Overview: On July 25, 2022, the President of the Philippines officially signed and approved the "Atomized Nicotine and Non-Nicotine Products Regulation Act" as a Republic Law (RA 11900). The bill was merged from H.No. 9007 and S.No. 2239. (the latter two were passed by the Philippine House of Representatives and the Senate on January 26, 2022 and February 25, 2022 respectively) to control the import and manufacturing of atomized nicotine and non-nicotine products (including e-cigarettes) and new tobacco products , sales, packaging, distribution, use and dissemination. On June 15, 2022, the Philippine Department of Trade and Industry DTI issued Ministry Order No. 06 of 2022 DAO 22-06. It decided to carry out mandatory safety certification for e-cigarette products Vapor Products. An 18-month transition period has been set, that is, from January 2024, e-cigarette products must pass BPS certification before they can be sold in the Philippines.




Overall product requirements

1. The Department of Trade and Industry (DTI) should consult with the Food and Drug Administration (FDA) to formulate quality and safety technical standards that must be met for registered products.

2. The nicotine content in atomized products shall not exceed 65 mg/mL (65 mg/mL)

3. Refill containers for atomized products should be child-proof, tamper-proof, and prevent breakage and leakage.

4. The minimum permitted age for the purchase, sale and use of aerosolized nicotine and non-nicotine products, their devices or novel tobacco products shall be 18 years.

Product Registration Requirements

1. Manufacturers and importers of atomized nicotine and non-nicotine products, atomized product devices, heated tobacco product devices and new tobacco products should submit information to the DTI to prove compliance with the requirements before they can sell, distribute or advertise;

2. For online sales, the DTI Minister has the power to issue an order after due process directing the closure of the website, webpage, online application, social media account or other similar platform of an online seller that does not comply with the registration requirements stipulated in this Act;

3. The DTI and the Bureau of Internal Revenue (BIR) shall also maintain on their websites a monthly updated list of vaping nicotine and non-nicotine products and novel tobacco products registered with the DTI and the BIR that are eligible for online sale. brand.



Advertising restrictions

1. Allow the publication of aerosolized nicotine and non-nicotine products, new tobacco products and other forms of consumer communication advertising at points of sale or retail establishments, through direct marketing and on the Internet;

2. Prohibit the sale of atomized nicotine and non-nicotine products that have been proven to be particularly unduly attractive to minors (if the flavor description includes fruit, candy, desserts or cartoon characters, it is considered to be unduly attractive to minors).

Certification Requirements - "New Technology Regulations on Compulsory Product Certification of Atomized Nicotine and Non-Nicotine Products"

1. PS Licensing Plan for short

2. Scope of control: finished electronic cigarettes/e-cigarette smoking sets/heated tobacco product systems.

3. Documents required to apply for PS license:

3.1 Application form

3.2 For foreign applicants, domestic agents need to submit equivalent foreign documents;

3.3 Latest income tax return and financial audit statement;

3.4 Quality management system manual, including product production/development/control and other steps;

3.5 Product tracking and identification process: such as raw material and process control description, etc.;

3.6 List of measuring and testing equipment, and proof of ownership, such as invoices, etc.;

3.7 Equipment and instrument calibration plans and procedures;

3.8 Labels, logos and trademark documents;

3.9 Factory layout diagram

3.10 Letter of responsibility signed by the importer.

4. PS license application process:

4.1 Foreign manufacturers and different importers need to apply separately;

4.2 Factory and product audit:

4.2.1 The audit is performed by the testing laboratory of the Philippine Bureau of Standards (BPS) or other testing laboratories recognized by BPS;

4.2.2 All samples involved in the brand must be tested by BPS-accredited laboratories;

4.2.3 If non-conformities are found during the audit, the auditor must notify the company to take corresponding corrective measures;

4.2.4 Complete corrective measures within 3 months;

4.3 If it is a foreign manufacturer, the importer or authorized representative must apply.

4.4 PS licenses can only be issued with satisfactory audit results based on Philippine standards;

4.5 If the audit result is not satisfactory, it can only be issued after satisfactory results are obtained after re-examination;

4.6 The certificate is valid for 3 years;

4.7 Re-apply for the certificate 6 months in advance;

5. Customs commodity clearance process

5.1 Basic information:

5.1.1 The application form shall be signed by the authorized agent;

5.1.2 Packing list;

5.1.3 Commercial invoice

5.1.4 Bill of lading;

5.1.5 Product batch number;

5.1.6 Satisfactory registration certificate;

5.1.7 List of dealers, indicating contact information and address;

5.1.8 Contract;

5.1.9 Import customs declaration form;

5.1.10 Performance Guarantee

5.1.11 Copy of PS certificate

5.2 Application for customs clearance of imported goods

5.2.1 Make an application;

5.2.2 Product inspection is performed by the testing laboratory of the Philippine Bureau of Standards (BPS) or other BPS-accredited testing laboratories;

5.2.3 Submit the samples to the testing laboratory recognized by BPS within three working days;

5.2.4 If the test results are qualified, BPS will issue a certificate;

5.3 Certification audit and sampling

5.3.1 Performed by the testing laboratory of the Philippine Bureau of Standards (BPS) or other testing laboratories recognized by BPS;

5.3.2 Product testing, test standard: PNS AFNOR XP D90-300-1/2/3: 2019

5.3.3 Field test: mainly for appliances

5.3 Labeling requirements

5.3.1 Information printed/engraved on the device

5.3.1.1 Model name

5.3.1.2 Brand name

5.3.1.3 Serial number

5.3.2 Information on individual packaging

5.3.2.1Model name

5.3.2.2 Brand name

5.3.2.3 Serial number

5.3.2.4 Production date

5.3.2.5 PS certification mark

5.3.5 Product Manual

5.3.4 Information on electronic attachments