China
From May 1, 2025, cosmetic companies will be required submit the full version of the safety assessment report registering/notifying their products. This would include safety assessments for all ingredients used in a formulation.
These measures were put in place to “enhance the cosmetics safety assessment system and improve the safety and quality of cosmetics products comprehensively”, said the China National Medical Products Administration (NMPA).
This comes after a one-year grace period granted by the NMPA, during which it published a list of substances that would be exempted from the rules.
“These are the substances that have already been used in the China market, so they will waive the data. There are around 2,700. You will find basic plant extract such as green tea extract in the list,” said Mike Sohn, chief executive of REACH24H, a cosmetics regulatory consultancy.
Sohn told CosmeticsDesign-Asia that the list of exemptions came at “a real relief” to stakeholders.
However, he highlighted that there was still some confusion over the accepted methods of safety assessment.
“There are quite a lot of methods of safety assessment. For example, you can use non-animal testing methods, animal testing methods, or you could also perform a read-across. Chinese regulators have stated in the past they would accept the read-across method. However, we are sceptical about this so I advise that companies should prepare with the more recognised methods,” said Sohn.
Sohn also expects teething issues come May 1.
“We are expecting hiccups. I expect things may be a bit confusing in the early stages of May. The regulators may want more data, more supplements, so it’s important to prepare in advance,” he said.
Sohn added that companies should expect to encounter differences at a local provincial level.
“Special cosmetics will be reviewed by the federal NMPA, but general cosmetics will be done at the local level, and we won’t know if how different it will be at the provincial level.”
As the regulation kicks off in May, Sohn anticipates it will shake up China’s burgeoning cosmetics industry.
“China is realising that cosmetics could be a big export. They really want to promote their local players on a global stage. Right now, with so many brands coming up from everywhere, they want to filter away the not so good players with this regulatory hurdle. This will be good for their own ecosystem.”
At the same time, it will pose a barrier to cosmetic innovation in years to come as it makes it more difficult to bring a new ingredient into market.
South Korea
South Korea is set to implement cosmetic safety regulations from 2028 onwards after a grace period from 2026 to 2027.
Stakeholders can expect to see a draft from the Ministry of Food and Drug Safety (MFDS) very soon this year. The draft was scheduled to be published in December 2024 but was delayed.
Sohn told us that we can expect the draft to include additional responsibilities for South Korea’s equivalent of a responsible person (RP).
“The local RP will take charge of the safety assessment this will be an added responsibility,” said Sohn.
Additionally, the draft is expected to include the establishment of a safety assessor,
“This will be a new role, and the person will need knowledge and experience related to cosmetics, toxicology – an expert that can do safety assessments. The qualifications will be at least a bachelor’s degree in medicine, pharmaceutical, biology, chemistry, toxicology… The requirements compared to the EU will be more relaxed,” Sohn elaborated.
According to Sohn, the regulators will not require companies to submit the safety assessment reports. Instead, companies are expected to prepare them and make them available during an audit, for instance.
One area of major contention among South Korea’s many OEM/ODM manufacturers is the confidentiality.
“We have huge manufacturers that are concerned that in order to let the RP have all the safety assessment details, they will have to disclose all the information including the formulation, which they see as a core asset. There was push back about this,” said Sohn.
He understands that a compromise has almost been worked out between the contract manufacturers and the regulators, where the former will provide RPs with approximations of the formula.
“They will provide the formulation with a range of each ingredient. For example, water from 60% to 80%. For the safety assessment, companies will then use the biggest value to conduct the safety assessment. However, if MFDS requires the exact formula, they will have to go directly to the contract manufacturers.”
The demand for safety assessment regulations is expected to increase across Asia Pacific.
“It’s the easiest thing you can do. As non-tariff barriers, they are easy for the regulators to justify under the need to protect consumer health and safety,” said Sohn.
He added that regulators from Japan and the Philippines are also considering implementing similar measures and are in the early stages of discussions.
Taiwan
In recent years, Taiwan’s Cosmetic Hygiene and Safety Act has undergone significant changes, replacing the Statute for Control of Cosmetic Hygiene, to align more closely with international standards.
This introduced new regulation, such as the establishment of Product Information Files (PIFs) and Good Manufacturing Practices (GMP) compliance, as well as new definitions and regulatory terms.
Taiwan Food and Drug Administration (TFDA), released the finalised Cosmetic Categories Required to Establish the Product Information File and Effective Dates (2024) and it took effect on July 1, 2024.
According to the document, baby products, lip products, eye products, as well as non-medicated toothpaste and mouthwash shall establish PIF starting from July 1, 2025.
General cosmetics will follow a year later on July 1, 2026.
Additionally, TFDA a released the finalised Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations, which took effect on June 28, 2024.
Starting July 1, 2025, manufacturing premises of baby products, lip products, eye products, as well as non-medicated toothpaste and mouthwash will need to comply with GMP requirements.
Similarly, general cosmetics will need to comply with the requirements from July 1, 2026 onwards.
Furthermore, the TFDA introduced its finalised amendments to the List of Prohibited Ingredients in Cosmetics to align itself more closely with those of the Association of Southeast Asian Nations (ASEAN) and the European Union (EU).
Firstly, the management regulations for cells, tissues or products of human origin and Zirconium and its compounds were updated.
The list of prohibited ingredients in cosmetics was also expanded with the addition of nine substances, including Aminocaproic acid (INN) and its salts.
The majority of the amendments took effect on January 1, 2025.
Indonesia
In July last year, Indonesia’s National Agency of Drug and Food Control (BPOM) introduced version 3.0 of its cosmetics notification application.
Most significantly, it highlighted how PIF files were managed.
BPOM required businesses to submit their PIF files digitally and allow it to store the files in their internal systems.
While this was aimed at modernising the process, companies have raised concerns about potential data breaches.
“In today’s world, you have to consider that hacking could be easy. If there is a hack and someone gets access to those files or links, confidential information would be stolen,” said Alain Khaiat, chairman of the Cosmetic, Toiletry and Fragrance Association of Singapore (CTFAS).
He added that according to the ASEAN Secretariat, “the directive states clearly that the PIF is to be kept that the name and address of the company placing the product on the market.”
Furthermore, he noted that this arrangement may place BPOM itself at risk legally if a data breach occurs.
“Companies could sue the regulators and ask for damages in their country of origins, not Indonesia. We hope they will understand the legal risks behind this.”
According to Khaiat, this issue has been discussed at “various meetings” but has yet to be resolved.