INTRODUCTION:

The Greek term for cosmetics is kosmetikos, which means "talent of order or placement." Its use in cosmetics in ancient Greece and Egypt is confirmed by archaeological evidence. Mixtures, of naturally occurring or artificially manufactured substances make up cosmetics. Cosmetics have various uses. Those meant for personal care and skin care can be used to clean or protect the skin and body.

They can also be used to enhance a person's natural features (like eyebrows and eyelashes), add color to the face, or precisely mimic the appearance of a person's face. In recent years, cosmetic scientists and related professionals have actively worked to advance this field.^1-6

OVERVIEW OF REGULATIONS FOR COSMETICS:

Most cosmetics laws are peculiar to a given nation. Cosmetics should generally be manufactured in accordance with Good Manufacturing Practices (GMP). Standardized testing procedures for identifying and detecting asbestos in cosmetic goods containing talc should be specified. Scientific information supporting the safety of perfluoroalkyl and polyfluoroalkyl substance use in cosmetic products, as well as any associated dangers, should be considered when using these chemicals.^7,8

The International Fragrance Association (IFRA) serves as the global representative body for the fragrance industry and works to ensure fragrances are used safely worldwide. In parallel, the Research Institute for Fragrance Materials (RIFM) functions as an independent international organization that evaluates the safety of fragrance ingredients. Certain substances such as alanroot oil (Inula helenium L.), leaf absolute (Ficus carica L.), and costus root oil (Saussurea lappa Clarke) are identified in cosmetic regulations and are restricted or banned under the IFRA Code of Practice. These prohibitions aim to protect individuals who may be sensitive or allergic by ensuring they are informed of potential allergenic components in cosmetic formulations.^9-13

Product Information File (PIF):

A Product Information File (PIF) is one of the most important legal criteria for bringing a product to market. Each cosmetic product must have its own PIF, which contains product-specific information such as the CPSR (Cosmetic Product Safety Report), product description, production procedures, and so on.

Importance:

The Product Information File is critical in ensuring that a cosmetic product meets all safety standards and is compliant with legislation. A product cannot be legally sold in the absence of a valid PIF, and failing to keep an up-to-date file may result in fines, product recalls, or market restrictions.¹⁴

COSMETICS REGULATIONS IN SPECIFIC COUNTRIES:

UNITED STATES OF AMERICA (USA):

In the United States, cosmetics are controlled by the Federal Food, Drug, and Cosmetic Act. The FDA monitors adherence to these standards. Cosmetics, unlike medications, do not need FDA permission for commercialization.

Cosmetic product makers, packers, and distributors in the United States who distribute their goods commercially can utilize the FDA's voluntary cosmetic registration program (VCRP), a post-market reporting system.¹⁵

Cosmetic regulations in US:

Laws that FDA Enforces for Cosmetics:

· Federal Food, Drug, and Cosmetic Act

· Modernization of Cosmetics Regulation Act of 2022

· Fair Packaging and Labelling Act External Link Disclaimer

· Microbead-Free Waters Act of 2015¹⁶

Safety Concerns:

Cosmetic items and chemicals do not require FDA approval before entering the market in the United States. Colour additives (other than those used in coal-tar hair colours) are the only exception, as they must be approved for their intended application. Companies and individuals that promote cosmetics have a legal obligation to assure the safety of their products. To take action against a cosmetic on the market for safety concerns, we need credible facts demonstrating that it is harmful when used according to the labelling or in the customary or expected manner.

Labelling requirements:

The FDA regulates cosmetic labelling in the United States under the FD&C Act and the Fair Packaging and Labelling Act.

The FD&C Act requires that label statements appear on both the inside and outside of any container or wrapper. FP&L Act obligations, for example. Ingredient labelling and a description of the net quantity of contents on the major display panel are only applicable to the exterior container label.

· Labeling regulations for the principal display panel, which is often shown for sale, require stating the product name and indicating its nature or application through a descriptive phrase or graphic.

· Provide an accurate statement of the cosmetic's net quantity in weight, measure, numerical count, or combination of both.

· The statement must be clearly visible, placed near the lower section of the label panel, aligned with the base of the package, and printed in a font size that is suitable for the container, in accordance with regulatory requirements.

· To measure a solid, semisolid, or viscous cosmetic, use the avoirdupois pound and ounce. For liquids, use the US gallon (231 cubic inches) and its subdivisions (quart, pint, and fluid ounces). If the net quantity of contents exceeds one pound or one pint, it must be expressed in ounces, followed by a statement of the largest whole units. The net quantity of contents can also be expressed in metric units.

