EUROPEAN REGISTRATION OF COSMETICS : How to ensure compliance? MARCH, 25 2013 PREAMBLE – THE LEGAL CONTEXT DATA TO GATHER 1) Have a detailed and compliant formula composition 2) Have a compliant label artwork 3) Have sufficient and adequate data on the raw materials and the finished product REVıEW OF YOUR DATA 1) Go through a formula review and a label review 2) Have a CPSR prepared 3) Have a PIF compiled FıNAL STEPS OF THE PROCESS 1) Get your label approved 2) Get your product notified CONCLUSıON I. PREAMBLE EUROPEAN REGULATION 1223/2009 puts heavy obligations on: Manufacturers Importers Distributors Responsible Person Obligation of SAFETY (Safety Assessment) & COMPLIANCE (PIF & CPNP) I. PREAMBLE CIVIL & PENAL RESPONSIBILITIES: For damages due to non respect of obligations and to defect product LISTED OBLIGATIONS in the Regulation pertain to: Safety, GMP, Safety Assessment, PIF, Sampling and Analysis, Notification, Substances, Animal Testing, Labeling, Claims, Access to Public of Information, Communication of Serious Undesirable Effects, Information on substances I. PREAMBLE What does this all entail? 1. Ensure that only safe products are placed on the market 2. Ensure that all stakeholders respect the precautionary principle 3. Ensure that competent authorities have harmonized means to do their controls on products that get more and more internationalized 4. Get a higher consumers’ confidence in products How can this be achieved? I. PREAMBLE COMBINED EFFORTS TO ACHIEVE SUCCESS! II. DATA TO GATHER 2.1 HAVE A DETAıLED AND COMPLıANT FORMULA COMPOSıTıON “The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.” II. DATA TO GATHER 2.1 HAVE A DETAıLED AND COMPLıANT FORMULA COMPOSıTıON Full composition with trade names, broken down in INCI names, and giving exact concentration %. Product name Formula code Formula date THE PERFECT « ID CARD » OF YOUR PRODUCT… II. DATA TO GATHER II. DATA TO GATHER 2.2 HAVE A COMPLıANT LABEL ARTWORK The function of the product, unless it is clear from the presentation of the product The nominal content A list of ingredients (INCI) Particular precautions to be observed in use/directions for safe use The date of minimum durability or, for products durable > 30 months, the period of safe use after opening The batch number of manufacture Contact information of the manufacturer or responsible for marketing the cosmetic product (located within the EU) Indication of the country of origin. II. DATA TO GATHER 2.2 HAVE A COMPLıANT LABEL ARTWORK - Primary and secondary artworks - Leaflets or inserts When lacking space OUR ADVISE: Be ready for considering possible changes impacting INCI list, Claims, PAO, Translations II. DATA TO GATHER II. DATA TO GATHER II. DATA TO GATHER 2.3 HAVE SUFFıCıENT AND ADEQUATE DATA ON THE RAW MATERıALS AND THE FıNıSHED PRODUCT 1) Exact product name i.e. as displayed on the label artwork Problem of internal ‘nicknames’ or different lab names 2) Corresponding lab names/codes 3) MSDS and COA of raw materials/finished product 4) Stability of the cosmetic product 5) Microbiological quality II. DATA TO GATHER 2.3 HAVE SUFFıCıENT AND ADEQUATE DATA ON THE RAW MATERıALS AND THE FıNıSHED PRODUCT 6) Results of preservation challenge test 7) Impurities, traces, information about the packaging material 8) Undesirable effects 9) Test data (RIPT, …) III. REVIEW OF YOUR DATA 3.1 GO THROUGH A FORMULA REVıEW AND A LABEL REVıEW III. REVIEW OF YOUR DATA 3.1 GO THROUGH A FORMULA REVıEW AND A LABEL REVıEW - Sending a full composition with trade names, broken down in INCI names, and %. PROBLEM: Compositions in INCI and/or ranges only - Sending raw materials’ MSDS and COA PROBLEM: No documents supplied or delivery lasts for months Particular problems with Nail Polishes: no trade names, no INCI names, MSDS/COA rarely supplied. III. REVIEW OF YOUR DATA 3.1 GO THROUGH A FORMULA REVıEW AND A LABEL REVıEW - Ingredients under restriction Need for specific lab statements or for reformulation - Fragrance/natural extracts/essential oils Need for an Allergen Report (rarely supplied