The Hidden Risks of Skipping a Proper CPSR

Your product looks great. But is it legally safe to sell?

You’ve spent months developing your cosmetic formula. The packaging is beautiful, the branding is on point, and you’re ready to launch. But there’s one step that brands consistently underestimate or worse, skip entirely: the Cosmetic Product Safety Report (CPSR).

Under EU Regulation (EC) No 1223/2009, a CPSR is not optional. It’s a legal prerequisite for placing any cosmetic product on the EU market. And yet, many brands — especially smaller ones entering the EU for the first time — either delay it, cut corners on it, or rely on reports that don’t meet the required standard.

The consequences can be severe.

 

What a CPSR Actually Is (and Isn’t)

A CPSR is a two-part scientific document prepared and signed by a qualified Cosmetic Product Safety Assessor — a professional with specific qualifications mandated by EU law. It covers:

• Part A: Safety information — ingredients, formula, physicochemical and microbiological properties, impurities, packaging compatibility, stability data, and more
• Part B: Safety assessment — the assessor’s professional conclusion that the product is safe for its intended use under reasonably foreseeable conditions

A CPSR is not a template you fill in yourself. It is not a certificate you purchase online. And it is not a one-size-fits-all document that can be copy-pasted across products.

The Risks No One Talks About

1. Market withdrawal and product recall

If a market surveillance authority — such as EOF in Greece, BfR in Germany, or ANSM in France — identifies a product on the market without a compliant CPSR, they have the authority to order its immediate withdrawal. You lose stock, you lose revenue, and you lose credibility.

2. Fines and legal liability

Non-compliance with Regulation 1223/2009 can result in significant administrative fines depending on the member state. More importantly, if a consumer suffers an adverse reaction and your CPSR is inadequate or absent, your legal exposure is substantial.

3. A “CPSR” that isn’t actually compliant

This is perhaps the most dangerous risk of all. Many brands obtain a CPSR that looks professional but fails to meet the technical requirements — missing toxicological data, incorrect exposure calculations, outdated SCCS opinions, or a safety assessor without proper EU-recognized qualifications. The product is on the market, the brand feels protected, but the document would not withstand regulatory scrutiny.

4. Cascade failures across your PIF

The CPSR is the centerpiece of your Product Information File (PIF). If the CPSR is flawed, the entire PIF is compromised — including your labelling, your claims, and your notified responsible person status. A domino effect that can unravel your entire compliance structure.

5. Blocked EU market entry

Distributors, retailers, and platforms increasingly request compliant documentation before listing your product. An inadequate CPSR doesn’t just risk regulatory action — it can cost you the deal entirely.

 

What a Proper CPSR Requires

A compliant CPSR in 2025 must reflect the latest regulatory landscape, including:

• SCCS/1611/19 (Notes of Guidance, 12th revision) methodology for safety assessment
• Updated SED/MoS calculations using current exposure factors
• Compliance with recently restricted or regulated ingredients (e.g., EU 2024/996 for Vitamin A derivatives, EU 2023/1545 for fragrance allergens)
• SPM assessment under REACH Annex XVII Entry 78 (EU 2023/2055) where relevant
• Assessor signature with proof of qualifications

This is not a static document. Regulations change, SCCS opinions are updated, and your CPSR needs to reflect that.

Why “Cheap” CPSRs Cost More in the Long Run

We understand cost pressure. But a CPSR prepared by an unqualified provider, without proper toxicological analysis, without access to current scientific literature, and without regulatory expertise, is worse than having no CPSR at all — because it gives you a false sense of security.

The ELINEK Approach

At ELINEK S.A., we have been preparing CPSRs for companies across Europe since 1997, combining:

• in-house laboratories (microbiology, physical chemistry, stability)
• real test data
• deep regulatory expertise

The data in your CPSR are not estimates. They are measurements.

 

Ready to Get Your CPSR Right?

Don’t wait for a market authority to knock on your door.

Contact ELINEK today for a CPSR review, a new assessment, or a compliance audit of your existing Product Information File.