Practical guidance regarding CBI claims on EU REACH

Sep. 26th, 2012
1515

In order to protect the business of companies in mainland of China from the damage caused by information publicly disseminated, the Reach24h Consulting Group repeatedly communicate the registration information with ECHA , and confirm the requirements of confidentiality claim. Reach24h Consulting Group will give an in-depth interpretation about the details of registration information, and share the updates about how to request for confidentiality claim with enterprises.

The guidance for dissemination of REACH registration information

Information that shall be publicly disseminated unless the registrant has submitted a confidentiality claim and ECHA has accepted that claim.

Item for which confidentiality is requested

Information contained in the confidential items

Degree of purity and/or identity of impurities or additives

(Degree of purity and/or identity of impurities or additives)
Relevant tonnage band (a total tonnage is calculated by summing data from all full registration dossiers in the joint submission, except those for which the tonnage band is claimed confidential.
A study summary or a robust study summary (data resource, study result type, year and study method, test results,
Information in the safety data sheet Registrant information(including OR, EU importer), registration number, PBT/vPvB assessment outcome, whether or not complete CSR
Trade name of the substance (confidentiality can be claimed on the trade name of the substance)
IUPAC name for non-phase in substances that are dangerous (confidentiality can be claimed on IUPAC name for non-phase in substances that are dangerous)

IUPAC name  for  dangerous  substances  used  as  intermediates, in scientific research  and  development  or  product  process  oriented research and development

(confidentiality can be claimed on IUPAC name  for  dangerous  substances  used  as  intermediates, in scientific research  and  development  or  product  process  oriented research and development )

The companies are allowed to claim some data as confidential business information (CBI) , including the identity of the registrant, the registration number of the registered substance and other items normally contained in a safety data sheet(SDS)

Registrant information: For EU manufacturer or importer, the information, such as LE name, full address and telephone number, will be disseminated unless they are claimed confidential.  For Only Representatives established in the EU and appointed by a non-EU entity, the information of importers, such as the name, full address and telephone number, will be disseminated unless claimed confidential, as well as information of ORs.

Registration number: the REACH registration number is in the format of 01-xxxxxxxxx-xx-xxxx. THE REACH registration number for each registrant will be disseminated in full unless claimed confidential; the REACH registration number will be partially disseminated where not claimed confidential but where there is a confidentiality claim on the legal entity name.

Other information: the information on the PBT/vPvB assessment will be disseminated, unless it is claimed confidential. This includes data from the endpoint study records and the endpoint summary.

From the endpoint summary the PBT assessment: overall result, justification and routes of exposure will be disseminated.

Impact of registration information released to enterprises from mainland of China

Different from the dissemination of information before that only focus on the chemical characteristic of substances, this dissemination of information refers to more information related with the company trade. The dissemination of information, to provide online access to the public, will not only influence the trade among the companies, but also change the whole environment of European chemical trade.

  • According to the ECHA, the information of manufacturers or suppliers from EU member states will be released unless the registrant submitted a confidentiality claim and ECHA accept it. This action is believed to divulge a trade secret.
  • According to ECHA, the registration numbers will be publicly disseminated in full unless they are claimed and approved as confidential. It is unavoidable that the registration number will be usurped by some companies who have not register on REACH.

How to claim confidential on registration information

If the companies from mainland of China do not expect the certain registration information to be publicly published on the website, they should request the Only Representatives (ORs) to update the registration dossiers, and to claim confidential on certain information. The documents to request confidentiality include 1) the justification that the information is CBI( confidential business information) 2) the justification of commercial value in protecting the information from being released. 3)the justification of the loss caused by dissemination of information about registrant or third part.

The deadline of confidentiality claims

From July 12 2012 to October 31 2012, the companies has nearly 3 months to submit the updated dossiers to claim confidential on certain information; ECHA will publish the information on its official website access to the public after the deadline unless claiming information confidential is accepted as valid. In order to realize the improvement and minimize the influence to the companies, ECHA released a new version of IUCLID5.4, and updated REACH-IT, the online platform to submit data and dossiers on chemicals, during July 6th 2012 to July 11th 2012.

The fee for claiming information confidential

The fee for claiming information derives from SDS, such as registration number, the identity of importer, OR confidential, is 3000 euro (joint submission will have 25% discount))According to Article10(a)(xi) of Regulation  (EC) No 1907/2006, the payment on different item for which confidentiality is claim is as follows:

Item for which confidentiality is requested

Cost of submission alone

Cost of joint submission

Comment

Degree of purity and/or identity of impurities or additives

€4,500

€3,375

company whose size is correspond to European SME standard can apply for discount on the payment
Relevant tonnage band

€1,500

€1,125

A study summary or a robust study summary

€4,500

€3,375

Information in the safety data sheet

€3,000

€2,250

Trade name of the substance

€1,500

€1,125

IUPAC name for non-phase in substances that are dangerous

€1,500

€1,125

IUPAC name  for  dangerous  substances  used  as  intermediates, in scientific research  and  development  or  product  process  oriented research and development

€1,500

€1,125

Should you have any problems with this newly-emerged CBI issue, please do not hesitate to contact us by sending email to info@reach24h.com

As the leader of chemical regulatory consultation in mainland of China,  REACH24H Consulting Group has provided global chemical compliance solutions to assist more than 400 companies to complete the EU REACH registration before 2012. REACH24H Consulting Group is ready to assist companies to prepare the confidentiality claims on registered substances, and submit the updated dossiers before the deadline.Our focus lies upon the following regulations:

  • REACH
  • China new chemical substance notification
  • GHS/CLP/SDS
  • Other regulation services

More information about this dissemination please click here