The challenges of cosmetic product safety assessment – data compilation

2018年6月6日

The EU Cosmetics 监管 requires that all cosmetic products put on the EU market undergo a robust safety assessment, 哪些必须由合格的安全评估人员执行.

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公式, 稳定性测试, 微生物测试, safety and efficacy testing) or raw material suppliers. 然而其他数据, such as the ingredient breakdown of raw materials and impurities, 不是总是现成的吗. 咨询的利记在线网址 海伦娜Eixarch博士 highlights the key challenges when compiling data for the safety report.

原料成分分解

W在这里as 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. 安全评估员必须 ensure that all ingredients present in the product are assessed, and these include preservatives and additives from raw materials, 即使它们在成品中的含量很低. 重要的是, 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.

安全评估员必须 request this information if s/he suspects a raw material may be preserved. 应该考虑到这一点, 例如, 对于含有大量水分的原料, 哪个对微生物污染更敏感.

杂质

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 监管. 作为一个例子, residual acrylamide (coming from polyacrylamide-containing raw materials) should not be present above 0.1毫克/公斤的免泡产品. 亚硝胺也被限制在50µg/kg以内, and can be formed when raw materials containing secondary amines contact nitrosating agents. Both acrylamide and nitrosamines are known human carcinogens.

其他 impurities do not have a maximum concentration specified in the Cosmetics 监管 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, 等. 因为它们是被禁止的, 环氧乙烷和1,4-dioxane may only be present at trace levels in finished cosmetic products. 安全评估员必须, 因此, request all the available information in order to make sure that a certain concentration threshold is not surpassed. 同样的道理也适用于汞等重金属, 铅和镍, 着色剂或天然粘土中的杂质是什么.

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.

过敏原

植物提取物被广泛用于化妆品中. 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. 安全评估员应该考虑到这一点. If information on the content of allergens is not provided by the raw material supplier in the first place, 应要求提供这些资料. 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 监管.

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.

利记网址 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 监管 at 利记网址E Forum’s conference The Challenges of the EU Cosmetic 监管: Practical Advice for the Industry 于7月10日在萨里郡的埃普索姆举行. 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. 点击链接查看 完整的计划.

通过分享: