risk to human health or the environment arising from the use of the substance is adequately controlled or, for substances falling under article 60(3), may grant an authorisation if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. 
Taking into account this direct link between the actor, the use and the substance, it is difficult to envisage how in the decision-making process on an authorisation application for a specific substance the potential combined effects caused by exposure to other substances (which may or may not fall under the authorisation regime) can be taken into account. 
A potential exemption to the situation described above might be where the applicant makes use of the provisions provided for in article 62(3) and submits an application dossier for a group of substances (fulfilling the requirements of section 1.5 of Annex XI). In cases where the applicant has based his grouping argumentation on a similar mode of (toxicological or ecotoxicological) action of the members of the group it could be expected that in the chemical safety assessment for this group the effects of potential combined exposure will also be addressed and therefore can be taken into account in the decision-making process. 
	
20090414	Mediterranean Information Office for Culture, Environment and Sustainable Development (MIO-ECSDE), Greece, NGO	MIO-ECSDE is for the prioritisation of musk xylene for inclusion in Annex XIV due to its persistence and bioaccumulation potential, which makes it an ubiquitous environmental contaminant especially in the aquatic environment. Musk xylene has been shown to be carcinogenic in mice causing an increase in hepatocellular adenomas and carcinomas and there is some evidence that the metabolites may be more hazardous than the parent compounds. Also, it has been found to be neurotoxic and develop testicular atrophy in rats. Also, musk xylene has a DNA damaging effect, a reproductive toxicity and functions as a co-mutagenic substance for polycyclic aromatic compounds. It has also been found that it affects the ability of cell transporters in aquatic organisms to remove other chemicals of concern.	Thank you for your support and the additional information.	
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 5-tert-butyl-2,4,6-trinitro-m-xylene.	Thank you for your support	

Transitional arrangements: comments on the proposal and conclusion
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090406	MSCA, United Kingdom	Earlier UK REACH CA comments: The substances has recently passed through the Existing Substances Regulation, including the agreement of risk assessments and, where deemed necessary, a risk reduction strategy. There is a need to reflect on how this recently-established EU regulatory position sits alongside a proposal that the substance should now be subject to Authorisation. Also, only 25 tonnes are believed to be on the market each year, so it could be argued that there may be little benefit in requiring Authorisation. That said, this substance clearly has a widespread dispersive use pattern. Perhaps some tonnage threshold needs to be considered at some point in the future? Additional comments received: There is very little information presented for the alternatives (it is odd that no reference is made to the ESR RARs for AHTN and HHCB – instead HERA assessments are mentioned instead). For information, the UK Environment Agency is planning to publish a report on the prioritisation of fragrance substances for environmental risk assessment later this year, which will hopefully be useful in this context.	See previous answer for the reference to earlier comments.

Thank you for the additional information provided on information related to alternatives. A reference to the risk assessments of AHTN and HHCB under the ESR program is provided in the technical report on Manufacture, export, uses, releases and alternatives. We agree that the reference to the RAR should have been made clearer.

Regarding the level of details of  information provided on alternatives we would like to clarify that the information collected by ECHA and its consultants about alternatives to the proposed substances does not aim to identify potential alternatives or to assess the technical or economic feasibility of such alternatives or risks related to them. The information is collected (and presented) to obtain an overview of the level of information available on the alternatives and the nature of the alternatives. In other words, this part of the assessment is not judging whether the alternatives are feasible or safer or how long it could take to transfer to the alternatives, but whether or not information seems to be available that facilitates compiling an analysis of alternatives by the future potential applicants. 

20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, International NGO	page 2 The timelines foreseen for transitional arrangements are too long. Given the availability of alternatives and the limited numbers of companies involved (limited actors) (see ECHA’s background report), it seems feasible to shorten the application date to 18 months (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). The substance has been known for a long time to have persistent and bioaccumulative properties and as a result many companies have already substituted it with safer alternatives (see Greenpeace report “Cleaning up our chemical homes” at http://www.greenpeace.org/raw/content/international/press/reports/chemical-home-company-progress.pdf). Biomonitoring studies have show that musk xylene was found in the blood samples of European families, including children (see WWF report “Generation X” http://assets.panda.org/downloads/generationsx.pdf).	Thank you for your comment.
Note that among the substances prioritised, for musk xylene 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 musk xylene.
	
20090410	AISE, Belgium, Industry or trade association	See attachment 	Thank you for your support. The additional information you provided will be taken into account.	
20090414	Mediterranean Information Office for Culture, Environment and Sustainable Development (MIO-ECSDE), Greece, NGO	Due to the limited number of levels of the supply chain of this substance (the supply chain is rather simple) the timeline for the transitional arrangements should be shortened to 18 months application date and 36 months sunset date. Caution should be given to the replacement of musk xylene with other synthetic musks such as polycyclic musks, macrocyclic musks and alicyclic musks. Although some of these alternative substances seem to be less toxic they may still have adverse impact on aquatic organisms.	Thank you for your comment.
Note that among the substances prioritised, for musk xylene 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 musk xylene.
	
20090414	MSCA, Sweden	We agree to the proposal of 24/42 months application/sunset dates. The justification seems appropriate.	Thank you for your support	
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the transitional arrangements as proposed by ECHA.	Thank you for your support	

Transitional arrangements: comments on the justification – NO COMMENT RECEIVED

Uses (or categories of uses) exempted: comments on the uses proposed to be exempted – NO COMMENT RECEIVED

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	
20090326	Germany, company	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_musk_xylene.pdf, page 3, section "5.Proposed exempted categories of use". Proposal: To exempt from the authorisation requirement the placing on the market of “musk xylene” 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 of “musk xylene” 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.

	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.	

Information on the need to exempt PPORD from the authorisation requirement, including the maximum tonnage – NO COMMENT RECEIVED

Review periods – NO COMMENT RECEIVED

Attachments

AISE:

ISTAS: