Regulatory Affairs
Regulation (EC) No 1223/2009 Complete technical support to bring your cosmetic product to the European market in compliance with Regulation (EC) No 1223/2009. Documentation, testing, safety assessment and notification — we are your specialist technical partner at every stage. Services · European Cosmetic Regulation
THE LEGAL FRAMEWORK

Cosmetic regulation in Europe

The European cosmetics market is governed by Regulation (EC) No 1223/2009, which sets out the mandatory requirements for any cosmetic product to be placed on sale in the European Union. Compliance with this regulation is not optional — it is a legal imperative that protects both the consumer and the company.

Phytosphera Azorica provides technical and regulatory support services to cosmetic brands and companies, acting as a specialist partner throughout the entire product lifecycle. Our approach combines scientific rigour with in-depth knowledge of European legislation and applicable technical standards.

We work with brands at the launch stage — who need to structure all their documentation for the first time — as well as established companies that need to update their technical dossier, reformulate products or expand into new markets.

Transparency in service delivery

Some specialised laboratory tests — namely microbiological safety and the Cosmetic Product Safety Report (CPSR) — are carried out in partnership with accredited external laboratories and certified Safety Assessors. This practice is standard in the cosmetics industry and guarantees full legal compliance and the highest scientific rigour.

Legislation and reference standards

Phytosphera Azorica services are provided in compliance with:

  • Regulation (EC) No 1223/2009 — European Cosmetics Regulation
  • ISO 22716:2007 — Good Manufacturing Practices (GMP) for cosmetics
  • EN ISO 11930:2019 — Evaluation of preservative efficacy
  • ISO 29621:2017 — Microbiology of low-risk cosmetic products
  • SCCS Notes of Guidance — EU Scientific Committee guide for cosmetics safety
  • Lists of prohibited and restricted ingredients (Annexes II, III, IV, V and VI of the Regulation)
  • REACH Regulation — for relevant chemical substances
  • IFRA Guidelines — for fragrances and aromatic ingredients

Why work with Phytosphera?

  • Practical experience in cosmetic formulation and regulation
  • Up-to-date knowledge of European legislation
  • Network of accredited partner laboratories for specialist testing
  • Direct communication and personalised support
  • Ability to work with brands of all sizes
  • Know-how of the Azores’ endogenous resources
  • Based in the Azores — with an international outlook

SERVICES

What we do for you

We provide services across four key areas of regulatory support — technical documentation, laboratory testing, product compliance and training.

Raw Material Technical Documentation

Technical Data Sheet (TDS)

Preparation or review of complete technical data sheets for cosmetic ingredients, including INCI nomenclature, origin, physicochemical specifications, cosmetic functions and use limits.

Includes

  • Identification and INCI nomenclature
  • Quality and purity specifications
  • Functions according to EC regulation
  • Storage conditions and shelf life

Material Safety Data Sheet (MSDS)

Preparation of MSDS for cosmetic raw materials, in compliance with Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP).

Includes

  • 16 mandatory REACH sections
  • Updated GHS/CLP classification
  • Safe handling information
  • Relevant ecotoxicological data

Composition Declaration

Preparation of a detailed Composition Declaration, identifying all components, concentrations and origin. An essential document for the PIF and the safety assessment.

Allergen Declaration

Identification and quantification of allergenic substances present in the ingredient or final formula, with reference to the mandatory allergen lists of Regulation (EC) No 1223/2009 (Annex III).

IFRA Declaration

Compliance verification of aromatic ingredients against International Fragrance Association (IFRA) guidelines and preparation of a compliance declaration for use in cosmetics.

Formula Review and Product Compliance

Final Product Formula Review

Critical analysis of the final formulation against current European regulation, identifying prohibited, restricted or non-compliant concentration ingredients, and proposing alternatives.

Includes

  • Verification of ingredients against Annexes II, III, IV, V and VI
  • Verification of maximum permitted limits
  • Ingredient compatibility analysis
  • Compliance report with recommendations

Labelling Compliance Review

Full review of the label design against the mandatory requirements of Regulation (EC) No 1223/2009, including INCI list, warnings and mandatory claims.

Includes

  • Correct INCI list ordered by concentration
  • Mandatory statements (expiry date, batch, weight, etc.)
  • Specific safety warnings
  • Verification of allergens declared in the INCI list
  • Compliance with language and legibility requirements

INCI List — Preparation and Review

Preparation or review of the ingredient list in correct INCI nomenclature, in descending order of concentration and in accordance with the official European Commission glossary.

Laboratory Testing and Safety Assessment

Biological Extract Testing in Formula

Assessment of the activity and compatibility of plant, marine and endemic Azorean plant extracts in cosmetic formulations, with protocols adapted to each matrix.

Includes

  • Activity tests (antioxidant, antimicrobial, etc.)
  • Compatibility assessment with the cosmetic base
  • Extract stability testing in formula
  • Protocol and technical report

Stability Studies

Accelerated stability testing (40°C/75% RH) and real-time testing for formulation validation, shelf life (PAO) verification and assessment of storage conditions.

Includes

  • Accelerated stability (cold/heat cycles, UV)
  • Organoleptic and physicochemical assessment
  • pH, viscosity, colour, odour, phase separation
  • Stability report for the PIF

Microbiological Safety

Challenge Test (preservative efficacy testing) and total microbiological count for validation of product microbiological safety, in accordance with EN ISO 11930 and the European Pharmacopoeia.

