REACH 2013

31 May 2013 is the deadline for industry to register all phase-in substances manufactured or imported in the EU at and above 100 tonnes a year under REACH.

Here you will find key information to support you in your preparations for the 2013 registration.

You will also find links to all the steps of the registration process: from the formation of the Substance Information Exchange Fora (SIEFs) to data sharing, dossier preparation and online submission.

Timeline for successful submission

 
 

The key moments for a successful submission are explained below according to this timeline.

Compiling the information required for registration

  1. Substance identification, hazard information, data-sharing
    1. Substance identification and sameness of substance: confirm with the other pre-registrants that you have the same substance;
    2. Hazard information: collect all data available on the intrinsic properties of the substance to be registered;
    3. Data sharing: as part of a joint registration, gather and share existing information, consider alternatives to testing and answer any information request from within your SIEF.
  2. Uses: ensure you collect the uses of all your downstream users.
  3. Chemical safety assessment: carry out a chemical safety assessment in order to produce a chemical safety report based on the hazard information collected and knowledge on the uses.

Roles in the joint submission

  1. Lead Registrant: one registrant acting with the agreement of the other assenting registrant(s) who will submit the joint registration dossier with all information. ECHA recommends this is done at least two months before the legal deadline, i.e. by 31 March 2013.
  2. Members: other registrants who have confirmed their membership in the Joint Submission in REACH-IT have to submit their registration after the Lead Registrant, and by 31 May 2013.

What should I do?

General tasks

  • Check whether your substance is already registered
  • Take action according to your specific role as a Member or Lead Registrant (see below)
  • Collect the uses from your Downstream Users (DUs) before 31 May 2012 in order to include them in your chemical safety report. Inform your DUs of your intention to register
  • If you have not been active in REACH-IT for a long time, update your contact details so that SIEF members can contact you easily

Role specific actions

 

(Candidate) Lead Registrant (LR) of a phase-in substance to be registered for the first time in 2013

Actions

Be active now in your SIEF: engage in SIEF formation based on a substance sameness agreement and conduct a survey among the pre-SIEF members to collect information on registration intentions.

Propose yourself as the LR for the SIEF.

Make sure that all SIEF members are informed and participate in the process of exchanging, gathering and sharing existing information. You need to consider information needs, identify information gaps by gathering all available information and generate new data or propose testing strategies.

Ensure that the sharing of the information between all SIEF members is determined in a fair, transparent and non-discriminatory manner.

Agree on the classification and labelling of the substance.

Create the joint submission object (JSO) in REACH-IT and submit as the LR, the joint registration dossier at least two months before the legal deadline, by 31 March 2013 (recommended by ECHA).

Recommended steps

  1. Check if your substance has been registered.
  2. Inform ECHA of your nomination using the LR notification webform. If your substance is not already registered, ECHA will publish the EC/List number of your substance on the list of nominated LRs, representing active SIEFs for 2013.
  3. On your pre-SIEF page in REACH-IT: take the SIEF Formation Facilitator (SFF) role [F] and fill in the SFF box, indicating your contact details and reporting your progress within the SIEF; download the xml file to have up-to-date details of all pre-registrants and send a survey to all. Please note that the pre-SIEF data can be used only for registration purposes.
  4. Get organised to manage your SIEF (Communication, IT Tools etc.) and start the SIEF/Data sharing agreements negotiations.
  5. Ensure good communication and keep a record of all communications with all SIEF members.

 

Member registrant of a phase-in substance to be registered for the first time in 2013

Actions

Get active now in your SIEF: confirm your substance identity and your intention for the 2013 registration; contribute to the nomination of the LR and sign SIEF/Data sharing agreements.

Make sure that you, as a member, are informed and contribute to the process of exchanging, gathering and sharing existing information. You must respond to any request for information from other SIEF members.

Confirm your membership in the joint submission and submit your member dossier after the LR, by 31 May 2013.

Recommended steps

  1. Check if your substance has already been registered.
  2. Check the list of nominated LRs representing active SIEFs for 2013 (i.e. substances are not yet registered) to see if there is already a LR for your substance.
  3. Await the contact from the LR; if the LR does not make himself known to you, you may contact ECHA via the Helpdesk.
  4. On your pre-SIEF page in REACH-IT: check the SIEF Formation Facilitator (SFF) box for contact details of the LR; if no information is available, download the xml file to have up-to-date details to contact all pre-registrants. Please note that the pre-SIEF data can be used only for registration purposes.
  5. Engage actively in the SIEF and answer any requests for data.
  6. Ensure good communication and keep a record of all communications with all SIEF members.
Potential registrant of a phase-in substance to be registered for the first time by 2013, and currently the only interested registrant

Actions

Keep the other potential registrants informed on the steps you have taken towards registration of the substance. In case other registrants for 2013 appear, be transparent, fair and non-discriminatory with them in your SIEF and data-sharing negotiations.

Create the joint submission object (JSO) in REACH-IT and submit, as a LR for the substance, your registration dossier by 31 May 2013.

In the future, if new SIEF members want to join, you must respond to any email communication from them and offer them to join your joint submission.

