ECHA webinar: QSARs, waiving information requirements, read-across, categories and QSARs

ECHA webinar: QSARs, waiving information requirements, read-across, categories and QSARs

You can see it here: http://echa.europa.eu/news/webinars_en.asp

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

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

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.

ECHA newsletter about uses

LESS THAN TWO MONTHS LEFT TO DEADLINE FOR USERS OF CHEMICALS TO INFORM SUPPLIERS

There are less than two months left for the Downstream Users of chemicalsubstances to inform their suppliers of the use they make of the substance.The deadline, 30 November 2009, applies only if the substance needs to beregistered before 1 December 2010.

As a user of a chemical (Downstream User) you should inform your suppliers about your useof a substance if you want the supplier to consider your use in relation to his registration.Before informing your supplier, you are advised to check the use mappings prepared by yourindustry association, and/or any communication from your supplier about the uses he intendsto cover.
Alternatively, you can assess later the use and fulfil the related duties yourself.

The advantage of communicating your use in time to your supplier is that your conditions ofuse are then more likely to be covered by your supplier’s Exposure Scenario, as theregistrant of the substance will have to take account of your use in preparing the ChemicalSafety Assessment. You then can expect your use to be an identified use and have anExposure Scenario covering your conditions of use, unless the registrant cannot support theuse. If the registrant cannot support your use for reasons of protection of human health or theenvironment, both the Downstream User and the European Chemicals Agency need to benotified.

If you do not communicate your use and it is not covered by your supplier’s ExposureScenarios, you will eventually need to prepare a Chemical Safety Assessment yourself oncethe substance has been registered.You need to provide your information in writing to your supplier on both the use and theconditions under which the substance is used.

ECHA has published a Fact Sheet that provides background information and further detailsabout the Downstream Users’ right to inform their suppliers of the use they make of thesubstance (see further information).

In addition, there is REACH guidance available, andtools have been developed by industry to help you. Your industry association may also beable to assist.

Links to background information are available overleafECHA/NA/09/19 News Alert:

Further informationREACH GuidanceGuidance for Downstream Users (chapters 4, 6, 7 and 8):http://guidance.echa.europa.eu/docs/guidance_document/du_en.htm?time=1254330774

Guidance on information requirements and chemical safety assessment Chapter R.12: Usedescriptor systemhttp://guidance.echa.europa.eu/docs/guidance_document/information_requirements_r12_en.pdfREACH

Fact SheetDownstream Users – How To Make Uses Known To suppliers:http://echa.europa.eu/doc/reach/reach_factsheet_du_en.pdfIndustry guidance and tools.

The Libraries section of the Cefic (European Chemical Industry Council) website contains an overview of Downstream Users’ use mapping activities, and links to the Downstream Users’tables of uses can be consulted at:http://www.duccplatform.org/activities/use_and_exposure_info.htmlhttp://cefic.be/en/reach-for-industries-libraries.html

Guidance on managing use communication in the supply chain developed by Cefic can beconsulted at:http://cefic.be/Files/Publications/Guidance_Use_and_ES_dvlpt_and_SCCm.dochttp://cefic.be/templates/shwPublications.asp?HID=750&T=806

The Downstream Users of Chemicals Coordination group (DUCC) member associations areusing the DUCC template for describing uses and providing basic Operational Conditions /Risk Management Measures. They have worked with Cefic to ensure respective templatesare complementary.

The DUCC UseR template (empty) can be found on the recentlyupdated DUCC website at:http://www.duccplatform.org1ECHA does not endorse tools or guidance developed by industry. Please contact the relevant industryassociation for further information about these tools. And keep also in mind that your own industry associationmay have additional guidance and tools.

Authority checks Only Representatives in Hungary

The authority started to check the compliance with REACH regulation in Hungary.
On the 18th of September I passed the authority checking as a REACH Only representative.

They checked:

1. the pre-registration reports
2. up-to-date information on customers sold to
3. Hungarian and English MSDSs
4. letter to the customers about appointment of an OR

The Hungarian competent authority is good at REACH, they got a good training.
What about the checking of REACH in other EU countries? Please share with us your experience.

Agnes Botos
REACH consultant
Phone: 36- 1 -9502710
Mobil: 36-20-2205737
Skype: agnes.botos
E-mail: agnes.botos@gmail.com
Link: http://www.reachexpert.eu/

REACH database -REACH softwares

Dear all,

I like to follow what kind of REACH softwares are available in the market, since many times I need to recommend a good REACH software for my customers.
I had the opportunity to see a presentation from a French company called RimaOne this week.
After the presentation I felt that their software is perfect for bigger companies.
The program looked quite user friendly, and they are able to fit it to the company's demand in few weeks, which is a huge advantage. If you are struggling with collecting uses , or need to send and save many customer questionnaires, then this tool looks prefect for you. Anyway, please check this link if you are interested in: http://rimaone.free.fr/R1_Demo%20SCC(No%20Sound).wmv and I will send you the contact person name at Rima One.

Please let us know if you know other good REACH software companies as well. Lets put them to this blog so my customers can choose.