Reusing Test Reports and Animal-Test History for a CPSR

Is reusing test reports from a manufacturer possible?

You can supply them, and the safety assessor decides whether each manufacturer's report is adequate for the EU file. The test reports you supply go into the PIF, and the safety report is based on the formula, test data and documents you provide.

Pay first, then upload the reports in your Eldris portal. Upload what you have and Eldris tells you what is still missing. Eldris prepares the CPSR and PIF from what you upload. 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.

Send each report with the formula it was run on, and name each file so it matches the product it covers. A reformulated product needs an updated notification and a new CPSR, priced as a formula, so a report belongs with the formula version it tested. A new pack size of the same formula adds nothing to the CPSR and PIF. The guide to lab tests for a CPSR explains what each test shows.

What about reports from a laboratory outside the EU?

It goes to the safety assessor, who decides whether it is adequate for the EU file, so this page gives no yes or no in advance.

After you pay, reports from outside the EU are uploaded in your Eldris portal like any other document, and the assessor decides on each one. Say who ran each report, on which formula and for which market, so the assessor can place it. Eldris does not carry out, arrange or recommend laboratory tests, so any new test is arranged by you with a testing laboratory, which sets the price.

In Great Britain the Responsible Person keeps a PIF in English that includes the product safety report, as GOV.UK guidance explains. A cosmetic may not be placed on the market in Great Britain without a Responsible Person established in the UK. Whether a CPSR made for the EU is accepted in Great Britain is not stated here. The short answer is in the FAQ hub: can I reuse my manufacturer's or foreign test reports.

Can stability tests be done at your own production site?

The safety assessor decides whether stability data from your own production site is adequate for the EU file. Stability data helps but is not needed to start, and Eldris does not run stability tests.

If you hold stability data from your own site, upload it with the other documents after you pay, and say which formula and pack it covers and when the tests were run. Eldris prepares the CPSR and PIF from what you upload, and the test reports you supply go into the PIF.

Stability and challenge test results follow the same route: they go into the PIF with your other reports. 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. That is a statement of Eldris's service, not a provision of the Regulation. At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B. The CPSR and PIF service is paid once, at the per-formula fee shown on the pricing page.

What does the Regulation say about animal testing?

As adopted, Article 18(1)(a) prohibits placing on the market a cosmetic whose final formulation, to meet the Regulation's requirements, has been animal-tested by a method other than an alternative method, once that method has been validated and adopted at Community level.

Article 18 has further paragraphs, including the dates from which its bans applied, that this page does not summarise, so read Article 18 as adopted on legislation.gov.uk.

Separately, Article 11(2)(e) puts data on any animal testing into the PIF. The two Articles do different jobs: Article 18 is a prohibition on placing on the market, while Article 11 lists what the PIF holds. Among the PIF's other contents are the CPSR, the manufacturing method and a GMP statement, and the Responsible Person keeps the PIF for ten years after the last batch is placed on the market. If your file holds animal-test data, upload it with your other documents after you pay, and say which test it was, on what and for which market's rules. How a particular test bears on your product is a question for the safety assessor.

What if the product was animal-tested for another market?

That is a question for the safety assessor, and this page gives no yes or no in advance.

Article 18 and Article 11(2)(e) are the two provisions this page points to. How a test done for another country's rules bears on your CPSR is for the assessor to judge once the facts are in front of them. This page does not say in advance that the history is acceptable or that it is not. Keep the original report with your PIF material, because Article 11(2)(e) puts data on any animal testing in the PIF.

When you upload, say what you know: which test, on the final formulation or on an ingredient, by whom, and for which market's rules. 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. Eldris prepares the CPSR and PIF from what you upload, and it does not run or arrange any test.

Frequently asked questions

Do I have to disclose animal testing I did years ago?

Article 11(2)(e) lists data on any animal testing among the PIF contents. Tell the assessor what you know when you upload your documents, including which test, under which market's rules and who ran it.

Does a manufacturer's report replace the CPSR?

No. A report is one input, and the safety assessor decides whether it is adequate for the EU file. At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B, and the safety report is based on the formula, test data and documents you provide.

Where do the reports I upload end up?

The test reports you supply go into the PIF. The Responsible Person keeps the PIF for ten years after the last batch of the product is placed on the market. It also holds the CPSR, the manufacturing method and a GMP statement.

Is a reformulated product covered by the same reports?

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. Reports belong with the formula they tested.

What happens if the assessor questions an older report?

The question appears in your portal. The 5–10 working days start again from the day you answer. The clock restarts; it never pauses. Eldris does not run laboratory tests, so any further testing is arranged by you with a testing laboratory.

Does a supplier's animal-test data matter?

Article 11(2)(e) lists data on any animal testing among the PIF contents, so upload what your suppliers give you. How a supplier's data bears on your CPSR is a question for the safety assessor.