14 REGULATIONS
compromised immune responses,” as these specific body areas or populations may be especially sensitive to microbial infections. Regarding raw materials, knowing the initial level of contamination (i.e. before product manufacture) is of utmost importance. Additionally, the possibility of microbial growth during transport or storage must be considered, especially, for example, for water- or plant-based raw materials. The presence of preservatives in these raw materials should be checked. As for the finished cosmetic product,
routine microbiological analysis after each batch manufacture is considered necessary in order to ensure that the level of contamination in the product made available on the market is acceptably low. The SCCS Notes of Guidance3
recommended quantitative and qualitative microbiological limits for cosmetics, which are based on the European Standard EN ISO 17516:2014.4
Total aerobic mesophilic
microorganisms should not be present at levels above 100 cfu/g or cfu/mL in products intended for children under the age of three or to be used on the eye area or the mucous membranes; the limit is 1000 cfu/g or cfu/mL for all other product types. Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans should not be detectable in 1 g or 1 mL of the cosmetic product. Compliance with the microbiological specifications discussed above ensures that the product is in an acceptable condition after the manufacturing process. Nevertheless, there may be a residual microbial burden which can grow in the product after manufacture, given appropriate environmental conditions. Additionally, once the product reaches the consumer and is opened for use, it may be exposed to additional microbial contamination coming from, for example, the hands of the product user, water or air. Therefore, in order to be considered safe, a cosmetic product must be able to resist microbial contamination, that is, the product must be properly preserved. To ensure that a preservative system is effective, a preservation challenge test must be performed and its results included in the CPSR. The SCCS Notes of Guidance are based on the US and European Pharmacopoeia methods and recommend testing the following microbial strains: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus brasiliensis.3 The microbiological quality of the
product is essential in order to justify the minimum durability and PAO of the finished cosmetic product, together with the stability test results.
Some special cases must be considered regarding the need of microbiological
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testing of certain cosmetic product types. Firstly, for single use products and products which cannot be opened and exposed to the environment (e.g. aerosols), challenge testing is unnecessary. Secondly, for low microbiological risk products (e.g. products with a high alcohol content, low water content, high or low pH), both the microbiological testing after product manufacturing and the challenge test can be waived. In both cases, the absence of testing must be clearly stated, discussed and justified in the CPSR. The International Standard ISO 29621:2017 provides some guidelines for the identification of low microbiological risk products.5
Impurities and traces describe the
The use of raw materials of the highest purity is recommended when manufacturing cosmetic products. Nevertheless, impurities (unintended substances in raw materials) may be present and they will result in the presence of traces (small quantities of unintended substances) in the finished cosmetic product. Traces may also originate during the manufacturing process (as by- products), through the chemical interaction of ingredients in the formula, by substance degradation over time (stability issues) or by migration from the packaging material (see section below). Data from raw material suppliers are critical to the identification of trace substances present in a cosmetic product. If no documentation is available, but there is suspicion that unwanted substances are present, a physical/chemical analysis of either the raw material or the finished product is recommended. Regardless of their origin, traces must also be evaluated by the safety assessor as they may have an impact on the finished product’s safety. Traces of restricted substances must comply with any concentration limits stated in the Regulation’s annexes. If traces of prohibited substances are present and no concentration limits are stated in the Regulation, Article 17 applies, that is, the levels of prohibited substances should be kept as low as technically achievable under good manufacturing practices; technical unavoidability must be demonstrated. The safety assessor must determine the safety of prohibited traces as well as of trace substances that are neither prohibited nor have a regulatory concentration limit, based on the available information.
Ensuring Good Manufacturing Practice is essential to avoid deleterious trace levels, but reformulation of the product must be an option if the presence of unwanted substances is considered to pose a risk to consumer health.
Packaging material
The characteristics of the packaging materials that are in direct contact with the product must be assessed, as they may have an impact on the finished product’s safety.
As stated in the impurities section above, some substances may migrate from the container to the product. Obtaining information on the composition of the packaging material, including the presence of additives or technically unavoidable impurities, will therefore allow assessment of potential risks. Compliance with EU legislation on food contact materials6,7
may
be useful, as these materials may have already undergone migration testing. Again, data obtained from suppliers are of utmost importance. Compatibility of the product with its container may be assessed as a part of the stability test (see section above). In addition to providing information on the potential migration of substances, compatibility testing will provide an indication of the (lack of) interactions between the product and the container and will assess possible deterioration of the product in contact with the packaging, which may also be influenced by the external environment. Correct assessment of the substance migration risk will help select the appropriate packaging material (e.g. for light-sensitive formulas) and storage conditions (which can be then indicated on the product label).
Normal and reasonably foreseeable use of the product The directions for use and warnings stated on the product label will strongly influence the way a consumer uses a cosmetic product and, consequently, will affect its safety profile. Special attention must therefore be paid to ensure that the product is not used in excessive amounts, is only applied to appropriate areas of the body, is left in contact with the skin for the appropriate period of time, used at the correct frequency and is not used by an unintended population.
Knowing the expected usage conditions
of a product, based both on the product type and on the labelled directions for use and warnings, is essential for the safety assessor to determine a relevant exposure scenario.
Exposure to the cosmetic product and the substances Exposure is defined as the amount of cosmetic product coming into contact with the human body, taking into account the intended application area, the frequency of use and the normal and foreseeable use. The safety assessor will calculate
exposure to the product (and hence to the April 2018
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