CPSR Service
Cosmetic Product Safety Reports
for new and existing products
Sie sind Hersteller, Markeninhaber oder Inverkehrbringer von Kosmetik und benötigen eine CPSR – sei es für neue Produkte, Sortimentserweiterungen oder die weitere Vermarktung bestehender Produkte. Oft geht es dabei nicht um Grundsatzfragen, sondern um eine zuverlässige Umsetzung, klare Zuständigkeiten und rechtssichere Ergebnisse.
As an outsourced regulatory partner, we prepare and maintain your Cosmetic Product Safety Report (CPSR) in accordance with the EU Cosmetics Regulation – professionally, transparently and efficiently.
Why a CPSR Is Required
Rechtssicherheit für das Inverkehrbringen kosmetischer Produkte
A Cosmetic Product Safety Report (CPSR) is a legal requirement for placing cosmetic products on the EU market.
Sie ist Bestandteil der Produktinformationsdatei (PIF) und muss vor Markteintritt vorliegen bzw. laufend aktuell gehalten werden.
For manufacturers and distributors, this means:
• Clear regulatory responsibilities
• Legal compliance requirements
• Documentation and record-keeping obligations
Unsere Rolle
CPSR als ausgelagerte regulatorische Dienstleistung
Wir verstehen die CPSR nicht als isoliertes Dokument, sondern als Teil einer funktionierenden regulatorischen Struktur.
Our clients engage our services because they:
• wish to outsource regulatory responsibilities
• are dissatisfied with their current service provider
• want to reduce the burden on internal resources
We do not work on a project-by-project basis. Instead, we provide responsible, long-term regulatory support.
Was die CPSR beinhaltet
Structure of the safety assessment
The CPSR consists of two parts:
Part A – Safety Information
• Qualitative and quantitative composition of the product
• Physicochemical characteristics and stability
• Microbiological quality
• Impurities, traces and packaging material
• Normal and reasonably foreseeable use
• Exposure assessment of the ingredients
• Toxicological profiles of the ingredients used
Part B – Safety Assessment
• Scientific assessment of product safety
• Conclusion on the product's safety
• Warnings and conditions of use for labelling
Unsere Leistungen im Bereich CPSR
Clear, structured, responsible
• Preparation of CPSR Part A & Part B
• Assessment of new cosmetic products
• Updating of existing safety assessments
• Re-evaluation following formulation or raw material changes
• Support with INCI, claims, and labelling requirements
• Integration of the CPSR into the Product Information File (PIF)
Unser Ansatz
A balanced regulatory assessment
Our CPSR preparationis guided by a clear principle:
• Scientifically sound
• Compliant with applicable regulations
• Practically and commercially viable
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We avoid:
• Unnecessary restrictions
• Overly conservative safety assumptions
• Assessments that are formally correct but impractical
Instead, we provide robust, well-founded assessments
that help keep your products on the market.
Typical challenges
When companies engage our services
• Initial CPSR preparation for new products
• Transfer of existing CPSRs from another service provider
• Switching providers due to quality or communication issues
• Outsourcing of regulatory affairs activities
• Updates following formulation or supplier changes
• Preparation for market surveillance activities or regulatory inquiries
Qualifikation & Verantwortung
Safety assessments by qualified safety assessors
Alle Sicherheitsbewertungen werden von qualifizierten Safety Assessoren gemäß den Anforderungen der EU-Kosmetikverordnung (VO (EG) Nr. 1223/2009) durchgeführt.
Our assessments are professionally substantiated, transparently documented, and fully auditable.
Einbettung in weitere Leistungen
CPSR as part of your regulatory support
We are also happy to assist with additional regulatory services:
• Erstellung und Pflege der Produktinformationsdatei (PIF)
• CPNP-Notifizierung
• Verpackungs- und Kennzeichnungs-Compliance
• Kommunikation mit Behörden
• Schulungen und Inhouse-Trainings
This ensures consistent regulatory support throughout the product lifecycle rather than isolated individual services.