In our article, How Do You Select the Right Cosmetics Regulatory Support for Your Brand?, we highlighted the main criteria to consider when choosing your Responsible Person (RP).
This time, we want to move from theory to practice. Below are real situations we’ve encountered with brands that came to us after experiencing problems with a distributor acting as their EU Responsible Person (RP). Details have been generalised to protect client confidentiality, but the risks and the lessons are very real.
Case Study 1: No Regulatory Monitoring
The Situation
A non-EU cosmetic brand reached out to us after experiencing ongoing difficulties with their distributor, who was also serving as their EU RP. Frustrated with the lack of support and responsiveness, the brand asked whether we could take over the RP role for their product portfolio.
What We Found
As part of our standard onboarding process, we conducted a full audit of the brand’s Product Information Files (PIFs).
The audit revealed a serious compliance gap: one of the products contained an ingredient that had been banned under EU cosmetics regulation for several years, which the previous RP had apparently never flagged or addressed. Several other ingredients were also identified as problematic and in need of review.
This is a textbook example of what happens when regulatory monitoring is not treated as an ongoing requirement. EU cosmetic regulations are updated regularly, and an RP who isn’t actively tracking those changes can leave a brand exposed for years without anyone noticing, until an audit or, worse, a consumer complaint brings the issue to light.
What We Did
Once the issue was identified, we moved quickly:
- Immediately advised the client to discontinue use of the banned ingredient
- Reformulated where necessary and guided the brand through the steps needed to bring the product back into compliance
- Completed a Cosmetic Product Safety Assessment (CPSR) in line with current EU requirements
- Reviewed the full portfolio to bring all products up to date with the latest regulatory requirements
The Outcome
Fortunately, the brand had not yet been selected for a market surveillance audit when we intervened. This meant we were able to resolve the issue proactively, before it escalated into regulatory action.
Had the situation developed differently, the brand could have faced:
- Product recall across EU markets
- Financial penalties imposed by national authorities
- Forced withdrawal from sale while corrective measures were implemented
- Lasting damage to brand reputation and consumer trust
Insight
An RP’s job doesn’t end once a PIF is filed. Regulation 1223/2009 is regularly updated, and its requirements can change over time. Ingredient restrictions, labelling rules, and safety requirements evolve, and someone needs to be watching for those changes on your behalf.
When a distributor takes on the RP role as a secondary responsibility, regulatory monitoring is often the first thing to fall through the cracks. By the time a brand notices, the exposure may have existed for years.
Case Study 2: English Only Labelling to Suit the Distributor
The Situation
A brand was advised by their EU distributor to keep product labels in English only. On the surface, this seemed like a convenient shortcut, and it was certainly convenient for the distributor.
English only labels made it easier to move the same inventory across multiple EU countries without the hassle of producing market specific labelling.
What the distributor didn’t make clear was that this “convenience” came at the expense of compliance. Under Regulation 1223/2009, cosmetic product labels must include mandatory information in the official language(s) of the market where the product is sold.
Language requirements are not optional or negotiable, and they are one of the most commonly checked items during market surveillance inspections.
Insight
This case highlights a conflict of interest that’s easy to overlook: a distributor’s advice is naturally shaped by what’s easiest and most profitable for their own operations, rather than by what keeps the brand compliant.
Language labelling rules exist to protect consumers’ right to understand product information, and non-compliance is one of the easiest violations for authorities to catch.
Case Study 3: CPNP Notification Without Any Compliance Check
The Situation
An EU distributor advised a brand that they could simply notify their products on the CPNP (Cosmetic Products Notification Portal) and that this alone was sufficient.
No Cosmetic Product Safety Report (CPSR), no Product Information File (PIF), and no label compliance review. Just a CPNP notification, and nothing else. When the distributor was audited by an EU authority, the cosmetic brand contacted us for assistance, and understandably, asked to transfer the RP role from their distributor to us.
Why This Is a Serious Problem
CPNP notification is only one small administrative step in the overall compliance process. It is not a substitute for the wider compliance requirements. Failing to carry out the CPSR, PIF creation, and label review means:
- The safety of the product has never actually been assessed or confirmed by a qualified safety assessor
- No documentation exists to demonstrate compliance if authorities request it
- Banned or restricted ingredients could be present without anyone knowing
- Mandatory label information in the required national language(s) may be missing entirely
In other words, the brand had a CPNP notification number, but no real assurance that the product was safe or legal to sell.
The Risk
If these products were selected for a market surveillance audit, and the authority discovered banned ingredients or non-compliant labelling, the brand could face an order to recall or withdraw the products from the market, along with the broader consequences that could follow, including financial loss, regulatory scrutiny, and damage to brand credibility.
Insight
CPNP notification is often mistaken for “being compliant,” when in reality it’s just one checkbox in a much larger process.
A distributor may be technically fulfilling the letter of the notification requirement while ignoring the substance of what actually keeps a product, and the consumers who use it, safe. A dedicated RP treats the CPSR, PIF, and label review as non-negotiable prerequisites, not optional extras.
Final Thoughts
These cases underline a pattern we see often: distributors are experts in sales and market access, not in the intricacies of EU cosmetics compliance. When the RP function is treated as a checkbox rather than a core responsibility, brands are the ones left carrying the risk.
If your current RP arrangement leaves you uncertain about what’s really in your PIFs, or whether your products still meet the latest EU requirements, it may be time for an independent audit.
Contact us today to learn how a dedicated Responsible Person can protect your brand, your products, and your customers, before it becomes a problem.
