Regulatory Framework
Classification of the product and consideration of relevant requirements for the intended European or international target market.
Regulatory Affairs
Safe and well prepared for market launch.
PLCC integrates regulatory requirements into your private-label project at an early stage — from target market and product documentation to safety assessment, labelling and preparation for launch.
Early
Integrate requirements into project planning from the outset
Structured
Consolidate product information, evidence and approvals transparently
Market-specific
Consider requirements for the intended target market
End-to-end
Connect regulatory with development, packaging, quality and production
Regulatory as Part of Development
Market readiness is not created only shortly before launch.
Formulation, application, packaging, product claims and target market influence the regulatory requirements of a cosmetic product. If these factors are reviewed only at the end, additional changes, coordination and delays may arise.
That is why PLCC treats Regulatory Affairs as an integral part of the entire project. Relevant requirements are identified early and coordinated with Product Development, Packaging & Design, Quality Assurance and manufacturing.
Our Services
Regulatory support on the route to a market-ready product.
The specific scope depends on the product, project status, target market and documentation already available.
Product Information File
Support with the structured preparation and compilation of required product information and evidence for the PIF.
Safety Assessment
Coordination of the required safety assessment and provision of relevant product, formulation and testing information.
CPNP Notification
Support with the notification process before a cosmetic product is placed on the market within the European Union.
Labelling & Claims
Review of mandatory product information and alignment of labelling and product claims with the product and target market.
International Requirements
Early identification of country-specific requirements and integration of relevant points into project planning, documentation and market launch.
Quality and Regulatory
Two areas with one shared objective: a reliable, market-ready product.
Quality assurance checks whether the product and packaging function reliably in the intended use. Regulatory Affairs translates the relevant product information into the requirements of the planned target market.
Quality Assurance & Product Safety
Test, assess and document.
- Formulation and product properties
- Stability and packaging compatibility
- Microbiological and product-specific testing
- Production controls and approvals
Regulatory Affairs
Prepare and coordinate market requirements.
- Target market and regulatory framework
- Product information and safety assessment
- Labelling, claims and notification
- Preparation for placing on the market
Both areas are connected at an early stage so that required testing, documents and approvals are not developed in isolation.
Explore quality assuranceTarget Markets
The intended market determines the regulatory route.
Requirements can vary depending on the sales territory. The target market should therefore be defined as early as possible rather than after development has been completed.
European Union
Cosmetic products for the EU market.
For products within the European Union, the requirements of the EU Cosmetics Regulation, product safety assessment, Product Information File, labelling and CPNP notification are taken into account, among others.
International Markets
Prepare launches outside the EU at an early stage.
Country-specific requirements can influence formulation, claims, documentation, labelling and the project timeline. Depending on the project, relevant requirements are integrated into the planning at an early stage.
Regulatory Process
Regulatory Affairs supports every relevant project phase.
The process is aligned with the product, development route and target market.
Define the Product
Product concept, application, target audience, packaging, claims and target market form the regulatory starting point.
Identify Requirements
Relevant legal, product-related and market-specific requirements are identified and incorporated into the plan.
Prepare Documentation
Product information, evidence, test results and other documents are compiled in a structured manner.
Coordinate Labelling
Mandatory information and product claims are aligned with packaging, artwork and target-market requirements.
Prepare Market Launch
Final assessments, documentation and notification steps are coordinated before the planned placing on the market.
Why start early?
Regulatory decisions affect the entire product concept.
The earlier the target market and product claims are defined, the better development, packaging, testing and scheduling can be aligned with them.
Formulation
Ingredients, product category and application need to fit the intended market and positioning.
Packaging
Packaging space, materials, artwork and mandatory information need to be planned together and be technically feasible.
Claims
Product claims should be defined early so that required evidence and an appropriate communication logic can be planned.
Target Market
Country-specific requirements can influence documentation, labelling, formulation and the project timeline.
Connected Services
Regulatory Affairs works in conjunction with the overall project.
Regulatory preparation draws on information and decisions from several project areas.
01
Product Development
Define product concept, application, target audience and positioning early.
Learn more → 02Formulations & Textures
Select the formulation and product properties to suit the category and target market.
Learn more → 03Packaging & Design
Plan packaging, artwork and mandatory information together and realistically.
Learn more → 04Quality Assurance
Use test results and product data as the basis for safety and documentation.
Learn more → 05Manufacturing & Filling
Connect production and approval steps with regulatory requirements.
Learn more → 06Project Management
Coordinate communication, documents, approvals and timelines across the project.
Learn more →Frequently Asked Questions
Questions about documentation, labelling and market launch.
You can find further general information about development, production and collaboration in our central FAQ section.
View all FAQsWhen should Regulatory Affairs be involved in the project?
As early as possible. Target market, product category, formulation, packaging and claims can influence regulatory requirements and the project timeline.
What does the Product Information File include?
The PIF brings together the information and evidence relevant to the product. The specific content depends on the product, formulation and regulatory framework.
Does PLCC support the safety assessment?
PLCC coordinates the required process and compiles the relevant product, formulation and testing information for the assessment.
Are labelling and product claims also reviewed?
Yes. Mandatory information and claims are reviewed in relation to the product, packaging, target market and available evidence.
Can PLCC support international market launches?
Depending on the target market and project scope, relevant country-specific requirements can be identified and integrated into further project planning.
Your Private-Label Project
Let us clarify the regulatory requirements for your product.
Tell us about your product idea, target market and planned market entry. Together, we will define the relevant next steps.
Send a non-binding project enquiry