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, explained Martin Hu of REACH24H Consulting Group, which provides global chemical compliance solutions to assist chemical manufacturers and importers.
On 1 April 2010 the SFDA issued technical evaluation guidelines for registration, 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.
New guidelines require assessment of all potential SRSs
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.
During the six months or so that followed the introduction of the guidelines, no new cosmetic products were approved by the SFDA. It claims that 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, 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.
Preparing risk assessment for SRS
In August 2010, the FDA issued new guidance on risk assessment preparation of SRSs in cosmetics which 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.
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, according to SFDA.
In April 2011 the Ministry of Health (MoH) authorized the Chinese Center for Disease Control and Prevention (CDC) to publish draft guidelines on the risk assessment of cosmetic raw materials which 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 with such processes being so time-consuming in China it is suggested that cosmetics manufacturers may seek to direct the pressure of regulatory compliance onto their ingredients suppliers and a reasonable solution be found.