Amazon Seller Guide: High-Risk Product Compliance - Cosmetics

3.2 EU Market Cosmetic Compliance

3.2.1 Overview of EU Cosmetic Regulations

Cosmetics in the EU must comply with Council Directive 76/768 EEC, Regulation (EC) No 1223/2009, and subsequent amendments.

3.2.2 Definition and Classification of EU Cosmetics

The EU defines cosmetics as any substance or mixture intended to be applied to the external parts of the human body (skin, hair, nails, lips, or external oral hygiene products) or to the teeth and oral mucosa, primarily for cleansing, perfuming, or protecting them, to keep them in good condition, improve their appearance, or correct body odors. They are broadly classified into two categories:

• Rinse-off Products: Cosmetics that are in contact with the skin, hair, or mucous membranes and are quickly rinsed off.
• Leave-on Products: Cosmetics that remain on the skin, hair, or mucous membranes for a period of time.

3.2.3 EU Cosmetic Recalls and Reasons

According to the EU Safety Gate report, 106 cosmetic products were recalled in 2020, with 14 from China, accounting for approximately 13% of the EU's annual recalls. The main reasons for cosmetic recalls include: presence of prohibited or restricted substances exceeding limits, heavy metal contamination, undeclared fragrance allergens, and mislabeling of leave-on products containing MCI/MI.

Data Source: EU Safety Gate, https://ec.europa.eu/safety-gate/. Safety Gate is the EU's rapid alert system for consumer products, assisting in taking action to remove dangerous non-food products from the market.

Non-compliance Cases:

• Whitening and moisturizing cream: Contains hydroquinone.
• Soap: Contains substances related to phthalates and suffocation risk.
• Perfume: Contains prohibited substances.
• Baby wet wipes: Contains propylparaben.
• Whitening toothpaste: Contains aminohexanoic acid.
• Lipstick: Uses food-like shapes.
• Children's hair softener: Poses a microbial risk.

Navigating cosmetic regulations can be complex. To ensure compliance, it is essential to maintain good manufacturing practices, accurate product notifications, safety assessments, and adhere to the EU's 'Guidelines on Claims and Advertising'.

Responsible Person and Duties

The EU adopts a Responsible Person (RP) system. The RP must be a legal entity or individual within the EU. Typically, the manufacturer, importer, or distributor of the cosmetic product serves as the RP. This can be done through written authorization or by appointing a third-party legal entity or individual.

According to EU Regulation (EC) No 1223/2009, the RP must notify the product through the unified EU online platform before it is placed on the market. The RP must also prepare a product information file for official inspections.

Cosmetic Products Notification Portal (CPNP)

Information covered includes: product category, product name, responsible person, country of sale, label and packaging, product formula, country of origin (for imported products), contact person, nanomaterials, and special ingredients like CMR substances.

Product Information File (PIF)

The PIF includes: product description, cosmetic product safety assessment report (Cosmetic Product Safety Report, CPSR), manufacturing process description, and Good Manufacturing Practice (GMP) statement, animal testing data statement, and product efficacy proof.

Note: The Cosmetic Product Safety Assessment Report (CPSR) has the strictest requirements. It is a crucial part of ensuring product safety and consists of two parts: Part 1 requires the manufacturer or RP to provide cosmetic safety information. Part 2 requires a toxicologist with European certification to compile and sign the report.

Labeling (Claims) Compliance

The EU 'Guidelines on Claims and Advertising' outlines six basic principles for cosmetic claims: legality, truthfulness, evidence-based, honest and fair, consumer information, and no misleading claims. Claims are managed across eight dimensions: efficacy, ingredients, sensory perception, consumer perception, comparative claims, environmental claims, lifestyle claims, and exaggerated claims.

• Efficacy Claims: Require efficacy testing, consumer use testing, and in-vivo/in-vitro experiments.
• Ingredient Claims: Must be supported by evidence of presence, concentration, and relevance.
• Sensory Claims: Such as greasiness or absorption, require expert evaluation.
• Consumer Perception: Based on the target audience's personal sensory perception.
• Comparative Claims: Subject to the EU MCAD Directive.
• Environmental Claims: Such as ISO 14020/14044.
• Lifestyle Claims: Such as vegan, halal, natural, or organic.
• Exaggerated Claims: Do not require substantiation.

