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REACH registration process

In the past few days, we have received quite a few inquiries regarding REACH registrations, and since most customers have similar questions, we decided to write a blog about the REACH registration process.


Who is required to have REACH registered substances?


Manufacturers and importers of substances at one tonne per year or more must collect information on the properties of those substances and communicate this information to ECHA through a registration dossier. Non-EU producers can achieve the requirements of REACH through a sole agent – only representative.


What are the steps of REACH registration?


1. SEND MAIL TO info@chem-consulting.si


First, of course, you must contact us and ask us for an informative offer :)


The cost of registration is calculated based on the following information:

1. Administrative fees paid to the European Chemicals Agency (ECHA),

2. Letter of Access (LoA) paid to the Substance Information Exchange Forum(s) – SIEF(s),

3. creation of an individual REACH dossier and registration of the substance – the service provided by Chem Consulting.


2. PREPARING AND SUBMITTING AN INQUIRY


The registration of any substance first requires the submission of a REACH inquiry dossier to determine whether a registration or another inquiry has already been submitted for the same substance so that data-sharing mechanisms can apply.


Which data are required for REACH inquiry?

  • legal entity composition of the substance:

- constituents,

- impurities,

- additives.


  • Analytical information

- methods and results of analysis.


  • Sites:

- site name,

- address (address, postal code, town, country, phone, email).


On the basis of the submitted REACH inquiry, we will receive the contact information of the lead registrant, who communicates the purchase price of the LoA.


3. DETERMINATION OF COMPANY SIZE


The size of the company must be determined in order to check the amount of the fee that must be transferred to the ECHA account. The administrative fees are set by Regulation 340/2800 (amended by Regulation 2021/876 on 31th May 2021) and are determined by company size and by yearly tonnage band. The fees are paid directly to ECHA.


We have already written about how to determine the size of the company. You can read more about this topic HERE.


4. DETERMINATION OF THE TONNAGE AREA


REACH registration is divided into yearly tonnage ranges:

  • 1 - 10 tonnes,

  • 10 - 100 tonnes,

  • 100 - 1000 tonnes,

  • > 1000 tonnes.

As a result, you have to calculate in which tonnage area the substance you want to register will fall.


5. PURCHASE OF LoA


The next step is to purchase the LoA. With a Letter of Access, the consortium of companies that have registered a substance allows a registrant to access the information in the substance’s dossier.

In other words, by buying the LoA, a company receives the right to use the data and studies in the dossier to perform the REACH registration.


The price of LoA, administrative fees related to the purchase and other fees are paid directly to the lead registrant or the representative of the group of registrants (SIEF or a consortium).


6. CREATION OF THE INDIVIDUAL REACH DOSSIER


This is a service that we provide for you.


Creation of the individual dossier and performance of the REACH registration includes the following activities:


- collection of required data for creation of the individual dossier,

- reviewing of the compliance of provided data with the data that was submitted by the lead registrant to ECHA,

- preparation of the technological process description (in cooperation with the client),

- supplementation of Chemical Safety Report (CSR) of the lead registrant,

- entering data into IUCLID6,

- ensuring completeness of the dossier,

- exporting the dossier into.i6z format.


Required REACH registration data are:

  • Estimated quantities in one year (total tonnage manufactured and imported)

  • Details in tonnages

- tonnage directly exported,

- tonnage for own use,

- tonnage used as intermediate under strictly controlled conditions.

  • Information on mixtures (if relevant)

  • Use and exposure information (determined based on the CSR provided by the lead registrant)

  • Uses advised against

After obtaining the entire documentation, we prepare a REACH dossier, which is then submitted via REACH-IT.


This is followed by a check of the entire documentation by the European Chemicals Agency.


7. PAYMENT OF ECHA FEE AND OBTAINING A REACH NUMBER


The last step is therefore to pay the fee to the European Chemicals Agency, followed by obtaining a REACH number.


I hope that with this description we have brought you a little closer to understanding the entire REACH registration process.


If you need any additional information or explanation please don't hesitate to contact us at info@chem-consulting.si. We are here for you!


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