COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC: PROPOSAL AND JUSTIFICATION

Substance name:	1,3,5 Trichlorobenzene	
CAS number:	108-70-3	
EC number:	203-608-6	

Reason of the submission of the Annex XV: PBT like substance, (equivalent level of concern)

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier.
The table does not contain any confidential information.

General comments
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
1	2010-10-14	International NGO,
Health and Environment Alliance,
Belgium	We support the inclusion of 1,3,5 Trichlorobenzene on the candidate list on the basis of its Annex XV dossier.	Thank you for your support.	
2	2010-10-14	National NGO,
Friends of the Earth Germany/BUND,
Germany	First, Friends of the Earth Germany / Bund für Umwelt und Naturschutz Deutschland as one of the major environmental NGOs working on REACH implementation in Germany, would like to thank ECHA for the opportunity to comment on the SVHC proposals. 

The number of chemical substances on the candidate list is still below what we expected and what would be needed for the effective substitution of at least the most important chemicals of very high concern. It is essential, that, besides CMR-substances, PBT and PBT-like chemicals with relevant environmental risk potential are included in the candidate list.

We support the German proposal to put Trichlorobenzenes as SVHC on the candidate list according to REACH Article 57f.	Thank you for your support.	
3	2010-10-14	International NGO,
WWF European Policy Office,
Belgium	WWF and CHEM Trust support the inclusion of 1,3,5 trichlorobenzene in the candidate list as chemical of equivalent concern due to its PBT-like properties.	Thank you for your support.	
4	2010-10-14	National Authority,
RIVM,
Netherlands	We would like to note that from a principle point of view a substance can not be classified both as a PBT substance and as a substance of equivalent concern as mentioned in the summary. Based on the data it is not appropriate to conclude that 1,3,5-trichlorobenzene is a PBT substance as both the B and T criteria are not fulfilled. 

We do agree that the substance fulfils the P and vP-criteria and has the potential for long-range environmental transport. However, after further consideration, as outlined below, we believe that the available data on the bioaccumulation potential and toxicity of 1,3,5-trichlorobenzene does also not justify the conclusion that the substance has properties of equivalent level of concern according to Article 57(f). 

