Member dossier  Information Requirements 

The registration dossier is the set of information submitted electronically by a registrant for a particular substance. Each registrant (manufacturer, importer or only representative) has to submit an individual dossier as part of the joint submission. This is known as a member dossier. 

member dossier mainly contains details regarding the identity of the manufacturer; the identity and purity of the substance (Spectral analysis); information on the manufacture and uses; exposure information for substances. 

Please note that in order to complete the member dossier preparation we require the below mentioned information: 

1.  Member dossier template along with spectral details– It lists all the information required for the preparation of a member dossier. The spectral details will be required for each substance.

·  UV, IR, NMR and GC/HPLC for organic substances  (all four spectral analysis are mandatory)and

·  XRD (X-Ray Diffraction diffractogram), XRF (X-ray fluorescence) or AAS (Atomic absorption spectra) for inorganic substances. 

2.   Sameness information sheet – It contains the information regarding the identity of the substance being registered including the typical purity range and structural details.

3.   The use profiles of the substance – we recommend that the same be obtained from each EU buyer of the substance so as to ensure that all the end-uses of the substance being registered are covered in the dossier.

4.   Letter of appointment on your company letter head – Official letter from the client appointing SSS as the OR for the purpose of REACH            registration.

5.   Tonnage band declaration– Calendar year wise information regarding the tonnage exported to EU after pre-registration. 

6.   SME Declaration for size of the company – It is required for the determination of the size of the company based on the criteria set out by ECHA for the purpose of REACH registration. The same has to be attested by the company’s Chartered Accountant (CA) as well. This is to ensure that the correct company size is considered during registration, as a discrepancy in company size, if detected at a later date, can lead to penalties by ECHA. 

7.   Transported Isolated Intermediate (TII)–In case the substance qualifies as an TII, a declaration for the substance would be required from each buyeron their letterhead in order to cover the tonnage of pre-registration.  

8.  The information sheet/ templates will be provided once a confirmation regarding the member dossier preparation is received.It will contain all the details required for successful REACH registration. If all the above mentioned information is compiled beforehand, the final step towards registration can be initiated as soon as your company confirms the LOA (Letter of access) cost from the Lead Registrant.