What the CPSR and PIF Contain, and What a Formula Change Means

What does the CPSR contain?

The CPSR has two parts, Part A and Part B, and a qualified safety assessor signs both.

Part A holds the safety information and Part B holds the safety assessment, as Annex I of the Regulation sets out. Before the assessment starts, Eldris checks the formula against Annexes II–VI for banned and restricted substances. The assessment rests on the formula, the test data and the documents you provide. The fee does not change with the number of ingredients, so a formula with peptides or plant extracts is one CPSR like any other. Eldris does not carry out, arrange or recommend laboratory tests, so stability, challenge, SPF and microbiology results come from a testing laboratory and reach the file through you. Under Article 10, the Responsible Person must ensure a safety assessment and a CPSR before a cosmetic is placed on the EU market. Both parts of the CPSR arrive in your Eldris portal, together with the PIF.

What does the PIF hold?

The PIF is the file the Responsible Person keeps for ten years after the last batch.

Under Article 11 of the Regulation, it holds the CPSR, the manufacturing method and a GMP statement, and data on any animal testing. With Eldris, the PIF is prepared with the CPSR, and the test reports you supply go into it. Eldris is not a testing laboratory, so the PIF holds the reports you provide and not tests Eldris has run. Stability data and a GMP statement help but are not needed to start. Certificates of analysis come from your ingredient suppliers, the GMP statement from your manufacturer, and stability and challenge tests from a testing laboratory. Your PIF arrives in your portal with the CPSR. The PIF is also the subject of an earlier guide for small brands. Great Britain has its own rule: there the Responsible Person keeps a PIF in English that includes the product safety report, according to GOV.UK guidance.

What are the label review and the INCI list?

The label review checks your label against Article 19, and the INCI list gives your ingredients in INCI names.

INCI names are the standard international ingredient names. Both are part of the per-formula fee. Article 19 sets what the container and packaging carry. As a rule, these include the name or registered name and address of the Responsible Person and the nominal content by weight or volume. They also include the batch number of manufacture or a reference identifying the product, and the date of minimum durability or, where that rule allows, the period after opening. The ingredients list may be given on the packaging alone. Where the precautions (point (d)) or the ingredients (point (g)) cannot practically be labelled, they go on an enclosed leaflet, label, tape, tag or card, referred to on the pack. The label review checks your label against these rules, while the check against Annexes II–VI looks at the formula.

How and when do the documents arrive?

Your CPSR and PIF arrive in your Eldris portal, 5–10 working days after Eldris receives your complete documents.

If the safety assessor needs more, the question appears in the portal and the 5–10 working days start again from the day you answer. The fee does not cover everything around the CPSR. Laboratory tests and the Responsible Person are not included. The EU notification is a separate line, in your total only when Eldris files it, and otherwise your Responsible Person files it through the Commission's CPNP. Great Britain, with its UK Responsible Person and UK notification, is priced separately. The per-formula fee is shown on the pricing page, and it is paid once, with no monthly fee for this service. You pay first and then upload your documents in the portal, so the portal is both where your documents go in and where the finished files come out. Eldris prepares them through its cosmetics compliance service.

What happens if you 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. A product that needs its own CPSR is priced as a formula and discussed with the customer first. The post on formulas and variations sets out how to tell a further shade or scent from a product that needs its own CPSR. Like any CPSR, a new one is delivered 5–10 working days after complete documents, and the safety assessor's questions appear in your portal as before. The updated notification is a separate step: the Responsible Person files it, and Eldris does so when it is your EU Responsible Person and the filing is ordered. A formula change therefore touches the CPSR, the PIF that holds it and the notification. The short version is in the FAQ entry on what you receive.

Frequently asked questions

Is the PIF part of the same fee as the CPSR?

Yes. The per-formula fee covers the signed CPSR, the PIF, the Article 19 label review and the INCI ingredient list for one formula, whatever the number of ingredients. Laboratory tests and the Responsible Person are not included. The documents arrive in your Eldris portal, and the fee is paid once.

How long is the PIF kept?

The Responsible Person keeps the PIF for ten years after the last batch, under Article 11 of the Regulation. The PIF holds the CPSR, the manufacturing method and a GMP statement, and data on any animal testing. The ten years run from the last batch, not from the date of the CPSR.

Are laboratory tests part of what I receive?

No. Eldris does not carry out, arrange or recommend laboratory tests. A testing laboratory runs them and sets the price. The test reports you supply go into the PIF, and Eldris names no laboratory. 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.

What do INCI names mean on my ingredient list?

INCI names are the standard international ingredient names. Your ingredient list in INCI names is part of the per-formula fee, alongside the CPSR, the PIF and the Article 19 label review. The label review is separate from the INCI list: it checks the label against Article 19.

Who files the notification after I receive the CPSR?

The Responsible Person files it. Eldris files it only when Eldris is your EU Responsible Person and you have ordered the filing. Great Britain has its own UK Responsible Person and UK notification, priced separately. Notification takes place before the product is placed on the market, under Article 13.

Where do I find the documents after the 5–10 working days?

In your Eldris portal, where you also upload documents and see any question from the safety assessor. If the assessor needs more, the 5–10 working days start again from the day you answer. You pay first, then upload, and the finished files appear in the same place.

Does a formula with many ingredients cost more?

No. The per-formula fee is one-off for each formula, whatever the number of ingredients. A formula with peptides or plant extracts is priced like any other formula. The cosmetics fees are paid once, with no monthly fee for this service.