TOPPHARM CONSULTING

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A thorough toxicological evaluation on raw materials is key if your company has ambition to sell raw materials to European manufacturers, as the raw materials must meet certain requirements to guarantee their safe use in cosmetic products. By making this evaluation available, you increase the sales possibilities all over Europe. This is also a key step to be able to approach the big players (L’Oréal, Estée Lauder, etc.) who will consider you as a serious partners as you will show a non-negotiable approach to quality and ensure the highest level of effectiveness and safety to end-customers. Taobé’s safety assessors will be able to develop a Dossier including: -A full toxicological assessment report of the raw material, according to the SCCS Notes of Guidance, demonstrating the safety of the cosmetic ingredient/s according to the utmost authority in Europe. -A CLP SDS, to provide to importers for REACH notification.

The very first step of every cosmetics registration in Europe starts with the full assessment of the formula of the product to confirm it meets the EU requirements. During this step, our Safety Assessors will: - Check all documents related to the ingredient (MSDS/COA/Non-animal testing/IFRA, etc.). - Verify that the ingredients do not have restrictions established by European regulations and that the limits of use (if there are any) are in compliance. - Check that the ingredients used are suitable for cosmetics (cosmetic grade ingredients). - Check the toxicological profile of each ingredient. - Verify if the ingredient contains any impurity. - Check the SCCS opinions, industry guidelines and other regulations (REACH, CLP). - Calculate the MoS (Margin of Safety) for each ingredient and/or search for supporting documents (reliable literature) that declare each ingredient safe at the added dose in the finished product.

The CPSR consists of two parts, A and B: in Annex I of the Cosmetics Regulation, all the information that must be collected and processed by the Safety Evaluator in order to identify and quantify the dangers that the cosmetic product may present for the human health, namely: PART A contains information on the safety of the cosmetic product, such as: 1. Quantitative and qualitative composition of cosmetic products; 2. Physical/chemical characteristics and stability of the cosmetic product; 3. Microbiological quality; 4. Impurities, traces, information on packaging material; 5. Normal and reasonably foreseeable use; 6. Exposure to the cosmetic product; 7. Exposure to substances and calculation of the MoS; 8. Toxicological profile of substances; 9. Undesirable effects and serious undesirable effects; 10. Information about the cosmetic product. PART B holds the conclusion, the warnings and instructions of use to label, the scientific reasoning and the assessor's diploma.