Overview: On July 25, 2022, the Philippines** officially signed and ratified the Aerosolized Nicotine and Non-Nicotine Products Regulatory Act into Republic law (RA 11900), which was enacted by HNo 9007 Act and SAct No 2239 (passed by the House of Representatives and Senate on January 26, 2022 and February 25, 2022, respectively) to regulate the import, manufacture, sale, packaging, distribution, use and dissemination of vaping nicotine and non-nicotine products (including e-cigarettes) and new tobacco products. On June 15, 2022, the Department of Trade and Industry of the Philippines (DTI) issued Ministerial Order No. 06 of 2022 DAO 22-06It was decided to carry out mandatory safety certification for e-cigarette products vapor products. And set an 18-month transition period, that is, from January 2024, e-cigarette products must pass BPS certification before they can be sold in the Philippines.
General requirements for the product
1.**In consultation with the Department of Industry (DTI), the Food and Drug Administration (FDA) should establish the quality and safety technical standards to be met for the products to be registered.
2.The nicotine content in the nebulized product must not exceed 65 milligrams (65 mg ml).
3.Atomized product refill containers should be child-safe, tamper-proof, and should be protected from breakage and leakage.
4.The minimum permissible age for the purchase, sale and use of vaping nicotine and non-nicotine products, their devices or novel tobacco products shall be 18 years.
Product registration requirements
1.Manufacturers and importers of vaping nicotine and non-nicotine products, vaping product devices, heated tobacco product devices, and novel tobacco products shall submit information to the DTI to demonstrate compliance with the requirements for registration before they can be sold, distributed, or advertised;
2.In the case of sales, the Minister of DTI has the power to issue an order directing the closure of the Seller's website, web page, app, social account, or other similar platform that does not meet the registration requirements set out in this Act, following due process
3.The DTI and the Internal Revenue Service (BIR) should also maintain a monthly updated list of brands of vaped nicotine and non-nicotine products and novel tobacco products registered with the DTI and BIR that are eligible for sale.
Ad Restrictions
1.Advertisements for vaped nicotine and non-nicotine products, novel tobacco products and other forms of consumer communication are permitted at the point of sale or retail establishment, through direct marketing and on the Internet;
2.The sale of atomized nicotine and non-nicotine products that have been shown to be particularly unduly appealing to minors is prohibited (if the flavor description includes fruits, sweets, desserts, or **characters, it is considered excessively appealing to minors).
Certification requirements - "New Technical Regulations on Compulsory Product Certification of Atomized Nicotine and Non-Nicotine Products".
1.Abbreviated as the PS Licensing Program.
2.Scope of control: e-cigarette finished products, e-cigarette smoking devices, heated tobacco product systems.
3.Information to be prepared to apply for a PS license:
3.1 Application Form.
3.2 For foreign applicants, domestic ** business operators need to submit equivalent foreign documents;
3.3 The latest income tax return of the latter financial audit declaration;
3.4. Quality management system manual, including product production, research and development, control and other steps;
3.5. Product tracking and identification process: such as raw materials and process control descriptions
3.6 List of measuring and testing equipment, as well as proof of ownership, such as invoices, etc.;
3.7. Equipment Instrument Calibration Plans and Procedures;
3.8. Labels, logos, trademark documents;
3.9 Factory layout diagram.
3.10 Letter of Responsibility signed by the importer.
4.PS Permit Application Process:
4.1 Foreign manufacturers, different importers need to apply separately;
4.2 Factory & Product Audits:
4.2.1 Audited by a testing laboratory of the Philippine Bureau of Standards (BPS) or other testing laboratories accredited by BPS
4.2.2 All samples involved in the brand are tested by a BPS accredited laboratory;
4.2.3. If non-conformities are found during the audit, the auditor shall notify the company to take corresponding corrective measures;
4.2.4. Complete corrective measures within 3 months;
4.3 In the case of a foreign manufacturer, the application must be made by the importer or authorized representative.
4.4 PS licenses can only be issued based on satisfactory audit results under Philippine standards;
4.5. If the audit result is not satisfied, it will be issued only after the satisfactory result is obtained after the review is re-examined
4.6. The certificate is valid for 3 years
4.7. Reapply for the certificate 6 months in advance
5.Customs Commodity Clearance Process
5.1 Basic Information:
5.1.1 The application form is signed by the authorized**;
5.1.2 Packing list;
5.1.3 Commercial Invoice.
5.1.4 Bill of Lading;
5.1.5 Product Lot Number;
5.1.6. Certificate of Satisfactory Registration;
5.1.7 List of dealers, indicating *** and address;
5.1.8 Contracts;
5.1.9 Import Declaration;
5.1.10 Performance Warranties.
5.1.11 PS copy of certificate.
5.2. Application for customs clearance of imported goods.
5.2.1 Make an application;
5.2.2 Product inspection is performed by a testing laboratory of the Philippine Bureau of Standards (BPS) or other testing laboratories accredited by BPS;
5.2.3. Submit the sample to the BPS accredited testing laboratory within 3 working days
5.2.4 If the test result is qualified, BPS will issue a certificate;
5.3 Certification audit and sampling.
5.3.1 Performed by a testing laboratory of the Philippine Bureau of Standards (BPS) or other testing laboratories accredited by BPS;
5.3.2 Product test, test standard: PNS AFNOR XP D90-300-1 2 3:2019
5.3.3. Field test: mainly for appliances.
5.3 Identification Requirements.
5.3.1 Information imprinted 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.
5.3.2.1 Model name.
5.3.2.2 Brand Name.
5.3.2.3 Serial number.
5.3.2.4 Date of manufacture.
5.3.2.5 PS certification mark.
5.3.5 Product Manual.
5.3.4 Information on Electronic Attachments.