Fictional example: launching a face cream in the EU
Illustrative scenario. This brand, product and sequence are fictional. They are here to show the decisions and documents involved in a typical enquiry, not to describe a SARVA client, a completed project or a proven launch result.
Imagine a small independent brand established in Belgium, selling under its own name, preparing one adult face cream in one formula and one pack size for sale in France. A Belgian contract producer has supplied an ingredient list and draft artwork. The quantitative formula is missing, and there is no evidence yet that the cream remains suitable in its intended jar. The brand wants a launch date; the file is not ready for a safety conclusion.
Start with a scope the brand can approve
The brand would tell SARVA what the product is, where it will be made and sold, who holds the formula, what documents already exist and who is intended to act as the EU Responsible Person. SARVA would set out the work and fees in a written quote: the safety assessment, product information file (PIF), label review, notification preparation and any optional Responsible Person mandate. One formula and one pack size are assumed here; a different formula, variant or market may change the scope.
The brand could request that quote with a product name and contact details. The formula need not be sent in a first enquiry. If the product already has a public page, the free product-page check is another starting point, not a required step.
Turn missing information into a supplier request
A useful early output would be a specific document checklist. In this scenario, the manufacturer would need to provide the quantitative formula and supporting raw-material information. SARVA would also identify which finished-product evidence is needed for this cream, including stability, microbiological quality and compatibility with the intended packaging where relevant. Manufacturing information, use instructions and final artwork would be checked as part of the file.
The gap list would distinguish what is in hand from what still has to come from the manufacturer or a laboratory. A printed INCI list cannot substitute for a quantitative formula. A statement that the jar is “suitable” cannot substitute for the evidence the assessor needs. The assessor would decide whether the evidence is sufficient for this particular product; no safety conclusion is assumed in this example.
The brand would have a written scope and supplier checklist first. If the evidence supports a completed assessment, the later deliverables could be a signed CPSR, an assembled PIF, a reviewed label and notification information prepared for the designated Responsible Person. Each depends on the evidence and agreed scope.
Assess, document, then notify
Only when the necessary evidence is available could David Vandevoort, SARVA’s pharmacist and safety assessor, complete and sign the cosmetic product safety report (CPSR) under Article 10 and Annex I of Regulation (EC) 1223/2009. The PIF would then hold the report and other required product information under Article 11. The final label would be reviewed against the product and its intended markets.
Before the product is placed on the EU market, a designated EU Responsible Person must be in place under Article 4. In this scenario, the EU-established brand selling under its name could hold that role or appoint SARVA through an accepted written mandate. SARVA can prepare the CPNP notification information; the designated Responsible Person is responsible for submitting it under Article 13. If SARVA is to submit it, that follows acceptance of its mandate. Notification does not itself mean the product has been approved by an authority.
What this fictional example shows
There is no completed outcome, launch date or client testimonial behind this scenario. The possible next decision is clear: obtain the missing formula and packaging evidence, then let the assessor determine whether the product can be signed off. If evidence remains insufficient, the assessment stays open and the launch should not be described as ready.
If this resembles your product, get a fixed quote. We will write down the scope, the fees and the initial documents needed for your own case.
Tell us the product, the variants and the markets — a fixed quote in writing.