Legal Cosmetics
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Safety

Legal support for Creatives, Artists, and Innovators.

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SAFETY ASSESMENTS

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In order to comply with Regulation (EC) No 1223/2009 each product must be subject to a safety assessment performed by a qualified person (Degree/Diploma in toxicology or similar), before the product can be placed on the EU market. The safety of any cosmetic product is based on its ingredients and in accordance with Article 10(1), one of the main elements of the Product Information File (PIF) is the Cosmetic Product Safety Report (CPSR).

“In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.- Article 10 (1) of Regulation (EC) No 1223/2009.”

The CPSR is split into two sections consisting of Cosmetic Product Safety Information (Part B) and a Cosmetic Product Safety Assessment (Part B). Part A of the CPSR is intended to collect the necessary data to justify the safety of the cosmetic product. As a minimum, it is required to contain the following: 

  • Quantitative and qualitative formula of the cosmetic product

  • What testing on the product? (E.g. Physicochemical characteristics and stability, Microbiological quality of the cosmetic product)

  • Impurities, traces, information about the packaging material

  • Normal and reasonably foreseeable use

  • Exposure to the product / ingredients and comparison with legal limits found in Annexes to Regulation 1233/2009 and other limiters such as narcotics conventions.

  • Toxicological profile including undesirable effects of the product. This includes calculations to determine daily exposure dose (SED) and the margins of safety (MOS) or equivalent for all ingredients.

As per Article 3, Part B of the CPSR is the actual evaluation in the form of the safety assessor’s expert opinion as to why the product is safe to be placed on the market. The opinion contains the following based on Part A of the review:

  • Conclusion of the evaluation

  • Warning and instructions for use on the label

  • Reasoning

  • References of the assessor and approval of Part B

What Legal Cosmetics® need from you to carry out a CPSR?

  • Legal Cosmetics® will provide a easy to follow template document that you can add in the required data that will form the basis of the data assessment we will use to produce part A of the CPSR.

  • The assessment will be based only on the data you provide us so ensure you include all ingredients and data as stated in the template document.

  • All products should be manufactured to suitable standards of hygiene and data recording, equivalent to the standards of GMP ISO 22716:2007

  • Our assessments are based on best practice and integrate the EU Scientific Committee on Consumer Safety (SCCS) notes of guidance for the testing of cosmetic substances.

  • Once completed the CPSR will be provided to you in PDF format and can be used with a sales specification for each ingredient (or a Certificate of Analysis of a single batch) and a Material Safety Data Sheet (MDS) for each ingredient (where applicable) to complete much of the PIF requirements.

  • The next steps include labelling and claims substantiation and final submission via the EU / UK notification portals.