Notification of Substances in Articles · 2011-05-06 · Notification of Substances in Articles...
Transcript of Notification of Substances in Articles · 2011-05-06 · Notification of Substances in Articles...
Notification of Substances in Articles
Majella Cosgrave and Roseleen Murphy
IBEC 5th May 2011
Overview Session 1
Article definition
Duties in relation to articles
Duty to register substances in articles
Duty to Notify
SVHCs and the Candidate List
Who must notify and when
Duty to communicate
SVHCs and Authorisation
Article
“An object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition”
Eg: furniture, clothes, vehicles, electronics
Function means the basic principle determining use of the object
Shape, surface and design means physical appearance; more relevant than chemical composition
REACH duties in relation to articles
Article 7(1) Duty to register
Article 7(2) Duty to notify
Article 33 Duty to Communicate
Duty to register
Article 7(1) of REACH
Producers and importers of articles shall submit registration to ECHA if substance is:
present in articles > 1t/a per producer/importer
and
Intended to be released under normal conditions of use
Duty to notify
Article 7(2) of REACH
Producers and importers of articles shall notify substance on the candidate list to ECHA if the substance is:
present in articles > 1t/a per producer/importer
and
present in article above concentration of 0.1%
Duty to notify
If substance is:
identified as SVHC
included on ECHA‟s candidate list
present in article produced or imported
may be a duty to notify
Duty to notify
1 tonne per annum per producer/importer per year - refers to total amount of a substance in all articles produced/imported by that producer/importer
Threshold of 0.1% applies to the entire article, as produced or imported
Duty also applied to packaging material; needs to be assessed separately
Exemptions from duty to notify
Notification not required if:
Exposure to humans and environment can be excluded during normal conditions of use, including disposal
Must be able to demonstrate that SVHC does not come into contact with humans/envt
Substance already registered for that use (ie process by which is included in article)
Any registration, same/other supply chain
Same substance and use covered in dossier
SVHCs
Substances of very high concern
Identified in accordance with criteria in article 57 of REACH
CMRs
PBTs or vPvBs
Substances of equivalent concern
Proposed by ECHA/Member States
Agreed by ECHA‟s Member State Committee
Included on candidate list
Candidate List
List of identified SVHCs
Currently 46 substances on list
Added to ~ twice yearly by ECHA
Public consultations (run by ECHA)
Maintained on ECHA websitehttp://www.echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
Registry of intentions on ECHA website –substances that may be identified as SVHCshttp://www.echa.europa.eu/chem_data/reg_intentions_en.asp
Duty to notify - who and when
Article importers (from outside EU) and EU article producers
Notification to be made at latest 6 months after substance on CL; starting 1st June 2011
Substances on list before 1st Dec 2010, deadline is 1st June 2011
Substances on list on/after 1st Dec 2010, notification must be submitted no later than 6 months after inclusion
Obtaining information on SVHCs in articles (i)
Need to know if, and in what concentration, SVHC present in article
Information via supply chain is key
Info in SDSs of substances/mixtures (useful to article producers)
Exposure scenarios – will cover incorporation of substances into articles and resulting life cycle stages of substance (useful to article producers and article 33 duties)
Obtaining information on SVHCs in articles (ii)
Proactive requests for information up the supply chain
May not need exact composition
Exclude/limit presence of substances on candidate list
Perhaps a guarantee from supplier that substances not used in production of products/used below certain conc. limit
Perhaps include criteria in supply contracts
Obtaining information on SVHCs in articles (iii)
Other means of obtaining information:
Sector knowledge
Publicly available information (Appendix 4 in guidance)
Chemical analysis of article (appendix 5 in guidance) – (generally not recommended as preferred route as costly, difficult and may yield ambiguous results)
Duty to Communicate
Article 33 of REACH
Aim: sufficient information passed down supply chain to ensure safe use of article
Immediate duty, once substance added to candidate list
Article 33 duties
33(1); supplier of article (containing SVHC at >0.1% w/w) to give recipient sufficient information to allow safe use of article
Recipient: industrial or professional user, including distributor, excluding consumer
If no particular information relevant, then substance name to be provided as minimum
33(2); info to be provided to consumer upon request, within 45 days
Article 33 duties
Information to be supplied free of charge
No tonnage trigger
Threshold concentration (0.1%) applies to entire article as supplied
Packaging to be treated as separate article
Date of supply of article is relevant date –will apply to articles produced/imported before substance on CL, but supplied after inclusion of substance on the CL
What to communicate
Risks arising from SVHC in article to be identified to determine what info to be provided to user to allow safe use of article
Can‟t depend on how available the info is; can‟t assume name of substance sufficient
Considerations:
Downstream life cycle stages
Potential routes of exposure
Hazards of the SVHC for human health and envt
Appropriate protection measures
