You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

October 5, 2012

Import Challenges for Cosmetic Products

Bangkok Post, Corporate Counsellor Column

By harmonizing the technical regulations governing the cosmetics industry in the ASEAN region over the past few years, the ASEAN Cosmetics Association has been the driving force toward better quality and standards. This harmonization has also helped remove trade barriers under the ASEAN Free Trade Area.

The ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) has set out the requirements for cosmetic products for all signatories, including Thailand, since January 1, 2008. Since then, a product manufactured or marketed in any signatory country can enter any other signatory country if it complies with the AHCRS requirements.

By harmonizing their regulations, the ten ASEAN countries, and particularly Thailand, have become an extremely attractive market in which cosmetics distributors can expand their businesses. There are, however, some technical regulations that have not been harmonized as they are subject to national controls, such as the restrictions on importation into Thailand.

Importing for Personal Use

The Thai Food and Drug Administration (FDA) has set forth clear guidelines to differentiate between cosmetic product imports intended for personal use and for sale. If a person brings into Thailand more than six items of the same cosmetic product from another country, the Import and Export Inspector from the Thai FDA at the port will conclude that the person intends to import the products for local sale.

Registration Requirements

When importing products for sale, each ASEAN country requires individual registration with the regulatory authorities where the product will be marketed. In Thailand, the FDA is flexible in allowing either a company or an individual to register as a distributor for a cosmetics business. And there is no limitation on the number of importers of one product, so the same product, with the same name, can be imported by several companies.

The Thai FDA requires that the company or person who intends to place any cosmetic on the market must register as an importer with the FDA, as well as register the product itself after the FDA approves the company’s or individual’s registration.

Using the established registration process, many individuals have tried to register themselves as authorized marketers or importers of a broad range of cosmetic products—even well-known products that are already registered with the FDA. These individuals have all eventually failed, as they are unable to produce the specific documentation the FDA requires for product registration. This includes, for example, the full ingredient listing and percentages of all ingredients contained in the product formula. This is important because this kind of information is extremely confidential and belongs only to the product owner and its authorized marketer.

A letter of authorization from the product owner or manufacturer is also required, especially when a well-known product brand is already registered with the FDA. It appears that some of these individuals lack the knowledge and experience to be importers or authorized marketers in accordance with FDA practice.

The FDA has also become more rigorous in post-marketing steps. FDA officials now regularly conduct random inspections of importers. Thai cosmetic companies are therefore required to prepare the four parts of the product information files, which consist of more detailed product information, in case they are randomly inspected.

Parallel Import

Importing cosmetics products into Thailand also creates some uncertainties with regard to parallel imports. For example, a manufacturer might give exclusive authorization to different distributors to sell its products in Malaysia and Thailand. The Malaysian distributor might then decide that it wishes to export the product to Thailand. In doing so, the Malaysian distributor will be required to carry out the registration process, and the Thai FDA will still be in a position to authorize the registration and import of such cosmetics on the basis that all documents have been provided.

If this happens, the Thai distributor, who had independently reached an agreement with the foreign manufacturer to be the only distributor in Thailand, will no longer be the exclusive distributor. The Thai importer would also not be able to claim trademark infringement against the Malaysian distributor. This is because Thailand recognizes the principle of exhaustion of rights. This principle holds that once a product has legally entered the market somewhere (in this case, in Malaysia), then resale of the product anywhere in the world no longer constitutes trademark infringement.

Faced with this scenario, the only available option is for the foreign manufacturer to claim breach of the contract it signed with the parallel importer (the Malaysian distributor), provided a clause exists that indicates that such distributor will not sell outside its designated territory.

In summary, if an individual wishes to import cosmetics into Thailand, he or she should first check the requirements, and then ensure that if they have a distribution agreement with the foreign manufacturer, sufficient provisions are included to allow them to enforce their rights.

