Business Case:
How Medpak Guided a Brand to Europe Cosmetic Regulation
Medpak Solutions, a leading private-label cosmetic manufacturer, has built a reputation for helping brands navigate the complex landscape of cosmetic regulations Europe.
One of our existing customers, a Cosmetics Brand looking to expand into the European Union (EU), faced several challenges in meeting the region’s stringent regulatory requirements.
Our expertise in cosmetic safety, formulation, labeling, and documentation provided the necessary support for the brand to successfully comply with the EU beauty standards governing cosmetics.
The Problem:
Cosmetics Brand had built a strong reputation over the years, with a loyal customer base and steady sales. Their skincare line, developed five years ago, was known for its effectiveness. However, shifts in consumer expectations and regulatory requirements were creating new concerns.
Several Areas Required Immediate Attention
Ingredient Compliance: Some ingredients in their formulations were not approved under EU regulations.
Labeling Standards: Existing packaging did not meet European labeling requirements.
Safety Assessments: Additional testing was necessary to confirm product safety.
Regulatory Documentation: The brand lacked the mandatory Product Information File (PIF).
Without immediate action, Cosmetics Brand risked missing a valuable market expansion opportunity. “We need to reach out again to Medpak Solutions to help us reformulate the skincare product in line with the EU regulations,” according to the Cosmetic Brand’s sales manager.
Solutions and Implementation:
Reformulating for Ingredient Compliance
Reviewed all product formulations and identified ingredients restricted or banned under EU regulations.
Reformulated the entire skincare line within three months, in which we replaced non-EU compliant ingredients with EU-approved alternatives.
Maintained the original texture, scent, and absorption rate to match customer expectations.
Conducted performance tests to confirm that the new formulations delivered the same benefits as the originals.
Labeling and Packaging Updates
Redesigned packaging to comply with Europe Cosmetic Regulation (EC) No 1223/2009, with clear ingredient lists following the INCI format.
Translated product labels into five languages (French, German, Italian, Russian, Spanish) for distribution across multiple European countries.
Adjusted warning labels to include legally required safety information, such as "For external use only" and "Avoid contact with eyes."
Verified that marketing claims were supported by appropriate testing and documentation.
Safety Testing & Quality Assurance
Conducted stability testing to confirm that reformulated products retained their effectiveness throughout their shelf life.
Performed microbiological tests to check for bacterial contamination.
Arranged patch testing for products marketed as suitable for sensitive skin.
Prepared a Product Safety Report (PSR) for each item to meet EU safety assessment requirements.
Documentation & Product Information File
Full formulation details with ingredient sources and concentrations.
Manufacturing process documentation, ensuring compliance with Good Manufacturing Practices (GMP).
Stability, microbiological, and safety testing results.
Copies of updated product labels and packaging.
Full-Scale Benefits
By working with Medpak Solutions, the Cosmetics Brand was able to deal with the complex EU regulatory environment with confidence. Our support enabled the brand achieved the following:
Regulatory Approval: Full compliance with EU standards.
Product Integrity: Reformulations maintained the original experience customers loved.
Market Expansion: Ability to distribute products across multiple European countries.
Speed to Market: A structured approach allowed the Cosmetics Brand to launch updated products efficiently.
Result: The Cosmetics Brand Has Now Entered a Key International Market with a Loyal Consumer Base
Through Medpak Solutions’s expert guidance, the Cosmetics Brand successfully met the EU’s rigorous standards and expanded its business into the EU market.
30% additional sales after launching in the EU
15% more brand visibility
6 months ROI
Full compliance (no penalties and recalls)
Faster time to market
“After all the meticulous processes, we’re now experiencing improved brand visibility and growth as we offer our premium products to EU consumers,” says the brand manager. “Medpak Solutions’ capabilities let us successfully enter the European market without disrupting existing sales.
This only meant that our rapid response to compliance requirements allowed the Cosmetics Brand to stay ahead of industry trends, which strengthened its position as a competitive skincare brand in the European market.
Medpak Solutions Made Compliance with the European Union Cosmetics Regulation Hassle-Free
EU regulations can be challenging, but with Medpak Solutions, everything is achievable. Our team carefully guided the Cosmetics Brand through ingredient sourcing, safety testing, labeling requirements, and necessary documentation to meet all EU standards.
If you’re thinking of navigating the same route, don’t risk delays or fines. Contact us today and let us help you enter the EU market with confidence, knowing your cosmetics are fully compliant and ready for success.
Frequently Asked Questions
Your Most Frequently Asked Questions About Europe Cosmetic Regulation
What additional requirements do buyers have for natural ingredients in cosmetics?
Buyers who opt for natural ingredients for the cosmetics sector focus on quality, ethical sourcing, and sustainability. Common requirements include certifications for fair trade, responsible sourcing, and organic or natural designations.
Are there additional EU requirements for cosmetic products beyond the main regulation?
Yes, cosmetics EU may need to comply with other laws depending on their formulation and packaging. These include:
- Chemical Restrictions: Limits on hazardous substances in cosmetics.
- Ozone-Depleting Substances: Regulations for aerosols containing harmful compounds.
- Aerosol Dispensers: Safety standards for pressurized products.
- Packaging Requirements: Rules on packaging waste, nominal quantities, and labeling.
How are safety assessments conducted for cosmetics?
Before a cosmetic can be sold, it must undergo an assessment based on the ingredients and their properties. A qualified professional must create a report and perform the assessment. For items intended for children under 3, a more detailed assessment is required. After the product is on the market, its safety is monitored.
What’s the requirement for labeling nanomaterials in skincare products?
Colorants, preservatives, and UV filters that contain nanomaterials require explicit authorization before use. In case your product includes other nanomaterials not already regulated, it may undergo a full safety evaluation at the EU level if flagged for review.