Cosmetics Regulations
Introduction
Navigating cosmetic regulations can be complex. Biorius offers over 15 years of expertise in helping brands comply with international regulations through comprehensive, turnkey solutions.
Why Trust Biorius?
- Experience: Over 15 years in cosmetic regulations.
- Expert Team: 50 regulatory experts, toxicologists, pharmacists, and chemists.
- Global Reach: Expertise in Europe, the UK, the USA, and over 60 countries.
- Proven Track Record: Evaluated over 100,000 products with zero compliance issues.
- Transparent Costs: No hidden fees for questions, calls, or meetings.
- Innovative Tools: Best-in-class IT tools provided free of charge.
Cosmetics Regulations in the EU
Market Overview: Europe, with nearly 500 million consumers, is one of the largest cosmetic markets but has stringent regulatory requirements. Biorius offers comprehensive assistance to ensure compliance with the EU Cosmetic Regulation.
To sell cosmetics in the EU, products must comply with Regulation 1223/2009, requiring:
- Formula Review
- Cosmetic Product Safety Report (CPSR A&B) signed by a Toxicologist
- Label and Claims Review
- PIF (Product Information File) preparation and EU CPNP (Cosmetic Products Notification Portal) notification
- Designation of an EU Responsible Person
Cosmetics Regulations in the UK
Regulatory Process:
Post-Brexit, UK regulations mirror EU standards but require separate compliance:
- Update regulatory processes for the UK post-Brexit.
- Update PIF (Product Information File)
- Notify via the UK SCPN (Submit Cosmetic Product Notification)*
- Designate a UK Responsible Person*
*Products sold in EU and UK must be notified both in the EU CPNP (Cosmetic Products Notification Portal) and the UK SCPN (Submit Cosmetic Product Notification) and have a EU and UK Responsible Person
What is a Responsible Person in cosmetics ?
As defined in Article 4 of Regulation EC No 1223/2009, a Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product in the EU market with relevant obligations as set forth in this Regulation. It can be the manufacturer (if based in the EU), the importer, the distributor or a third party located in the EU who has been designated by a written mandate.
To sell cosmetic products in the EU and the UK, it is legally mandatory to have both an EU Responsible Person AND a UK Responsible Person, each with offices in their respective regions.
The EU and UK Responsible Person will be responsible for the following:
- Protecting your brand against compliance issues
- Assisting you with legal questions related to the EU Cosmetics Regulation and UK Cosmetics Regulation
- Answering all questions from National Competent Authorities (27 EU Member States and UK)
- Managing all inspections decided by the Supervisory Competent Authorities
- Keeping a close eye on regulatory developments and keeping you up to date
- Handling all cosmetovigilance issues (undesirable effects) by following-up with the consumers and ensuring the best course of action
It is important to note that being a Responsible Person implies many responsibilities and is an important and delicate matter that should not be taken lightly, check out why. For your information, Biorius can be the EU AND UK Responsible Person.
Cosmetics Regulations in the USA
Regulatory Landscape: The USA is the largest beauty market with complex federal and state regulations. Recent updates include the Modernization of Cosmetic Regulation Act (MoCRA), enhancing FDA’s regulatory power.
Another “complication” in the US could arise from state-specific regulations, with California being the most challenging due to:
Cosmetics Regulations in Japan, South Korea, and China
Japan:
- Differentiates between cosmetics and quasi-drugs.
- Requires pre-approval for quasi-drugs.
South Korea:
- Distinguishes between cosmetics, functional cosmetics, and quasi-drugs.
- Functional cosmetics include products for whitening, wrinkle reduction, and UV protection.
China:
- Regulated by the National Medical Product Administration (NMPA).
- New Cosmetic Supervision and Administration Regulation (CSAR) implemented to reform the regulatory landscape.
International Compliance
Ensuring compliance in all targeted countries is critical to avoid penalties and ensure product safety. Biorius provides safety and regulatory evaluation services for various regions, including EMEA, North America, South America, Asia, and Oceania.
Cosmetic Certifications
Biorius offers certification services to help brands meet legal compliance, consumer expectations, and specific ethical standards. Certifications include natural, organic, vegan-friendly, and others.
Get in Touch
Need a piece of advice, a quotation or answers to your questions? Contact us…
Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!
As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:
- First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
- 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
- A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
- No hidden costs: Biorius does not charge you for any question, call, or meeting.
- A best-in-class IT tool, free of charge, and saving a lot of your time.
- More than 1,500 international clients have already chosen Biorius!
- We evaluated more than 100,000 products and have always successfully managed compliance over 15 years of existence
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