[Kim Taemin's Food and Drug Story] How Should Criteria for Determining Harmful Substances Be Set?

The air we breathe, the water we drink, and the cosmetics, pharmaceuticals, and food we apply directly to our skin are not composed solely of beneficial substances. Although we know that scorched rice crusts and slightly burnt meat are not good for our health, we still enjoy eating them. Dietary habits vary across different cultures, and it is common to find cases where ingredients permitted in foods abroad are banned in Korea, or vice versa.

Benzene, a carcinogen, is present in the bottled water we drink. However, it is an exaggeration to say that drinking bottled water causes cancer. Scientifically, a minimum safety standard is established by calculating the amount humans are exposed to or consume over a lifetime, and as long as this standard is met, there is no need to worry about safety. Although present only in trace amounts, many foods and cosmetics contain substances we call carcinogens, but in reality, cases where they affect health are extremely rare.

Recently, an issue has arisen regarding a shampoo dyed with natural materials developed by a university professor. The Ministry of Food and Drug Safety (MFDS) announced an administrative notice to include 1,2,4-trihydroxybenzene (THB), an ingredient banned by the European Union (EU), in the revision of the “Regulations on Safety Standards for Cosmetics,” thereby prohibiting its use in Korea. The company involved claims that the announcement exaggerates problems related to usage methods, sparking controversy. Consumers who purchased the shampoo are confused and questioning the MFDS’s sudden decision. It is difficult for consumers to judge whether it is reasonable for an ingredient previously allowed before the revision to suddenly be classified as harmful to humans due to legal changes, and whether the company’s claim that the application method differs from the EU’s ban and thus poses no toxicity is valid.

The EU limited its judgment on this substance to cases where it is used simultaneously mixed with common hair dye ingredients, stating there is a concern about genotoxicity only in such cases. Therefore, the company’s argument that it should not be equated with the shampoo used alone domestically is also persuasive. The shampoo is used in very small amounts, for only a few minutes, and is rinsed off, making it even less harmful to the human body.

There are many similar cases. For example, black carrot extract colorant, which was used without issue in a famous American jelly product, was once banned from import because it was not included in the MFDS’s “Standards and Specifications for Food Additives.” At that time, products were either administratively sanctioned or completely discarded as import non-compliant without even assessing whether it was harmful to humans. However, after numerous complaints, the MFDS revised the notice, allowing legal import.

In such cases, although there was no safety problem, import was prohibited simply because the legal regulations changed. From the perspective of businesses that suffered losses from previous imports, this is understandably frustrating. Another example is the mountain silkworm pupae, which Chinese people enjoy eating. Except for size, it is not much different from the silkworm pupae we consume, but mountain silkworm pupae are not registered as food ingredients under the Food Sanitation Act, so all processing and cooking are prohibited. If the MFDS revises the notice, it can be legalized immediately. The equation that illegal means unsafe does not necessarily hold true.

The public must rely on the MFDS’s approval and supervision to determine whether ingredients used in foods and cosmetics are safe. Ultimately, since the MFDS holds all authority to judge the harmfulness of ingredients, there must be principles that everyone can accept.

Paracelsus, known as the father of toxicology who judges the harmfulness of ingredients, left the famous phrase, “The dose makes the poison.” The principle that something is harmful should ultimately be decided scientifically based on the amount of intake or absorption of the ingredient, not merely on the presence or absence of a harmful substance. If this unchanging principle collapses, accusations of inconsistency (“Ihyeonryeong Bihyeonryeong” - “bells on the ears, bells on the nose”) cannot be avoided, and only public confusion will increase.

/Lawyer, Food Hygiene Law Research Institute