Documents Required for Completion of a Cosmetic Product ...



Documents Required for Completion of a Cosmetic Product Safety AssessmentAbout YouPlease provide your details below: NameCompanyEmailAre you the manufacturer, importer or acting on behalf of the Company (above)? Please delete as appropriate:1) Manufacturer 2) Importer 3) Agent 4) OtherAbout Your ProductPlease tell us about your product:Describe your cosmeticHow your product is to be used Delete as appropriate:E.g Body butter, face creamLeave on / Rinse offName to appear on reportHow many variants? Does it contain CBD?Include Address and product code (optional)None / [X] (use the extra boxes to capture variant formulations in section 1 below)Yes* / No If your product contains CBD*Please tick the box below to confirm your product complies with the following terms:The CBD is not derived from the flowering or fruiting tops of the plant or the whole plant where the flowering or fruiting top remains intact for processing (including ‘hemp’ varieties);?The preparation or other product is not designed for administration of the controlled drug (e.g THC) to a human being or animal;?The controlled drug in any component part is packaged in such a form, or in combination with other active or inert substances in such a manner, that it cannot be recovered by readily applicable means or in a yield which constitutes a risk to health;??No one component part of the product or preparation contains more than?one milligram of the controlled drug or one microgram in the case of lysergide or any other N-alkyl derivative of lysergamide as verified by the Certificate of Analysis (CoA). Please tick : ? By ticking the box you confirm that your products comply with the terms above. Guidance on completing this formWhere applicable, either: Add requested information in the boxes provided;Create (copy and paste) new boxes to capture extra information if required e.g for variant formulationsEnter ‘Attached’ and attach document to your email orEnter ‘Not applicable’.Not all information is required; it depends on your product. Guidance on completing each section is provided. See ‘Guidance’ boxes. Links to Dropbox or Google Drive or similar drives are not accepted because this may delay the order/quote process.Note: Payment shall only be taken when the assessor has confirmed required information is complete. Information on chemical substances / ingredientsChemical names, CAS and percentages, Material Safety Data Sheets (MSDS’ or SDS)Certificate of Analysis (CoA)GuidanceList all ingredients and any ingredients that make up mixtures. MSDS / SDS and CoA should be available from your manufacturer free of charge. CBD products: CoA must show that no THC is present or ‘Not detected’ for an assessment to be conducted. IMPORTANT: To process your quote or order efficiently please type formulation below. Do not include links to required information e.g. Google Drive, Dropbox as it may delay the process.Chemical NameCAS or EC Number1Percentage (%)2Please note: 1. Not all chemicals have CAS/EC numbers. Leave blank if number not available.2. Percentages must be provided. Other units e.g. mg/g are not acceptable. For variant formulations only: Use above table for base and tables below for variant formulations (copy and paste or delete tables as applicable):Variant 1Chemical NameCAS or EC Number1Percentage (%)2Variant 2Chemical NameCAS or EC Number1Percentage (%)2Information on Testing of the substances / ingredients and finished productsMicrobiological Tests. E.g. Total Viable Counts resultsSpecific Pathogens Test results.Preservative (known also as Antimicrobial) Challenge Test result.pH.GuidanceTotal Viable Counts: Test indicates whether the total number of microorganisms in the product is or not at a safe level. Of particular importance in products that readily support growth of microorganisms. May not be necessary for oil, dry, non-aqueous, aerosol products, etc. which do not sustain growth.Specific Pathogens: Test indicates whether very harmful microorganisms are present. Should not be detected in 1 g of product. Preservative: Test indicates whether the preservative present is enough to maintain below harmful level, the microorganisms in the product. May not be necessary for oil, dry, non-aqueous, aerosol products, etc. which do not sustain growth.pH: Generally applicable for soluble aqueous products.Client ResponseTest results of Stability of finished product and storage conditionsGuidanceRequired for all products. Indicates in months or years how long the product will remain safe and stable under the condition of storage. That is, derive products “Best Before …”, “Expiry date” or “Period After Opening”.Client ResponseInformation on purity and stability of packaging materialsGuidanceAre chemical components of the packaging materials likely to be carcinogenic, mutagenic or toxic to reproduction (CMR) or not? Do the chemicals have the potential to leach out of the packaging into the product and cause harm or not? Supply existing document or test result on the product packaging components and compatibility with the product.Client ResponseReport of evidence of Adverse Effects or Serious Adverse Effects (SUE)GuidanceProvide evidence of consumer complaints of “Adverse Effects” or “Serious Adverse Effects (SUE)”. See the appropriate reporting documents from the European Commission. Not expected to be available yet of a new product on the market.Client ResponseInformation of animal test resultsGuidanceCosmetic ingredients and products are no longer permitted to be tested on animals. However, if this is done, the information must be supplied.Client ResponseInformation on nanomaterials and its toxicologyGuidanceMust be supplied if presence in a product. If an ingredient is in a nanomaterial / nanoparticle state, it should be indicated on the CoA or MSDS supplied to you by your Manufacturer.Client ResponseInformation on Allergen ListingGuidanceThis is relevant only if perfume(s) and / or essential oils containing allergens are present in the product. The Allergen Declaration List / Certificate should be supplied free of charge by your Perfume House or Essential Oils supplier.Client ResponseInformation on Ingredient LabellingGuidanceProvide the text (or PDF, PNG, JPG file of mock up) to appear on the label. Client ResponseInformation on ClaimsGuidanceAny claims made on the product must be substantiated. That means proof is required to show that the product has the efficacy claimed. False claims are illegal.Client ResponseNotesNanomaterials: Require a) CPNP to EU Commission 6 months prior to placing nanomaterial-containing product on the EU market. b) Listing nanomaterials on the product label. Allergens: Allergens for listing on the product label: Equal or greater than 0.01%: rinse-off. Equal or greater than 0.001%: leave-on Use applicable forms for Reporting of Serious Adverse Effects of a finished product. Producers are expected to comply with Good Manufacturing Practice (GMP).CHECK LISTHave you completed all the boxes?Have you attached all MSDS and other attachments in your email reponse to sales@medicpro.london?For CBD Cosmetics only: Have you ticked the box and attached your CoA confirming ZERO THC has been detected. (This includes 9-THC and 8-THC). Email your response with attachments to sales@medicpro.london. Call 020 3411 0872 if you have any questions. ................
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