Today we take a look at the cosmetic labelling requirements from around the world. As always we do our best to provide accurate information but we recommend that you consult with a solicitor before implementing any requirements for your labels.
First stop, our friends across the pond!
Canada
Labelling is a vital aspect when it comes to marketing cosmetic products as it helps consumers understand accurate details of the product. In Canada, cosmetics and personal care products are regulated by Health Canada (HC). Cosmetic labelling is regulated by the Food and Drugs Act, the Cosmetic Regulations, and the Consumer Packaging and Labeling Act and Regulations.
It is mandatory to display the following details on a cosmetic label in Canada:
- Ingredient list
- Common name of the product
- Amount of product in metric units or the count
- Name and address of the manufacturer or distributor
- Warnings or cautions
- Directions for use
The details should be in English and French languages apart from the ingredient list, which should be indicated in the INCI nomenclature. Ingredient labels in cosmetics allow consumers to make informed decisions about the products they are willing to purchase. Consumers can also identify the cosmetics that they may be sensitive or allergic to with the help of ingredient labels.
The names for cosmetic product ingredients are technical chemical names that might be difficult for consumers to understand. However, the INCI names act as universally recognized symbols representing a substance that may otherwise have different trade names. However, as Health Canada regulations allow only INCI names, consumers in Canada need to know a single name for an ingredient instead of multiple technical names.
Apart from Canada, several other countries also use INCI nomenclature for cosmetic labelling. Due to this, Canadian citizens travelling abroad can also recognise and avoid ingredients if required; without knowing additional terminology.
The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (SOR/2024-63) were published on April 24 in the Canada Gazette, Part II, making them final. This publication brings several changes to the Cosmetic Regulations, under the Food and Drugs Act:
- They mandate the disclosure of fragrance allergens on cosmetic labels if they exceed a certain limit.
- They offer more flexibility for disclosing ingredients in cosmetics sold in small packages.
- They strengthen notification requirements for cosmetics and Health Canada’s ability to enforce compliance.
- Other administrative changes are also included.
While these changes primarily affect cosmetic manufacturers, retailers should be aware of the new disclosure requirements to ensure the products they sell comply. This is especially important for retailers dealing with private-label cosmetics. Additionally, the introduction of a 10-day stop sale provision, requiring communication of intent to continue selling a cosmetic in Canada within 10 days of its first sale by the manufacturer or importer should be noted.
The Regulations will be implemented in two stages. All amendments, except those related to fragrance allergen disclosure, on cosmetic labels, take effect 180 days after registration, by October 9, 2024. Provisions regarding fragrance allergen disclosure come into effect two years after registration, on April 12, 2026.
South America
The most relevant aspects of Resolution No. 2310 of the General Secretariat of the Andean Community, published in the Official Gazette of the Cartagena Agreement No. 5095 of December 16, 2022. The Resolution includes the labelling requirements that cosmetic products must comply if marketed in the countries of the Andean Community (Bolivia, Colombia, Ecuador and Peru).
The effective date is December 16, 2024 and holders, manufacturers, and parallel importers of Mandatory Sanitary Notifications (NSO) issued in Colombia, Peru, Bolivia, and Ecuador must comply.
Mandatory labelling requirements
- Product name
- Generic name
- Cosmetic group
- Commercial brand
- Holder´s name or Parallel importer´s name
- Country of origin
- Net content
- Ingredients and/or substances warnings
- Batch number.
- NSO code issued by the Competent Authority of the Country Member.
- INCI list of ingredients, preceded by the word “ingredients” in descending order according to their total weight.
- Expiration date or shelf life of the product.
- Directions for use, when applicable.
- Storage conditions, when applicable.
- Warnings, precautions, and restrictions established by the manufacturer, when applicable
Mandatory labelling requirements in small containers or packages
- Product name
- Generic name
- Holder´s name or Parallel importer´s name.
- NSO code issued by the Competent Authority of the Country Member
- Net content
- Batch number
- INCI ingredients, which imply a health risk or warning.
- Expiration date or shelf life of the product.
The following will not be allowed:
- Texts, images, or any other symbols that attribute therapeutic properties or that create confusion with another category of products.
- Benefits and claims that have not been justified with the appropriate technical and scientific studies.
- The use of a complementary label or sticker to correct misinformation printed in the original label.
As with most countries, a local Responsible Person is either required or recommended for successful product approvals. The technical and legal documents often vary from country to country, so it is important to understand the requirements. Experienced regulatory experts such as International Cosmetics and Chemical Services, Ltd, can guide you with these requirements as your liaison.
Each South American country has specific regulations required prior to selling products in their country. The product category may also differ, which will determine the document requirements as well as the time needed to obtain product approval. Of equal importance are the language requirements. Almost every country will require Spanish except for Brazil, which requires Portuguese. You should be prepared to have a formal Product Approval with an approval number that may be required on the labelling of each product.
There are a variety of countries in Central and South America. They primarily follow International regulations for cosmetics adopting some of the EU and US rules. The biggest cosmetic market in South America is Brazil. They also tend to have the most complicated regulations to follow. But INMETRO has published a document which will aid formulators who are interested in selling products in this market.
