Preliminary Regulatory Assessment
A rapid opinion on whether a formulation is viable for EU entry before deeper investment.
- Ingredient legality screen
- Novel Food exposure
- Claims viability
- Go/no-go recommendation
EU Regulatory Intelligence
Your Supplement and Cosmetic Regulatory Partner
Independent regulatory assessments, CPNP registration, and Responsible Person services for Korean and Chinese supplement, nutrition, and cosmetics brands preparing to enter European markets.
Korea-China–EU Market Entry Specialists
Evidence-Based Assessments
Commercially Focused Advice
Assessment Through Market Placement
Trusted by Korean nutrition and beauty brands & European eCommerce and retailers
Why K-Regulatory
The EU is not one market. It is twenty-seven regulatory conversations you need to have before you ship.
Korean nutrition and beauty brands routinely arrive in Europe with strong science, established manufacturing, and a formulation optimised for a different regulatory reality. What passes at home is not always what passes in Brussels, Berlin, or Paris. For supplements, the exposure is formulation, claims, and twenty-seven national notification regimes. For cosmetics, it is more absolute: no product reaches the EU market without a Responsible Person established here and a completed CPNP notification.
K-Regulatory sits between your product and the European market. We assess independently — and where a product is ready, we carry it through notification and act as its regulatory representative in Europe. We do not sell manufacturing, distribution, or certifications. What we provide is a defensible regulatory position, early enough that it can change decisions and structured enough that it can be defended to investors and partners.
Services
We provide cosmetic and supplement regulatory services to help you achieve fast and compliant market entry across the EU.
Framework 01
Supplements & Nutrition
Comprehensive Regulatory Assessment
A full dossier covering formulation, labelling, claims, and market-specific requirements.
- Full ingredient dossier
- Claim substantiation review
- Labelling & packaging audit
- Country-level notification map
Reformulation & Compliance Support
Targeted guidance to adjust formulations and dossiers so products meet EU expectations.
- Ingredient substitution advice
- Dosage & threshold alignment
- Compliant claim rewriting
- Notification-ready documentation
Any Format, Any Project
From capsules to cushions — we support every supplement and cosmetic format.
Whatever your product takes shape as — tablets, gummies, powders, softgels, serums, ampoules, sheet masks or sunscreens — we guide it through European regulatory pathways with the same evidence-based rigor. No category is out of scope.
Capsules
Softgels
Gummies
Tablets
Food Bars
Soft Chews
Liquids
Powders
Caplets
Gelcaps
Framework 02
Cosmetics
A five-step pathway from formula to compliant market placement — the same sequence we run for every cosmetic engagement.
Formula Review
Screen the formulation against EU Cosmetics Regulation annexes and INCI requirements.
CPSR Part A & B
Safety Assessment prepared by a qualified assessor and integrated into the dossier.
Label & Claims Review
Full label and marketing-claim audit against the Common Criteria and national rules.
PIF Preparation
Product Information File assembled and maintained for competent-authority access.
CPNP & SCPN Notifications
EU CPNP notification and UK SCPN notification completed before market placement.
Our Approach · Regulatory Assessment
How we run an assessment — a four-step method that turns regulatory ambiguity into a plan. The same method applies whether the product is a supplement or a cosmetic.
- 01
Product Review
Formulation, claims, and target markets.
- 02
Regulatory Assessment
Against EU food or cosmetics frameworks and national rules.
- 03
Risk Identification
Ingredients, claims, and labelling exposure.
- 04
Strategic Recommendations
A clear path to compliant market entry.
Outcomes
Reduce Risk Before You Invest.
Every engagement is designed to make the next commercial decision cheaper, faster, and better supported.
- Avoid costly formulation changes discovered late in launch
- Understand market-specific notification requirements
- Identify non-compliant claims before packaging is printed
- Reduce the risk of border rejection or product recall
- Prioritise markets by regulatory feasibility and effort
- Present investors and partners with a defensible plan
- Clear CPNP notification before distributor commitments
- Hold compliant EU representation once products are on shelf
Principles
At K-Regulatory, we believe regulatory compliance should enable growth—not slow it down. Our approach is built on three core principles: speed, quality, and certainty.
We deliver efficient, risk-based regulatory solutions that accelerate market entry without compromising compliance. Every assessment is thorough, scientifically grounded, and aligned with EU regulatory requirements, ensuring a high standard of quality in every engagement.
Our goal is to provide clear, practical guidance and predictable outcomes, giving clients the confidence to launch and grow their products across the EU with certainty.
Dimitris T.Advisor
Questions
Frequently asked.
No. K-Regulatory is an independent advisory firm. We provide regulatory opinions and assessments; we do not issue certifications, approvals, or licences. Formal notifications and authorisations are handled by national competent authorities in each EU member state.