Cosmetic Regulatory Consultancy Services for the EU Market
SHAPYPRO provides cosmetic regulatory consultancy services for manufacturers, brands, importers and distributors that need to place cosmetic products on the European Union market and other international markets.
Support may include formula, labelling and claims review, preparation of the PIF and CPSR, CPNP notification, Responsible Person support and adaptation of technical documentation to the requirements of the target market.
- Regulation (EC) 1223/2009
- PIF and CPSR
- CPNP Notification
- Responsible Person
Regulatory Support Throughout the Product Lifecycle
Cosmetic compliance does not begin when the finished product is ready. Regulatory decisions affect ingredient selection, formulation design, required testing, manufacture, labelling, claims and the market access strategy.
SHAPYPRO supports products from the first development stages through market placement and subsequent maintenance, connecting regulatory review with technical documentation and the available evidence.
Support can cover a specific need or a complete regulatory pathway adapted to the product type, the company’s role in the supply chain, the target market and the actual status of the documentation.
Cosmetic Regulatory Consultancy Services
Services are configured according to the needs of each project. Before work begins, the product, available documentation, intended markets and the responsibilities of each operator are reviewed.
Regulatory Strategy and Product Classification
Initial review of the category, presentation, intended purpose and claims to confirm that the product falls within the cosmetics framework and to identify possible borderline issues.
Formula and Ingredient Review
Assessment of ingredients, concentrations, restrictions, conditions of use, preservatives, colourants, UV filters, allergens and other aspects that may affect formula compliance.
Labelling Review
Verification of mandatory information, INCI list, precautions, nominal content, batch, minimum durability or PAO, product function and Responsible Person details.
Claims Review and Substantiation
Assessment of functional, dermatological, efficacy, sensory, environmental and free-from claims, together with the evidence supporting them.
Product Information File · PIF
Preparation, review, reorganisation or update of the technical file required to demonstrate cosmetic product compliance.
Cosmetic Product Safety Report · CPSR
Coordination and preparation of the safety assessment based on composition, exposure, toxicological information, intended use and available technical data.
CPNP Notification
Preparation and submission of the information required through the European portal before the product is placed on the EU market.
Responsible Person Service
Support associated with the obligations of the Responsible Person established in the European Union, according to the contracted scope and available documentation.
Regulatory Maintenance and Updates
Review of changes to formula, labelling, claims, documentation or legal requirements that may require the PIF, CPSR, CPNP notification or other records to be updated.
PIF, CPSR and Technical Documentation
Technical documentation must reflect the actual product placed on the market. Formula, labelling, claims, testing and safety assessment must be consistent with each other and kept up to date throughout the commercial life of the product.
SHAPYPRO reviews existing documentation, identifies omissions or inconsistencies and coordinates the information needed to complete or update the file.
Product Information File · PIF
Contains the product description, CPSR, manufacturing information, evidence of GMP, proof of claimed effects and other applicable documentation.
Cosmetic Product Safety Report · CPSR
Includes the cosmetic product safety information and the assessment performed by a qualified person, together with the conclusion, reasoning and safe conditions of use.
Product Testing and Evidence
May include stability, microbiological quality, Challenge Test, clinical safety testing, efficacy studies, toxicological information and technical literature.
Manufacturing, Quality and Traceability
Information on manufacturing method, controls, specifications, batches, suppliers, raw materials and documents related to good manufacturing practice.
Version Control and Updates
Monitoring of changes to formula, suppliers, packaging, claims, labelling or safety information to keep the file aligned with the marketed product.
Formula, Labelling and Claims Review
A coordinated review of these three elements helps identify issues before packaging is printed, large batches are manufactured or market placement begins. A compliant formula can still be undermined by incomplete labelling or claims that go beyond the available evidence.
Formula and Ingredients
Restrictions, prohibitions, concentration limits, purity, conditions of use, allergens, nanomaterials and suitability of ingredients for the intended function.
Mandatory Labelling Information
Product function, nominal content, precautions, batch, minimum durability or PAO, country of origin where applicable, Responsible Person and ingredient list.
Claims and Commercial Presentation
Review of statements to ensure that they are truthful, understandable, consistent with the evidence and aligned with the common criteria for cosmetic claims.
Supporting Evidence
Assessment of studies, instrumental tests, panels, literature, ingredient data and other information used to substantiate communicated benefits.
Target Market Adaptation
Review of languages, warnings, national requirements and information presentation for each country or sales channel.
Responsible Person, CPNP and Post-Market Compliance
Every cosmetic product placed on the European Union market must be linked to a Responsible Person established in the EU. This role ensures that the product complies with the applicable obligations and acts as the contact point for competent authorities.
Compliance continues after notification. Relevant changes, new safety information, incidents, serious undesirable effects and corrective measures may require the file to be reviewed, the notification to be updated or action to be taken on the product.
Responsible Person Support
Product and documentation review, definition of responsibilities and maintenance of the required information according to the contracted service.
CPNP Submission and Updates
Preparation of the initial notification and update of information when relevant changes occur.
Regulatory Monitoring
Review of legal changes, ingredient restrictions and developments that may affect the product or its documentation.
Ongoing Document Maintenance
Update of PIF, CPSR, labels, claims and internal records when the product changes or new information becomes available.
Support in the Event of Incidents
Technical and documentary assistance to analyse incidents, assess corrective actions and respond to information requests within the agreed scope.
International Market Access
Requirements vary according to the country, product category and role of the company. Before adapting a formula or reusing European documentation, the specific obligations of the destination market must be reviewed.
SHAPYPRO analyses the available documentation and defines an adapted regulatory strategy, avoiding the assumption that a file prepared for the European Union can be transferred unchanged to every other market.
Great Britain
Review of the GB Responsible Person, SCPN notification, labelling and documentation requirements before the product is made available on the market.
United States
Assessment of MoCRA obligations, including safety substantiation and, where applicable, facility registration, cosmetic product listing and labelling review.
European Union
Integrated support for Regulation (EC) 1223/2009, Responsible Person, PIF, CPSR, labelling, claims and CPNP notification.
Other International Markets
Case-by-case review for Latin America, China, India and other destinations according to product category, responsible operator and applicable procedures.
Working Methodology
Each project starts with a realistic assessment of the product’s situation. The scope is defined according to the development stage, the quality of the available documentation and the market to be accessed.
Initial Assessment
Review of the product, formula, claims, labelling, economic operator, target markets and available documentation.
Regulatory Plan
Identification of requirements, missing documents, required testing, responsibilities and the recommended order of actions.
Document Preparation and Review
Preparation, review or update of PIF, CPSR, labels, claims, evidence and associated documents.
Notification and Market Access
Support with CPNP, SCPN, listings, registrations or other procedures applicable to the destination and contracted scope.
Follow-Up and Updating
Support to resolve observations, keep documentation current and adapt the product to subsequent changes.
Regulatory Consultancy Adapted to Your Cosmetic Product
Each product has different requirements depending on its formula, claims, presentation, responsible operator and target market.
SHAPYPRO assesses the starting point and proposes a proportionate regulatory scope, with clear documentation and a strategy aimed at reducing issues before and after market placement.
