E-cigarette compliance requirements in the Philippines

Background:

In the Philippines, electronic atomizers are called. Steam products . On 25 July 2022, the President of the Philippines signed the Regulation of Vaporized Nicotine and Non-Nicotine Products Act into Law of the Republic (RA 11900), effective 15 days from the date of promulgation. The Bill, which is the result of a merger of House Bill No. 9007 and Senate Bill No. 2239, regulates the import, manufacture, sale, packaging, distribution, use and distribution of vaporized nicotine and non-nicotine products and novel tobacco products. DTI, through the Philippine Bureau of Standards (BPS), has issued Departmental Administrative Order No. 22-06, 2022, which includes steam products (vapor product Systems & Vapor Product Units with or without nicotine) and heated tobacco product systems as mandatory product certification. The DAO is in transition for 18 months from its effective date. Currently, all manufacturers of vaporized nicotine and non-nicotine products can apply for voluntary certification using the DAO's Rule 8 (Product Testing).

Scope of application:

ENDS/ENNDS; ends/ennds;

New tobacco products

RA11900

Product restriction requirement

Nicotine content shall not exceed 65mg/mL (65mg/ ml)

The maximum capacity of the storage tank for electronic conveying equipment shall not exceed 2 mL allowed. (2019-0007, for reference)

The maximum volume of e-liquid and refill containers containing or without nicotine shall not exceed 10 mL(2019-0007, for reference)

Health warnings and packaging requirements

Colour warnings (Content, format and size of graphic health warnings shall be specified by the Ministry of Health)

Unit packaging of Vapor Product Refills, HTP Consumables or Novel Tobacco Products or any external consumption packaging shall have a highly visible full colour picture warning

2.2 Language version of health warning

nicotinic

” This product is harmful and contains nicotine which is a highly addictive substance. It is not recommended for use by  nonsmokers.”

nicotine-free

” This product may contain a substance that is harmful. It is not recommended for use by nonsmokers.”

The warning text shall not exceed the full area of the graphic health warning, be legible and contrasted by format, layout and color, and shall not use any borders, frames or any other design that can effectively reduce the size of the text warning;

No content shall be printed or used in a location that may partially or wholly obscure or obscure health warnings;

No part of the warning shall be erased, obscured, folded, cut off or rendered unreadable when opening or closing the package or removing the package from the package;

2.3 Packaging

Comply with the Internal Revenue and fiscal labeling requirements of Republic Act RA 8424 and other applicable regulations: Steam products and supplements, HTP consumables or new tobacco products imported into the Philippines shall bear a BIR-designated identification or nameplate.

Tamper-proof and child-proof design Supplementary containers for steam products shall be child-proof, tamper-proof, and shall be protected from breakage and leakage. Non-refillable receptacles shall not be tampered with.

It is prohibited to sell steam products that are packaged, labeled, displayed or marketed with flavor descriptions that have been shown to be particularly attractive to minors.

Age restriction The minimum permissible age for the purchase, sale and use of ENDS/ENNDS, HTPS or new tobacco products should be 18 years.

Product display Vaporized nicotine and non-nicotine products and new tobacco products shall not be displayed next to products of particular interest to minors.

Product communication restrictions. Other forms of consumer communication are permitted at the point of sale or in retail locations, through direct marketing and advertising of vaporized nicotine and non-nicotine products or new tobacco products on the Internet, subject to certain conditions.

Registration requirements

Manufacturers and importers of vaporized nicotine and non-nicotine products, vaporized product installations, heated tobacco product installations and new tobacco products shall submit to the DTI information proving compliance with the requirements for registration before selling, distributing or advertising.

Transitional period Manufacturers, distributors, importers and retailers of vaporized nicotine and non-nicotine products or their devices and new tobacco products shall have a transitional period of eighteen (18) months from the date of publication of the Implementing Rules and Regulations of this Law in order to comply with the requirements of this Law.

DAO NO. 22-06

In order DAO NO. 22-06, the BPS of the Philippines has published on its official website that e-cigarette devices and products are subject to BPS mandatory product certification in the Philippines (transition period of 18 months, effective 30 June 2022, mandatory products must have PS/ICC certification on 30 December 2023). Its compulsory certification scope includes the following products:

•   Steam product systems, including nicotine-containing and nicotine-free

•   Steam product plant

•   Heating tobacco product system

PS certification

The Philippine Standard (PS) Safety and Quality Certification Mark Licensing Program applies to local and foreign manufacturers selling or distributing vaporized nicotine and non-nicotine products in the Philippine market. The competent authority grants a licence to use the PS certification mark to companies that meet the requirements.

SOC Certification /ICC certification

Importers should apply for a PS Certified Statement of Confirmation (SOC) or Import Commodity Clearance (ICC) for Non-PS Certified Nicotine Vaporized and non-Nicotine Products for each shipment on the basis of the Bill of Lading/Air Bill of Lading. The ICC certification scheme applies to items imported from factories without a valid PS licence and certifies products on a per-shipment basis, requiring mandatory product testing for each shipment.

Figure A: PS Certification mark for electronic atomizing system and heating tobacco system

Figure B: PS Certification mark for atomized e-cigarette equipment

The PS mark affixed to the product or its packaging may be enlarged or reduced to the appropriate size provided its dimensions conform to the specifications in Figure A or B.

Tags and information

Shall comply with their relevant PNS, Philippine Consumer Law and this Act requirements