China Drafts Cosmetic Technical Safety Standard

In an effort to develop regulatory protocols and standards which match the technical and supervisory capacity of the cosmetic industry, the CFDA is revising the 2007 Hygienic Standard for Cosmetics. To date the most significant progress made in amending this standard was the release of the revised body of the 2007 Hygienic Standard (renamed Technical Safety Standard for Cosmetics) in 30 Nov 2012. Since January 2014 the CFDA has coordinated with the National Institutes for Food and Drug Control (NIFDC) in a further revision of this draft. Following over a year of detailed revision work, the NIFDC is now soliciting opinions from the public on the new draft of the Technical Safety Standard for Cosmetics. The period for public consultation will end on February 28 2015.

 The basic revision work for the NIFDC are the adjustment of the regulatory framework (the new draft is divided into two parts: body and appendixes), the standardization of contents and wordings and the correction of some errors, such as typing errors, wrong CAS numbers, etc.. The most significant changes to the new draft are that the NIFDC added testing methods of 50 prohibited/restricted substances, improved partial testing and evaluation methods in the appendixes and amended the negative lists.

Keeping Pace with Technical Changes in EU Regulations

The CFDA has been developing regulations based on the EU cosmetic regulations in recent years. Xu Liang, technical expert from CFDA’s technical review expert panel advised cosmetic companies to pay close attention to EU regulation, “What EU is planning to ban for use shall be prohibited in China sooner or later so companies can regard this as a golden rule when developing cosmetic formulations.” China’s revised negative list is full of substances which have been banned based on their initial EU bans. For instance the banning of Isobutylparaben, Benzyl Hydroxybenzoate and Hydroxy benzene amyl under EU regulation No358/2014 released on the 9^th of April 2014 was shortly followed by these substances being added to China’s negative list. The range of application of Isothiazols has also been broadened, again aligning with EU Regulation No 1003/2014(18 September 2014).

Dramatic Change to "Methods of Safety and Efficacy Evaluation in Human"

A dramatic change in the new draft is the amendments to the appendix "Methods of Safety and Efficacy Evaluation in Human". Referring to National Standards ISO 24444 and ISO 24442, the NIFDC added preparation methods of high SPF products. Furthermore, the NIFDC changed the requirements for labeling of SPF value, which can be summarized as follows:

• SPF <2 no indication of sun protection effect
• SPF =2~50 indication of integer of calculated SPF value
• SPF >50 & integer of standard deviation > 50 indication of SPF 50+

It should be noted that the new draft has not included technical requirements for oral care products due to lack of related technical requirements, standards and review/evaluation methods although oral care cosmetics will be regulated as cosmetics as prescribed in the draft of “Regulations concerning Supervision and Administration of Cosmetics”.

* Please contact us at [email protected] if you are interested in obtaining the bilingual full-text of the new draft.