# Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) (2013/674/EU), Division 3.1: Quantitative and qualitative composition of the cosmetic product

Extent: E+W+S+N.I.

The aim of that section of the cosmetic product safety report is to provide the exact quantitative and qualitative composition of the finished product, starting from the raw materials. Raw materials are substances or mixtures used in the manufacturing of the cosmetic product. The intended function of each substance is to be indicated.
The complete product composition is to be specified, stating the name and identity (qualitative) of each raw material (including chemical name, INCI, CAS, Einecs/ELINCS, where possible), and the amount of each raw material, stating the weight percentage (quantitative). Ranges should not be used, unless this can be justified (e.g. viscosity or pH adjusters). If concentration ranges are unavoidable, toxicological considerations and calculations should be based on the highest concentration figure. It may also be useful to indicate the supplier(s) of the raw materials.
All substances entering into the composition of commercial mixtures supplied as raw materials (including directly added preservatives, antioxidants, chelators, buffering agents, solvents, other additives, etc.) are to be identified and quantified in the formula of the finished product. This also applies to all substances indirectly added to the product, such as preservatives used for preserving raw materials. The intended function of each substance is to be indicated.
When chemically well-defined substances are present, their quantity and molecular formula should be given together with their analytical specifications (degree of purity, identification of major impurities, criteria and test methods used).
When complex ingredients are present, their nature and quantity together with a clear definition of the mixture and the material(s) used should be given in order to identify the substances with regard to their composition and effects (manufacturing and purification processes, including physical, chemical, enzymatic, biotechnological and microbiological steps). The purity criteria and test methods used should be provided. Examples of complex ingredients include those of mineral, botanical, animal or biotechnological origin. The scope of the information needed on complex ingredients, depending on their nature and origin, is explicitly listed in the Scientific Committee for Consumer Safety (SCCS) Note of Guidance.
When a mixture of both chemically well-defined substances and complex ingredients is present, the above guidance also applies.
Where any fragrance (or flavour) compound comprising a mixture of fragrance (or flavour) ingredients and functional components with olfactory, odour-enhancing, odour-protecting or blending properties is formulated and intentionally added to a cosmetic product to impart a scent (or flavour) or to cover a malodour, its identification is to include the name and code number as well as the identity of the supplier. Qualitative and quantitative information about regulated substances in the fragrance (or flavour) compound and information relevant for a safety assessment should be disclosed to the responsible person and the safety assessor, and should be included in the safety report.

---
Source: https://www.legislation.gov.uk/eudn/2013/674/annex/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.