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

Substance name:	1,2,3-trichloropropane	
CAS number:	96-18-4	
EC number:	202-486-1	

Reason of the submission of the Annex XV: CMR

Note: The Response to Comments table has been prepared by the European Chemicals Agency in consultation with the European Commission. The comments were received during the public consultation of the Annex XV dossier. RCOM has not been agreed by the Member State Committee nor has the document been modified as a result of MSC discussions.

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

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
13	2011/04/07	International NGO
Health and Environment Alliance
Belgium	We support the inclusion of 1,2,3 TCP on the candidate list, on the basis of information in the Annex XV dossier. 1,2,3 TCP	Thank you for your support.	
12	2011/04/07	Member State
United Kingdom	1,2,3 - trichloropropane was proposed as an SVHC by the Commission and the Annex XV dossier prepared by ECHA. As no RMO paper was produced it is unclear what the intention is, what options were considered and whether authorisation is the intended outcome? 

Most of the uses are as an intermediate and exempt from authorisation therefore, Candidate listing would appear to achieve little in reducing risk. Could restriction of certain uses be considered instead?
	Thank you for your comment.

There was insufficient time to prepare an RMO analysis between the request by the COM to prepare the Annex XV dossier and the submission deadline. However, we intend to make an RMO paper available before the next step in the authorisation process provided the substance is included in the Candidate List.	
11	2011/04/07	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as carcinogen category 1B and toxic for reproduction category 1B	Thank you for your support.	
10	2011/04/07	Member State
Germany	The German CA supports the proposal of 1,2,3-trichloropropane as SVHC.

In part II, section 1, more details on the questionnaire (e.g. percentage of answers received from member states) could be given.

In part II, section 1.2 a more detailed description on the amounts intentionally produced, used for further processes and incinerated could be given. Currently one might assume, that most of the substance produced is incinerated again.
	Thank you for providing your opinion.	
9	2011/04/06	Member State
Netherlands	The NL-CA supports the proposal to include 1,2,3-trichloropropane in the candidate list of substances of very high concern. 	Thank you for your support.	
8	2011/04/06	Member State
Norway	The Norwegian CA supports that  1,2,3-trichloropropane should be identified as a substance of very high concern and should be included in the Candidate list.	Thank you for your support.	
7	2011/04/06	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	1,2,3-TCP is mainly a by-product of other chlorinated compounds, including epichlorohydrin, dichloropropene, propylene chlorohydrin, etc. and an intermediate in the production of chlorinated solvents like carbon tetrachloride, trichloroethylene, or methylene chloride. These solvents are themselves highly regulated and one of the main goals of REACH-regulation is the substitution of substances having intrinsic properties like the mentioned solvents.
Thus we support strongly 1,2,3-trichloropropane being included into Annex XIV.
	Thank you for the information and your support.	
6	2011/04/05	Member State
Belgium	Belgium supports the identification of 1,2,3-trichloropropane as SVHC according to article 57(a) and (c).	Thank you for your support.	
5	2011/04/05	Member State
Sweden	The Swedish CA agrees that 1,2,3-trichloropropane, being classified as Carc. 1B and Repr. 1B, meets the criteria according to Article 57(a) and 57(c) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for providing your opinion.	
3	2011/03/25	Other contributor
CEFIC / Allylics REACh consortium
Belgium	The members of the Allylics REACh consortium and registrants for the 1,2,3-Trichloropropane have reviewed the Annex XV dossier for this substance. We confirm that this dossier is of good quality and information from the REACh registration dossiers and also information from the ECHA/ENTEC inquiry has correctly been used. 
The members of the Allylics REACh consortium, that are manufacturers of 1,2,3-Trichloropropane wish to confirm here again that manufacture and all uses of this substance are carried out under Strictly Controlled Conditions (SCC) according to Article 18(4) of the REACh law. This is mandatory for transported intermediate use, but SCC is also voluntarily applied during the monomer use of this substance. This has also been correctly described in the Annex XV dossier.	Thank you for your comment.	
2	2011/03/18	Company
Dow Deutschland Anlagengesellschaft mbH
Germany	Dow Deutschland Anlagengesellschft mbH (Dow) as the lead registrant for the 1,2,3-Trichloropropane (1,2,3-TCP) has reviewed the Annex XV dossier for this substance. We confirm that this dossier is of good quality and information from Dow’s REACH registration dossier and also Dow’s information provided via the ECHA/ENTEC inquiry has correctly been used. 
Dow as a manufacturer of 1,2,3-Trichloropropane in Germany wishes to confirm that manufacture and all downstream uses of this substance are carried out in closed systems under Strictly Controlled Conditions (SCC) according to Article 18(4) of the REACH law. Dow has written confirmations from all downstream users of 1,2,3-TCP that they apply SCC.
The application of SCC is mandatory for transported intermediate use, but SCC is also voluntarily applied during the monomer use of this substance. This has also been correctly described in the Annex XV dossier.	Thank you for your comment.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of 1,2,3-trichloropropane as SVHC.	Thank you for your support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
10	2011/04/07	Member State
Germany	Concerning the IUCLID file:
1.2 composition: The given degree of purity of > 87 is not in accordance with the purity stated under constituent and in the report. Please clarify and correct it if necessary. Also please add the missing unit. 
4.2 melting point: A value of 14.7°C for the melting point is given. Please add the missing minus sign.
	Thank you for your comment. The IUCLID file has been corrected.	
4	2011/04/04	Member State
Ireland	1,2,3-trichloropropane  is classified as Carc.1B and Repr.1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) and (c) of REACH.	Thank you for providing your opinion.	
3	2011/03/25	Other contributor
CEFIC / Allylics REACh consortium
Belgium	The Part I Justification contains correctly copied information from the lead registration dossier and some additional information in table 5 created by ECHA on water solubility and partition coefficient. 
The conclusions drawn in section 6.2 CMR assessment are acceptable interpretations of the available data.	Thank you for providing your opinion.	
2	2011/03/18	Company
Dow Deutschland Anlagengesellschaft mbH
Germany	The Part I Justification contains correctly copied information from Dow’s lead registration dossier and some additional information in table 5 created by ECHA on water solubility and partition coefficient. 
The conclusions drawn in section 6.2 CMR assessment are acceptable interpretations of the available data.	Thank you for providing your opinion.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	1,2,3-trichloropropane is included in the Trade Union Priority List for REACH authorisation (entry n°2)
see http://www.etuc.org/a/6023	Thank you for providing this information and reference.	

