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EUCRI – European Union Cosmetic Regulatory Institute
Regulatory services catalogue

Specialist services for cosmetic products in the EU

From the first formula review to ongoing portfolio maintenance. Search the catalogue or open one of nine specialist service areas.

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01

Regulatory assessment of cosmetic products and formulas

Review of formulas, ingredients, product classification and readiness for lawful placement of cosmetic products on the EU market.

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  1. 001Review of formula compliance with Regulation (EC) No 1223/2009
  2. 002Review of prohibited and restricted substances
  3. 003Review of preservatives, colorants and UV filters
  4. 004Regulatory review of fragrances and fragrance allergens
  5. 005Assessment of nanomaterials
  6. 006Review of synthetic polymer microparticles and microplastics requirements
  7. 007Review of CMR substances
  8. 008Determination of the cosmetic product category
  9. 009Assessment of borderline products: cosmetics, medicinal products, biocides, medical devices or detergents
  10. 010Gap assessment and evaluation of readiness for the EU market
02

Cosmetic product safety assessment and CPSR

Preparation and review of the CPSR, toxicological assessment of ingredients, exposure, margin of safety and finished product safety.

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  1. 011Preparation of CPSR Part A and Part B
  2. 012Toxicological assessment of ingredients
  3. 013Calculation of systemic exposure and margin of safety
  4. 014Assessment of local effects, irritation and sensitisation
  5. 015Assessment of impurities, traces and packaging materials
  6. 016Assessment of products for children or sensitive groups
  7. 017Safety assessment of fragrance compositions and essential oils
  8. 018Review of stability, compatibility and microbiological quality
  9. 019Update of an existing CPSR following formula or regulatory changes
  10. 020Independent expert review of a CPSR prepared by another assessor
03

Product Information File and regulatory documentation

Preparation, review and maintenance of the Product Information File, including the CPSR, GMP information, evidence of effect and change control.

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  1. 021Preparation of a complete Product Information File
  2. 022Review and completion of an existing PIF
  3. 023Organisation of supplier documentation
  4. 024Preparation of the product description and manufacturing method
  5. 025Integration of the CPSR and evidence of effect
  6. 026Review of the GMP statement
  7. 027Alignment of the PIF, formula, labelling and CPNP notification
  8. 028Digital structuring of PIF documentation
  9. 029Version and change control for regulatory documentation
  10. 030Periodic maintenance and review of PIFs and product portfolios
04

CPNP notification and access to the EU market

Preparation, submission, verification and maintenance of CPNP notifications before cosmetic products are placed on the EU market.

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  1. 031Preparation of information for CPNP notification
  2. 032Product notification under Article 13
  3. 033Submission of the frame formulation
  4. 034Review of label and packaging images
  5. 035Management of variants, shades and product names
  6. 036Update of an existing CPNP notification
  7. 037Notification of products containing nanomaterials under Article 16
  8. 038Support for distributors and consistency review across CPNP, PIF and the marketed product
05

EU Responsible Person for cosmetic products

EU Responsible Person and regulatory representation services for cosmetic brands, manufacturers and importers, including ongoing compliance maintenance.

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  1. 039Acting as the Responsible Person for a cosmetic product
  2. 040Retention and availability of the PIF
  3. 041Regulatory verification before placing a product on the market
  4. 042Management of CPNP notifications
  5. 043Communication with competent authorities
  6. 044Management of regulatory changes
  7. 045Handling complaints and undesirable effects
  8. 046Handling serious undesirable effects
  9. 047Coordination of corrective action, withdrawals and recalls
  10. 048Annual product maintenance and representation of non-EU manufacturers
06

Cosmetic product labelling and claims

Regulatory review of labels, INCI lists, mandatory particulars and substantiation for cosmetic claims on packaging, websites and advertising.

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  1. 049Complete regulatory review of product labelling
  2. 050Preparation or correction of the INCI list
  3. 051Review of nominal content
  4. 052Review of minimum durability and PAO labelling
  5. 053Review of warnings and conditions of use
  6. 054Review of country-of-origin statements
  7. 055Review of Responsible Person details
  8. 056Review of fragrance allergen labelling
  9. 057Regulatory review of translations for individual EU markets
  10. 058Final artwork review before printing
  11. 059Review of websites, catalogues and advertisements
  12. 060Review of influencer and social media communication
  13. 061Preparation of claim substantiation documentation
  14. 062Assessment of claims such as “dermatologically tested”, “hypoallergenic”, “natural”, “free from”, “clean” and “anti-ageing”
  15. 063Assessment of the boundary between cosmetic and medicinal claims
  16. 064Planning of instrumental, clinical or consumer studies
07

GMP, ISO 22716 and quality systems

Gap assessments, documentation, SOPs, audits and practical support for cosmetic manufacturers implementing GMP and ISO 22716.

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  1. 065Initial GMP gap assessment
  2. 066Preparation for ISO 22716
  3. 067Preparation of standard operating procedures
  4. 068Preparation of specifications for raw materials, packaging and finished products
  5. 069Preparation of batch manufacturing documentation
  6. 070Preparation of cleaning and hygiene procedures
  7. 071Supplier qualification
  8. 072Deviation and change control
  9. 073Implementation of a CAPA system
  10. 074Management of non-conforming products
  11. 075Implementation of complaint, withdrawal and recall procedures
  12. 076Internal GMP audit
  13. 077Audit of a contract manufacturer
  14. 078Staff training
  15. 079Preparation for an inspection or customer audit
08

Additional specialist regulatory services

Regulatory support for formulation development, reformulation, fragrances, essential oils, testing, packaging, private labels and due diligence.

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  1. 080Regulatory alignment of formulations during development
  2. 081Replacement of prohibited or restricted ingredients
  3. 082Reformulation following regulatory change
  4. 083Advice on product preservation
  5. 084Regulatory assessment of essential oils and botanical extracts
  6. 085Review of fragrance composition documentation
  7. 086Coordination of stability and compatibility testing
  8. 087Coordination of preservative efficacy and microbiological testing
  9. 088Coordination of SPF, UVA and water-resistance testing
  10. 089Coordination of dermatological and instrumental testing
  11. 090Regulatory review of packaging
  12. 091Preparation of products for private labels
  13. 092Regulatory support for importers
  14. 093Regulatory due diligence before acquiring a brand or portfolio
  15. 094Expert opinions and regulatory assessments
  16. 095Workshops for formulators, manufacturers and marketing teams
09

Ongoing regulatory support

Monitoring of cosmetics legislation, SCCS opinions and ingredient restrictions, with impact assessment for formulas, labels and portfolios.

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  1. 096Monitoring amendments to the Annexes of Regulation (EC) No 1223/2009
  2. 097Monitoring new SCCS opinions
  3. 098Monitoring new ingredient restrictions
  4. 099Assessment of regulatory change impacts on a portfolio
  5. 100Planning reformulation and label-change deadlines
  6. 101Monthly or quarterly regulatory report
  7. 102Subscription-based expert support with priority review of formulas and labels
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