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EU Regulatory Insights
Regulatory updates, compliance guides, and EU market entry insights for supplement brands, cosmetic companies, and North American exporters.
What 'Natural', 'Anti-Ageing', and 'Clinically Proven' Must Actually Prove Under EU Cosmetics Law
Regulation 655/2013 sets six strict criteria for EU cosmetic claims. What 'natural', 'anti-ageing', and 'clinically proven' must actually prove — and where brands get caught.
CMR Substances in EU Cosmetics: How CLP Reclassifications Create Overnight Formulation Bans
When a substance is reclassified as CMR under EU CLP Regulation, it can instantly become prohibited in cosmetics under Article 15 of Regulation 1223/2009. Here's what brands must monitor.
Cosmetics Stability Testing Under EU Regulation 1223/2009: What Your Product Information File Actually Needs
Stability testing is a legal requirement under EU Regulation 1223/2009. Here's what your PIF must include to support a compliant cosmetics safety assessment.
EU Sunscreens Are OTC Drugs in the USA: The FDA Compliance Gap European Exporters Miss
EU sunscreens are classified as OTC drugs in the USA — not cosmetics. Learn the formulation, labeling, GMP, and registration gaps European exporters must close before shipping.
Nitrosamines in EU Cosmetics: The In-Formulation Risk That Every CPSR Must Address Under EC Regulation 1223/2009
Nitrosamines can form inside your finished cosmetic even when every ingredient is individually compliant. Here's what EC Regulation 1223/2009 and the SCCS require you to assess.
Heavy Metals in Herbal Supplements: The EU Testing Limits European Brands Are Missing
EU Regulation 2023/915 sets binding limits on lead, cadmium, mercury and arsenic in botanical supplements. Most European brands test too late against the wrong spec.
Collagen Supplement Testing in Europe: Why Market Growth Is Outpacing Quality Controls
Europe's collagen supplement market is booming — but testing standards are lagging badly. Here's what brand owners must know about identity testing, adulteration, and EU compliance.
Cosmetics Vigilance Reporting in France: What Article 23 of Regulation 1223/2009 Actually Demands
Article 23 of Regulation 1223/2009 requires SUE reporting within 20 days. What France's ANSM expects from cosmetic brands — and where most fall short.
CPNP Notification Errors That Delay EU Cosmetics Launches — What Regulation (EC) No 1223/2009 Actually Requires
Five CPNP notification mistakes that delay EU cosmetics launches under Regulation EC 1223/2009 — and how to catch them before market entry.
EU Annex IV vs FDA Color Additives: What European Cosmetic Brands Must Know Before Exporting to the US
EU Annex IV colorants under Regulation (EC) No 1223/2009 don't map directly to FDA-approved color additives. Here's the compliance gap that catches European brands off guard.
SPF Claims Under EU Regulation 1223/2009: What ISO 24444 Testing Demands Before You Print a Number
EU sun protection products require ISO 24444:2019-compliant SPF data and UVA testing under Regulation 1223/2009. Here's exactly what your PIF must contain.
ISO 11930 Preservative Efficacy Testing: The Criterion A vs. Criterion B Mistake Most EU Cosmetic Brands Make
Most EU cosmetic brands misclassify their products under ISO 11930, defaulting to Criterion B when Criterion A applies. Here's what the standard actually requires — and what it costs when you get it wrong.
Regulation (EU) 2025/40 and Your Cosmetics Range: What the PPWR Actually Requires — and When
Regulation (EU) 2025/40 is already in force. Here's what PPWR's packaging recyclability and recycled content rules mean for EU cosmetics brands before 2030.
Heavy Metals in EU Cosmetics: What Regulation 1223/2009 Actually Requires (and What It Doesn't)
EU Regulation 1223/2009 bans many heavy metal compounds but sets no contaminant limits. Here's what your safety assessor actually needs for a compliant PIF.
What EU Regulation 655/2013 Requires Before You Print 'Clinically Proven' on Your Cosmetic Label
EU Regulation 655/2013 sets six mandatory criteria for every cosmetic claim. Here's what adequate evidence actually looks like — and where DGCCRF inspections typically begin.
Heavy Metals in Herbal Supplements: Why EU Concentration Limits Don't Guarantee Health Canada Compliance
European herbal brands often assume Ph.Eur. heavy metal limits satisfy Health Canada's NPN requirements. Here's why the daily intake framework tells a different story.
CBD in EU Cosmetics: What Regulation (EC) No 1223/2009 Actually Says — And What Most Brands Get Wrong
Cannabidiol occupies a regulatory grey zone under EU Cosmetics Regulation 1223/2009. Here's what your CPSR must cover, why THC in Annex II matters, and how national enforcement varies.
EU Sunscreen Regulation vs FDA OTC Monograph: Why European SPF Formulations Need a US-Specific Rethink
EU sunscreens are cosmetics under Regulation 1223/2009; US sunscreens are OTC drugs. Here's what this means for European brands — and which UV filters can't cross the Atlantic.