The EU
The Single Market – the term used to describe the free movement of goods, capital, people and services within the Member States of the European Union – is a cornerstone of the European Union. In order for it to work for a specific product sector, there must be similar legislation in place in all the Member States. For example, if a product is to move freely within the European Union, the same labelling, packaging and safety regulations must apply. In the early 1970’s the Member States of the European Economic Community (now called the European Union – EU) decided to harmonise their national cosmetic legislations in order to enable the free circulation of cosmetic products within the Community, on the basis of commonly agreed safety standards. The Cosmetics Directive was adopted in 1976. This Directive was reevaluated in 2009 to enable further harmonization and an EU-wide Cosmetics Products Regulation entered into force in July 2013.
The EU Cosmetics Regulation stipulates that all cosmetics products must be manufactured in accordance with the harmonised standards laid out in GMP, in turn described in the Official Journal of the European Union. GMP ensures that products are prepared in a clean environment and that the products are not contaminated in production. Microbial contamination can be quite common as many microorganisms live freely in the atmosphere around us, and could lead to degradation and, in severe cases, could cause harm to the consumer.
Before being placed on the European market, all cosmetics products must be listed on a centralised database, the Cosmetic Products Notification Portal (CPNP), managed by the European Commission. When a product has been notified in the CPNP, there is no need for any further notification at the national level.
The EU Cosmetics Regulation sets the principles for claims that manufacturers can make on their packaging. This is complemented by the common criteria on claims regulation and guidelines that outline how claims should be made. In addition to the regulatory framework, they have a self-regulatory initiative that dictates responsible advertising on elements such as taste and decency, advertising to children, and respect for the human being. Cosmetics Europe has published the ‘Charter and Guiding Principles on responsible advertising and marketing communication’ to assist members.
The EU Cosmetics Regulation includes a set of strict rules for labelling of cosmetic products, all of which must be present on the product container, packaging, or if not possible given space restrictions, in an enclosed leaflet. Without proper labelling, a product will not be permitted onto the market.
Under the Cosmetics Regulation, the system of cosmetovigilance, whereby serious undesirable effects must be reported to the Responsible Person and relevant authorities, ensures that the safety of cosmetic products placed on the EU market is monitored throughout Europe.
A competent authority of the member state in which an undesirable effect occurs must inform the competent authorities of other member states. Moreover, if serious undesirable effects are reported to the competent authority of the member by end users or health professionals, that competent authority must transmit the information to the competent authorities of other member states and to the Responsible Person.
China
Jincong Li is an expert in the field of Chinese cosmetics regulations. He is the founder of the Cosmetics Forbidden Words website and vice director of the Cosmetic Policy and Regulations Committee of the Guangdong Institute of Cosmetics Science and Technology. Li is currently serving as a regulatory consultant for multiple cosmetics companies in China. His Wechat social media account, Jincong Li, specializes in interpreting Chinese cosmetic regulations. He has approximately 25,000 followers.
In recent years, China’s cosmetics regulations have undergone significant changes and attracted attention internationally. What are the key changes? What new issues and challenges have local and international companies faced in China? The Chinese American Cosmetic Professional Association (CACPA) is a non-profit organization. It aims to enhance communication, learning, and mutual development among professionals in the cosmetics industry. CACPA also serves as a platform for exchange and collaboration between the cosmetics industries in China and the US.
State Council Order No. 727, “Regulations on the Supervision and Administration of Cosmetics,” enacted on Jan. 3, 2020, and effective from Jan. 1, 2021, marked a significant update in China’s cosmetic regulations. During the past three years, the National Medical Products Administration (NMPA) introduced supporting regulations that impact areas such as cosmetic registration, safety assessment, efficacy claims and production standards. It means the regulations have been comprehensively updated and revised to further strengthen the supervision and management of cosmetic production and operation over the past 30 years. It represents a new phase in China’s cosmetic supervision and administration.
According to publicly released data, a total of 14 new cosmetic raw materials were approved from 2004 to 2020. The issue of new regulations in 2021 largely accelerated the filling of new ingredients. As of Dec. 30, 2023, 95 new ingredients (65% domestic, 35% imported) were filed, entering a three-year safety monitoring period. After the monitoring period, the NMPA will make the final decision and determine whether to include them in the catalogue of used cosmetic ingredients.
During the process of new ingredient filing, some registrants or filers have faced challenges in understanding the classification and conditions of the new ingredients. This led to issues such as unclear differentiation between new and existing ingredients, functionalities of ingredients exceeding cosmetic definitions, and incorrect determination of new ingredient conditions. To address this, the National Institute for Food and Drug Control (NIFDC) issued several new guidelines to guide and standardize cosmetic new ingredient filling and registration.
On Jan. 1, 2024, new requirements went into effect for ingredient safety supervision. Registrants and filers must provide all safety-related information for ingredients required by “Management Regulations for the Registration and Filing Data of Cosmetic New Ingredients.” Cosmetic ingredient manufacturers can use an online registration platform to submit this information. Chinese cosmetic regulations currently include 40 toxicological testing methods, comprising 30 animal testing methods and 10 alternative methods, categorized into local toxicity and systemic toxicity. When registering or filing cosmetic products and ingredients, the methods specified in the “Cosmetic Safety Technical Specification” must be chosen.
Currently, the most conducted toxicological tests are under local toxicity and genotoxicity. Options of in vitro tests are available other than animal tests. In terms of systemic toxicity testing, Chinese cosmetic regulations have not yet introduced alternative methods to animal testing. Companies opting not to conduct animal testing, or those situated in regions where animal testing is prohibited, encounter significant challenges in fulfilling Chinese regulatory requirements. Nevertheless, NIFDC is investing heavily in research to accelerate the creation and validation of new alternative methods to animal testing.
