- 1. in vitro diagnostic reagents, buffers and analytical standards and test kits containing a dangerous drugs and controlled chemicals
- 2. FDA-registered pharmaceutical oral drug preparations containing ERGOMETRINE/ERGONOVINE, ERGOTAMINE, NOREPHEDRINE and their salts, and compounded galenical preparations (solutions) containing POTASSIUM PERMANGANATE intended as disinfectant, antibacterial and antifungal agents
- 3. Completely formulated paints that contain all paint or coating components Included but not exclusive in this category are clear coats, top – coats, primers, varnishes, sealers, adhesives, lacquers, stains, shellacs, inks, temporary protective coatings and film – forming agents, epoxies, vinyl, lacquer, contact cements, waxes, cleaning agents
- 4. Silicone product that is a sealant, adhesive or coating or other products containing ACETIC ANHYDRIDE
- 5. Perfume and soya sauce or other products containing ANTHRANILIC ACID
- 6. Preparations or mixtures of fragrances or flavorings containing <50% ANTHRANILIC ACID intended to be used in a food, drug, cosmetic or household product.
- 7. Beverages, baked foods, desserts, and preserves; various cosmetic products; food additives and food packaging; nail polish remover; superglue remover; skin adhesive remover; varnish removers and other paint related solutions; lacquers for automotive or furniture finishes; cellulose acetate films and fibers; photographic films and plates casting; coatings; inks; resin thinners; general purpose cements; degreasing and degumming agent; paint; varnish; lacquer strippers; cosmetic products; home products including nail polish, hair colors, hair tonics and conditioners, sun tan and other lotions applied on the skin, baby wipes, pre-moistened towels; art material including clay, finger paints, and tempera colors, paint thinners, leather shoes and dressings, shoe polishes and creamers, pet flea and tick products, pet collars, household surface cleaners, furniture polish and cleaners, particleboard furniture, cabinets or fixtures, wooden furniture, car polish and cleaners, insecticides and pesticides used at home and garden or other articles or products containing ACETONE
- 8. Toilet bowl and drainage cleaners or other household products containing HYDROCHLORIC ACID
- 9. Lacquer, varnishes, paint remover, glues, polysterene cement, cleaning agent, dry erase markers or other household products containing METHYL ETHYL KETONE
- 10. Perfume, bird and insect repellents or other products containing PHENYLACETIC ACID
- 11. Rubber vulcanization accelerator or other products containing PIPERIDINE
- 12. Synthetic vanilla flavor, candies, and perfume or other products containing PIPERONAL
- 13. Drain and metal cleaners, anti-rust compounds, lead-acid (e.g. car) batteries containing less than 51% sulfuric or other products or compounds containing SULFURIC ACID
- 14. Polystyrene kits, coatings for floors and furniture, artificial sports tracks, ski suits and waterproof leisure wear, nail cosmetics, adhesive remover intended for use on humans or animals, adhesive used on humans and animals, tape, contact paper, wallpaper, shelf liners, or any other product with an adhesive incorporated onto or in an inert substrate, spray paints and glue at concentrations less than 0.1 per cent by weight or other articles or products containing TOLUENE
- 15. Lithium – thionyl chloride batteries or other articles or products containing THIONYL CHLORIDE
NOTE: Section 4 (6) (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), and (l) pertain to FINISHED PRODUCTS that are intended for sale to the general public
General Public refers to all buyers of the said product(s) domestically.
- 16. Chemical mixtures containing <35% ACETONE. (Note: aggregate sum rule applies; please refer to Clarification No. 4)
- 17. Chemical mixtures containing <30% HYDROCHLORIC ACID
- 18. Chemical mixtures containing <35% METHYL ETHYL KETONE (Note: aggregate sum rule applies; please refer to Clarification No. 4)
- 19. Preparations or mixtures of fragrances or flavorings containing <40% PHENYLACETIC ACID
- 20. Chemical mixtures of fragrances or flavorings containing <35% PIPERIDINE intended to be used in a food, drug, cosmetic or household product.
