The FDA recently suspended the requirement of securing a certificate of product registration for household and urban hazardous goods. The FDA issued a two (2) year suspension, to take effect until 31 December 2023. This means that during this period, businesses and stakeholders do not need to secure a certificate of product registration before selling, importing, marketing, distributing or manufacturing household and urban hazardous goods, such as detergents, paint, sprays, and other covered goods.
FDA Circular No. 2021-011-A Suspends Product Registration Requirement for Household Hazardous Goods
Based on the recently issued FDA Circular No. 2021-011-A from the Food and Drug Administration (FDA) of the Philippines, the requirement for importers, distributors, sellers, manufacturers and all other stakeholders to first secure market authorization before commencing importation, sale, manufacture or distribution of their products, was suspended until 31 December 2023. Previously, one needed to secure a certificate of product registration before they could import, sell, market or distribute any household or urban hazardous substances. By virtue of FDA Circular No. 2021-011-A, the requirement was suspended until 31 December 2023.
According to the FDA, the circular was released due to appeals made by the Household/Urban Hazardous Substances to give them a longer time to comply and secure the certificates of product registration for their goods, under FDA Circular No. 2020-025. FDA Circular No. 2020-025 requires that all stakeholders should have secured licensing the registration requirements for their products until 31 December 2021.
Coverage of the New FDA Guidelines
Household/urban hazardous substances (HUHS) has been defined under FDA Circular No. 2020-025 as any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizer, pesticide, and insecticide and other economic poisons, radioactive substance, or substances intended for use as fuels, coolants, refrigerants and the like. It also includes toys or articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard.
FDA Memorandum Circular 2013-0045 specifically lists down products which are covered by its regulations, when household or urban hazardous substances and goods are in question. These include:
a) Paints, lacquers, varnish;
b) Solvent paint, lacquer thinner, mineral spirits;
c) Adhesives (contact cement);
d) Polishes and Waxes (metal polish, wood polish, shoe polish);
g) Disinfectant sprays;
h) Detergent (bar, liquid, and powder);
i) Dishwashing (liquid and paste);
j) Glues and paste;
k) Fabric (dyes, softeners, and conditioners)
l) Educational set and miscellaneous chemistry set;
m) Stationeries and art paper (colored and/or scented);
n) Air Fresheners (deodorizer, fabric freshener, aromatherapy product, scented candles, gels, oil, spray), and the like.
Therefore, under FDA Circular No. 2021-011-A, importers, distributors, sellers, marketers and all others engaged in the marketing, sale, production, importation or distribution of the above listed products no longer need to secure a certificate of product registration before they sell, market, import, or distribute their goods in the Philippines.
LTO is Still Necessary for Household Hazardous Goods
While the requirement of securing a particular or individual market authorization for goods defined as household or urban hazardous goods has been suspended until 31 December 2023, the FDA made it clear that the 2-year extension shall not apply to the licensing of HUHS establishments. On the contrary, the FDA reiterated the rule that “effective 01 January 2022, a LTO as HUHS establishment shall be mandatory for all establishments engaged or intending to engage in HUHS-related activities”.
With this statement, it became clear that the suspension of the requirement to secure certificates of product registration for the goods is suspended under 31 December 2023, those engaged in the sale, import, marketing, distribution, or manufacture of goods falling under the category of HUHS must secure a License to Operate with the FDA, in the particular category or class at which they deal with HUHS goods or products.
Effect of Suspension of Product Registration Requirement on Importation and Clearances
Because of its recent release and effectivity, other government agencies, including the Philippines’ Bureau of Customs, may not be familiar with the new regulation. Thus, the FDA clarifies that securing Sales and Promo Permits for household hazardous goods, and Customs Clearances which are required to import the goods in the Philippines, are not required during the period of the suspension. Thus, the FDA suggests that those applying for clearances and permits submit a copy of FDA Circular No. 2021-011-A and the valid License to Operate of the HUHS establishment to the concerned government and non-government entities, in lieu of the FDA issued market authorization.
What Happens after the Suspension is Lifted on 31 December 2023?
The FDA clarified that once the suspension is lifted on 31 December 2023, beginning 01 January 2024, obtaining a Certificate of Product Registration for all HUHS covered goods shall become mandatory. Likewise, Sales and Promo Permits will once again be required for promotional and advertising activities. The same is true with Customs Clearances, which shall be required starting 01 January 2024.
About Nicolas and De Vega Law Offices
If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, household hazardous products, urban hazardous products, drug, cosmetic, medical device or food registration, registration of cosmetics, food supplements, licenses to operate or other applications with the Food and Drug Registration, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues, we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines. You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines. You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at email@example.com. Visit our website https://ndvlaw.com.