Bioceutica Ltd is the appointed EU Responsible Person for Bioceutica Milano, handling regulatory compliance under Regulation (EC) No 1223/2009 for all cosmetic products sold across the European market.
We handle end-to-end EU regulatory compliance for the Bioceutica Milano cosmetic product line.
Complete product notification on the European Commission's Cosmetic Products Notification Portal, ensuring compliance before market placement.
Preparation and maintenance of the Product Information File (PIF) as required by Article 11 of the EU Cosmetics Regulation.
Coordination of cosmetic product safety reports prepared by qualified safety assessors in accordance with Annex I of Regulation 1223/2009.
Acting as the designated Responsible Person for non-EU manufacturers, ensuring all obligations under the Cosmetics Regulation are met.
Review and guidance on product labelling requirements including INCI nomenclature, mandatory mentions, and language requirements per market.
Ongoing monitoring of regulatory changes across EU member states and proactive guidance on compliance updates affecting your product portfolio.
Bioceutica Ltd is a Cyprus-registered company (HE 473153) that serves as the EU Responsible Person for Bioceutica Milano, a direct-to-consumer skincare brand. We manage all regulatory requirements necessary for the brand's cosmetic products to be legally sold across the European Economic Area.
Our role ensures that every Bioceutica Milano product meets the strict safety and documentation standards set by the EU Cosmetics Regulation (EC) No 1223/2009, from initial product notification through ongoing compliance monitoring.
We operate across multiple EU markets, handling CPNP registration, Product Information Files, safety assessments, and label compliance so the brand can focus on product development and customer experience.
Our services are structured around the key requirements of the European regulatory framework for cosmetic products.
The primary legislation governing cosmetic products in the EU, establishing the safety, labelling, and market surveillance requirements that all cosmetic products must meet.
The Cosmetic Products Notification Portal is the EU's centralised system where all cosmetic products must be registered before being placed on the market.
A comprehensive dossier maintained for each product, including the safety report, product description, GMP evidence, and proof of claimed effects.
The EU Responsible Person ensures cosmetic products comply with all applicable requirements, maintains the PIF, handles notifications, and cooperates with competent authorities.
For inquiries about our regulatory services or to discuss your compliance needs.
Bioceutica Ltd
Nicosia, Cyprus
Registration: HE 473153
Visit the Bioceutica Milano store at
bioceuticamilano.com
For regulatory and legal inquiries, reach us at
legal@bioceutica.org