Special Notes:

A special inspection report by the EU Commission on cosmetic claims found that approximately 10% of 38,995 products across 21 member states had non-compliant claims. Of these non-compliant claims, 70% were found online, 17% on product labels, and 13% in brochures. Sellers should be aware of the following common claim violations:

• Claims of containing legal ingredients: For example, claiming 'paraben-free' is compliant according to EU regulations because it is a legally authorized ingredient. However, claims like 'alcohol-free', 'fragrance-free', or 'soap-free' are acceptable as they cater to consumer choices due to allergies or religious reasons.
• Claims of containing prohibited ingredients: This is considered non-compliant as it misleads consumers.
• Hypoallergenic claims: If a cosmetic product claims to be hypoallergenic, it should completely avoid known allergens and allergenic ingredients. For example, a hair dye claiming to be hypoallergenic but containing ingredients like resorcinol and p-phenylenediamine, which are known allergens, is non-compliant.
• Therapeutic claims: EU member state competent authorities consider therapeutic claims to be the most dangerous misleading claims for consumers.

3.2.4 EU Cosmetic Compliance Recommendations

1. Conduct relevant tests (e.g., heavy metals, microbial tests).
2. Complete the first part of the cosmetic product safety assessment: Provide cosmetic safety information.
3. Verify label information and advertising claims to avoid exceeding the intended use.
4. Establish and maintain a robust system for reviewing and recording raw material information.

3.3 Japan Market Cosmetic Compliance

3.3.1 Overview of Japanese Cosmetic Regulations

Cosmetics in Japan are regulated by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and local governments (prefectures). Sellers must comply with relevant laws and regulations, including the Act on Securing Quality, Efficacy and Safety of Products, Medical Devices and Regenerative Therapies (Pharmaceuticals and Medical Devices Act), the 'Guidelines for Labeling of All Cosmetic Ingredients', the 'Guidelines for Cosmetic Ingredient Standards', and the 'Guidelines for Appropriate Advertising of Cosmetics'.

3.3.2 Definition and Classification of Japanese Cosmetics

In Japan, cosmetics are legally classified into two categories: cosmetics and quasi-drugs. The definitions are as follows:

Cosmetics:

Articles for cleansing, beautifying, promoting attractiveness, or altering the appearance of the human body (skin, hair, nails, lips, or oral mucosa) by applying, rubbing, pouring, sprinkling, or similar methods to any part of the body, which are mild in effect on the human body. Compared to quasi-drugs, their effects are milder and not as recognized for improving rough skin, preventing acne, or sterilizing the skin. Therefore, claims of efficacy are not permitted on packaging.

They are used for:

• Preventing nausea, physical discomfort, bad breath, or body odor.
• Preventing prickly heat or chafing.
• Preventing hair loss (hair), promoting hair growth (hair), or removing hair (hair).
• Repelling or preventing mice, mosquitoes, or other insects.

Quasi-drugs:

These are products with approved active ingredients added at a certain concentration. Rather than being for treatment, they are manufactured for preventive purposes. Common examples include products for acne, sun protection, whitening, oil control, hair dyeing, and hair loss prevention. These products, recognized by the MHLW for their specific effects on the skin, will have the phrase 'active ingredient' indicated on the packaging.

(This includes products designated by the Minister of Health, Labour and Welfare, designated items, and 'special cosmetics' in Japan.)

3.3.3 Japanese Cosmetic Compliance Requirements

According to PMDA data: In May 2022, PMDA announced the recall of 13 non-compliant cosmetic products and 4 quasi-drug products. Cosmetics were rejected due to incorrect country of origin labeling or changes in product nature. Quasi-drugs were recalled for inconsistent ingredient information. In June 2022, PMDA announced the recall of 76 non-compliant cosmetic and quasi-drug products. These recalls were mainly related to non-compliant labeling, including inconsistent ingredient names, product names, or manufacturer information, or failure to provide information in Japanese.

Based on the reasons for cosmetic recalls in Japan, violations related to product manufacturing, sales, ingredients, and labeling significantly impact sellers' smooth operations. Therefore, Amazon will guide you through the relevant compliance requirements.

Production/Sales/Import Compliance

Application Qualifications

• Cosmetic manufacturing license
• Cosmetic manufacturing and sales license

Apply to the respective prefectural government to obtain a license.

Submission of Documents

• Notification from foreign manufacturer to PMDA
• Cosmetic manufacturing license
• Cosmetic manufacturing and sales license

Customs

Import

Packaging, Labeling, Storage

Data Source: Japan PMDA, Pharmaceuticals and Medical Devices Agency.

Production Compliance:

Japanese cosmetic manufacturing and sales operate on a notification system. Companies only need to apply to the respective prefectural governments and provide cosmetic manufacturing and sales licenses. Once accepted by the prefectural government, production and sales can commence.

Manufacturing License

• Manufacturing License (General): For repackaging bulk cosmetics into smaller containers or bags.
• Manufacturing License (Packaging, Labeling, Storage): For the final packaging, Japanese labeling, or storage of cosmetics.