· The marketing firm's name and location must be listed on the label's information panel.

· The information must be provided in the English language.

Declaration of Ingredients:

The ingredients must be listed in decreasing order of predominance. Color additives and compounds under 1% can be stated without regard for predominance. Ingredients must be listed using the terminology specified by the regulation. Those recognized by the FDA as excluded from public disclosure may be indicated as "and other ingredients." Cosmetics that are also drugs must state the active ingredient before listing cosmetic ingredients.

Label Warnings:

Cosmetic products that could pose risks when misused must include clear warning statements and instructions for safe use on their labels. These warnings should be easy to notice and written in straightforward, unmistakable language

Law Enforcement:

The FDA has the authority to examine and investigate products, inspect manufacturing facilities, and confiscate hazardous or mislabelled cosmetics^15.

Placement of Information on Labels:

Outer Container:

Principal Display Panel:

· Product name

· Product identity

· Net quantity of contents

Information Panel:

· Directions for use

· Warning statements

· Name and address of the manufacturer or responsible business

· Full ingredient declaration

All of the information listed above must appear on the label of the outer container, which may be a box, folding carton, wrapper, or any other packaging that encloses the immediate container. If the cosmetic product is sold without an external carton or box, then the immediate container itself functions as the outer container, and the required details must appear on it.

Inner Container:

Front Panel:

· Product name

Information Panels:

· Directions for use

· Warning or cautionary information

· Name and address of the manufacturer or responsible company

· Net quantity of contents

Figure:1 Example of US cosmetic labelling requirement¹⁷

These details must be printed on the inner (immediate) container that actually holds the cosmetic product. When this inner container is packaged and displayed inside a non-transparent outer box or carton, the labeling on the inner container serves this purpose. However, if the outer packaging is removed and the inner container is displayed for sale on its own, the label on the immediate container then becomes subject to the same requirements as an outer container label.¹⁶

EUROPE UNION (EU):

The EU's cosmetic legislation is based on Council Directive 76/768/EEC from July 27, 1976, which aims to align Member States' regulations on cosmetic products.

Manufacturers, including those in the United States, are responsible for ensuring that cosmetic products fulfill regulatory criteria before they are marketed. The manufacturer or importer of cosmetics must demonstrate that the product is safe for its intended use.

The EU enforces regulations at the national level, with each country having an authorized organization in charge of ensuring conformity.¹⁸

Safety Considerations:

Under Cosmetic Regulation (EC) No. 1223/2009, any cosmetic product marketed within the European Union must have an assigned Responsible Person who is required to maintain a Product Information File (PIF). This file must be retained for a minimum of ten years after the final batch of the product has been released onto the market. Additionally, any modification to the formulation or product details must be reflected in the PIF without delay.

Contents of the Product Information File:

1. Product description:

This section makes a direct link between the cosmetic product and the relevant PIF. It usually contains information such the product's name, formula, identification code, designation in official EU languages, and if the product is intended for distribution inside EU member states.

2. Product Safety Report:

The major goal of the safety report is to determine the safety of the cosmetic product. It is broken into two sections:

· Part A: Provides all the scientific and technical data necessary for safety evaluation, including microbial quality, toxicological information, exposure levels, and relevant physical and chemical properties.

· Part B: Presents the assessor’s conclusions regarding safety, supported by scientific justification. It also includes references, the rationale behind the evaluation, and any label-related instructions necessary for safe use.

1. Manufacturing Method:

This section outlines the manufacturing process and includes a declaration confirming that the product has been produced in accordance with Good Manufacturing Practices (GMP).

2. Evidence Supporting Product Claims:

Documentation or test results supporting any claims made about the product must be included here.

3. Animal Testing Information:

If no animal testing was conducted during the development of the product, this must be explicitly stated in the PIF.

Format and Language Requirements:

· The PIF may be kept in electronic form or on paper, as long as it remains accessible.

· The information provided should be clear and easily interpretable by authorities reviewing the file.

· It must be written in the official language of the country where the file is stored.¹⁹

Labelling requirements:

The 76/768/EEC directive requires cosmetic labeling to include the manufacturer's name or trade name, address or registered office, product weight or volume, precautions to take, and a distinctive batch number or product reference number. The expiry date can be expressed in two ways:

1) For items with a minimum durability of less than 30 months, utilize the "Best before the end" date. of
2) For items with a minimum durability of more than 30 months: the time after opening when the product can be used without damage to the user (marked by a particular symbol symbolizing an open cream jar).