Remark on the Annex XV dossier
Read across is used in conjunction with QSAR results to support the validity of experimental
data and QSAR results for the following endpoints:
•	Persistence: biodegradation (DT50) and OH radical reaction (kOH)
•	Bioconcentration: BCF
•	Ecotoxicity (read across for 1,3,5 trichlorobenzene only)
Long-term toxicity to fish
Long-term toxicity to invertebrates
The analogue approach is mainly based on the structural isomer 1,2,4-trichlorobenzene. The read across was very well documented and QMRF and QPRF were included.	Thank you for this hint. We have considered them in the updated dossier. We have both updated the chapter on bioaccumulation and given a more detailed rationale for 57f.	
5	2010-10-14	European institution,
European Chemicals Agency,
Finland	It has been proposed to identify 1,3,5-Trichlorobenzene as a substance giving rise to an equivalent level of concern in accordance with Article 57 (f) of the REACH Regulation on the basis of the information available on its persistent, bioaccumulative and toxic properties and on its long-range transport potential.
Article 57 (f) serves as a kind of “safety net” for covering any substance properties that could give rise to an equivalent level of (very high) concern in relation to the properties addressed in Article 57 (a) to 57 (e). Therefore, circumstances and considerations to be taken into account when deciding on whether a substance gives rise to an equivalent level of concern as set out in Article 57(f) can be very diverse and appear not to allow the definition of a generally applicable set of criteria. Consequently, Article 57 (f) requests a case by case consideration. To allow this, the Member State Committee should discuss for all three trichlorobenzene isomers whether it considers the information available sufficiently conclusive to identify these isomers as meeting the “equivalent concern” definition set out in Article 57 (f) and record carefully in the agreement documents the arguments applying for its conclusion. 
In our opinion, the argumentation brought forward in the Annex XV dossier appears not to be fully adequate to allow a decision on whether 1,2,3-TCB can be identified as a SVHC in accordance with Art. 57 (f). 	Thank you for your hints. We have considered them in the updated dossiers. We have both updated the chapter on bioaccumulation and given a more detailed rationale for 57f.	
6	2010-10-13	National Authority,
Climate and Pollution Agency,
Norway	The Norwegian CA supports that 1,2,3-Trichlorobenzene (CAS number 87-61-6), 1,2,4-Trichlorobenzene (CAS number 120-82-1) and  1,3,5-Trichlorobenzene (CAS number 108-70-3)  should be identified as substances of very high concern and should be included in the Candidate List.	Thank you for your support.	
7	2010-10-13	International NGO,
International chemical secretariat, Sweden	Full support regarding its identification as a SVHC.	Thank you for your support.	
8	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	We support 1,3,5-Trichlorobenzene to be placed on the candidate list. Following the Annex XV report is mainly used as an intermediate and therefore expect that it will be registrated as an intermediate. This Trichlorobenzene isomer is also used as a process solvent that means under strictly controlled conditions. We recommend to keep this in mind when discussing the inclusion in the authorisation process. Furthermore to authorise solely these uses that have to fulfill all requirements of art. 17 or art. 18 of the REACH regulation. 	Thank you for your support. We have considered your hint in the dossier.	
9	2010-10-06	MSCA,
Sweden	Sweden supports the proposal to identify 1,3,5 Trichlorobenzene as a substance of very high concern	Thank you for your support.	
10	2010-09-03	Trade union,
European Trade Union Confederation, Belgium	ETUC supports the inclusion of 1,3,5 Trichlorobenzene in the Candidate List.	Thank you for your support.	
11	2010-09-03	MSCA, Spain	From our point of view the dossier is very complet and we consider that the categories approach is correct and enough to justify the inclusion of this chemical as PBT/vPvB and equivalent level of concern.	Thank you for your supportive comment.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
12	2010-10-14	National NGO,
Friends of the Earth Germany/BUND,
Germany	The T criterion for PBT may not be met, nevertheless the properties of these chemicals are very close to fulfilling the given criteria. Trichlorobenzenes are still found in surface waters in relevant concentrations and are ubiquitous contaminants. It appears to be very reasonable to consider the “equivalent concern” route, as trichlorobenzenes fulfill the P- and B-criteria and in addition have a very high potential for long-range transport via air. The PBT Working Group of the formerly known European Chemicals Bureau therefore stated that 1,2,3-TCB and 1,2,4-TCB should be considered as PBT-substances. 
Long-range transport occurs in the case of volatile and persistent substances and leads to global distillation processes, i.e. relatively high concentrations of the chemical in arctic and antarctic regions. Due to the low temperature in these areas, biodegradation is significantly lowered, thereby accumulation and environmental risk increases. 
A very high potential for long range transport via air is demonstrated in the Annex XV report, based on physico-chemical data. In addition, publications on Trichlorobenzenes are indicative for the occurrence of such a process: Concentrations of 1,2,4-trichlorobenzene and 1,2,3-trichlorobenzene were shown to be higher in herring from the North Atlantic compared to those from the North Sea, moreover, concentrations in herring from remote deep sea areas were higher than levels found in herring from marine areas close to the coast (Stiehl 2007, see also Norwegian Institute for Water Research, 2005). 
Accumulation via global distillation processes is to be seen as a severe threat to the very sensitive polar areas and should be considered as equivalent concern (according to Article 57f) for the environment.  References:  Thorsten Stiehl (2007). Abschlussbericht des Projektes “Globale Destillation. Belastung von Heringen im Nordatlantik, der Nordsee und der Ostsee mit PBT- und vPvB-Substanzen”. http://www.bvl.bund.de/...abschlussbericht_globale_destillation.pdf Norwegian Institute for Water Research (2005). Concentrations and levels of POPs from long-range transboundary air pollution in freshwater fish and sediments. http://www.niva.no/2...079-2005_200dpi.pdf_	Thank you for your comment. We have considered the given details in the dossier.	
13	2010-10-14	International NGO,
WWF European Policy Office,
Belgium	It is proposed to consider the following studies for inclusion in the dossier to support the presented information regarding the potential for bioaccumulation in wildlife and long range transport:   
Detection in seals, fish and invertebrate: 
D. Muir, T. Savinovab, Vladimir Savinov, Ludmila Alexeeva, Vladimir Potelov, Vladislav Svetochev: Bioaccumulation of PCBs and chlorinated pesticides in seals, fishes and invertebrates from the White Sea, Russia, Sci Total Environ.306, 2003, 111-131.  

Detection in polar bears: 
T.W. Bentzen, D.C.G. Muir, S.C. Amstrup, T.M. O'Harad: Organohalogen concentrations in blood and adipose tissue of Southern Beaufort Polar Bears, Sci Total Environ. 406, 2008, 352-367.  