Cosmetic Manufacturing and Sales License

• Sales, rental, lending of manufactured or imported cosmetics (including consignment for others, but not manufacturing for others).
• Establishment of a quality management system.
• Responsibility for product notification.

Sales Compliance:

According to the Pharmaceutical and Medical Devices Act, Japanese manufacturers of general cosmetics must submit a cosmetic manufacturing and sales notification to the prefectural governments, including the product's sales name, a brief description of the manufacturing process, and information about the manufacturing site. This notification must be accepted before sales can commence. Manufacturing sites in Japan must also obtain permits from the prefectural governments.

For cosmetics manufactured overseas, after submitting the cosmetic manufacturing and sales notification, an import notification must also be submitted to the local health bureau. This includes information such as the names, addresses, and relevant personnel of the overseas cosmetic manufacturers, as well as the names and addresses of their offices, factories, and the application must be submitted to the MHLW.

Import Compliance:

The importer must be a local Japanese company. A subsidiary of a foreign company in Japan can also act as an importer or distributor. The importer/primary distributor is responsible for the product's quality and safety. The importer must appoint 1 to 3 responsible persons according to the regulations.

Ingredient Compliance

In Japan, the holder of the marketing license is fully responsible for ingredient safety. To verify product safety, Amazon recommends conducting ingredient analysis to ensure compliance with Japanese cosmetic ingredient regulations.

Sellers must have samples analyzed by a testing and inspection institution designated by the MHLW. The analysis should cover: preservatives, UV absorbers, antioxidants, heavy metals, and Japanese designated colorants and prohibited substances. Additional specific tests may also be conducted, such as pH, viscosity, specific gravity, bacterial count, and patch testing for stability.

Special Note:

This analysis is not mandatory, and a report does not need to be submitted before market entry. However, the MHLW may request such reports if they deem the product unsafe.

Relevant Regulations:

Ingredient Name Requirements:

Sellers are obligated to list all ingredients on the label for cosmetics sold and distributed in Japan. The ingredient names displayed must use the names designated by the Japan Cosmetic Industry Association (JCIA), which are the Japanese International Nomenclature Cosmetic Ingredient (INCI) names.

If an ingredient does not have an INCI name, you must first apply to the JCIA to register an INCI name.

• Application Period: Approximately 3 months.
• Application Materials:
• Registration form: Downloadable from the JCIA website.
• Copy of the original INCI (ICID or INCI) monograph.
• Fee: 1,000 Japanese Yen.

Labeling (Claims) Compliance

The importer bears all quality assurance and product liability. They must inspect the packaging of each product and affix Japanese labels. According to Japanese regulations, all information must be clearly and accurately expressed in Japanese. False or misleading statements and unapproved efficacy claims are prohibited.

Necessary Labeling Content:

Scope of Efficacy Claims:

The Ministry of Health, Labour and Welfare has released a list of 56 'Cosmetic Efficacy Claim Scopes'. Cosmetics can only use claims specified within these scopes and terms. Examples include:

1. Cleansing the scalp and hair.
2. Removing scalp odor and discomfort.
3. Maintaining scalp and hair health.
4. Increasing hair strength and tensile strength.
5. Moisturizing the scalp and hair.
6. Keeping hair and scalp moisturized.
7. Smoothing hair.
8. Making hair easy to comb.
9. Maintaining hair luster.
10. Brightening hair.
11. Removing dead skin and itchiness.
12. Inhibiting dead skin and relieving itchiness.
13. Replenishing and maintaining hair moisture, resulting in shiny hair.
14. Preventing split ends and breakage.
15. Easy combing and maintaining hairstyle.
16. Preventing static electricity in hair.
17. Removing dirt and cleansing the skin.
18. Cleansing the skin, removing acne and pimples (for facial cleansers).

3.3.4 Japanese Cosmetic Compliance Recommendations

1. Clarify the intended use of the product and confirm its classification.
2. Prepare qualification applications in advance (6 months) and select a qualified import agent.
3. Conduct ingredient review before notification to confirm Japanese INCI names and formula compliance, thereby mitigating risks.
4. Verify label information and advertising claims to avoid exceeding the intended use.

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More learning content awaits you.

Course Path Overview

• 3.2 High-Risk Product Compliance - Electronic Products
• 3.3 High-Risk Product Compliance - Cosmetics
• 3.4 High-Risk Product Compliance - Lighting Products

Content: Learn about high-risk product compliance for cosmetics.

In addition to the high-risk product compliance covered in this chapter, there is more content in the product compliance series. Don't forget to continue learning!

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