· The list of contents must be labeled using common ingredient nomenclature, which is preferable for all member states, and should be presented in descending order.

· This information must be in the national or official language or languages of the respective Member State.¹⁸

ASSOCIATION OF SOUTH EAST ASIAN NATIONS (ASEAN):

Since its establishment in 2003, the ASEAN Cosmetic Committee (ACC) has been tasked with overseeing, evaluating, and coordinating the application of the ASEAN Cosmetic Directive (ACD). They are made up of the ASEAN Cosmetic Association (ACA) and the ASEAN National Cosmetic Regulatory Authorities.

In order to improve collaboration among ASEAN Member States in guaranteeing the safety and quality of cosmetic products marketed in ASEAN, the ACA and the ASEAN Member States developed the ACD.¹⁹

ASEAN countries have come to an agreement known as the ASEAN Cosmetic Directive (ACD) to standardize specifications for cosmetic products in an effort to lower technical trade obstacles within the region. Singapore began implementing the ACD on January 1, 2008.²⁰

Cosmetic regulation in ASEAN:

The ASEAN Cosmetic Directive governs the cosmetics industry in the ten ASEAN member states of Singapore, Brunei Darussalam, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Laos, Cambodia, and Myanmar. The directive defines cosmetics as "any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair and scalp, nails, lips, or external genital organs) or with the teeth and the mucous membranes of the oral cavity with the exclusive or main intent of cleaning them, odor-correcting them, altering their appearance, or maintaining their quality.”²¹

ASEAN cosmetics labelling requirements:

1. The following particulars shall appear on the outer packaging of cosmetic products or, where there is no outer packaging, on the immediate packaging of cosmetic products.

a) The name and function of cosmetic products, unless it is evident from the product's presentation.

b) Instructions for using cosmetic items, unless this is evident from the product name or presentation.

c) Full ingredient listing. The ingredients must be stated using the nomenclature from the most recent edition of standard references.

Botanicals and extracts of botanicals should be identified by their genus and species. The genus name may be shortened, however the following are not considered components.

Impurities in the raw materials utilized.

· Subsidiary technical ingredients utilized in preparation but not in the final product;

· Essential solvents or carriers for perfume and aromatic mixtures.

d) Country of manufacture

e) Company name and address for local market placement

f) Product weight or volume in metric or imperial system

g) Manufacturer's batch number

h) Clear manufacturing or expiry date (e.g. month/year).

I) Special precautions must be taken when using the product, notably those listed in the column "Conditions of use and warnings which must be printed on the label in Annexes", as well as any other precautionary advice on cosmetic goods.

Member states may need additional warning statements based on local rules, such as declarations about animal-derived substances. Under these circumstances:

i) The product label must clearly indicate, in any suitable format, that the formulation contains ingredients derived from animals.

ii) If the ingredients are obtained from bovine or porcine sources, the specific animal must be identified on the label.

iii) Ingredients originating from human placenta must be explicitly declared on the product label.

j) The product must also display the registration number issued by the country where it was manufactured or originally registered.

2. If the container or packaging is too small, oddly shaped, or otherwise unsuitable for displaying all the information listed in points 1(a)–1(i), companies may provide the required details through additional materials such as leaflets, pamphlets, hang tags, display cards, or shrink-wrap labels.

However, the following information must still be present on the immediate small container:

(a) The name of the cosmetic product

(b) The manufacturer’s batch number²²

Safety concerns:

Product information file:

The ASEAN Cosmetic Directive (ACD) requires individuals or businesses that place a product on the market to maintain a product information file "readily accessible to the regulatory authority of the Member State concerned at the address specified on the label in accordance with article 6 of this Directive."

The major purpose of this ASEAN Product Information File (PIF) Guideline is to advise enterprises launching cosmetic items on how to organize and produce the PIF using a predetermined PIF structure. This paper also describes who is responsible for maintaining the PIF and provides some principles for PIF audits.

The Product Information File (PIF) is divided into four major sections to guarantee clarity and compliance.

Section I covers administrative documents and product overview,

Section II focuses on raw material quality information

Section III: Finished Product Quality

Section IV: Safety and Efficacy Documentation

Each of these four sections should include a clearly displayed table of contents.