How to communicate
REACH does not specify format
Must be readily available to recipient
Possible formats:
Modification of existing documents
Information on labels
Links to website with up-to-date info
Standard formats developed by industry associations
SVHCs and authorisation
Substances on candidate list may be prioritised by ECHA for authorisation and included in Annex XIV
First Annex XIV published; 6 substances http://www.echa.europa.eu/reach/authorisation_under_reach/authorisation_list_en.asp
Applications and sunset dates given
Expected to be updated yearly; 2nd
recommendation made; 3rd one end of year
Applications can now be submitted
Session 2 OverviewDossier Preparation and Submission
1. Identify the substance(s) in article (SVHC)
2. Determine the % concentration and tonnage range of the SVHC
3. Establish whether a Registration has been submitted for that use
4. Gather the Required Information
5. Create the Notification Dossier
6. Complete Pre submission checks
7. Submit the Dossier to ECHA
1. Identify the Substance
Contact your supplier for substance profile of imported articles or mixtures
Cross check against the Candidate List
Up to date Candidate List Available
2. Calculate the Concentration
SVHC must be present in 0.1% w/w and at 1 t/yr
Based on the entire article
Tonnage calculated per year
2. Calculate the Tonnage
Year: the calendar year for which the tonnage calculation has been made
If article produced/imported for 3 consecutive years, the tonnage will be the average produced/imported during these 3 full years
3. Establish if Registered
A Registration under Article 6 or 7(1) including use of substance in the Article has been submitted
Contact your supplier or trade organisation to establish
Check the ECHA public dissemination website
If a Registration exists for that use – no need to notify
Document Evidence
Company Imports belt buckles from outside the EU
Is the object an Article?
Yes
Does the article contain a SVHC listed on the CL? Yes (supplier indicated conc. of 0.3% w/w)
Does the SVHC meet the threshold conc?
Yes, at 0.3%w/w
Duty to inform recipients under Article 33
Determining the Obligation to Notify Example
Determining Obligation to Notify Example
Is the SVHC imported at > 1t/yr in the articles?
Import quantity of buckles=13M units
1 buckle = 100g
0.3g x 13,000,000 = 3.9 t/yr
YES
Has the substance been registered for that use?
No
Can exposure to humans of the environment be excluded during normal or reasonably foreseeable conditions of use?
No, given the use of the buckle
Conclusion: Notification is required
4. Gather the Required Information
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
Classification and Labelling
Manufacture, use and exposure3.2 Estimated quantities
3.3 Sites
3.4 Form in the supply chain
3.5 Identified uses
5. Create the Notification Dossier
Download Substance Dataset from CL
Import substance dataset & Create Notification Dossier
Export Dossier
Submit Dossier to ECHA
The Candidate
List
IUCLID 5
IUCLID 5 is the tool for industry to fulfill their REACH requirements
Available free of charge
The only tool for preparing the dossier
Use IUCLID 5.3
Icons Explained
Legal Entity: Imported from REACH-IT LEO Legal Entity Site
Substance Dataset Reference Substance
Repeatable Block (hide; move block down; up; create; delete)
Golden Link: links information from local and downloaded inventories
Magic wand: allows you change information in automatically filled boxes
Mixture Dataset
Paper clip: allows you to attach files (word processing or pdf)
Confidentiality flag: fields that you can hide from public dissemination (cost)
LEO Synchronisation
If you have signed-up in REACH-IT but have not yet synchronised IUCLID 5 with REACH-IT you must:
1. Login on the REACH-IT webpage
2. Download from REACH-IT the company information (LEO)
3. Upload the LEO in your IUCLID 5 application (during installation)
Gather the Required Information
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
Classification and Labelling
Manufacture, use and exposure3.2 Estimated quantities
3.3 Sites
3.4 Form in the supply chain
3.5 Identified uses
Pre-Filled Data from the ECHA website
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
Classification and Labelling
Manufacture, use and exposure3.2 Estimated quantities
3.3 Sites
3.4 Form in the supply chain
3.5 Identified uses
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Pre-filled substance Datasets
Import substance dataset
Select the substance dataset to be imported
Update substance dataset
Select Notification SIA
Sections to be filled in IUCLID 5
Remaining Sections to be filled in IUCLID 5.3
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
Classification and Labelling
Manufacture, use and exposure3.2 Estimated quantities
3.3 Sites
3.4 Form in the supply chain
3.5 Identified uses
Section 1.1 Identification
Required under Article 7(4)
Identity and contact details of the article producer or importer. The Legal Entity Details
Identity of Substance Composition included in pre-filled datasets
Role in the Supply Chain. Tick box, Manufacturer or Importer of Articles
Legal Entity and Role
Contact Details
Insert Company Name
Contact for person
responsible for the
submission
1.2 Substance Composition
Note the information on Substance Composition is included in the Pre-
filled datasets on Candidate List once downloaded. This information is
sufficient and there is no need to provide any further information. If you
agree with the pre-filled information ECHA recommend that you skip this
section. However if you have more detailed information you may include
here.
