ECHA webinar: QSARs, waiving information requirements, read-across, categories and QSARs
You can see it here: http://echa.europa.eu/news/webinars_en.asp
2010. január 9., szombat
ECHA webinar: Robust study summaries, weight of evidence approach and in vitro data
ECHA webinar: Robust study summaries, weight of evidence approach and in vitro data
You can see it here: http://echa.europa.eu/news/webinars_en.asp
You can see it here: http://echa.europa.eu/news/webinars_en.asp
Submission of C&L notification(s) as a group of Manufacturers/Importers is possible
Please read or view the following CLP (GHS) presentation preapred by ECHA and presented on the Dec. 7 2009 in Helsinki on the Stakeholder Day.
http://echa.europa.eu/doc/press/events/stks_day_20090712/3rd_stk_day_pres_it_tools_classification_labelling.pdf
Important part of the presentation:
Different CLP notification submission tools will be available in 1st Q 2010. :
⇒ IUCLID 5 (Wait for IUDLID 5 5.2 version!!!!)
⇒ Online creation and submission of C&L for SMEs
⇒ XML creation and Bulk Submission for company withmany notifications
• Specification and management of “group ofManufacturers/Importers”
Submission of C&L notification(s) as a group of Manufacturers/Importers is possible !!!! GREAT news for industry! Less job for industry!!!!
"A group of manufacturers or importers can be one of the following:
- a Corporate company with different legal entities
- several companies that have no specific links between each other
- a SIEF
- a Joint Submission …that agree on a common C&L for the same
http://echa.europa.eu/doc/press/events/stks_day_20090712/3rd_stk_day_pres_it_tools_classification_labelling.pdf
Important part of the presentation:
Different CLP notification submission tools will be available in 1st Q 2010. :
⇒ IUCLID 5 (Wait for IUDLID 5 5.2 version!!!!)
⇒ Online creation and submission of C&L for SMEs
⇒ XML creation and Bulk Submission for company withmany notifications
• Specification and management of “group ofManufacturers/Importers”
Submission of C&L notification(s) as a group of Manufacturers/Importers is possible !!!! GREAT news for industry! Less job for industry!!!!
"A group of manufacturers or importers can be one of the following:
- a Corporate company with different legal entities
- several companies that have no specific links between each other
- a SIEF
- a Joint Submission …that agree on a common C&L for the same
14 new substances on candidate list
14 new substances of very high concern to be added to the Candidate List: All together 29 chemicals. You can check it on ECHA webpage:
http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
NEW candidate list
SUBSTANCE NAME
EC NUMBER
CAS NUMBER
1
Anthracene oil
292-602-7
90640-80-5
2
Anthracene oil, anthracene paste, distn. lights
295-278-5
91995-17-4
3
Anthracene oil, anthracene paste, anthracene fraction
295-275-9
91995-15-2
4
Anthracene oil, anthracene-low
292-604-8
90640-82-7
5
Anthracene oil, anthracene paste
292-603-2
90640-81-6
6
Pitch, coal tar, high temp.
266-028-2
65996-93-2
8
Aluminosilicate RefractoryCeramic FibresAluminosilicate RefractoryCeramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008, and fulfil the two following conditions:a) Al2O3 and SiO2 are present within the following concentration ranges:• Al2O3: 43.5 – 47 % w/w,and SiO2: 49.5 – 53.5 % w/w,or• Al2O3: 45.5 – 50.5 %w/w, and SiO2: 48.5 – 54 % w/w,b) fibres have a length weightedgeometric mean diameter lesstwo standard geometric errors of6 or less micrometers (μm).
_
_
9
Zirconia Aluminosilicate, Refractory Ceramic Fibres Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008, and fulfil the two following conditions:a) Al2O3, SiO2 and ZrO2 arepresent within the followingconcentration ranges:• Al2O3: 35 – 36 % w/w,and• SiO2: 47.5 – 50 % w/w,and• ZrO2: 15 - 17 % w/w,b) fibres have a length weightedgeometric mean diameter lesstwo standard geometric errors of6 or less micrometers (μm).
