EU Cosmetic Regulation 1223/2009 and the Role of Responsible Person (RP) Dr Lin Yang BSc (Hons) MSc PhD MRSB Toxicologist Lin.Yang@delphichse.com 1
Content EU Cosmetic Regulation 1223/2009 Definitions & Borderline products Structure of the regulation & Ingredient restrictions Responsible Person (RP) and the Role of RP Product Information File (PIF) preparation Product labelling and claims review CPNP notification and post market surveillance EU Market Regulation Compliance Product Safety 2
EU Cosmetic Regulation 1223/2009 3
EU Cosmetic Regulation 1223/2009 Definitions: Cosmetics Cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Functions: Cleaning Perfuming Changing Appearance Protecting Keeping in Good Conditions Correcting Body Odour Applied To: Epidermis Hair System Nails Lips External Genital Organs Teeth Oral Cavity 4
EU Cosmetic Regulation 1223/2009 Borderline Products Several factors influence whether a product is a cosmetic or other good, including: Primary use or purpose of the product, Ingredients Intended application and end user Claims Case by case approach! Ask the competent authorities within Member States pre-market Temporary Tattoo Cosmetic Toy Anti-microbial Soap Contact with skin Change its appearance A mixture/preparation Applied to dolls vs children Toy Directive Annex II (10): Comply with cosmetic reg. Cosmetic ingredients Cosmetic primary function Secondary biocidal activity and claims. Fake eyelash glue/adhesive Cosmetic making kit Medicinal activity/claims Medicine 5
EU Cosmetic Regulation 1223/2009 Structure of the Regulation Compilation of various articles relating to specific elements Lists of controlled ingredients published as Annexes. Key ideas about cosmetic safety A Good Standard of Manufacturing Ingredients being of a quality grade and fit for their intended purpose Assessing all elements of the final product to ensure safety Emphasis on the role of the responsible person Additional Legislation Claims Common Criteria 655/2013 6
EU Cosmetic Regulation 1223/2009 Ingredient Restrictions Article 15 General prohibition on materials classified as Carcinogens, Mutagens or Reproductive Toxins (CMRs). Article 17 Traces of prohibited materials are permitted as impurities if technically unavoidable and determined to be at a safe level. Annex II Prohibited Materials Over 1,300 individual substances and group entries. Many pharmaceutical entries Many entries relating to ingredients from oil / petroleum industries Lyral (HICC) 2017/1410 of 2 August 2017 Placing new product on the market: 23 August 2019 Making available any product on the market: 23 August 2021 8
EU Cosmetic Regulation 1223/2009 Ingredient Restrictions Annex III Restricted Materials Over 290 individual substances and group entries Product types & Concentration limits & Label warnings required Annex IV Permitted Pigments 153 permitted pigments. Only pigments on that list are allowed to be used. Mica and Tin Oxide are not on the list, but classified as opacifiers (not pigments ) so can be used. Zinc Oxide 2017/1413 of 3 August 2017 Entry 144: Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation 9
EU Cosmetic Regulation 1223/2009 Ingredient Restrictions Annex V Preservatives Over 55 individual substances and group entries. Only preservatives on this list are allowed to be used. Methylisothiazolinone (MIT) 2017/1224 of 6 July 2017 Rinse-off products, 0.0015% Annex VI UV Filters Over 25 permitted UV Filters. Only UV Filters on that list are allowed to be used. UV filters are for protecting the consumer not the formulation. Benzophenone-3 2017/238 of 10 February 2017 Maximum concentration as a UV-filter in cosmetic products: 6 % w/w + Warning 0,5 % to protect product formulation, not required warning as Contains Benzophenone-3 10
Responsible Person (RP) and the Role of RP 11
Who is the Responsible Person? Legal responsibility for safety and compliance of cosmetics in EU Must be based in Europe Responsibilities include: 1. Compiling a Product Information File (PIF) 2. Safety assessment 3. Claims reviews (claims must be substantiated) 4. Label reviews (Labels are compliant) 5. EU registration (CPNP Notification) On the market 6. Ongoing surveillance and due diligence 12
The Role of RP Product Information File (PIF) preparation The PIF should contain: A description of the product Information on the quality of the raw materials (RM specifications) A Cosmetic Product Safety Report (CPSR) A description of the method of manufacturing and a statement on the compliance with Good Manufacturing Practice (GMP) Proof of an effects claimed by the product Evidence to support compliance with animal testing regulations Sales data & Details on complaints and health effects Reference: Article 11 cosmetic regulation and Cosmetics Europe PIF guidelines 13
The Role of RP Product Information File (PIF) preparation Description of the product Product name Formulation (% level; INCI; CAS no.) Instructions for use Age range of intended consumers Product functions Raw material specifications Appropriate grade and quality Cosmetic regulation 1223/2009; Food additives regulation 231/2012 MSDS, Spec/TDS, COA Additional information Perfumes and Essential Oils (Allergen Declaration26, IFRA Statement) Spray, aerosol or talc base (Particle size & shape) Traces materials or impurities Nano-materials 14
