Chemlinked Cosmetic Portal, which provides market information on regulations and compliance announced the regulatory development following a year of R&D revision considerations for cosmetics companies.
The Safety and Technical Standards for Cosmetics (STSC) 2015 officially took effect from 1st December 2016.
The STSC 2015 provides comprehensive information on the technical standards applied to cosmetics regulation in China. The regulations supply guidance on general safety standards; definitions relating to prohibited, restricted and permitted ingredients; and setting testing methods for the manufacture and operation of cosmetics products in China.
Under the 2015 standards, the manufacture and/or import of any new cosmetics that fail to comply with its stipulations will be prohibited from entering the Chinese marketplace.
In addition, the standards impose strict compliance relating to product information and refer to specific details including warning, application conditions and ingredient list on labels and packaging; formulae; quality control specification and product technical specification, and testing reports.
Previously, companies were able to notify changes in product formulation via an online platform. However, as this too closed on 1st December 2016, companies must comply with new product registration requirements as well as those requirements relating to formulations, as set out by the standard.
To ease the transition for Chinese companies, the China Food and Drug Administration (CFDA) holds that cosmetics already in circulation, which have been manufactured and/or imported, can continue to be sold in the market until their expiration date.
On 1st June 2016, CFDA announced specific details relating to transitional processes for implementing the STSC 2015, outlining measures and deadlines.
The major and most significant revisions that will affect brands launching new products relate to the standards’ list of ingredients as these now contain increased numbers of prohibited ingredients and fewer permitted options.
There are 1388 types of prohibited ingredients, 47 kinds of restricted ingredients, 51 permitted preservatives, 27 permitted sun screeners, 157 colourants and 75 hair tints listed in CSTS 2015.
The new standards highlight the importance of the safety of both products and ingredients. To emphasise this, it has improved evaluation methods from the previous standard by aiming to produce a more comprehensive and scientific technical reference.
Its aim is to promote cosmetics R&D, as well as indicate relevant standards for all cosmetics in the Chinese marketplace.
Coming into effect
At the end of 2015, CFDA announced that CSTS 2015 had been reviewed and accepted by Cosmetic Standards Expert Committee.
“For already approved or filed cosmetics, the manufacturers and importers should submit modification applications to CFDA before 1st Dec 2016,” said the CFDA.
“Domestic non-special cosmetics only require submission of new formula and packaging while other categories require submission of description and diagram of the production process, safety assessment report (for risk-concern substance) and testing reports together.”
Following the transition of ownership from the China Ministry of Health in 2007, which had been the competent authority for cosmetics supervisions for the first, second and third versions of the standard, CFDA took over from 1st September 2008 for the fourth version of the standard.
After comparing China’s testing methods with global standards, the CFDA concluded that the APAC nation’s measures were outdated and the cosmetic product requirements were either overly simplistic or non-specific.
As a result, in 2009, CFDA authorised National Institutes for Food and Drug Control (NIFDC) to be responsible for revising the standard to modernise it and put it on a par with international standards.
Although consultation on the main body of the standard took place in December 2012, the full version was not analysed until February 2015.
Amendments were made and a second full version was presented in August 2015, before the standard was finalised in December 2015.