Detection in fish for consumption: 
T. Stiehl, J. Pfordt, M. Ende, S. Effkemann, R. Kruse, E. Bartelt, W. Peuckert: Anreicherung von “persistenten, bioakkumulierenden, toxischen Substanzen” und von “sehr persistenten, sehr bioakkumulierenden Substanzen” in Heringen aus dem Nordatlantik, der Nordsee bzw. der Ostsee, Journal of Consumer Protection and Food Safety, J. Verbr. Lebensm. 3, 2008, 82 - 94. 	Thank you for your comment.	
14	2010-10-14	National Authority,
RIVM,
Netherlands	Bioaccumulation 
We share the opinion that 1,3,5-Trichlorobenzene is a bioaccumulative substance. However, the valid bioconcentration study for 1,3,5-Trichlorobenzene do not show a bioconcentration factor in excess of 2000. These values ranged from 150 to 1700. There is one study which provided a BCF value > 2000 when normalized to 5% lipid content, BCF of 2330. However, this study was considered invalid for different reasons. One not mentioned in the dossier is the very low test concentrations, questioning the accuracy of the BCF values derived. In addition, for both analogues 1,2,3,-Trichlorobenzene and 1,2,4-Trichlorobenzene there is no convincing evidence to believe that the BCF values are close to the B-criterion of Annex XIII.
We recognize that substances with a BCF close to the trigger value or even lower could still biomagnify in the food web. However, analysis of trichlorobenzenes in different trophic levels showed that both in water-respiring and air-breathing organisms biomagnification were insignificant (ref: Muir D, Savinova T, Savinov V, Alexeeva L, Potelov V, Svetochev V. Bioaccumulation of PCBs and chlorinated pesticides in seals, fishes and invertebrates from the White Sea, Russia. The science of the Total Environment. 2003:306:111-131) and Kelly BC, Ikonomou MG, Blair JD, Morin AE, Gobas FAPC. Food Web–Specific Biomagnification of Persistent Organic Pollutants. Science. 2007:317:236-239.). With respect to air-breathing animals, this can be explained by the fact that the Koa of the trichlorobenzenes is not high enough to cause a slow respiratory elimination. In conclusion, both aquatic BCF values as field BMF values are in support that 1,3,5-Trichlorobenzene does not meet the B-criterion or are of equivalent concern.

Toxicity

Although the substance can be classified as very toxic (read across approach was carried out, comparing both analogues 1,2,4- and 1,3,5-trichlorobenze), obviously all toxicity data do not meet the T-criterion and are in the same order of magnitude for different taxonomic groups, indicating a general mode of action due to non-polar narcosis. In addition, no other concerns, like endocrine disruption, are known to consider the substance of equivalent concern according to Article 57(f).

Emissions and exposure
The Annex XIV dossier indicates that extensive restrictions exist for 1,2,4 – trichlorobenzene and that the main uses as an intermediate and as a process solvent in closed applications are not considered to result in a release of 1,2,4-TCB into the environment. All other uses are restricted.
As stated in the Annex XV dossier, “With regard to the known uses of the three Trichlorobenzenes, current exposure is expected to be low, but trichlorobenzenes should be considered for further regulatory steps due to their SVHC properties.  Our argumentation is the opposite: exposure is relatively low due to the fact that the main uses are as intermediates and process solvents in closed systems.  SVHC properties are not yet a given, but in the case of 57(f), should be shown in by “scientific evidence of probable serious effects to human health or the environment” 
In the case of a 57(f ) substance with PBT like properties,  “equivalent level of concern” should be demonstrated by scientific evidence and thus introduces a WoE approach.

Conclusions in a weight of evidence approach
Given the fact that the PBT criteria are not fulfilled for the trichlorobenzenes, when the appropriate BCF normalization to 5% lipids is applied, the conclusion on identification as SVHC under Article 57(f) hinges on the quality of the argumentation that these substances are of ‘equivalent level of concern’. In our view, this should be based on scientific evidence of probable serious effects: how else would we define ‘substance of very high concern’, in the context of REACH article 57(f)?
We conclude that the trichlorobenzenes are substances that have vP properties, but do not meet the B and T criteria. Especially for the B criterion, there are no data that show that these substances are borderline B, nor do they biomagnify in aquatic and terrestrial ecosystems. 
The emissions and exposure of these substances are limited due to the current restrictions and types of uses, leading to a low exposure potential. The combination of hazardous properties that are not PBT or borderline PBT, restricted or controlled uses and expected relatively low exposure does not lead to scientific evidence of probable serious effects to human health or the environment that need to be regulated through the status as SVHC under Article 57(f). 
In our view, these substances are not clear candidates for ‘equivalent level of concern’, under Article 57(f).	Thank you for your comments. We have   considered them in the dossier. We have updated the chapter on bioaccumulation and given a more detail on the rationale for 57f.

We have normalized the few available BCF to 5% lipids in the updated dossier version. For 1,3,5-trichlorobenzene highest reliable BCF of 1620-1700 were reported in the MITI-List, although lipid normalization is not possible because no information on lipid content are provided. 

