Regulatory Background
The EU Cosmetics Regulation (Regulation (EC) 1223/2009) has been implemented as national law in 27 EU member states (as well as Norway, Iceland and Liechtenstein) since July 11, 2013. The regulation stipulates many requirements for the circulation of cosmetics in the EU market, including the responsible person, the responsibility and obligations of distributors, safety assessment, product information documents, requirements for notification, requirements for banned and restricted substances (and CMR substances), animal experiments, Label writing requirements and market supervision.
The U.S. Food, Drug and Cosmetic Act, the Fair Package and Labeling Act and other regulations simultaneously control cosmetics sold in the United States. These regulations stipulate that when circulating in the U.S. market, the responsibility and obligations of responsible persons and distributors need to be met, the requirements for the use of prohibited and restricted substances, especially colorants, label writing, safety assessment, and market supervision. At the same time, some states (such as California, etc.) have more local regulatory requirements. When the sales scope includes these states, it is also necessary to pay attention to meeting additional local requirements.
Scope of control
Since the definition of cosmetics in each region is different, please define cosmetics according to the region:
Cosmetics refers to any part of the human body surface (epidermal, hair, nails, lips and genitalia, etc.) or contact with teeth and oral mucosa, the only function or main function is to clean, impart fragrance, change appearance, protect, make Any substance or mixture that is in good condition or that corrects body odor, etc.
—— EU Cosmetics Regulation (EC) No. 1223/2009
Cosmetics are articles intended to be smeared, sprayed or sprayed, or otherwise applied to the human body for the purpose of cleaning, beautifying, enhancing glamour or improving appearance. Common products in this category are: body lotions, perfumes, lipsticks, nail polishes, eye and facial makeup products, shampoos, hair perms, hair dyes, toothpastes, deodorants, and any intended use as an ingredient in cosmetic products substance.
- U.S. Federal Food, Drug, and Cosmetic Act
Some situations that require special attention:
Product Category | EU Regulatory Category | US Regulatory Category |
anti-dandruff shampoo | cosmetic | Over-the-counter OTC |
acne products | drug | drug |
hair growth products | Cosmetics/Pharmaceuticals (depending on claims) | drug |
sunscreen products | cosmetic | Over-the-counter OTC |
cleaning wipes | cosmetic | cosmetic |
tattoo stickers | cosmetic | cosmetic |
soap | cosmetic | Cosmetics/General Consumer Goods (depending on composition and function) |
plastic fake nails | non-cosmetic | cosmetic |
Regulatory requirements
1. EU:
a. Domestic responsible person:
Each cosmetic product needs to designate a legal person or natural person in the EU as the domestic responsible person, responsible for ensuring that the product meets the regulatory requirements. Depending on the situation, it can be a manufacturer or importer, distributor, etc.
b. Safety Assessments, Product Information and Product Notifications:
Before placing on the market, it is necessary to ensure that the product has undergone a safety assessment and completed a safety assessment report, and reported to the EU Cosmetic Products Notification Portal (CPNP).
When placing on the market, the responsible person shall retain the Product Information File (PIF), which shall be reported in electronic or other forms, which can be queried according to the address indicated on the label, and shall be kept for 10 years after the last batch of products is placed on the market. The information needs to include information description, safety assessment report, description of manufacturing method and declaration of compliance with good manufacturing practice, evidence to prove efficacy or properties of cosmetic products, etc.
c. Ingredient use restrictions:
- Prohibited: Substances listed in Appendix II of the Cosmetics Regulations are prohibited from being used in products
- Restricted use: Restricted substances in Appendix III of the Cosmetics Regulations, colorants in Appendix IV, preservatives in Appendix V, and UV absorbers in Appendix VI must be used under the conditions of use
- CMR (carcinogenic, mutagenic or reproductive toxicity) substances: Except for the special cases that meet the EC 1272/2008 CLP regulation, the remaining 1A, 1B, 2 CMR substances shall not be used in cosmetics
d. Labeling Requirements:
- The product shall be marked with the following information in a conspicuous position on the display surface of the sales package in a clear and easily identifiable sign:
- Name and address of the responsible person (imported products need to indicate the country of origin)
- The indicated content shall be indicated by weight or volume. If it is less than 5g or 5ml, or free samples and disposable products are excluded. Prepackaged products need to indicate the quantity of the product
- The shortest shelf life is marked according to the requirements of Points 2 and 3 of Appendix VII of the Cosmetics Regulations
- Precautions, including at least the contents of Appendix III to VI of the Cosmetics Regulations, as well as the precautions for the use of professional cosmetics
- Production batch number or reference number, if this information is displayed on the product due to characteristics such as small packaging, it can only be provided on the packaging
- Cosmetic efficacy
- Ingredient list
2. United States:
a. Prohibited substances and colorants use:
- Prohibited Substances: 9 substances listed in 21 CFR 700.11-21 CFR 700.35 shall not be used
- Pigment use: According to the situation, only the pigments listed in 21CFR Part 73, 74, 82 can be used, and it is necessary to pay attention to whether the application site is suitable
b. Labeling requirements:
The product shall be marked with the following information in a conspicuous position on the sales package with a clear and easily identifiable label:
- Product name (required on the main display)
- Net content (required on the main display surface), marked in the form of weight, size, quantity or combination, should be marked in the bottom 30% of the main display surface (except in special cases). Depending on the main display surface, the character height needs to meet different size requirements. Units should be expressed using "oz", "fl.oz.", "lb", etc.
