A positive answer to each question indicates that you are on schedule with the REACH and CLP requirements. If a question is unclear to you or you want support for your REACH and CLP implementation, don’t hesitate to contact essenscia. Essenscia does not only help her members with REACH and CLP but has also projects to help downstream users and consultants.
For more information how essenscia can support you, please contact Aysel Karademir, tel. 02/238 98 65, akarademir@essenscia.be
- Progress 2010 registrations : These questions are also relevant for registrants with a later deadline but the joint dossier is due on 1 December 2010.
o Do you have updated information on the status of the registration dossier ?
If you don’t know the Lead Registrant or the Lead Registrant is not responsive to your requests, you can inform the ECHA about this.
The list of preregistered substances with (Candidate) Lead Registrants and the list of substances identified for registration in 2010 can be consulted on the ECHA website.
o Do you know when the Lead Registrant will submit the joint dossier ?
o Do you know when the Lead Registrant will freeze the information for the joint dossier ?
Be sure to communicate your registration intentions, substance information, uses (in case of a joint CSR) and concerns to the Lead Registrant prior to this cut‐off date. Check that your substance is covered by the chemical identification profile defined by the SIEF.
o Has the SIEF agreement been communicated ? Have you signed the agreement and/or do you know what to do in case that you have a later registration deadline ?
o Have the cost sharing rules been communicated ? Do you know how much, when and how you will have to pay for the joint dossier ? Do you know what you will get in return ?
o Have you started the individual part of your registration dossier ?
o Can payments of the registration fee be made within 2 weeks ?
Essenscia recommends to follow closely the SIEFs and add the current status of the SIEF to your REACH
Inventory: Lead Registrant, substance identification, agreement, progress joint dossier, C&L discussion, ….
- Have you updated your IUCLID version to IUCLID 5.2 ? For the latest version and plugins, see the website iuclid.echa.europa.eu
- Do you have substances that may be classified as “dangerous to the environment” or as CMR ?
Pay attention to unknown classifications due to lack of data, especially for the category “dangerous for the environment (N, R50/53)”. The registration deadline may move up to earlier deadline if found out that the substance should be classified as N, R50/53. This is also possible for CMR properties defined by self classification. Check with the SIEF if needed.
- Have you defined your communication strategy for the uses of your substances ?
o If you are a downstream user : Have you mapped the uses for all purchased substances and decided if and when communication is needed with your suppliers and customers ? Are you sure that your uses and the uses of your customers will be included in the registration dossier.
o If you are a manufacturer/importer : Have you prepared a detailed overview of the known uses and exposure scenarios and decided if further communication is needed with your customers ?
Verify with the SIEF if the CSA/CSR will be part of the joint dossier and if your uses will be covered. Check with your sector federation if common exposure scenarios are being developed.
- Secure that the OR is registering your imported substances. Do you have evidence of this on file ?
Try to communicate directly with the OR, not only with your supplier. The OR needs the actual list of imported quantities. Communicate the actual imported tonnage of 2009 to the OR.
- In case you act as OR for a non‐EU company : Are contracts in place clearly defining your role en responsibilities ?
- Do you have a system to keep your REACH Inventory (substances, tonnage, role, …) up‐to‐date ? Does this change any of your REACH obligations (e.g. registration deadline)?
- Include the REACH process in your standard business processes (procedure, training evidence, document control, …). Product Safety Management should become part of your existing management system.
- Did you check the presence of candidate list substances in imported and manufactured articles and did you communicate concentrations above 0,1% (w/w) to your customers ? Don’t forget that Belgium considers the 0,1%(w/w) limit per homogenous part.
Current candidate list contains 30 substances. Check the ECHA website for the full list.
- Did you include packaging materials in your inventory and checked REACH obligations for those materials ?
- Will all your SDSs be compliant with the REACH format by 1/12/2010 ? Don’t forget that SDSs for substances must have the CLP classification and labeling by that date. The current annex II (SDS format) of REACH will be revised soon (expected mid May 2010). Consider using already the new format for further updates. The draft of the extended SDS guidance is available on the ECHA website.
- Are you ready for an inspection by the Authorities ? Inspections have started !
Essenscia developed a self assessment tool to check compliance with the REACH regulation. All articles for which you can be penalized in Belgium including the level of the penalization are listed in the tool.
The tool is available on the esssenscia extranet.
- Get ready for CLP :
o Classification and labeling (according to the Dangerous Substance Directive or CLP) should be agreed in the SIEF before 1/12/2010 independent of the volume.
• Substances with later registration deadline – Are you following up how the SIEF is approaching this ? Do you want to become involved ?
• Substances for which you don’t have registration obligations – Is there a SIEF for these substances and do you want to participate in the SIEFs ?
o Remember that, as manufacturer/importer of a substance you will have to notify the classification and labeling of the substance to the ECHA by end 2010.
• Have you made an inventory o f the substances to notify ? Don’t forget the dangerous substances below 1 ton.
o Have you trained your employees on the new classification and labelling ?
o Have you reviewed the impact of the first ATP to the CLP regulation ? Implementation of this ATP is due 1 December 2010.
o Are you monitoring the new harmonized C&L proposals? (see Registry of Intention on the ECHA website)
Essenscia developed a tool to define classification and labeling of your substances and mixtures. The tool provides a summary of all the applicable rules in a condense spreadsheet and is available on the essenscia extranet.