Compliance with Safety Regulations in the Cosmetics Act Is a Necessary Condition, Not a Sufficient One
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Compliance with Safety Regulations in the Cosmetics Act Is a Necessary Condition, Not a Sufficient One
  • By Lim, Doo-hyeon, CSO,
  • Accepted 2023.10.20 16:25
  • Comments 0
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Korea's Cosmetics Safety Policies
Lim Doo-hyeon CSO, L’s Safety and Efficacy
Lim, Doo-hyeon CSO, L’s Safety and Efficacy

Cosmetics consumers have a few expectations as they go through the process of purchasing and consuming cosmetics products. First, they expect moisturizing, anti-aging, whitening, and the sunscreen effect, all of which are great for skin. They also expect not to experience any adverse effects while using the products. In other words, cosmetics users view safety and efficacy as the most basic value of cosmetics.

Governments around the world are demanding cosmetics manufacturers prove the efficacy of cosmetics in a reasonable, scientific, and truthful manner. The detailed means may differ, but the gist of the idea is very similar. Different countries are guaranteeing safety by reflecting their respective regulations on the verification.

How then is Korea ensuring the safety of cosmetics products? I’d like to introduce Korea’s policy below.

Korea’s cosmetics are regulated under the Cosmetics Act, the Enforcement Decree of the Cosmetics Act, the Enforcement Rule of the Cosmetics Act, and notifications by the Minister of the Food and Drug AdministrationMFDS. These regulations stipulate a variety of requirements to ensure the safety of cosmetics.

Basic requirements can be found in the regulations on the registration of cosmetics businesses. Article 3(Registration of Business) of the Cosmetics Act states that “a person who intends to register his or her responsible cosmetic distribution business shall comply with the standards for quality control and responsible post-sale safety control of cosmetics and shall employ a manager capable of managing such standards.” Thus, mandating that the person running a responsible cosmetics distribution business ensure the safety of such products. 

 

MFDS, the safety authority of cosmetics

The fundamental policy in establishing the safety standards of cosmetics in Korea is to have the Minister of the MFDS implement important standards for cosmetics. 

Article 8(Safety Standards for Cosmetics) of the Cosmetics Act specifies that the Minister of the MFDS must designate and provide notification of ingredients that are banned from being used in cosmetics. Regarding ingredients like preservatives, colorants, and sunscreens, all of which are subject to special restrictions, the Minister of the MFDS should set standards on their usage and provide notification of such to the public. As for ingredients with potential risks, the MFDS Minister must quickly evaluate them, and give notification of safety standards for distributed cosmetics. See Regulation on Safety Standards of Cosmetics, an MFDS notification for cosmetics ingredients that are prohibited from use, those restricted from use, and safety control standards for distributed cosmetics. Below is an excerpt from the important section in the Safety Standards on Distributed Cosmetics.

Stronger safety policies apply to cosmetics that are made for infants and children in Korea’s safety policy for cosmetics. 

Article 9 (Safe Containers and Packaging) of the Cosmetics Act stipulates that cosmetics distributors and sellers of custom cosmetics products must use safe containers and packaging to prevent children from being physically harmed from misuse. There are standards for using safe containers and packaging, for example, applying caps that are difficult to open for a runny mineral oil product. Article 4-2(Management of Cosmetics Used by Infants or Children) of the Cosmetics Act states that when responsible cosmetics distributors intend to label or advertise cosmetics to be used by infants or children, they must develop and maintain Safety Data by Product that verifies the safety and quality of each product. Examples of the Safety Data by Product include a product introduction, how a product is manufactured, the results of safety assessment, and evidence proving the efficacy and effects of their products. 

An excerpt from the Safety Standards on Distributed Cosmetics 
• Lead: 50 ppm in powder products with clay, 20 ppm in other products 
• Nickel: 35ppm in eye makeups, 30ppm in color makeups, 10ppm in others 
• Arsenic: 10 ppm 
• Mercury: 1 ppm 
• Antimony: 10ppm 
• Cadmium: 5 ppm 
• Dioxane: 100ppm 
• Methanol: 0.2% (v/v), 0.002% (v/v, wet tissues) 
• Formaldehyde: 2,000ppm, 20ppm (wet tissues) 
• Phthalates: 100ppm (Combination of dibutyl phthalate, butyl benzyl phthalate and diethylhexyl phthalate) 
• Total number of aerobic probiotics 
: 500/g (mL) or less in products for infants and young children and eye makeups 
: Number of bacteria and fungi in wet tissues: 100/g (mL) or less 
: Other cosmetics : 1,000/g (mL) or less 
• Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus: None

Moreover, the Minister of the MFDS must carry out a regular survey on safety data, consumer usage, and adverse effects after using cosmetics intended for infant and child use. The Minister should also devise plans for reducing risks, and educate the public, while promoting safe use of cosmetics products. Here, infants refer to young children aged three or younger, and children refer to children aged between four and thirteen. The safety data on cosmetics for infants and children must include the physical and chemical characteristics and toxicity data, along with the standards specifications data of each ingredient. In addition, the Minister must examine documents that specify whether the given product meets the safety standards of distributed cosmetics as specified in the regulations on safety standards of cosmetics.

