Documents and NDAs Before You Buy a CPSR: How It Works

Does a quotation include a document review?

No. A quotation does not include going through a prospect's documents before onboarding.

A quotation prices the formulas and variations listed and states what the price includes and leaves out. Questions sent before paying are answered. The first step after a quotation is therefore payment, not a document exchange. Once the order is paid, your documents go into the Eldris portal, and the safety assessor works from what is there. To ask something earlier, reply to the email your quote came with, before you pay. Answering a question is not a review of your formula or your documents. The duty sits with the Responsible Person. Article 10 asks for a safety assessment and a CPSR before the cosmetic is placed on the market, and the order of steps is built to produce that CPSR. The short answer is also in the FAQ entry on reviews and NDAs.

What is the order of steps from quotation to CPSR?

Pay securely from the quote, then upload your documents in your Eldris portal.

1. Pay securely from the quote. Pay securely from the quote; the per-formula fee, the variation fee and the notification fee are shown on the pricing page.
2. Upload your documents in your Eldris portal. Upload what you have in your Eldris portal, and Eldris tells you what is still missing. You do not need every document in hand to begin.
3. The safety assessor writes the CPSR. The 5–10 working days start once the documents are complete; a question from the assessor appears in the portal and restarts the count from the day you answer.
4. Your CPSR and PIF arrive in the portal. When the CPSR and PIF are done, the Responsible Person files the notification through the CPNP; Eldris does that when it is your EU Responsible Person and you have ordered the filing.

Upload what you have, and Eldris tells you what is still missing. The safety assessor then writes the CPSR, and your CPSR and PIF arrive in the same portal. You do not need every document in hand to begin. The 5–10 working days start once the documents are complete, and the post on how long a CPSR takes explains what restarts the count. The portal holds the whole sequence in one place: the uploads, any question from the assessor and the finished files. When the CPSR and PIF are done, the Responsible Person files the notification through the Commission's CPNP. Eldris does that when it is your EU Responsible Person and you have ordered the filing. The per-formula fee, the variation fee and the notification fee are shown on the pricing page. Laboratory tests and the Responsible Person are separate from the per-formula fee.

Is the CPSR based on the final formula?

The safety report is based on the formula, test data and documents you provide.

If the manufacturer's final formula is the one you upload, that is the formula assessed. A product reformulated afterwards needs an updated notification and a new CPSR. That new CPSR is priced as a formula, so it is worth ordering on the formula you will actually sell. Upload the final formula, not a draft. The formula can be uploaded as a file or typed in as a full ingredient list. Before the assessment starts, Eldris checks it against Annexes II–VI for banned and restricted substances. The test reports you supply go into the PIF. The GMP statement from your manufacturer and stability data help but are not needed to start. You can upload them as you obtain them, because Eldris tells you what is still missing. Eldris prepares the CPSR through its cosmetics compliance service.

Can the order start before trial-batch results?

Yes. An order can begin before trial-batch results exist.

Stability data and a challenge test help but are not needed to start. Eldris does not carry out, arrange or recommend laboratory tests, and the laboratory sets the price of the tests it runs. A formula that is still being adjusted is better settled before the order, because a reformulated product needs a new CPSR. Eldris asks for a challenge test report (ISO 11930) for products that contain water, not water-free ones. SPF and microbiology tests likewise come from a testing laboratory, and Eldris names no laboratory. Reports from your trial batch can be uploaded in the portal when you have them, and the test reports you supply go into the PIF. Article 10 asks for the CPSR before the cosmetic is placed on the EU market, so the order belongs ahead of that point.

What does the process say about NDAs and confidentiality?

Eldris states no NDA terms on this page.

What it states is the process: documents are requested after payment, they go into your own Eldris portal, and the finished CPSR and PIF come back through the same portal. A confidentiality question is a question like any other, so send it before you pay. The reason to ask early is how long the record lasts. Under Article 11 of the Regulation, the Responsible Person keeps the PIF for ten years after the last batch. The PIF holds the CPSR, the manufacturing method and a GMP statement, and data on any animal testing. The GMP statement comes from your manufacturer, and the test reports come from the laboratory you choose. In Great Britain the Responsible Person keeps a PIF in English that includes the product safety report, as GOV.UK guidance explains. So raise any question about how your documents are handled before you pay and upload, not after.

Frequently asked questions

Where do I send a question before paying?

Reply to the email your quote came with, before you pay. Questions sent before paying are answered, whether they are about the process, the fee or what to upload. A question about confidentiality is sent and answered in the same way. The quotation states what the price includes and what it leaves out.

Do I need every document before I pay?

No. Pay first, then upload what you have in your Eldris portal, and Eldris tells you what is still missing. The 5–10 working days count from the day your documents are complete, not from the day you pay. Stability data and a GMP statement help but are not needed to start.

Where do the finished CPSR and PIF arrive?

In your Eldris portal. The same portal takes your uploads and shows any question from the safety assessor, and the 5–10 working days start again from the day you answer it. A qualified safety assessor signs Part A and Part B of the CPSR before it arrives.

Does Eldris test my trial batch?

No. Eldris does not carry out, arrange or recommend laboratory tests. A testing laboratory runs stability, challenge, SPF and microbiology tests and sets its own price. Eldris asks for a challenge test report (ISO 11930) for products that contain water, not water-free ones. The reports you supply go into the PIF.

What if I change the formula later?

A reformulated product needs an updated notification and a new CPSR, priced as a formula. A new pack size of the same formula adds nothing to the CPSR and PIF. Settling the formula before you order means the CPSR is written for the formula you will sell.

Who files the notification?

The Responsible Person files it. Eldris files it only when Eldris is your EU Responsible Person and you have ordered the filing, so the filing is a separate line from the per-formula fee. Great Britain has its own notification and UK Responsible Person, priced separately.

Do I need the manufacturer's GMP statement before ordering?

No. A GMP statement from your manufacturer and stability data help but are not needed to start. Upload them when you have them, and Eldris tells you what is still missing. Under Article 11, the GMP statement forms part of the PIF.