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

36

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 reach-clp@hsa.ie