Raw Materials Safety Assessment

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.

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.

All cosmetic products must display the following mandatory information on both the container (inner label) and packaging (outer label): - Name and address of the Responsible Person - Nominal content - Date of minimum duration or PAO - Country of origin (if the product is imported into the community) - Product function (unless it’s clear from its presentation) However, there are exceptions for the following three items, which we will discuss in detail later in this article. - Warnings - Batch number - INCI list Please keep in mind that the items mentioned above are specified in EU Regulation 1223/2009, which outlines the requirements for cosmetics. However, it’s important to understand that various laws govern product labelling, such as the Packaging & Waste regulations, which can vary from country to country. We encourage you to explore our article on Labelling and Packaging Regulations for more information, including details about recycling symbols.

Having an International Nomenclature Cosmetic Ingredient (INCI) name for each ingredient is absolutely mandatory for every personal care product, allowing customers to identify the product’s content before making the purchase. However, it can happen that you are using an ingredient that is so unique, rare or sourced in remote places that it does not have an International Nomenclature of Cosmetic Ingredients name yet. In that case, to be able to use it in a product in Europe or the UK, it will need to be registered via the Personal Care Products Council. By going through the application process with PCPC, an ingredient will receive a unique INCI name systematically generated and internationally identified. Let our experts guide you through this process and optimise your chances for the new INCI name to be approved.