- 21. Chemical mixtures containing <30% SULFURIC ACID
- 22. Chemical mixtures containing <35% TOLUENE. (Note: aggregate sum rule applies; please refer to Clarification No. 4)
- 23. Chemical mixtures containing <35% ETHYL ETHER. (Note: aggregate sum rule applies; please refer to Clarification No. 4)
- 24. Chemical mixtures containing <15% POTASSIUM PERMANGANATE
NOTE: The aggregate sum rule, if applicable, provides that the total percentage content of all controlled chemicals present in the chemical mixture shall not exceed the given concentration weight limit provided in Annex “D”, the given percentage weight per controlled substance in a chemical mixture.
Section 4 (7) (a), (b) and (c) refer to CHEMICAL MIXTURES or ARTICLES / PRODUCTS not covered under Sec. 4(6) (a to l).
Definition of Terms:
“Article” means a manufactured item other than a fluid or particle (i) which is formed into a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical, and does not pose a physical hazard or health risk.
“Chemical mixture” means a combination of two or more chemical substances, at least one of which is not a controlled chemical, except that such term does not include any combination of a controlled chemical with another chemical that is present solely as an impurity.
Completely-formulated paint or coating” is defined as any clear or pigmented liquid, liquefiable or mastic composition designed for application to a substrate in a thin layer that is converted into a clear or opaque solid protective, decorative, or functional adherent film after application
Controlled chemical” means a substance listed as controlled precursor and essential chemical as defined pursuant to Section 3(h), Article I, RA 9165 and includes those classified as such by the Dangerous Drugs Board pursuant to Section 93 Article XI of RA 9165 for domestic control.
'In-vitro diagnostic reagents' are reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its sequelae.
Test Kit” means a substance
- (i) that contains reagent systems or buffering agents or both to show the presence of a substance,
- (ii) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and
- (iii) the contents of which are not intended for administration to humans.
“Sell,” means any act of giving away any dangerous drug and/or controlled precursor and essential chemical whether for money or any other consideration
- Legal Basis
- Import Permit / Clearance / Certification
Legal Basis is given to the Dangerous Drug Board to regulate this commodity via DDB REGULATION NO.1, 2014.
Certificate for Exemption – issued to products (finished products/Articles/chemical mixtures containing controlled chemicals as mentioned in Section 4 (6)(a-l) and (Section 4 (7) )
Board Resolution for Exemption – issued to products/chemical mixtures containing controlled chemicals exceeding the percentage thresholds provided in the Annex “D”.
- 1.Duly Accomplished Application Form (Download form here)
- 2.Updated PDEA License(s)
- 3.Company Profile (History/description of the company)
- 4.Duly notarized Sworn Statement (stating its use, purpose of importation, and other relevant information) (Download form here)
- 5.Material Safety and Data Sheet (MSDS) and/or Certificate of Analysis (assay)
- 6.Estimates on the monthly consumption of the product(s)
- 7.Formulation for each product list (For Manufacturer/Compounder)
- 8.Samples (for products containing above 30% threshold)
All applications and attached annexes for certificate of Exemption shall be submitted in pdf format (CD or USB Flash Drive)
Proceed to the Dangerous Drugs Board Legal Division for evaluation of the documents.
- Legal Division receives, processes and prepares certification; Chief Legal recommends to the Executive Director approval/disapproval of application.
- The Executive Director approves/disapproves the application.
All applications for Board Resolution for exemption shall be subjected to deliberation by the Technical Working Group composed of representatives from different agencies such as DDB, PDEA, NBI and PNP and shall recommend to the Board for approval such request.
8-10 WORKING DAYS
P 300.00 /Request (maximum of 10 items/request)
|Atty. Philip Josef T. Vera Cruz- Chief, LEGAL
||Tel. 9297136/9294544 loc 151
|Maribel T. Felix, R.Ph. Executive Assistant III
||Tel. 9297136/9294544 loc 151
Toluene is banned in spray paints and glues at concentrations equal to or higher 0.1% by weight that is intended for sale to the general public. Manufacturers, importers and distributors of such products shall be given one (1) year from the effectivity of the Regulation (or until March 12, 2016) to dispose of and retrieve/recall said products from the market.
With respect to importation of chemical mixtures exceeding the percentage thresholds provided in the matrix, the importer with valid PDEA License may either apply for a certificate of exemption with the Dangerous Drugs Board OR a Special Permit with the PDEA prior to importation
Applications submitted without the pdf format requirement are no longer accepted. No hard copy shall be received/accepted.
Only those with complete requirements shall be processed.