RELATED INSIGHTS​ 

May 23, 2023
The latest update to Practical Law’s Life Sciences Global Guide includes a new “Life Sciences Regulation in Thailand” chapter by attorneys in Tilleke & Gibbins’ Bangkok office. The chapter covers a range of regulatory issues related to development, manufacturing, and selling of pharmaceutical products and medical devices in Thailand. The chapter provides important information on the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Developments, reforms, and proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Thailand” chapter can be accessed on the Practical Law website.
May 10, 2023
Cambodia’s Ministry of Health (MOH) has issued a notification reminding advertisers of health products and cosmetics in the country to obtain the required advertising approvals from the MOH. Issued on April 21, 2023, MOH Notification Letter No. 2198 on the Unauthorized Advertising of Modern Medicines, Traditional Medicines, Health Supplements, Medical Devices, and Health Supporting Products confirms that the MOH is aware of unauthorized advertising taking place in Cambodia, and signals its intention to increase enforcement efforts. It is therefore important for advertisers not yet in possession of the necessary approval to obtain the required advertising authorizations before marketing their health products in Cambodia. Advertising Framework for Health Products in Cambodia To legally advertise a health product in Cambodia, it must first be registered with the MOH (except for cosmetics, which only require notification). Only then can advertising approval be sought from the MOH, which will review the content of the proposed advertisement for compliance with Cambodian law. Approval is subject to a time limit, depending on the manner of advertising. All forms of advertising are covered under the MOH’s purview, including online, offline, business-to-consumer (B2C), business-to-business (B2B), promotion to healthcare professionals, and any other form of advertising. Key regulations prescribing general advertising rules are the Law on Consumer Protection, the Law on E-commerce, and the Sub-Decree on the Management of Commercial Advertising of Products and Services. However, product-specific regulations may also apply, depending on the type of product. For example, certain products may be subject to the regulation that sets rules for trading cosmetics in Cambodia, the (amended) Law on the Management of Pharmaceuticals, or others. Usually, product-specific regulations apply first, with the general product advertising rules being applied in addition wherever they do not conflict with the product-specific regulations. A key issue found among both general and product-specific
May 3, 2023
Attorneys from Tilleke & Gibbins have contributed the Laos and Thailand chapters to the newly released CMS Expert Guide to Cannabis Law and Legislation. The Thailand chapter was provided by Alan Adcock, partner and head of the firm’s regional life sciences team, while Dino Santaniello, head of Tilleke & Gibbins’ office in Laos, produced the Laos chapter. The guide provides an overview of the legal framework regulating cannabis in 33 jurisdictions around the world. It covers topics such as medical, recreational, and industrial use of cannabis, as well as the patentability of cannabis-based products. The guide’s chapters offer high-level information on the legal approach taken in each jurisdiction, as well as guidance for companies and business activities exploring possibilities in relation to cannabis and hemp. The Laos and Thailand chapters—as well as the full guide to cannabis law in 33 jurisdictions—are available on the CMS website.
April 20, 2023
Food safety is one important area of focus as Cambodia continues to improve its regulatory framework surrounding consumer protection. Last year, the new Law on Food Safety set out the main principles to regulate the food sector, providing general rights and obligations of food businesses and requirements for food products traded in Cambodia. Then in the first months of 2023, two implementing regulations were issued to clarify the overarching principles of the Law on Food Safety, as well as its enforcement mechanisms. The adoption of these enforcement-related regulations is once again a clear signal to the market that the Cambodian government is taking the enforcement of consumer protection laws seriously. Food Surveillance, Seizure, and Recalls The first of these implementing regulations was Sub-Decree No. 13 on the Conditions, Formalities and Procedures for Food Surveillance and Seizure, dated January 6, 2023 (SD 13), followed the next month by Prakas No. 080 on the Forms and Procedures to Seize Unsafe Foods or Foods Not Complying with Technical Regulations, dated February 22, 2023 (Prakas 80). These implementing regulations give clarity on how the authorities will monitor and inspect the food sector, and in what cases the authorities may resort to recalls or seizure of foods. Prakas 80 also provides the necessary paperwork for both inspecting officers and companies to use when reporting on unsafe foods to authorities and the public. Lastly, the regulations further clarify the obligations for food businesses and the penalties for noncompliance. The Consumer Protection, Competition, and Fraud Repression Directorate-General (CCF) of the Ministry of Commerce takes a key role as the main enforcement authority under the regulations. The CCF receives reports on unsafe foods, manages voluntary recalls, publishes warnings to the public regarding unsafe foods, seizes unsafe or otherwise noncompliant goods, and applies the administrative fines and penalties