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FAQs Vol.16 | China Clarifies Essential Oil Cosmetics Definition and Notification Requirements

On January 18, 2024, the Guangzhou Administration for Market Regulation (AMR) issued a set of FAQs aimed at standardizing the classification and notification process for essential oil products. These clarifications can help stakeholders differentiate between commonly confused concepts and avoid notification failures. ChemLinked will continue to provide updates on new FAQs. Please stay tuned for the latest information.
1. How to Differentiate Terms Related to Essential Oils?

According to GB/T 26516-2011 Massage Essential Oil and QB/T 4079-2010 Massage Base Oil, Massage Oil, essential-oil-related terms are defined as follows:

Terms

Definition

Essential Oil

Products obtained from plant raw materials firstly through methods such as "water distillation or steam distillation," "mechanical processing of the outer peel of citrus fruits," or "dry distillation.", then through physical methods for the separation of the essential oil from the water phase.

Absolute

An aromatic product obtained by extracting extractum, flower balsam, or fragrant resin with ethanol at room temperature. Typically, the ethanol solution shall undergoe cooling and filtration to remove waxes, followed by distillation to eliminate ethanol.

Massage Essential Oil

This product, designed for human skin care, is made by blending one or more essential oils and/or absolutes, fragrance components, and an appropriate amount of solvents, antioxidants, etc.


Importantly, this product is a cosmetic that cannot be directly applied to human skin. It requires appropriate dilution with massage base oil before being applied to the skin through smearing or massaging.

Massage Base Oil

Made from a mixture of refined vegetable oils, mineral oils, antioxidants, and other raw materials, this product is for diluting massage essential oils and/or oily products used for human skin massage.

Massage Oil

Massage product formulated with massage essential oils and base oils.

From the provided definitions, it's evident that massage essential oil products are unsuitable for direct application on human skin. Before being smeared or massaged on the skin, they should be diluted properly with massage base oil.

Massage oil is a massage product formulated from a blend of massage essential oils and massage base oils, designed for direct application to the skin.

The Guangzhou AMR advises notifiers to accurately and normatively name specific essential oil products based on their characteristics and intended methods of use during the notification process.

2. Which Essential Oil Products Are Not Cosmetics?

Under the Cosmetic Supervision and Administration Regulation, cosmetics are daily chemical products intended to be applied on human skin, hair, nails, lips, etc., by smearing, spraying or other similar ways for purposes like cleansing, protection, beautification, or grooming.

Essential oil products fall under the cosmetic category when their usage method, purpose, and application site align with cosmetics’ definitions. However, if they claim medicinal effects, or serve purposes like aromatherapy, air purification, soothing and sleep aids, etc., they are not considered cosmetics.

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3. How to Notify Massage Essential Oil Cosmetics?

As outlined in Article 35 of the Provisions for Management of Cosmetic Registration and Notification Dossiers, for cosmetics containing two or more independent formulas that must be used together or have inseparable packaging containers, each formula shall be filled out separately. However, the cosmetic product is regarded as one product during registration and notification.

4. What Should We Pay Attention in the Naming and Claim of Essential Oil Cosmetics?

Cosmetics must not expressly or implicitly claim to have medical effects. Their properties and appearance should not be confused with that of food, medicine, or other products.

The names of essential oil cosmetics should avoid containing the names of medical celebrities and medical terms, such as Zhongjing (a medical scientist in ancient China), Hua Tuo (a Taoist priest and physician in ancient China), nourishing and activating the collaterals, etc. The parts used should comply with cosmetics definitions and should not be described as specific parts like joints or acupuncture points by words or imagery. The efficacy shall not contain similar claims such as conditioning the body, dredging the collaterals, soothing the body and mind, etc.

5. How to Conduct Safety Assessment of Essential Oil Products?

Article 7.1.1 of the Technical Guidelines for Cosmetic Safety Assessment 2021 stipulates that safety assessments of cosmetic products should be exposure-oriented, considering factors such as application methods, areas, amounts, and exposure levels (including residue) to ensure product safety.

For products used with two or more doses combined, each component of the mixture should be evaluated based on the usage method specified in the instructions. If each part can also be used separately according to the usage method, it should undergo a separate assessment.

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