In addition, a field-study by Burkhard (ETC Vol. 16, 1997, 1677-1686) still indicates a significant potential for bioaccumulation for the two other isomers (1,2,3- and 1,2,4-trichlorobenzene). Based on the read-across a similarly high accumulation potential was derived for 1,3,5-trichlorobenzene.

We agree with your interpretation that the T criterion is not met. However, the chronic toxicity is close to the trigger value, this has been acknowledged in the dossier.
	
15	2010-10-13	International NGO,
International chemical secretariat,
Sweden	The classification is clearly justified due to its PBT properties and its wide dispersive use.	Thank you for your comment.	
16	2010-10-13	National Authority,
Health & Safety Authority,
Ireland	The Irish Competent Authority (CA) agrees with the identification of 1,3,5-Trichlorobenzene as an SVHC in accordance with Article 57(f) of EU No. 1907/2006. In addition, we agree with the justification provided for the read-across from 1,2,4-Trichlorobenzene and 1,2,3-Trichlorobenzene. While the substance does not fulfil the B and T criteria in accordance with Annex XIII, the scientific evidence provided in terms of measured data and read-across from 1,2,4-Trichlorobenzene and 1,2,3-Trichlorobenzene indicates that the substance is very toxic to the aquatic environment (NOEC values <1 mg/l) and has bioaccumulative values close to the cut-off value of 2000 for BCF. 
In addition, the information provided on persistency in soil (≥ 194 days), fulfils the P and vP criteria. Also, in accordance with the Technical Guidance Document (TGD) for PBT assessment, the half life in air shows potential for long range transport (estimated half-life in air is 24 days; TGD value > 2 days) and a characteristic travel distance of 11600 km.  
Regarding the justification provided for the (Q)SAR values estimated with AOPWIN, the Irish CA would welcome the clarification on the following point: Section 3.3(a)(ii) of the QPRF states that the chlorine fragments were included in the training set, which contains 1,2,4-thrichlorobenzene, 1,2-dichlorobenzene, 1,4-dichlorobenzene, 1,3-dichlorobenzene and chlorobenzene.  However, Section 5.4 of the associated QMRF states that substances containing other atoms than carbon, hydrogen, oxygen, nitrogen, sulphur and phosphorous should be regarded as being outside the applicability domain.	Thank you for your supportive comments. We have updated section 5.4 of the QMRF.
	
17	2010-09-03	Trade union,
European Trade Union Confederation,
Belgium	That substance is also included in teh TU Priority List for REACH Authorisation  see http://www.etuc.org/a/7479 	Thank you for your comment.	
18	2010-09-03	MSCA, Spain	We are in agreement with the German conclusions to include the 1,3,5 trichlorobenzene as PBT/vPvB and equivalent level of concern assessment (pages 21 and 22).	Thank you for your support.	

INFORMATION ON USE, EXPOSURE, ALTERNATIVE AND RISKS ON ANNEX XV SVHC

Substance name:	1,3,5 Trichlorobenzene	
CAS number:	108-70-3	
EC number:	203-608-6	

Reason of the submission of the Annex XV: PBT like substance, (equivalent level of concern)

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier.
The table does not contain any confidential information.

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
1	2010-10-13	International NGO,
International chemical secretariat,
Sweden	This substances is most probably used in a very similar way as 1,2,3 trichlorobenzene and 1,2,4 trichlorobenzene. That is used in:

Textile, electronics, electric cables nad wires, paints, polishes, anti corrosion fluids, metals, dye carrier, degreasing agents, septic tank and drain cleaners, wood preservatives, and abrasive formulations, dielectric fluid, solvent, heat-transfer medium, synthetic transformer oils, lubricants, pesticide. 
Sources: HSDB; Swedish EPA; US EPA; ECB	Thank you for this information.	
2	2010-10-13	National Authority,
Health & Safety Authority,
Ireland	In Ireland, emissions of  1,3,5-Trichlorobenzene are less than the European pollutant release and transfer register reporting threshold of 1 kg/annum to water and 10kg/annum to air.	Thank you for this information.	
3	2010-09-03	Trade union,
European Trade Union Confederation,
Belgium	That substance is causing recognized occupational diseases.
See:
1) Commission Recommendation 2003/670/EC of 19 September 2003 concerning the European schedule of occupational diseases: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003H0670:EN:HTML
 
The substances listed in Annex I are causative agents for diseases which have been scientifically recognised as being occupational in origin, which are liable for compensation and which must be the subject of preventive measures in all MS.
 
 2) "Information notices on occupational diseases: a guide to diagnosis" 
http://www.beroepsziekten.nl/sites/default/files/documents/Information-Notices-2009.pdf
 
This document contains additional information on entries listed on Annex I of the European Schedule of Occupational diseases.	Thank you for this hint.	

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RIVM document