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What is Letter of Access / LoA?
The short answer to the question What is Letter of Access (LoA) is: LoA is a written permission that gives you the right to use test data of a substance in your own record. Turkish version is access letter. The party that produces the data or holds the rights gives this permission in return for a fee. Thus, the same test is not repeated and animal testing is prevented.
Why is LoA required?
KKDIK is based on joint registration logic. Companies registering the same substance share a single data set. Without having this data the file cannot be submitted. Therefore, the access letter is the legal, not the technical, key to the record. If there is no data, there is no record.
How is the price determined?
The price is calculated by dividing the production cost of the dataset by the number of members. Tonnage band also affects the price; The company in the low band should not pay for the entire data set. Additionally, management and administrative expenses should be shown as separate items. You have the right to object to non-transparent single item prices.
What should be taken into consideration in negotiation?
- Which tonnage band does the price cover?
- How to calculate additional payment if band increases
- Which studies are covered and whether the list is attached
- Whether the scope includes only KKDIK or REACH
- Group companies and whether the right is transferred in case of transfer
- Whether there is a refund mechanism
Is registration possible without an access letter?
Theoretically yes: the company can set up its own testing program. However, this is much more expensive and is not preferred due to the obligation to share data in vertebrate animal tests. In practice, companies decide by comparing the LoA cost with their own testing costs. We prepare the comparison table together.
Common error
The most common mistake is to treat the LoA as an invoice and not read the attachment. Whereas the scope list determines what you will pay in future tonnage increases. The second mistake is to receive the letter in the name of the wrong entity; Permission obtained on behalf of another company within the group does not transfer to the company that made the registration. For details, see our KKDIK access letter page.
Related pages
Official full text of the regulation: KKDIK Regulation - Official Gazette.
For questions, contact ONAY Mühendislik.
Link between LoA and shared registration
The access letter is not a stand-alone record; It is the tool that allows you to join the joint registration file. After receiving the letter, you submit your file through KKS and pay the fee. Therefore, take negotiation time into account when planning the schedule. In practice, negotiations last from a few weeks to a few months and become even longer closer to the deadline.
Transfer and group companies
The scope of the letter may cause problems in case of company merger, title change or intra-group transfer. The most practical solution is to write this possibility into the contract from the beginning. Otherwise, a portion of the fee may be requested again for the new legal entity.