REACH Registration: FAQs

Sr. No.

Questions and Answers

 

1.       

In what tonnage can the REACH registration be done, if the substance is pre-registered in 1-10 or 10-100 tonnage band?

The REACH registration can be done in any of the following tonnage bands as required by the company (even if the substance is pre-registered in a lower tonnage band).

·        1-10 tons/ year

·        10-100 tons/ year

·        100-1000 tons/ year

·        1000+  tons/ year 

 

2.       

If exports above 100 tons are envisaged for a substance pre-registered in 10-100 tpa, then what should be done?

If a possibility of exceeding the pre-registered tonnage band is foreseen, then the company has to proceed for registration in the higher tonnage band applicable before exporting the substance above the tonnage threshold. 

 

3.       

If the registration is done with the lower tonnage band and it has to be changed to higher band at a later date, then what would be the costs involved?

If registration is done in the lower tonnage bandnow and needs to be upgraded to higher tonnage at a later date, then the company shall have to pay the following fees as a result of tonnage upgradation:

  • Difference in the LoA fees applicable at that point of time
  • Difference in ECHA fees as applicable as a result of tonnage upgradation

4.       

What will be the fee involved for REACH Registration?

The total cost varies – the Registration cost includes – Data cost (including Technical Dossier and Chemical safety Assessment), ECHA Fee (fixed for the Size of the company and tonnage band used for registration); Individual Dossier preparation cost; Substance Identification (Spectral details); and finally the Registration Facilitation fee. The variation in total cost is primarily because of the data cost (including technical dossier and CSR) all other costs are mostly standardized.

 

5.       

What is the Letter of Access (LOA) fees for and can any discount be availed on it?

Kindly note that LOA cost is a compensation fees that a company (EU as well as non EU companies) will have to pay to the Lead for the cost which they have already incurred for submission of the Lead dossier. Your company would be paying this compensation fees in order to access the data for REACH registration without which it will not be possible to export beyond the last deadline of 31st May 2018.

LOA cost is not negotiable and is transferred by the OR as actuals to the Lead. 

 

6.       

Why is there a variation in LOA cost for different substances?

The cost of registration is different for each chemical, as the same is dependent on the total cost incurred by the Lead Registrant for complete dossier preparation and also on the number of SIEF members registered till date. 

 

7.       

Is the Registration fees (LOA + ECHA fees + facilitation charges) a recurring expense?

Registration is a onetime activity and the fees (LOA + ECHA fees + facilitation charges) is a one-time expense for the final registration of a substance.

The recurring expense post-registration would be the Annual Maintenance Fees (AMF) of the Only Representative. 

 

8.       

How much time is required for the registration process to be completed?

Ittakes 3 – 5 months to finalize a registration – if substance is already registered by the Lead Registrant,

In case the Lead Registrant has not yet registered then we will first have to wait for the Lead to register following that we can then process our registration. 

 

9.       

How much time is required for getting the Letter of Access details from the Lead Registrant?

Inorder to provide the LOA cost details in time,the OR needs to collect the information from the Lead Registrant (which is a time consuming activity). This process in some cases takes more than 6 month time period, since they do not respond to initial mails and the OR has to send repeated reminders to receive the cost to be shared by the client company. 

 

10.    

What type of Data is required for REACH registration and from where can be get all the Data?

The data requirement for registration is dependent on the tonnage of registration.

We need about 50 data endpoints, these includes Phys-Chem characterization, Eco-toxicological endpoint; environmental fate endpoints, and toxicology endpoints.

If there is already a Lead Registrant for the substance, it’s the Lead’s responsibility to compile the data.

In case where there is yet no Lead and no one is claiming that position, then the Registrant itself has to consider the role of Lead, all studies (Toxicology; Ecotoxicology) is typically to be performed in OECD GLP Laboratories. 

 

11.    

If LR is not there and if we take up the LR position, what are pluses and minuses of becoming LR for any substance?

If you will be the only company who has registered the substance then all European buyers will be dependent on you after June 2018 for the above mentioned substance.