The challenges of cosmetic product safety assessment – data compilation

June 06, 2018

The EU Cosmetics Regulation requires that all cosmetic products put on the EU market undergo a robust safety assessment, which must be performed by a qualified safety assessor.

The most extensive part of the safety report comprises a compilation of information on the cosmetic product. Some of this information can be readily obtained from the product manufacturer (e.g. quantitative-based formula, stability testing, microbiological testing, safety and efficacy testing) or raw material suppliers. However other data, such as the ingredient breakdown of raw materials and impurities, are not always readily available. TSG Consulting’s Dr Helena Eixarch highlights the key challenges when compiling data for the safety report.

Raw material ingredient breakdown

Whereas the general quantitative formula from the manufacturer will provide the basis for the safety assessment, obtaining detailed information from the raw material suppliers is of utmost importance (and often challenging). Raw materials may contain preservatives and additives that are sometimes (incorrectly) not taken into account in the general formula. The safety assessor must ensure that all ingredients present in the product are assessed, and these include preservatives and additives from raw materials, even if their levels in the finished product are low. Importantly, if the finished formula contains several raw materials with the same preservative, these amounts must be added up to ensure the resulting levels are below the maximum legal limits.

The safety assessor must request this information if s/he suspects a raw material may be preserved. This should be taken into account, for instance, for raw materials containing high amounts of water, which may be more sensitive to microbial contamination.

Impurities

The safety assessor should request information on impurities from all raw materials, but special attention should be paid to certain ingredients which are known to contain traces of banned substances.

Some of these impurities are specifically restricted by the EU Cosmetics Regulation. As an example, residual acrylamide (coming from polyacrylamide-containing raw materials) should not be present above 0.1 mg/kg in leave-on products. Nitrosamines are also restricted to a maximum 50 µg/kg, and can be formed when raw materials containing secondary amines contact nitrosating agents. Both acrylamide and nitrosamines are known human carcinogens.

Other impurities do not have a maximum concentration specified in the Cosmetics Regulation but are completely banned substances. Ethylene oxide and 1,4-dioxane, which are also known carcinogens, are two examples. These substances are carry overs and by-products present in polyethylene glycol (PEG) ingredients, among others. As they are banned, ethylene oxide and 1,4-dioxane may only be present at trace levels in finished cosmetic products. The safety assessor must, therefore, request all the available information in order to make sure that a certain concentration threshold is not surpassed. The same applies to heavy metals such as mercury, lead or nickel, which are impurities in colorants or natural clays.

If raw material suppliers are not able to provide data on these substances, the safety assessor may need to request testing of the finished cosmetic product in order to make sure the levels are safe. This is of utmost importance in the case of nitrosamines, as their concentration may build up with time; or for cosmetic products containing high amounts of colourants: as concentrations of heavy metals in raw materials are usually provided as maximum possible levels and not absolute values, this adds some uncertainty to the expected maximum level of impurity.

Allergens

Plant extracts are widely used in cosmetics. While natural ingredients are perceived as safe by the consumer, many of these extracts may contain high amounts of allergens, the presence of which may pose a health risk to sensitized individuals. The safety assessor should take this into account. If information on the content of allergens is not provided by the raw material supplier in the first place, this information should be requested. If data are not available, the finished product should be tested to assess allergen content. Stating the presence of allergens on the labeled ingredient list is mandatory according to the EU Cosmetics Regulation.

While documentation is usually the main source of information about a cosmetic product, testing should always be regarded as an option in order to address risk issues associated with certain ingredients.

TSG can provide robust safety assessments for your cosmetic products and assist with obtaining data, either by liaising with raw material suppliers or by suggesting the most appropriate testing strategy.

We’re going to be examining some of the challenges of the EU Cosmetic Regulation at TSGE Forum’s conference The Challenges of the EU Cosmetic Regulation: Practical Advice for the Industry held on 10 July in Epsom, Surrey. Join expert speakers and gain practical advice on topics including practical aspects of PAO and expiry date calculation; regulatory aspects of customizable cosmetic products; cosmetics and the microbiome; borderline products; and guidelines for natural and organic cosmetics. Follow the link to see the full programme.

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