Regulatory Compliance for Cosmetic Products
Cosmetic compliance depends on a clear connection between the formula, safety evidence, technical documentation, labelling and post-market duties.
Reviewing each element in isolation can create inconsistencies that delay notification, weaken a claim or cause issues after launch.
SHAPYPRO supports manufacturers, brands and importers throughout the product lifecycle and adapts the strategy to the jurisdiction where the cosmetic will be marketed.
Regulatory Support Throughout the Product Lifecycle
Regulatory work starts before notification. A formula must be checked against ingredient restrictions, but it must also fit the cosmetic function, intended use and proposed claims.
That foundation determines the studies required, the safety assessment and the structure of the product documentation.
The file must remain current after launch. Changes to a supplier, formula, packaging, claim or regulation may affect the previous assessment.
SHAPYPRO helps identify what has changed, which records require an update and whether the modification triggers a new notification or another action.
Cosmetic Regulatory Consultancy Services
Support is adapted to the project stage and may cover the process from the initial formula review to product-file updates after marketing.
Classification and Formula
We review function, presentation, ingredients, concentrations and target-market restrictions before development is finalised.
Testing Strategy
We define the stability, microbiology, safety and efficacy studies required based on the product's risk profile and intended claims.
PIF and CPSR
We prepare or review the Product Information File and Cosmetic Product Safety Report so that the documentation is complete, traceable and consistent.
Labelling and Claims
We compare mandatory particulars, language, presentation and advertising claims with the available evidence.
Notification and Registration
We manage or support the submissions required by each jurisdiction using validated product and operator information.
Vigilance and Updates
We help maintain the product file, assess undesirable effects and review the impact of regulatory or technical changes.
The EU Compliance Framework
Before a cosmetic is placed on the European Union market, a Responsible Person established in the EU must be designated.
The product requires a safety assessment completed by a qualified assessor, a PIF available to the competent authority, manufacture in accordance with good manufacturing practice and notification through the CPNP.
The label must comply with Article 19 of Regulation (EC) No 1223/2009, while claims must meet the common criteria established by Regulation (EU) No 655/2013.
PIF
The Product Information File contains the product description, CPSR, manufacturing method, GMP statement, proof of the claimed effect where justified and the required animal-testing information.
CPSR
The Cosmetic Product Safety Report connects composition, exposure, toxicological profile and finished-product data to reach a safety conclusion for the intended conditions of use.
Responsible Person
The Responsible Person ensures that the applicable obligations are met and keeps the documentation accessible to the authorities for the required period.
CPNP
Notification takes place before marketing and must be consistent with the formula, label, Responsible Person and product placed on the market.
Formula, Labelling and Claims as One System
A permitted formula may still create a compliance issue if a claim changes the product classification or if the label omits a warning linked to an ingredient.
An efficacy study also loses value when it does not reproduce the conditions of the claim shown on the packaging. SHAPYPRO therefore reviews these elements together.
The review covers the product name and function, INCI list, nominal content, precautions, batch identification, durability, country of origin where applicable and required language.
It also considers whether digital and advertising communications extend or alter what the label says.
International Market Access
A strong technical file can be reused, but it cannot be transferred to another jurisdiction without review. Each market defines its own classification, ingredient lists, local operator, notification route and labelling rules.
SHAPYPRO starts with a central evidence package and prepares the adaptations required for the selected market.
European Union
Regulation (EC) No 1223/2009, Responsible Person, PIF, CPSR, CPNP and the common criteria for cosmetic claims.
United Kingdom
A UK-established Responsible Person, an available product file and notification through the relevant UK service.
United States
Classification based on intended use and compliance with FDA and MoCRA obligations where applicable.
Other International Markets
A market-specific review of requirements, ingredients, documentation, registrations and labelling before the market-access plan is defined.
Working Methodology
Define the Market
We identify the jurisdictions, operators, product category and planned timeline.
Review the Gaps
We compare the existing documentation with applicable requirements and prioritise what is missing.
Build the Technical Plan
We coordinate formula review, testing, safety assessment, claims and supplier documents.
Prepare the File and Submission
We prepare or review the dossier, label and relevant notification or registration.
Maintain Compliance
We assess changes and updates to keep the product compliant after launch.
Frequently Asked Questions About Regulatory Compliance
When Should Regulatory Review Begin?
Ideally, it should begin during development, before the formula and packaging design are final. This allows restrictions to be addressed, testing to be planned and late changes to be avoided.
Are the PIF and CPSR the Same Document?
No. The CPSR is the cosmetic product safety report. The PIF is the wider product file that contains the CPSR and the other required information.
Can the Same Label Be Used in Several Countries?
Only after each market's requirements have been reviewed. Language, responsible operator details, warnings, units and the presentation of certain claims may differ.
What Happens When the Formula or Supplier Changes?
The effect on safety, stability, labelling and documentation must be assessed. Depending on the importance of the change, studies, the CPSR, PIF or notification may need to be updated.
Can SHAPYPRO Review an Existing Product File?
Yes. A documentary audit can identify missing, inconsistent or outdated information before an acquisition, product launch or authority review.
Regulatory Consulting Adapted to Your Product
Send us the formula, target market and current status of the product file. SHAPYPRO will identify the gaps and propose a work plan proportionate to the product and project timeline.