- Company name and address
- Ingredient identification
- Warning words (if any)
- Instructions for safe use
c. Security requirements:
Ingredients and final products must be fully demonstrated to be safe before they can be sold.
d. Additional California requirements for cosmetic products:
The following are the local requirements for products sold to California under California Proposition 65:
- Lead (County of Alameda Court case No. H217587 [consolidated with 01-032306]: ≤5ppm (lipstick and lip balm); ≤10 ppm lead content (eye shadow and blush)
- Cocamide DEA (County of Alameda Case No. RG 13 698427): Not to be manufactured, distributed, sold
- Dioxane (1,4-Dioaxne): ≤ 10 ppm, otherwise require warning labels (soaps and shampoos)
For the requirements of some OTC cosmetics , that is, when some products meet the definitions of cosmetics and drugs at the same time, they need to meet the requirements of cosmetics and drugs at the same time:
This can happen when a product has two intended uses. For example, shampoo is cosmetic because its intended use is to cleanse the hair. An anti-dandruff formulation is a medicinal product because its intended use is to treat dandruff. Clearly, anti-dandruff shampoos are both cosmetic and pharmaceutical. Other cosmetic/pharmaceutical combinations are as follows: toothpaste with fluoride, deodorants that are also antiperspirants, and moisturizers and cosmetics sold under the slogan of sun protection.
Cosmetic and pharmaceutical laws and regulations differ in terms of approvals, good manufacturing practices, registration and labelling. The following is an incomplete description to remind you that there are certain differences. For specific regulatory requirements, it is recommended to refer to the Food, Drug and Cosmetic Act, etc.
- Approval and registration: Cosmetics do not need to be approved by the FDA before they are marketed. The voluntary registration program VCRP (Voluntary Cosmetic Registration Program, 21 CFR 710 and 720) is implemented, and it is not required to provide the FDA with a list of formulas.
√ A drug must be approved by the FDA through the New Drug Application (NDA) process before it can be marketed, or comply with a “single line rule” that applies to a specific category as determined by FDA’s over-the-counter prescription review agency. And need to provide product formula to FDA.
√ The various types of over-the-counter medicines covered by the OTC single-line regulations are as follows: acne medicines, medicines for the treatment of dandruff, seborrheic dermatitis and psoriasis, sunscreens, etc.
OTC drugs must be labeled in accordance with the OTC Drug Regulations, including "drug information" labeling (21 CFR 201.66), and mixed OTC drugs/cosmetics must be labeled as mixed OTC drugs/cosmetics. For example, pharmaceutical ingredients must list "active ingredients" in alphabetical order, followed by cosmetic "inactive ingredients" in order of greatest advantage.
- Good Manufacturing Practices: FDA provides guidance for cosmetic GMP but does not prescribe specific requirements. Drugs not only have to strictly comply with drug GMP (cGMP) requirements, but also stipulate minimum requirements in 21 CFR 210 and 211.
e. Good Manufacturing Practice for Cosmetics (GMPC):
The Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics was revised in April 2008. Labels, complaints and other aspects are required to help manufacturers have good infrastructure and production equipment, reasonable production processes, and perfect quality management and testing systems to ensure that the final product meets regulatory requirements and is not considered to be participation and false labels. important production specifications, reducing the risk of product recalls and ensuring product traceability.
Regulatory basis
For more information on cosmetic regulations, please visit the following websites:
EU Cosmetics Notification Import
US FDA Cosmetics Regulations Website
U.S. Cosmetic Labeling Regulations
How to tell if a product is a cosmetic or a drug or both?
Please Note: The above information is not legal advice and should not be construed as or to represent the legal advice or conclusions of a government regulatory agency. Furthermore, this information cannot be promised or guaranteed to reflect the latest legal developments. For more information, please consult the competent authorities of the destination country/region or a professional law firm, third-party certification/testing/consulting company according to the product characteristics
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