Documents to Start a CPSR and PIF Order

What are the documents to start a CPSR?

Eldris needs the formula, a safety data sheet (SDS) for every raw material and certificates of analysis. With fragrance, the IFRA certificate, the allergen declaration and the fragrance level are needed too.

The formula can be uploaded as a file, or typed in as an ingredient list that adds up to the whole formula. Each raw material in the formula needs its own SDS, which is the supplier's safety data sheet for that material, so the sheets you send should match the materials on your list one for one. Certificates of analysis come from your ingredient suppliers and describe the materials you buy from them. Product photos are not needed to start.

A product with fragrance also needs the IFRA certificate, which covers fragrance safety, the allergen declaration and the fragrance level. Eldris writes your ingredient list in INCI names, the standard international ingredient names, as part of the per-formula fee shown on the pricing page. Think of the start list as the recipe plus the supplier papers for every material in it. Everything beyond this list is covered next.

Which documents help but are not needed to start?

Test reports, such as stability data and a challenge test, and a GMP statement help but are not needed to start. An existing label design helps too.

Each comes from a different place. The GMP statement comes from your manufacturer. Stability tests and challenge tests come from a testing laboratory, which sets its own price, and the guide to lab tests for a CPSR explains what each test shows. A label cannot be reviewed before the CPSR result, so the Article 19 label review in the per-formula fee comes after it.

Laboratory tests are not in the per-formula fee, and Eldris does not carry out, arrange or recommend them or name a laboratory. The safety report is based on the formula, test data and documents you provide, and the test reports you supply go into the PIF. A report from your manufacturer or from a laboratory outside the EU goes to the safety assessor, who decides whether it is adequate for the EU file.

If your supplier sends only an SDS, an IFRA certificate and an allergen sheet, this guide to supplier paperwork shows what that set leaves out.

How do you send the documents, and when does the clock start?

Pay first, then upload your documents in your Eldris portal, where Eldris tells you what is still missing.

You do not have to wait for a full set. Upload what you have and Eldris tells you what is still missing. Which documents count as complete for your formula is something Eldris tells you after you upload. The CPSR and PIF service is paid once, with no monthly fee for this service.

The CPSR and PIF are delivered 5–10 working days after Eldris has your complete documents. If the safety assessor needs more from you, the question appears in your portal, and the 5–10 working days start again from the day you answer. The clock restarts; it never pauses. The guide to how long a CPSR takes explains the count.

Your CPSR and PIF arrive in the same portal, where any question from the assessor also appears. The short version of this list is also in the FAQ answer on which documents start a CPSR and PIF.

Does fragrance, water or sun protection change the list?

Fragrance adds documents to the start list. Water changes whether Eldris asks for a challenge test report, not what you send first.

If the product has	What to add	Needed to start
Fragrance	IFRA certificate, allergen declaration and fragrance level	Yes
Alcohol or solvents	A safety data sheet for each, as for every raw material	Yes
Water	A challenge test report (ISO 11930), which Eldris asks for	No: you can start your order without it
No water	Nothing: Eldris asks for no challenge test	Not asked for
Sun protection	No extra start document	No

The challenge-test rule is a statement of Eldris's service, not a provision of the Regulation. Each further shade or scent is a variation that shares the formula's CPSR. A new scent can need its own CPSR if the fragrance ingredients change significantly, and a different SPF level usually does. A product that needs its own CPSR is priced as a formula, and Eldris discusses that with you first.

What do the documents turn into?

They become the CPSR, which Article 10 requires before a cosmetic is placed on the EU market, and the PIF.

The CPSR has Part A, the safety information, and Part B, the safety assessment, as Annex I sets out. At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B. The Responsible Person keeps the PIF for ten years after the last batch is placed on the market. Among its contents are the CPSR, the manufacturing method, a GMP statement and data on any animal testing. Because the PIF holds a GMP statement, gather one early, though the order can start without it.

Before the product is placed on the market, the Responsible Person also notifies it through the Commission's CPNP, its free online notification system. In Great Britain the Responsible Person keeps a PIF in English that includes the product safety report, as GOV.UK guidance explains. For the wider picture, read the general guide to EU cosmetics documentation.

Frequently asked questions

Do I need a safety data sheet for every raw material?

Yes. The start list asks for a safety data sheet for every raw material, plus certificates of analysis. After you pay, upload the sheets you have and Eldris tells you what is still missing. If the safety assessor needs more, the question appears in your portal, and the 5–10 working days start again from the day you answer.

Can I type the formula in instead of uploading a file?

Yes. The formula can be uploaded, or typed in as an ingredient list that adds up to the whole formula. Eldris then writes the ingredient list in INCI names as part of the per-formula fee, whatever the number of ingredients.

What if I only have some of the documents?

Pay first, then upload what you have in your Eldris portal. Eldris tells you what is still missing, and you can upload an incomplete set. The 5–10 working days run from the day Eldris has your complete documents.

Do I need the IFRA certificate if my product has no fragrance?

The IFRA certificate, the allergen declaration and the fragrance level are needed with fragrance. For a product without fragrance they are not part of the start list. The formula, a safety data sheet for every raw material and certificates of analysis are still needed.

Is a GMP statement needed to start?

No. A GMP statement helps but is not needed to start. It comes from your manufacturer, and the PIF that the Responsible Person keeps still lists a GMP statement among its contents.

Is a challenge test needed before I order?

Eldris asks for a challenge test report (ISO 11930) for products that contain water, not water-free ones, but you can start your order without it. A testing laboratory carries it out and sets the price. This is a statement of Eldris's service, not a provision of the Regulation.

Do I need product photos or a finished label to start?

No. Product photos are not needed. An existing label design helps when there is one, but a label cannot be reviewed before the CPSR result, so the Article 19 label review comes after the CPSR.