The Role of RP Product Information File (PIF) preparation Cosmetic Product safety Report (CPSR) The CPSR is prepared by using a subset of data from the PIF. This data is reviewed and assessed to make a conclusion on the COMPLIANCE and SAFETY of a product. Split into two parts: Part A raw material data and safety information include test results etc. Part B Cosmetic Product Safety Assessment (CPSA) It is the RPs responsibility to ensure this data provided is correct and complete at all times Safety Assessments should be reviewed and reassessed when: There are changes to the safety information; formulation, specification etc. Every 18m 2 years to ensure the product remains complaint and up to date with the latest regulatory information on raw materials 16
The Role of RP ISO 22716 is a recognised standard and can be used as a template in areas: o o o o o Product Information File (PIF) preparation Good Manufacturing Practice (GMP) Personal health and hygiene Clean factory Accepting and rejecting raw materials Consistency in your manufacturing methods Quality control Certification is NOT a mandatory requirement Must state compliance with principles of GMP and adopt similar practices Animal Testing The regulation banned animal testing on both ingredients and final product for the purposes of the cosmetic applications since 2013 Most RM suppliers and manufactures will provide a regulatory compliance statement 17
The Role of RP Product Information File (PIF) preparation Product testing Required to prove a number of things such as: Safety in use Fit for purpose / quality Shelf life of final product Tests typically cover: Product Stability & Packaging Compatibility Accelerated test generally 3 months; various conditions and temperatures Microbiological profile Total Viable Counts and Yeasts and Moulds High risk products <100 CFU/g; Low risk products <1000 CFU/g Preservative efficacy testing (PET) / challenge test Generally 28 days; various acceptable methods (EP, USP51, ISO11930:2012) Product Specific testing they may not all be needed (water free; high alcohol level) 18
The Role of RP Claims Review Responsible person s obligation to ensure all claims comply: Appropriate substantiation In line with the common criteria 655/2013 Justification of claims use in cosmetics (Legal compliance; Truthfulness; Evidential support; Honesty; Fairness; Informed decision-making) All claims require substantiation Claims can creep into the medicinal area, be careful! You cannot make a claim about a legal requirement; the only exception is No Animal Testing Examples found on some Beauty products: Non toxic ingredients DNA Changing' Repairs broken and damaged skin 9 out of 10 women consider Wonder Cream better than the leading brand Contains strawberry (if it only contains a strawberry flavour or fragrance) SPF 30 80% reduction in wrinkles 19
The Role of RP Two types of packaging Product labelling Container (primary or inner packaging) o Designed to come into direct contact with the product Packaging (secondary or outer packaging) o Designed to contain one or more containers Majority of the required labelling items should appear on both There are exceptions for specific products and sizes 20
The Role of RP Product labelling *Where it is impossible to label due to size, it is only required on the outer packaging alone **required on the primary packaging where there is no secondary packaging Aerosol Dispenser needs also comply with ADD (Aerosol Dispensers Directive 2013/10/EU) regulation labelling requirement 21
The Role of RP CPNP Notification and Post Market Surveillance Cosmetic Product Notification Portal (CPNP) is a free online notification system created for the EU Cosmetic Regulation 1223/2009 It s purpose is to make information readily available to Competent authorities o o o o Market surveillance Market analysis Evaluation Consumer information Poison centres o Medical treatment The following information are required on the registration: Name of product any additional languages that the product appears in RP address and contact details formulation exact concentrations / ranges / frame formulations Specialist packaging aerosols or product presentation that is uncommon The country the product is first sold in Details of CMRs and Nanomaterials A description of the final label or a copy of the artwork 22
The Role of RP CPNP Notification and Post Market Surveillance When to update notification: If your formulation changes When the concentration of the ingredient changes by more than 20% of the value previously declared If your product name changes If any of the mandatory Label requirements change If decide to distribute in another country Post market surveillance should cover the following: Keeping up to date with the latest regulatory changes Regulatory checks of your products Recording of complaints Notifying of SUES (Serious Undesirable Effects) Sampling and Analysis Responding to significant changes of the product 23
The role of Responsible Person (RP) CMR (A 15) Safety Report (A 10) Ensure product is safe (A 3) Traces of prohibited substances (A 17) Restrictions on substances (A 14) Nanomaterial (A 16) Labelling (A 19) Notification (A 13) Responsible Person Animal Testing (A 18) GMP (A 8) Info at request of Competent Authority (A 7) (A 24) Product claims (A 20) PIF (A 11) Access to info for public (A 21) Undesirable Effects (A 23) Sampling and Analysis (A 12) A = Article of Regulation 1223/2009 24
Delphic HSE UK Office 5 th Floor, 282 Farnborough Road, Farnborough, Surrey. GU14 7NA. UK Tel: +44(0)1252 856 700 Email: Tra@delphichse.com HK Office Unit 205 2/F Building 12W Hong Kong Science Park Shatin, Hong Kong Tel: +852 2657 8373 Email: Tra-hk@delphichse.com 25
Delphic HSE Speakers: For more information, please contact: Tra-HK@Delphichse.com 26
Thank you for your attention! Q&A 27