Section 1: Administrative Documents and Product Overview:

This first section of the PIF combines all administrative data and critical summary facts about the specific cosmetic product. It offers a short overview of the final project. Content of this section typically includes:

a. Administrative documentation

b. Detailed qualitative and quantitative formulation

c. Product presentation details and labelling information

d. Manufacturing statement or declaration

e. A summarized safety assessment prepared according to the ASEAN cosmetic safety guidelines

f. A summary of any known undesirable or adverse effects related to the product

g. Supporting evidence for claims appearing on the product packaging

Section II: Quality Information of Raw Materials:

This Section contains comprehensive technical data describing the quality of each ingredient used in the formulation.

It should include:

A. Specifications and testing techniques for all raw materials, including water quality where relevant. The analytical method employed must meet the ingredient criteria. In the case of scent components, the composition name, code, supplier information, and confirmation of compliance with the most recent IFRA requirements must be supplied.

B. Safety information for each raw material, obtained from supplier documentation, published scientific data, or regulatory body evaluations such as the ASEAN Cosmetic Scientific Body (ACSB), the EU Scientific Committee on Consumer Products (SCCP), or the US Cosmetic Ingredient Review (CIR).

Section III: Quality Information for Finished Product

This section contains detailed technical details proving the quality of the final prepared product.

It often includes:

a. The whole qualitative and quantitative formula.

b. Details on the manufacturing process

c. Specifications and analytical procedures used to assess the completed product

d. A summary report of stability testing for products with a durability term of less than 30 months.

Section IV: Safety and Efficacy Documents

The last component of the PIF contains the complete safety examination of the cosmetic product, as well as evidence supporting its efficacy and product claims. This includes:

A. The complete safety assessment

B. The most recent compiled report of any confirmed or documented adverse effects associated with product use

Evidence supporting the claims displayed on the product packaging²³

GULF COOPERATION COUNCIL (GCC):

Cosmetic regulation:

The Gulf Cooperation Council Standardization Organization (GSO) has introduced a draft regulation, GSO 1943:2015, titled “Cosmetic Products – Safety Requirements for Cosmetics and Personal Care Items.” This proposed guideline outlines product definitions, safety criteria, labelling rules, claim requirements, packaging standards, and the conditions under which products may be accepted or rejected.

Labelling Requirements:

1. All cosmetic and personal care items must display essential information in a permanent, clear, and easily readable manner. This includes:

a) The product name along with its trademark

b) The manufacturer’s or distributor’s name and address

c) The country where the product was produced

d) The declared quantity or volume of the product

e) Labelling instructions on the product's stability before and after 30 months from the manufacturing date.

f) Instructions for usage, cautions, and any required precautionary remarks

g) The batch or lot identification code.

h) The product's intended use or function.

i) A comprehensive list of ingredients, which must be printed on both the outer packaging and the primary container, or at least on the main packaging, tags, or supporting cards.

2. The information specified in points (a) to (h) shall appear on both the container and outside packaging of each cosmetic product.

3. Details necessary under points (a) to (e) must be in Arabic or English. However, the following information must be presented in both languages:

· Product name

· Product function and/or instructions for use

· Warning and cautionary statements

· Storage conditions required for safe handling

4. Additional specific labelling rules apply to certain product categories, including:

· Toilet soaps sold without external packaging

· Gift sets or kits containing multiple cosmetic products

· Hotel or hospitality-use cosmetic items

· Multi-pack cosmetic and personal care products

· Ampoules and vials, which must include the following bilingual statements:– Use only externally; keep your hands away from your eyes; open carefully.

Safety Requirements:

Cosmetic and personal care items must comply with the following safety standards:

1. The product must not contain pork or any pork-derived substances.

2 The formulation should be safe for human use under normal or reasonably predictable conditions.

3. Products must remain uniform, stable, and retain their quality throughout storage and use as instructed.

4. They must not contain spoiled, contaminated, or degraded materials.

5. The packaging and labelling must avoid imagery or statements that contradict Islamic values or the cultural norms of GCC countries.

6 Products must not include any ingredients restricted or prohibited in the referenced regulatory annexes.

7 Trace amounts of substances listed in Annex 2 may be tolerated only when they are technically unavoidable despite adherence to good manufacturing practice.

8 The specifications given in Articles 5.11 and 9.9 of GSO 2237:2012 "Cosmetics – Sunscreen Products" must be satisfied by sunscreen formulations.

9 Good Manufacturing Practices (GMP) must be followed by manufacturers. When production complies with recognized harmonized standards like GSO ISO 22716, compliance is presumed.

5. Products must adhere to the microbiological requirements set out in GSO ISO 17516, "Microbiology – Microbiological Limits."

