REGULATORY CHINA & KOREA


authorisation. Your account is only set up successfully after the NMPA has approved your application.


FINISHED PRODUCTS IN CHINA For finished cosmetic products in China, NMPA is also the principal authority The overarching regulation is CSAR, standing for the cosmetic administration and supervision regulation, said Julie Harrington, Senior Regulatory Consultant, CIRS Europe.


Cosmetics are classified into ordinary and special


The special group contains products including hair dye, sunscreens and anti-hair loss products. There is also a category for ‘products with new efficacy’, which are automatically considered a special cosmetic. There is also a toothpaste regulation, which is in the draft phase and due to be implemented at the end of 2023. Soap, meanwhile, can be imported to China without any pre-market compliance.


To import finished cosmetics to China you need to have a local legal entity You need a domestic responsible person (DRP) who has to meet certain criteria. They must be based in mainland China and must also have a business licence of a cosmetic nature, and permission to import and export. The DRP must be authorised by the registrant to act on their behalf.


Ordinary cosmetics are managed by filing, also known as notification


Registration, meanwhile, is for special cosmetics which do contain more high-risk ingredients. The time frame is also longer for special cosmetics due to testing requirements.


For special cosmetics in China, animal testing cannot be exempt


For ordinary ones, there is the possibility of exemption under certain conditions. These include having a GMP certificate issued by the government of the country of origin. There also shouldn’t be any claims for use on children, pregnant women or breastfeeding women; the filer should not be a key supervision target by the NMPA; and the product formula should not contain ingredients within a three-year monitoring period. If animal testing is waived, only hygiene tests apply, but these must be in an NMPA accredited lab.


There are new labelling requirements These include the executive standard number; the complete ingredient list; and a new option for indicating the expiry information on the label, both the production date and PAO.


A new Safety Assessment Report has been introduced


This came into effect in 2022 as part of the CSAR regulation, in greater alignment with the EU.


42 June 2023


To import finished cosmetics to China you need to have a local legal entity


It must be prepared according to the Technical Guidelines for Cosmetic Safety Assessment, a Chinese standard, so it is not possible to use a safety assessment generated for the EU market.


Pre-market approval is required, unlike in the US or EU


The extent of the approval depends on the classification.


SOUTH KOREA MARKET KNOW-HOW In Korea, there are five administrative categories for cosmetics


These are functional, natural, organic, custom and general. Functional cosmetics must be registered with the Ministry of Food and Drug Safety (MFDS). The category includes products for whitening, wrinkle improvement, protecting from UV or aiding in tanning skin; changing or removing the colour of hair or nourishing hair; and preventing or improving dryness, splits, etc of skin or hair.


Functional cosmetics’ registration can be via report submission or examination Examination is the formal way, but takes more than 60 days; report submission is a quicker, free and more simple way, with 95% of functional products registered via report submission.


Korean labelling must be written in Korean It must have a standardised Korean name, registered with KCID, the Korean Cosmetics Ingredient Dictionary. If not, you have to apply to register a standardised Korean name to be reviewed by a deliberation committee


cosmeticsbusiness.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60