China SFDA Prepares Risk Assessment Guidelines for Impurities in Cosmetic Ingredients

SpecialChem - Jul 19, 2011 Following the publication last year of guidelines for the risk assessment of impurities in cosmetic ingredients, China is preparing similar guidelines for assessing the ingredient themselves, explains Martin Hu of REACH24H Consulting Group. In keeping with the strategy of the Ministry of Health (MoH), China's State Food and Drug Administration (SFDA) mainly focused on the supervision of the quality and safety of finished cosmetic products. This was until several cosmetic safety incidents occurred including the discovery of chromium and neodymium in products in 2006, traces of acrylamide in facial creams in 2007, illegal black hair dyes and 1,4-dioxane in baby products in 2009. The SFDA gradually realized that merely supervising the safety of the cosmetics by means of "terminal control" and neglecting the quality of raw materials was insufficient and risky. Although the Hygiene Standard for Cosmetics (2007) lists prohibited and restricted substances, it is obvious that no cosmetics company would admit that its products contain any illegal substances, and thus the standard's list of substances is considered as a mere formality. Therefore, on 1 April 2010 the SFDA issued technical evaluation guidelines for registration. This was designed to harmonize the registration dossier requirements, as well as introduce the concept of "safety risk substances" (SRSs) - potentially hazardous substances present in cosmetic raw materials or introduced during the manufacturing process. For example, if ethanol is one of the ingredients, then methanol will be a SRS. The situation is the same for polyacrylamide/ acrylamide and polyethylene glycol with the impurity 1,4-dioxane. The guidelines require each applicant for cosmetic product approval to submit a risk assessment of all potential SRSs, based on the concentration and safety limits, or if the applicant claims that no SRSs are involved, a letter of declaration stating that is the case. Most cosmetics companies prefer to submit such a letter rather than spending time and money preparing a risk assessment report. The risk assessment is brand new to both China's cosmetics industry and the SFDA. During the six months or so that followed the introduction of the guidelines, no new cosmetic products were approved by the SFDA. Many applications for approval were rejected because applicants submitted a "no SRS" declaration but failed to provide assessments of SRSs that the SFDA believed would be present in such a product. However, as the SFDA has not issued an inventory of SRSs, the only clues available to industry in identifying them came from a training workshop arranged by the SFDA. Until the SFDA publishes a formal inventory of SRSs, applicants for cosmetic product approval are recommended to refer to substances and restricted substances listed in the 2007 standard as a reference in the meantime. So how should a company prepare a risk assessment for an SRS? In August 2010, the FDA issued new guidance on risk assessment preparation of SRSs in cosmetics. This guidance clarified some of the uncertainties of cosmetics applicants.According to the guidance, a complete risk assessment report of a SRS in cosmetics should include:

 

the source of the SRS;

a general description of the SRS e.g. its chemico-physical and biological properties;

the concentration of the SRS and the test method;

world-wide references (in regulations or the literature) of restricted limits of the SRS in cosmetics, food, water, air etc;

toxicology related materials;

risk assessment based on the products;

pesticide residue (botanical ingredients only); and

description on how to reduce the concentration of SRS based on current technical capabilities.

 

The core part of the risk assessment report is similar to the chemical safety report (CSR) required under REACH, excluding environmental exposure. The risk assessment procedure for SRSs can be divided into four parts: hazard identification; hazard characterization (dose response relation evaluation); exposure evaluation; and risk characterization. But unlike REACH, the calculated margin of safety (MOS) value is used to determine the risk. The SFDA's view is that if the value of MOS is above 100, then the risk of the SRS in cosmetics is controllable and will approve the use in cosmetics of an ingredient which may contain the SRS.  Although this system focuses on the "unwanted" substances present in cosmetic products or raw materials, rather than assessing the potential risks of the cosmetic raw materials used as ingredients themselves, this approach may change in the future. In April 2011 the MoH authorized the Chinese Center for Disease Control and Prevention (CDC) to publish draft guidelines on the risk assessment of cosmetic raw materials. These guidelines will become another national standard and will be a recommended standard instead of a compulsory one. The standard applies to the safety assessment of the actual cosmetic raw materials rather than the SRSs they may contain. Although no regulations require such a procedure yet, the publication of this future national standard reveals the ambition of the SFDA and the MoH. It could be that the risk assessment of SRSs is just a beginning and the risk assessment of complete cosmetic raw materials is their final goal, possibly as part of their approval for use as cosmetic ingredients in products. However, this process is expected to take a considerable length of time. In China, the process of integrating a national standard into the relevant regulation normally takes a number of years and the Chinese cosmetic industry would no doubt be opposed to such a regulatory burden, especially considering that the current risk assessment of SRSs is already seen as over-burdensome. Perhaps cosmetics manufacturers will seek to direct the pressure of regulatory compliance onto their ingredients suppliers and a reasonable solution will be found.