6. Generally speaking, cosmetic products should have a pH between 4 and 8. Products made with a pH outside of this range could be allowed provided safety data supports their usage and scientific evidence shows that the pH is required to produce the desired effect.

7. Small, unintended traces of banned substances may be acceptable when their presence is technically unavoidable under proper manufacturing practices, provided safety is not compromised.²⁴

In the case of its presence as an impurity, cosmetic and personal care products should not exceed the following limits:

Substance	Limit
Lead	10 ppm
Arsenic	3 ppm
Cadmium	3 ppm
Mercury	5 ppm
Antimoy	10 ppm

Figure:3 Example of cosmetic labelling requirements for GCC²⁵

CONCLUSION:

Cosmetic labelling requirements differ significantly among the EU, US, ASEAN, GCC, and CIS countries, reflecting varied regulatory environments geared at protecting consumer safety and product transparency. In the United States, the FDA controls cosmetic labelling, which must disclose product identification, ingredients, and net quantity. However, unlike the EU, there is no pre-market approval, although statements must be honest and not misleading. In the labelling statement, the language of the expiry date varies by area. In the EU, it is based on the product's durability after 30 months, however there is no legislation governing expiration dates in the USA. The necessity for a Product Information File, highlights the importance of safety evaluations and compliance paperwork in EU and ASEAN countries. The ASEAN Cosmetic Directive supports member countries' harmonization by mandating labels to include ingredients, product function, and safety warnings. GCC regulations require that labels be in Arabic and include critical information such as ingredients and usage instructions. Regulations in the CIS countries are less uniform, with different standards for product labelling. In this article, we conclude that, while there are certain shared elements, such as the need for ingredient transparency and safety warnings, each region has its own regulatory structure. Companies seeking to market cosmetics in these locations must manage complex regulations and assure compliance to ensure the protection of consumer health and secure market access. Understanding these distinctions is critical for successful product development and marketing strategies in the global cosmetics sector.

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Received on 15.10.2024 Revised on 11.06.2025

Accepted on 26.11.2025 Published on 18.04.2026

Available online from April 25, 2026

Research J. Topical and Cosmetic Sci. 2026; 17(1):51-59.

DOI: 10.52711/2321-5844.2026.00010

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

ASIAN Countries		Europe Union
Regulatory Framework	The ASIAN Cosmetics Directive humfonizes regulations across. in ember states, focusing	Government by the EU Cosmetics Regulation (EC) No. 1223/2009, - which has strict safety and efficacy standards
Contents	Brief safely Assessment data is required	Detailed safely Assessment data including animal testing reports are required.
Registration	Not all ASIAN countries require PIF submission. Some may have less stringent requirements,	Submission of the PIF to the Eurogean Commissian viu the cosmetic Product Notification Portal (CPNP) before market launch
Stringency	Less stringent	EU regulations are generally morasgent
Market Access	ASEAN countries allow for quicker access	EU has a more formalized pre-market approval process

Labelling Requirements	US	EU	ASEAN	GCC	CIS
Regulatory Body	Federal food drug and cosmetic act (FDCA	European Medicine Agency (EMA)	ASEAN cosmetics directive (ACD)	GCC standardization organization	CIS consists of 12 countries each has its own regulatory body
Languages	Must be in English	National or official language or languages of the respective Member State	Must be in official language (S)	Must be in Arabic and English if required	National language of specific member state
Country of Origin	Not required	If the product is made in Europe, such mention is not mandatory. But if the product is imported from countries outside of the EU, you should mention the country of origin.	required	Should be specified	Should be specified
Manufacture Information	Must be given	Must be given	Must be given	Must be given	Must be given
Product Functions	Clearly stated on label	The function of a product must be clearly indicated and it must be translated into native language	Same as EU	Clearly stated on label	The intended purpose of the product, if it is not already clear from its name.
Ingredients List	The ingredients must be listed on the label in order of their decreasing weight.	The ingredients must be mentioned on the label in decreasing weight order.	On the label, the components must be stated in decreasing weight order.	The label must list the ingredients in decreasing order of weight.	The label must list the ingredients in decreasing weight order.
Batch Number or Lot Code:	Required for traceability	Required for traceability	Required for traceability	Required for traceability	Required for traceability
Net quantity	stated in both metric and US customary units	Stated in metric system	The quantity must be expressed using both metric units and the imperial system.	expressed in UI standards units	Stated in metric system
Expiry Date	Required for product shelf life	Should be specified	Should be specified	Should be specified	Should be specified