_
_
10
2,4-Dinitrotoluene
204-450-0
121-14-2
11
Diisobutyl phthalate
201-553-2
84-69-5
12
Lead chromate
231-846-0
7758-97-6
13
Lead chromate molybdate sulphate red (C.I. Pigment Red 104)
235-759-9
12656-85-8
14
Lead sulfochromate yellow (C.I. Pigment Yellow 34)
215-693-7
1344-37-2
15
tris(2-chloroethyl)phosphate
204-118-5
115-96-8
Old candidate list
SUBSTANCE NAME
EC(CAS No)
1
Triethyl arsenate
427-700-2
2
Anthracene
204-371-1
3
4,4'- Diaminodiphenylmethane (MDA)
202-974-4
4
Dibutyl phthalate (DBP)
201-557-4
5
Cobalt dichloride
231-589-4
6
Diarsenic pentaoxide
215-116-9
7
Sodium dichromate
234-190-3(7789-12-0 and 10588-01-9)
8
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
201-329-4
9
Bis (2-ethylhexyl)phthalate (DEHP)
204-211-0
10
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified:
247-148-4 and 221-695-9
11
Alpha-hexabromocyclododecane Beta-hexabromocyclododecaneGamma-hexabromocyclododecane
(134237-50-6)(134237-51-7)(134237-52-8)
12
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
287-476-5
13
Bis(tributyltin)oxide (TBTO)
200-268-0
14
Lead hydrogen arsenate
232-064-2
15
Benzyl butyl phthalate (BBP)
201-622-7
7 Substances recommended for the Annex XIV:
SUBSTANCE NAME
EC(CAS No)
3
4,4'- Diaminodiphenylmethane (MDA)
202-974-4
4
Dibutyl phthalate (DBP)
201-557-4
8
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
201-329-4
9
Bis (2-ethylhexyl)phthalate (DEHP)
204-211-0
10
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified:
247-148-4 and 221-695-9
12
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
287-476-5
15
Benzyl butyl phthalate (BBP)
201-622-7
Tasks related to candidate list:
1. Authorisation
Substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an authorisation.
2. Notification requirement
Notification requirement and registration requirement are two different tasks. You have a notification requirement to the European Chemical Agency, if any candidate listed substance can be found in the given article at a quantity exceeding 1 ton, and at a weight concentration exceeding 0.1 percent. The first notification deadline is 1 June 2011. By this date the company should prepare an agenda of how it will test the presence of the candidate listed substances in its end products. I would like to emphasize that the 0.1 weight percentage is calculated for the entire article and not its components.If you have a candidate listed chemical substance in your article, then your best choice is to replace this substance with a less hazardous chemical substance by latest 1 June 2011.You can find the candidate list at the following link:http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
3. Communication requirement:
If any of the chemical substances in the given candidate list can be found in the article at a concentration exceeding 0.1 weight percentage (w/w), then the manufacturer /importer of the article must indicate in a statement for their supply chain in the next supply, and at the request of the consumers, that the article contains chemical substance included in the candidate list. The related information must be provided to the consumers free of charge, within 45 days of receiving the request. Therefore the main objective is to exclude all chemical substances from the articles, which are found in the candidate list, in order to avoid having to comply with the additional requirements. I would like to raise your attention to the fact that the addition of further substances to the candidate list will depend on the results of the toxicological tests. It is expected that a new list will be issued every year.
http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
NEW candidate list
SUBSTANCE NAME
EC NUMBER
CAS NUMBER
1
Anthracene oil
292-602-7
90640-80-5
2
Anthracene oil, anthracene paste, distn. lights
295-278-5
91995-17-4
3
Anthracene oil, anthracene paste, anthracene fraction
295-275-9
91995-15-2
4
Anthracene oil, anthracene-low
292-604-8
90640-82-7
5
Anthracene oil, anthracene paste
292-603-2
90640-81-6
6
Pitch, coal tar, high temp.
266-028-2
65996-93-2
8
Aluminosilicate RefractoryCeramic FibresAluminosilicate RefractoryCeramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008, and fulfil the two following conditions:a) Al2O3 and SiO2 are present within the following concentration ranges:• Al2O3: 43.5 – 47 % w/w,and SiO2: 49.5 – 53.5 % w/w,or• Al2O3: 45.5 – 50.5 %w/w, and SiO2: 48.5 – 54 % w/w,b) fibres have a length weightedgeometric mean diameter lesstwo standard geometric errors of6 or less micrometers (μm).