 

Ban on animal testing for cosmetics

Toxicity testing is an important element in Korea’s safety policy on cosmetics. As of March 2018, Korea has prohibited animal testing for all cosmetics. Article 15-2(Prohibition of Distribution or Sale of Animal-Tested Cosmetics) of the Cosmetics Act bans the distribution and sales of cosmetics manufactured or imported using ingredients that have been tested on animals. 

However, there are several exceptions of limited cases backed by a number of reasons. Such cases include where animal testing is needed to determine the standards for using ingredients subject to restriction in use, including preservatives, colorants, and sunscreens, or when it is necessary to conduct a risk assessment on ingredients that are of concern regarding public health. In these cases, the distribution and sale of cosmetics are allowed even after animal testing. In addition, the following cases are not subject to the prohibition of distribution of sales even after performing animal tests: Where animal testing is necessary due to the absence of an alternative to animal testing; where animal testing is required to import and export cosmetics under the statutes and regulations of the country where the cosmetics are imported from or exported to; where ingredients developed through animal testing conducted under other statutes and regulations are used for the manufacture of cosmetics; and other cases as prescribed by the Minister of MFDS where animal testing is inevitable.

The Korean cosmetics regulations guarantee the safety of cosmetics by obliging cosmetics companies to meet certain requirements. 

Article 4 (Examination of Functional Cosmetics) of the Cosmetics Act ensures the safety of cosmetics by enforcing functional-cosmetics businesses to undergo an examination by the Minister of MFDS or by having them submit a report to the Minister of MFDS regarding the safety and efficacy of their functional-cosmetics products. 

Article 5 (Obligations of Business Operators) of the Cosmetics Act stipulates that responsible cosmetic distributors must comply with the requirements prescribed by Ordinance of the Prime Minister regarding the quality control standards of cosmetics, responsible post-sale safety control standards, methods for and obligation of quality tests, the obligation to report information on the safety and efficacy of cosmetics, and the obligation to establish safety measures. It also states that responsible distribution managers, among others, must receive education on securing the safety and quality control of cosmetics every year. Where deemed necessary to prevent potential risks to public health, the Minister of MFDS may order cosmetic manufacturers, responsible cosmetic distributors, and sellers of custom cosmetics to receive education on cosmetics safety-related issues, including how to ensure safety and manage the quality of cosmetics. Article 5-2(Recall of Hazardous Cosmetics) of the Cosmetics Act specifies that cosmetics companies must recall or take measures necessary to recall cosmetics without delay, as soon as they learn that cosmetics that pose or could pose a risk to public health are on the market. Article 10 (Matters to Be Stated on Packages of Cosmetics) of the Cosmetics Act stipulates that all ingredients used in the manufacturing of cosmetics must be marked on the label, along with the use-by date or best-before date after opening the container for safe use of cosmetics.

The MFDS is the safety authority of cosmetics in Korea. A photo of the MFDS, Osong Health and MedicalAdministrative Town, Cheongju, Chungcheongbuk-do. ⒸMFDS
The MFDS is the safety authority of cosmetics in Korea. A photo of the MFDS, Osong Health and MedicalAdministrative Town, Cheongju, Chungcheongbuk-do. ⒸMFDS

The manufacturing number must also be marked to track and manage products posing a safety concern. Article 15 (Prohibition of Sales Business) of the Cosmetics Act specifically bans the manufacture, import, sale, and storage of cosmetics that pose a safety concern. Such cosmetics include the following: Fully or partially deteriorated cosmetics; cosmetics contaminated by pathogens; cosmetics mixed or mingled with unwanted substances; cosmetics made of ingredients that should not be used in cosmetics, or cosmetics that fail to meet safety control standards for distributed cosmetics; cosmetics manufactured either under conditions which are likely to cause harm to health and sanitation, or in facilities that do not meet facility standards; cosmetics which are likely to cause harm to health or sanitation due to poor containers and/or packaging; cosmetics that have forged or falsified the use-by date or best-before date after opening; cosmetics which are likely to be consumed or misused as food because of the shape, smell, color, size, container, packaging, among others, of food products. 

 

Compliance with safety regulations in the Cosmetics Act is a necessary condition, not a sufficient one

The purpose of the Cosmetics Act of Korea is to improve public health. Thus, the Act spells out various regulations to ensure that safe cosmetics are manufactured, imported, and distributed in the country. Compliance with safety regulations specified in the Act is a necessary condition, not a sufficient one, regarding the manufacture, import and distribution of safe cosmetics. Establishing and implementing more rigorous safety policies, in addition to complying with safety regulations of the Act, is essential in not only guaranteeing user safety, but also in the pursuit of sustainable business. 

We cannot help but admit that there are disparities between the safety policies in Korea’s cosmetics regulations and the global standard, such as those from Europe and the US. Therefore, priority should be given to robust safety standards on ingredients, product preservative effectiveness tests, and stronger stability tests over anything else. 


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