Section 1.3 Identifiers
Section 1.3 Identifiers
Add the registration number for the substance in the article where available
Article Importers may not have access to the Registration Number
Article Producers should check SDS
Section 1.3 Identifiers
In Regulatory programme identifier box complete
•Select ‘other’ as regulatory programme
•Specify number in the ID field
Section 2 Classification and Labelling
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
Classification and Labelling
Note the information on Substance Classification & Labelling is included in
the Pre-filled datasets on Candidate List once downloaded. This information
is sufficient and there is no need to provide any further information. If you
agree with the pre-filled information ECHA recommend that you skip this
section.
Section 3 Manufacture, Use and Exposure
General Information1.1 Identification
1.2 Composition
1.3 Identifiers
Classification and Labelling
Manufacture, use and exposure3.2 Estimated quantities
3.3 Sites
3.4 Form in the supply chain
3.5 Identified uses
3.2 Estimated Quantities
3.3 Sites
Article Producers Only need to complete this section
To include a production site in the dataset, must create the site under the same legal entity
Section 3.4 Form in the Supply Chain
Tick the box
Substance in
Article
Include a
Description of
the article in
free text
The tonnage
range of the
substance at a
minimum
Note: Ensure that information on uses is consistent with section 3.5
3.5 Identified Uses
Provide information on the uses and technical function of the article
Describe the use during its service life or use phase
Recommended to base the description on the Use Descriptor System
Use Descriptor System
Catalogue of known uses
by workers in an industrial setting
by professional workers
by consumers
Must enter information for all 3 uses as appropriate
Details of the Descriptor system found Chp. 12 Guidance for Information Requirements
Sections to be completed
Identified Use (IU) Number
Manually assign where article has multiple uses
Identified Use (IU) Name: Concise, descriptive and consistent with section 3.4 Eg. „Use of computer cables‟
Environmental Release Category (ERC)
Article Categories (AC)
Section 3.5 Identified Uses
Create the Dossier
On the IULCID Main Page select „Update‟ from Substance
Select the substance you want
Right Click and select „Create Dossier‟
Create the Dossier
6. Complete Pre-submission Checks
ECHA will perform completeness check and will not accept dossier if errors or omissions
Run check on the dossier using the Technical Completeness Check (TCC) Tool
Select the Dossier right click and Run TCC
Running the TCC Tool
Any errors will show up in a report
Correct errors and run TCC again
Complete when no further errors arise
Exporting your Dossier
Export Dossier to PC when no more
errors occur
Prepare for submission in REACH IT
7. Submit dossier to ECHA
Log in to REACH IT
Select „Submit Registration /notification from the menu
Select Substance in article notification
Requested to agree with a declaration re information and company size correctness
REACH IT Sign Up
Select SIA Notification
Company Size declaration
Upload your Notification
Confirm Submission
Receive Your Reference Number
Reference Number will be located in your Internal Messaging system
Post Submission
Follow progress of submission
ECHA will perform Business Rules Check
Once submission has passed receive a Notification Number
A submission failure will be communicated via internal RIT message
Download the submission report for accurate reason for failure
Correct and re submit dossier
Guidance & Help
Data Submission Manual Part 20
ECHA Webinar 19th May live web-streaming available on ECHA website
ECHA Guidance for Substances in Articles
SIA web-pages on ECHA website
Helpdesk [email protected]