_
_
9
Zirconia Aluminosilicate, Refractory Ceramic Fibres Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008, and fulfil the two following conditions:a) Al2O3, SiO2 and ZrO2 arepresent within the followingconcentration ranges:• Al2O3: 35 – 36 % w/w,and• SiO2: 47.5 – 50 % w/w,and• ZrO2: 15 - 17 % w/w,b) fibres have a length weightedgeometric mean diameter lesstwo standard geometric errors of6 or less micrometers (μm).
_
_
10
2,4-Dinitrotoluene
204-450-0
121-14-2
11
Diisobutyl phthalate
201-553-2
84-69-5
12
Lead chromate
231-846-0
7758-97-6
13
Lead chromate molybdate sulphate red (C.I. Pigment Red 104)
235-759-9
12656-85-8
14
Lead sulfochromate yellow (C.I. Pigment Yellow 34)
215-693-7
1344-37-2
15
tris(2-chloroethyl)phosphate
204-118-5
115-96-8
Old candidate list
SUBSTANCE NAME
EC(CAS No)
1
Triethyl arsenate
427-700-2
2
Anthracene
204-371-1
3
4,4'- Diaminodiphenylmethane (MDA)
202-974-4
4
Dibutyl phthalate (DBP)
201-557-4
5
Cobalt dichloride
231-589-4
6
Diarsenic pentaoxide
215-116-9
7
Sodium dichromate
234-190-3(7789-12-0 and 10588-01-9)
8
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
201-329-4
9
Bis (2-ethylhexyl)phthalate (DEHP)
204-211-0
10
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified:
247-148-4 and 221-695-9
11
Alpha-hexabromocyclododecane Beta-hexabromocyclododecaneGamma-hexabromocyclododecane
(134237-50-6)(134237-51-7)(134237-52-8)
12
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
287-476-5
13
Bis(tributyltin)oxide (TBTO)
200-268-0
14
Lead hydrogen arsenate
232-064-2
15
Benzyl butyl phthalate (BBP)
201-622-7
7 Substances recommended for the Annex XIV:
SUBSTANCE NAME
EC(CAS No)
3
4,4'- Diaminodiphenylmethane (MDA)
202-974-4
4
Dibutyl phthalate (DBP)
201-557-4
8
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
201-329-4
9
Bis (2-ethylhexyl)phthalate (DEHP)
204-211-0
10
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified:
247-148-4 and 221-695-9
12
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
287-476-5
15
Benzyl butyl phthalate (BBP)
201-622-7
Tasks related to candidate list:
1. Authorisation
Substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an authorisation.
2. Notification requirement
Notification requirement and registration requirement are two different tasks. You have a notification requirement to the European Chemical Agency, if any candidate listed substance can be found in the given article at a quantity exceeding 1 ton, and at a weight concentration exceeding 0.1 percent. The first notification deadline is 1 June 2011. By this date the company should prepare an agenda of how it will test the presence of the candidate listed substances in its end products. I would like to emphasize that the 0.1 weight percentage is calculated for the entire article and not its components.If you have a candidate listed chemical substance in your article, then your best choice is to replace this substance with a less hazardous chemical substance by latest 1 June 2011.You can find the candidate list at the following link:http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
3. Communication requirement:
If any of the chemical substances in the given candidate list can be found in the article at a concentration exceeding 0.1 weight percentage (w/w), then the manufacturer /importer of the article must indicate in a statement for their supply chain in the next supply, and at the request of the consumers, that the article contains chemical substance included in the candidate list. The related information must be provided to the consumers free of charge, within 45 days of receiving the request. Therefore the main objective is to exclude all chemical substances from the articles, which are found in the candidate list, in order to avoid having to comply with the additional requirements. I would like to raise your attention to the fact that the addition of further substances to the candidate list will depend on the results of the toxicological tests. It is expected that a new list will be issued every year.
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