Includes

  • Total aerobic microorganism count
  • Specific pathogen testing
  • Challenge Test according to EN ISO 11930
  • Report for inclusion in the PIF

Accredited partner laboratory

Safety Assessment Report (CPSR)

The Cosmetic Product Safety Report is the central document of the technical dossier (PIF) and is a legal requirement for any cosmetic product marketed in the EU. It comprises two parts: the safety assessment of the ingredients (Part A) and the final safety report issued by the qualified Safety Assessor (Part B).

Includes

  • Part A: toxicological profile of all ingredients, exposure assessment and safety margin calculation
  • Part B: final assessment by the certified Safety Assessor (Person Responsible)
  • Integration of stability and microbiology data
  • Analysis of reported adverse effects

Product Information File (PIF)

Compilation and organisation of the complete Product Information File, which must be available to the competent authorities for 10 years after the last marketing of the product.

Includes

  • Description and quantitative formula of the product
  • Manufacturing method and GMP declaration
  • CPSR (Safety Assessment)
  • Efficacy data and marketing claims
  • Data on adverse effects

Notification, Labelling and Training

CPNP Notification

Submission of the notification on the Cosmetic Products Notification Portal (CPNP) of the European Commission, mandatory before placing any cosmetic product on the EU market.

Includes

  • Preparation and submission of the notification
  • Upload of formula, label and frame formula
  • Updating of existing notifications
  • Confirmation of completed notification

Trademark and Intellectual Property Registration

Guidance and support in the process of registering cosmetic trademarks with the INPI (National Institute of Industrial Property) and EUIPO for European-level protection.

Includes

  • Prior search for existing trademarks
  • Identification of relevant Nice classes
  • Support in preparing the registration application
  • Process follow-up

Training in Cosmetic Regulation

Personalised training sessions for product, marketing and quality teams at cosmetic brands — from an introduction to European regulation to the analysis of specific practical cases.

Includes

  • European legal framework — Regulation (EC) No 1223/2009
  • PIF: what it is, what it contains, how to maintain it
  • Labelling: common mistakes and best practices
  • Problematic ingredients and alternatives
  • In-person or remote format

TECHNICAL DOCUMENTATION

Raw material technical data sheets

Raw material technical documentation is the foundation of any solid regulatory dossier. For each ingredient, a specific set of documents is required for the PIF and for the safety assessment.

Technical Data Sheet (TDS)

Reference document for the ingredient containing all relevant technical specifications for cosmetic use.

  • INCI nomenclature and CAS/EINECS
  • Origin and method of production
  • Physicochemical specifications (appearance, colour, odour, pH, refractive index, etc.)
  • Cosmetic functions according to INCI dictionary
  • Recommended use concentrations
  • Known incompatibilities
  • Storage conditions and shelf life

Safety Data Sheet (SDS/MSDS)

Mandatory document for substances and mixtures with hazardous properties, in accordance with REACH/CLP Regulation.

  • Substance/mixture and supplier identification
  • Hazard identification (GHS)
  • Composition and information on components
  • First aid measures and fire-fighting measures
  • Exposure/PPE and physicochemical properties
  • Toxicological and ecotoxicological information

Composition Declaration

Detailed list of all ingredient components, with percentages and identification of relevant impurities.

  • Identification of all components (INCI + CAS)
  • Individual concentrations
  • Identification of solvents and adjuvants
  • Identification of impurities above the declaration threshold

Allergen Declaration + IFRA

Specific documentation for aromatic ingredients and extracts that may contain allergenic substances.

  • List of the 26 mandatory allergens (Annex III of the Regulation)
  • Concentration of each allergen in the ingredient
  • Compliance with IFRA limits by product category
  • IFRA compliance declaration signed by the supplier
  • Allergen calculation in the final formula for label declaration

Note on subcontracted services

Microbiological safety laboratory tests (Challenge Test and total count) and the Safety Assessment Report (CPSR — Part B) are carried out exclusively by accredited laboratories and Safety Assessors with qualifications recognised under European legislation. Phytosphera Azorica coordinates the entire process, ensures documentation quality and acts as the sole point of contact for the brand.

WHEN TO CONTACT US

How we can help you

Whatever stage you are at, we have the right service for you.

NEW PRODUCT

You are launching a cosmetic product

You need all the regulatory documentation — PIF, CPSR, INCI list, labelling, CPNP notification. We support the process from the very beginning through to market placement.

EXISTING PRODUCT

You have products on the market but the documentation is out of date

Legislation changes and ingredients may be restricted. We carry out a regulatory audit of your portfolio and update whatever is necessary.

REFORMULATION

You need to change a formula

Any significant change to the formula requires a PIF revision and potentially a new CPSR. We manage the entire documentation update process.

MARKET EXPANSION

You want to export outside the EU

Each market has its own specific requirements. We support the adaptation of documentation and labelling for markets such as the UK, USA, Canada or Japan.

RAW MATERIALS

You want to introduce a new ingredient

We verify the regulatory compliance of the ingredient, prepare the technical documentation and assess the impact on the safety of the final product.

TRAINING

Your team needs regulatory knowledge

We offer personalised training sessions — from general introductions to European regulation to focused workshops on labelling, CPNP or PIF management.

Have a regulatory project in hand?

Send us a message with your needs — we will respond within 48 hours with a tailored proposal.

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