Recommended steps

  1. Check if your substance has already been registered.
  2. Check the list of nominated LRs representing active SIEFs for 2013 (i.e. substances are not yet registered) to see if there is already a LR for your substance.
  3. On your pre-SIEF page in REACH-IT: download the (pre-SIEF page) xml file to have up-to-date contact details of all pre-registrants and get confirmation that they do not intend to register in 2013. Please note that the pre-SIEF data can be used only for registration purposes.
  4. If you have not yet taken the SIEF Formation Facilitator (SFF) role, indicated with a [F] in your pre-SIEF page, ensure you click the "Become facilitator" button.
  5. Make use of the SFF box to inform all pre-SIEF members of your contact details and registration activities.
New member registrant of a phase-in substance already registered

Actions

Make sure that the substance registered is the same as the one you want to register by 2013.

Get in contact with the existing Lead Registrant (LR) in order to enter into SIEF and data sharing agreement negotiations.

Join the joint submission object (JSO) in REACH-IT and submit your member dossier by 31 May 2013.

Recommended steps

  1. Check if you have already received any communication from the LR.
  2. On your pre-SIEF page in REACH-IT: check the SIEF Formation Facilitator (SFF) box for contact details of the LR; or download the xml file to have up-to-date details to contact all pre-registrants. Please note that the pre-SIEF data can be used only for registration purposes.
  3. Start data sharing/ SIEF agreements negotiations.
  4. Engage actively in the SIEF and answer any requests for data.
  5. Ensure good communication and keep a record of all email exchanges with all SIEF members.
Lead Registrant (LR) of a phase-in substance already registered

Actions

Be aware that you will be contacted by SIEF members who need to register the same substance by the upcoming deadlines.

Confirm to the (pre-)registrants that you will continue in the LR role.

As an LR you need to be efficient in your communication towards all SIEF member.

Ensure that you make all efforts in sharing the information with the new member(s) in a fair, transparent and non-discriminatory manner.

Recommended steps

  1. Ensure good communication, for example on your pre-SIEF page in REACH-IT by filling in the SFF box and also by contacting pro-actively by email all pre-SIEF members that have the 2013 deadline.
  2. Keep a record of all email exchanges with all SIEF members.
  3. Answer any request for information and data.
  4. Agree on the classification and labelling of the substance.

 

Active SIEFs for the 2013 deadline

ECHA publishes regularly a list of active SIEFs preparing for the next registration deadlines in 2013 and 2018, and especially, ECHA informs whether a lead registrant has initiated the SIEF formation and activities.

For the 2013 preparations, ECHA increases the amount of information published:  

  • The lead registrant name will be disclosed, if the lead registrant has allowed ECHA to do so. Note that as a consequence of agreeing to publish the name, the lead registrant can no longer claim it confidential in the registration dossier.
  • ECHA will systematically check whether the substance has been registered and will indicate whether a registration dossier has been submitted by the same lead registrant (who informed ECHA) or by a different (lead) registrant.

Lead registrants and candidate lead registrants who are active in their SIEFs are advised to inform ECHA of their nominations: 

Lead Registrant Nomination web form.

Download the list in the following formats: [PDF] [XLS]

Last update: 03/02/2012

Note: The list reproduces the information filled in by lead registrants in the web form.  If the company name is not mentioned for your substance, it means that the lead registrant has not authorised to publish its name.

Lead registrant nomination

The role of the lead registrant is laid down by REACH and it is mandatory for each SIEF.  

ECHA wishes to record your information regarding your substance and your SIEF. Additionally, if you authorise ECHA, your company name will be published on the list next to your substance information, and your contact details can be forwarded to the members of your SIEF members who contact ECHA to find you.

As the work within the SIEF progresses, the lead registrant is expected to keep ECHA regularly updated of any modification such as the change of lead registrant, the update of number of SIEF members, the confirmation of registration deadlines, etc.

This data is provided on a voluntary basis. ECHA will assume no responsibility regarding the possible confidentiality on the information. ECHA does not endorse or reject lead registrant nominations. ECHA holds no responsibility for, neither can it guarantee the accuracy or validity of, the information contained in the list. ECHA does not (and will not) edit the content provided.

How can ECHA support me?

The Agency will offer a special service for Lead Registrants and specific support for those among them that come from small and medium-sized companies.

Advice

ECHA Helpdesk provides technical support on ECHA's IT tools and advice related to registration and its various processes.

National helpdesks offer local support in your language.

Find in the Document Library any document published on ECHA's website, including guidance, manuals, questions and answers, and other support documents.

Training

ECHA organises webinars on specific topics of interest to the registrants, which can be followed in real time or on demand.

Creating a dossier

IUCLID website is a gateway to the IUCLID software with which you need to prepare the registration dossier.

Chesar, the CSR tool can help you with the Chemical Safety Assessment of the dossier.

ECHA's 2010 Evaluation Progress Report highlights the lessons learnt from the first registration deadline.

Submitting a dossier

The REACH-IT section explains how to submit a registration dossier to ECHA and the manuals that are relevant for the various steps of the process.

Keeping up-to-date

Subscribe to receive the weekly e-News and the bi-monthly ECHA Newsletter.

 

 

Final deadline

31 May 2013

Registration of phase-in substances manufactured or imported in the EU above 100 tonnes a year

 

Highlights