The Requirements for International Cosmetic Packaging and Labeling

There is a diverse range of cosmetic packaging materials, such as glass, metal, plastic, and soft paper packaging. As the last process in the modern cosmetics industry, packaging is necessary to keep the contents clean and safe. However, it is also important to make sure the packaging itself does not pollute the cosmetics or add any unsafe factors to the contents. In addition, consumers’ understanding and judgment of cosmetics products often relies on the information provided on the products and by the sellers, the display of such information, to a large extent, determines consumers’ purchasing decisions and use methods for products.

Regulatory Requirements for Cosmetic Packaging Materials in Various Countries

China

Safety and Technical Standards for Cosmetics (2015 Edition) specifies that packaging materials are packaging container materials that are in direct contact with cosmetic ingredients or cosmetics. Packaging materials that are in direct contact with cosmetics must be safe, must not be chemically reactive when coming into contact with cosmetics, and must not transfer or release toxic and harmful substances to the human body.

Standards related to packaging materials include:

• QB/T 1685-2006 Requirements of Packaging Appearance for Cosmetic Products;
• DB37-T 1269-2009 General Rules for Cosmetic Primary Packaging; and
• T/FDCA 001-2018 Determination of Migratable Fluorescent Whitening Agents in Cosmetic Packaging Materials

The European Union

EU Cosmetics Regulation 1223/2009 does not directly regulate the safety of product packaging materials. However, according to Article 17, the non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, and migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is safe to the human body.

In addition, relevant properties of the product packaging materials, especially their purity and stability should be included in the safety information section in Appendix I – Cosmetic Safety Report. The packaging materials of products are often one of the trace sources of prohibited components in products, which should be taken into consideration in the safety assessment of cosmetics.

Japan

There is no specific regulation on the safety of cosmetics packaging materials in Japan. In principle, cosmetics packaging materials shall comply with the Pharmaceutical Affairs Law, namely, in foreseeable conditions of use, it shall not harm human health.

South Korea

To protect children, South Korea sets specific regulations on cosmetics packaging. According to Article 9 of the Cosmetics Act, in order to avoid accidental poisoning due to incorrect operations, manufacturers and sellers should use safe containers and packaging when selling manufactured or imported cosmetics. To protect children, these safe containers and packages must be difficult for children to open yet not difficult for adults to open. The specific standards and test methods for the degree of difficulties in opening should follow relevant regulations of the Ministry of Trade, Industry and Energy of Korea.

Regulatory Requirements for Cosmetic Labeling in Various Countries

China

On June 3, 2021, the National Medical Products Administration (NMPA) issued and implemented the Measures for Administration of Cosmetic Labelling, which standardized the requirements for the administration of existing cosmetic labeling. Cosmetics registrants and filers must complete the update of the product label before May 1, 2023.

Article 6 of the Measures points out that cosmetics must have Chinese labels. Article 7 regulates the contents that Chinese cosmetic labels must cover. Furthermore, products with packaging boxes must also mark the Chinese name and shelf life of the product on the packaging containers that come into direct contact with the contents.

Articles 8 to 17 of the Measures detail the specific requirements for the Chinese name of the product, the information of the product-related enterprises (including the registrant, the filer, the domestic responsible person, and the manufacturer), the product implementation standards, the total ingredients, the net content, the shelf life, the use method, and the necessary safety warning words that should be included in the Chinese label. In addition, the Measures also clearly regulate the management of innovative terms, text requirements, basis for efficacy claims, contents of prohibited labels on cosmetics, management of prohibited words, and terms.

The European Union

Article 19 under Chapter VI of the EU Cosmetics Regulation 1223/2009, describes the label requirements in detail. Cosmetics can be marketed only when their containers and packages carry information that cannot be washed off, is readable, and is printed in a visible font. The information that must be marked on the product label includes:

• product name,
• relevant information of the responsible person,
• product content information,
• shelf life,
• product use,
• warning information required to be identified,
• production batch number,
• product composition information.

It is also necessary to refer to the regulatory requirements related to their product categories, for example, in terms of sunscreen products, it is necessary to refer to the European Commission’s Recommendations on the Efficacy of Sunscreen Products and Related Claims.

America

The United States Federal Food, Drug and Cosmetic Act defines labelings as “written, printed or graphic materials displayed on direct containers”. Any information required by section 201 (k) of the Act to appear on the label of a direct container shall also appear on or be clearly visible through the outer container of a retail container.

Articles 701 and 740 of the Federal Food, Drug and Cosmetic Act provide the specific information and requirements to be marked on the label, in which the direct container shall be marked with the product name, safe use method, necessary warning words, manufacturer information, net content, and other required product information; The external container shall be marked with product name, product attribute, safety warning information required by 21 CFR 740.10, net content, safe use method, necessary warning words, manufacturer information, ingredient information, and other required product information.

Japan

In Japan, cosmetics are divided into “cosmetics” and “foreign products of the pharmaceutical department”. According to the Japanese Law on the Quality, Efficacy and Safety Assurance of Medicines, Medical Devices, etc., the contents of cosmetics to be marked include the name and address of the manufacturing and marketing enterprise, product name, production batch number, list of all ingredients, shelf life (cosmetics designated by the Minister of Health, Labor and Welfare), precautions, and other necessary matters. The contents of the external products of the Ministry of Medicine should be marked on their containers or packages, including the information of manufacturing and marketing enterprises, the words “external products of the Ministry of Medicine”, product name, production batch number, capacity, name, and content of effective ingredients (external products of the Ministry of Medicine designated by the Minister of Health, Labor and Welfare), other special ingredients required to be marked (ingredients designated by the Minister of Health, Labor and Welfare), shelf life, precautions, and other necessary matters. According to Article 4 of the Japanese Notice on the Use of Cosmetics, medical cosmetics that have the effect of inhibiting melanin production and have obtained the foreign product approval of the Ministry of Medicine shall be marked with the use precautions related to white spots on the visible surfaces of the outer boxes, and containers.

South Korea

In South Korea, the definition of cosmetic packaging is divided into "primary packaging" and "secondary packaging".

Primary packaging refers to the packaging containers that are in direct contact with the contents during the manufacture of cosmetics.

Secondary packaging refers to packaging and protective materials that can accommodate primary packaging, as well as packaging for marking contents (including instructions).

Article 10 of the Cosmetics Law of South Korea stipulates that the primary or secondary packaging of cosmetics must be marked with the following contents:

• the name and address of the cosmetic,
• the name and address of the manufacturer and seller,
• the total ingredients,
• the content,
• the manufacturing number,
• the service life,
• the shelf life after opening,
• the price,
• functional cosmetics must be marked with the words “functional cosmetics”,
• precautions during use, and
• other specified matters.

The primary package must be marked with the name of the cosmetics, the name of the manufacturer and the manufacturer and seller, the manufacturing number, and the shelf life after opening. The specific identification standards and methods are specified in the Detailed Rules for the Implementation of Cosmetics.

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