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

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organi-sation/MSCA)	Comment	Response	
10	2011/04/07	Member State
Germany	Information on uses:
In part II, section 2.1.2, uses as intermediate are described based on a consultation with the manufacturers. Only 95% of the produced amounts are covered in table 11. Use description is missing for volumes between 500 tonnes per year (lower estimate based on a production volume of 10.000 tonnes per year) and 2500 tonnes per year (upper estimate based on a production volume of 50.000 tonnes per year.) We would appreciate a clarification on the fate of these volumes.	As noted in Table 11 about 5 % of the total volume produced is incinerated which corresponds to a range of 500 – 2.500 t/y. These estimates are based on information we received in consultation with industry whilst preparing the Annex XV report.	
5	2011/04/05	Member State
Sweden	Section 1.4.2, Table 10 (p. 11): 
The values for dermal exposure appear to be 10-100 times too high for different ranking groups, assuming equal ranking for inhalation and dermal exposure. For example: 3000 mg/70 kg = 42.8 mg /kg/day;  3 mg/70 kg = 0.043 mg/kg/day.
	We will investigate this issue and use the correct data in the further process.	
3	2011/03/25	Other contributor
CEFIC / Allylics REACh consortium
Belgium	Comments on 1. Manufacture: There are only three producers of 1,2,3-Trichloropropane in Europe. This substance is a co-product of the manufacture of higher value substances. Thus, manufacturers try to reduce the unintentional formation of 1,2,3-TCP to the lowest possible level by technical and organizational means. Manufacturing takes place under Strictly Controlled Conditions in closed systems. The releases from production are described correctly in the Annex XV dossier.

Comments on 2. Uses: In all uses of the 1,2,3-TCP the substance is completely converted into another chemical substance (intermediate use) or into a polymer (monomer use) in industrial environments. These processes also take place under Strictly Controlled Conditions (SCC). The manufacturers do not sell 1,2,3-TCP into any other uses. 
Incineration of 1,2,3-TCP is not a preferred use as the energy and chlorine recovery value is less than the value for other applications and increases the carbon footprint, i.e. CO2 emissions.

Comments on section 3. Releases from uses: Section 3 of the Annex XV dossier correctly describes the current situation regarding emissions from uses. All users of 1,2,3-TCP apply Strictly Controlled Conditions to ensure that emissions to the environment are minimized. 	Thank you for providing your opinion and supplementary information.	
2	2011/03/18	Company
Dow Deutschland Anlagengesellschaft mbH
Germany	Comments on 1. Manufacture: The 1,2,3-TCP is an unwanted by-product of the manufacture of Epichlorohydrin, a higher value substance. Thus, Dow continuously improves its manufacturing processes to reduce the unintentional formation of 1,2,3-TCP to the lowest possible level by technical and organizational means. Manufacturing takes place under Strictly Controlled Conditions in closed systems. 
The information about releases from production have been taken from Dow’s Chemical Safety Report and are described correctly in the Annex XV dossier.

Comments on 2. Uses: In all downstream uses of the 1,2,3-TCP, the substance is completely converted into another chemical substance (intermediate use) or into a polymer (monomer use) in closed systems exclusively in industrial environments. These processes also take place under Strictly Controlled Conditions (SCC). Dow does not sell 1,2,3-TCP into any other uses. 

Incineration of 1,2,3-TCP is not a preferred use as this increases the carbon footprint, i.e. CO2 emissions.

Comments on section 3. Releases from uses: Section 3 of the Annex XV dossier correctly describes the current situation regarding emissions from uses. All users of 1,2,3-TCP apply Strictly Controlled Conditions to ensure that emissions to the environment are minimized. 	Thank you for providing your opinion and supplementary information.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	1,2,3-trichloropropane is a chloroalkane identified as causative agent of occupational diseases.
see http://www.beroepsziekten.nl/sites/default/files/documents/Information-Notices-2009.pdf	Thank you for providing this information and reference.