REGULATIONS 13
The safety assessment of cosmetic products
Helena Eixarch, David Andrew – TSG Consulting, UK
Article 3 of EU Regulation 1223/2009 on cosmetic products (‘the Regulation’)1
states
that: “a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use”. As stated in Article 10 of the Regulation, in order to ensure compliance with Article 3, the Responsible Person (RP) must, before placing the product on the market, ensure that it 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”.
The Cosmetic Product Safety Report (CPSR) – Part A The structure and contents of the CPSR are described in Annex I of the Regulation. Part A of the CPSR contains the minimum information on the cosmetic product that must be used to support the safety assessment conclusion given in Part B. Very importantly, in addition to this minimum information, the safety assessor may use any additional relevant data. On the other hand, if any of the minimum information is not considered necessary (e.g. considering the product type), the absence of these data must be clearly justified.
The CPSR Part A
requirements as described in Annex I of the Regulation and its Guidelines2
are discussed in the sections below.
General information on the cosmetic product (composition and specifications)
The CPSR must include qualitative information on the cosmetic product including the chemical identity of the raw materials it contains, Note 1
their
molecular formula, INCI name and intended function. The identity of the raw material suppliers may also be considered.
April 2018
Microbiological quality The acceptable microbiological specifications of both the raw materials and the finished cosmetic product must be determined and discussed in the CPSR. As specifically stated in the Regulation: “particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing
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The quantitative composition of the product (i.e. the exact concentration of each raw material and individual ingredient) must also be indicated. Concentration ranges should not be used, but if this is unavoidable, the highest concentration should be used as a worst case for toxicological considerations. All substances intentionally added to the product must be listed, including those added indirectly (e.g. substances preserving raw materials). Compliance with any restrictions on
ingredient concentration as stated in Annexes II to VI of the Regulation should be checked at this stage. The physical and chemical
characteristics, both of the substances and the finished cosmetic product must also be taken into account. The SCCS Notes of Guidance3
describe the basic and minimum
properties to be considered for individual chemically well-defined cosmetic ingredients (e.g. molecular weight, solubility or purity) as well as for complex ingredients like mixtures of mineral, botanical, animal or biotechnological origin
(e.g. details of the preparation process or microbiological quality).
If a perfuming or flavouring substance is used, the name, code number and the identity of the supplier must be provided and the presence of any regulated substances (e.g. allergens) must be identified.
Stability of the cosmetic product A safe cosmetic product is expected to be stable under reasonably foreseeable storage conditions, as well as during transport and handling. Exposure to changing temperature, humidity, UV light or mechanical stress could affect the properties of the product, consequently reducing quality and affecting consumer safety. Relevant stability tests, adapted to the cosmetic product type, should be carried out. Stability tests can detect pH changes, colour or odour variations, phase separations or precipitation of substances, among other issues. The results of a stability test can provide useful information for the estimation of the product’s expiry date and ‘Period After Opening’ (PAO), which must be justified in the CPSR. Additionally, these results can reveal the need of specific storage or usage conditions for the product which, importantly, must be then communicated to the end users through the product label (e.g. “do not expose to heat” or “shake well before use”). This will contribute to improve the product’s performance and safety.
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