for extracts) Objective: DETERMINE YOUR INCI LIST III. REVIEW OF YOUR DATA III. REVIEW OF YOUR DATA III. REVIEW OF YOUR DATA 3.1 GO THROUGH A FORMULA REVıEW AND A LABEL REVıEW - Review your product function and claims (make sure the product is not borderline) - Review your net weight statement - Review your PAO reasoning - Review your translations - Review your symbols Objective: ENSURE A COMPLIANT LABEL III. REVIEW OF YOUR DATA 3.2 HAVE A CPSR PREPARED III. REVIEW OF YOUR DATA 3.2 HAVE A CPSR PREPARED Mandatory ‘blocking’ items: 1) Formula Composition & Allergen Reports (when necessary) 2) Raw Materials Data (MSDS & COA) & Attests (NAT, Restrictions) 3) Label Artworks and Leaflets/Inserts 4) COA of the Finished Product (preferred to Specifications) 5) Preservative Challenge Test (PET) Results 6) Stability Test Results (IN and OUT) DO NOT FORGET STABILITY FOR ANHYDROUS PRODUCTS! III. REVIEW OF YOUR DATA 3.2 HAVE A CPSR PREPARED Desired ‘missing’ items: 1) Microbiological Quality 2) Packaging Information 3) Compatibility of Packaging 4) Batch Numbering Procedure 5) Metrology Attest/SOP for Filling 6) Quality Control SOP 7) Undesirable Effects Statement III. REVIEW OF YOUR DATA 3.2 HAVE A CPSR PREPARED - Review the composition and the characteristics of raw materials and the finished product - Review the exposure to the product and to the substances Calculate the Margins of Safety Specific attention to cosmetics used around the eyes, on mucous membranes, on damaged skin, on babies, on elderly people and persons showing compromised immune responses - Review the presence of impurities - Review the compatibility between container-content Objective: PREPARE A SAFETY CONCLUSION III. REVIEW OF YOUR DATA 3.3 HAVE A PIF COMPıLED Desired ‘missing’ items: 1) Non Animal Testing Statements for FP & RM 2) Manufacturing Method 3) GMP Certificate 4) Claims Substantiation SOLUTION: Biorius has ready-made templates for most of these items. III. REVIEW OF YOUR DATA 3.3 HAVE A PIF COMPıLED Other items for 100% full compliance: 1) Packaging: MSDS, Material, Purity, Compatibility test results 2) Quality control of water 3) Quality control SOP Objective: PREPARE A COMPLIANT PIF PARTICULAR CASES PRODUCT COUNT Problems with: - Aromas often mixed up with shades Example: Lip Gloss Peach, Berry, Mint makes 3 distinct products, not 1 with 3 shades - Borderline products often mixed up with cosmetics Examples: Antibacterial Soap, Lip Plumping Gloss, Eyelash Enhancer, Aromatic Mists, Cleaning Products, Nail Jewels, … - Nail Polishes: Often considered by ‘category’ with one base and variations in shades BUT usually, they are different products. BORDERLINE vs. COSMETIC PRODUCTS BIOCIDE COSMETIC GATHERING THE DATA - ISSUE # 1: When working with different manufacturing labs/vendors necessity to adapt the process to each vendor/lab - ISSUE # 2: When data are sent as one compiled PDF (+300 pages) instead of one PDF per item - ISSUE # 3: When data are submitted using unorganized zip file or Link to YouSendIt, … GATHERING THE DATA SOLUTIONS: 1) Direct communication with the manufacturing lab/vendor signing of a NDA, specific access to CosmOS 2) Use of CosmOS 3) Or follow the organized dataset (per CosmOS structure) when submitting the data GATHERING THE DATA DATASET - COSMOS REVIEWING THE LABELS ISSUES: wrong INCI list, missing translations, borderline claims, … SOLUTIONS: 1) Consider overlabelling when packaging is already printed 2) If you need to print new packaging have BIORIUS perform first the formula review to determine your INCI list 3) Ensure translations of at least the product function 4) Document/Reword your claims IV. FINISH THE PROCESS 4.1 GET YOUR LABEL APPROVED - Sufficient Claims Substantiation PROBLEM with Borderline Claims, Ingredients Literature, Claims requiring Efficacy Tests - Correct INCI List 4.2 GET YOUR PRODUCT NOTıFıED - Getting the Final Correct Artwork SOLUTION: Biorius can help you prepare a draft artwork for notification. CONCLUSION THANK YOU!
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