1

Notifying Member

Philippines

2

Title of new legislation/procedure

Department Administrative Order No. 24-02 "Supplemental Technical Regulations for DAO 22-06, series of 2022 on the Mandatory Product Certification of Vaporized Nicotine and Non‑Nicotine Products"

3

Date of Publication

8 June 2024

4

Date of entry into force

8 June 2024

5

Website link/Official publication of the new regulation/procedure

https://bps.dti.gov.ph/component/edocman/7-laws-and-issuances/11-department-administrative-orders

6

Have you attached a copy of the regulation (PDF) to the Secretariat

[X] Yes. (Please attach a copy of the regulation to the notification.)

246-Annex C.1_DTI DAO No 24-92 Vaporized Nicotine_BPS.pdf

[] No.

7

Type of notification

[] (a) New licensing regulation/procedure[2]; (please answer question 8 to 14)

[X] (b) Changes to a regulation/procedure which has been previously notified in document: _G/LIC/N/2/PHL/177 (please answer question 15 and 16)

8

List of products subject to licensing

9

Nature of licensing

Automatic: []

Non-Automatic: []

10

Administrative purpose/measure being implemented

(a)

Protect public morals;

(b)

Protect human, animal or plant life and health; protect environment;

(c)

Collect trade statistics or market surveillance;

(d)

Protection of patents, trademarks and copyrights, and the prevention of deceptive practices;

(e)

Pursue obligations under the UN Charter and other international treaties (i.e. CITES, Basel Convention, Rotterdam Convention, UNSC Resolutions etc.)

(f)

Quota (including TRQ) administration;

(g)

Regulate imports of arms, ammunition or fissionable materials and safeguard national security;

(h)

Other: ______________ (please specify)

11

Administrative body(ies) for submission of applications

12

Contact point for information on eligibility

13

Expected duration of licensing procedure

14

A summary of the notification in one of the WTO official languages

15

In the case of 7(b), please indicate the type of new change(s)

16

Please elaborate the changes in detail (in one of the WTO official languages)

DAO 24-02 was issued to supplement the implementation of DAO 22‑06. Revisions and, supplemental requirements/information are made at the following:

1._   Revision on scope

a)_    Vapor product system;

b)_    Vapor products or vapor product refills;

c)_     Vapor product devices;

d)_    Heated tobacco product (HTP) system;

e)_    HTP consumables; and

f)_     HTP devices

2._   Indicated required markings/design/technical product requirements specifically on the packaging, device, leaflet or digital codes, accessories, etc.

3._   In addition to the documentary requirements specified under DAO 22-06 Rule 5 for PS license applications and Rule 6 for Import Commodity Clearance (ICC) and Statement of Confirmation (SOC) applications, the DAO 24-02 also required importers applying for SOC or ICC to submit summary of the production batch/lot/serial numbers. For manufacturers and importers applying for PS license or ICC certificate, they shall also submit product formulation of the e-liquid/vape juice/vapor product refill or HTP consumables duly signed by a licensed Chemist. For imported vapor products, the declaration from the manufacturer duly signed by a licensed Chemist shall be authenticated by the Philippine Embassy in the country where the manufacturing plant is located. Toxicological risk assessment is also required from the manufacturer duly signed by a toxicologist. For imported products, the declaration form from the manufacturer duly signed by a toxicologist shall be authenticated by the Philippine Embassy in the country where the manufacturing plant is located.

4._   The use of DTI logo or any of its offices/bureaus/other instrumentalities in connection with the product is prohibited. The PS mark or ICC shall be affixed or marked on the product and/or package of the product.

5._   Product with medicinal, therapeutic, and reduced risk claim or statement shall require the approval from the FDA.

6._   All wholesales, traders, and distributors of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products shall apply for a Certificate of Registration from the DTI.

7._   Both imported or locally manufactured shall be delivered and/or stored in a BPS registered warehouse. All shall secure a Certificate of Warehouse Registration (CWR) from the BPS for the warehouses they own/lease/rent/utilize for the storage of vaporized nicotine and non-nicotine products and novel tobacco products.

8._   The DAO also stipulated additional penalties for any manufacturer, importer, wholesaler, trader, distributor, retailer or any other person or entity found in violation of any provision. In addition to the penalties prescribed in Rule XIV of DAO 22‑16:2022, there will also be cancellation or revocation of Certificate of Registration or Certificate of Warehouse Registration pursuant to a final and executory decision rendered by an administrative agency or the regular courts. And watch-listing and/or blacklisting of wholesaler, trader, distributor, or retailer.