Introduction
Environmental agents used in Taiwan is regulated by Environmental Agents Control Act, which was promulgated and implemented on November 10, 1997 and revised on December 7, 2016. The law stipulates that environmental agents shall be registered and managed by Taiwan Environmental Protection Administration (EPA).
In order to prevent the spread and breeding of vector pests and microorganisms, environmental agents have long been an important household hygiene commodity for the general public. Environmental agents, whether chemical or biological, must be appropriately managed to avoid misuse or abuse by the public, which may affect the environment and ecology or even endanger human health. According to the provisions of the Environmental Agents Control Act, the environmental agents can be divided into three types, including environmental health agents, pollution control agents and microbial preparations used as environmental agents. In addition, according to their concentration and use, they can be divided into general environmental agents, special environmental agents and technical grade environmental agents. At present, the registration permit system, operational management system and spot check system are mainly set up for environmental agent management, and the supporting regulations have been issued and implemented as the basis of law enforcement.
Restricted Substances
The environmental agents for which a permit should be applied are as follows:
Environmental sanitation agents: Pesticides, miticides, rodenticides, bactericides/fungicides used for environmental sanitation, and other chemical agents used against organisms injurious to environmental sanitation.
Pollution control agents: Synthetic chemical agents used to prevent air, water, or soil pollution, or treat waste, and that have been officially announced by the central competent authority.
Environmental agent microbial preparations: Microbial preparations produced from natural or artificially-modified microbe organisms or their metabolic products, and used to control air pollution, water pollution, or soil pollution, treat waste, or control environmental sanitation disease vectors. The Bacillus thuringiensis, Wolbachia Pipientis, Metarhizium anisopliae, Beauveria bassiana, and Bacillus sphaericus are currently announced as microbial preparations for the prevention and control of environmental sanitation vectors.
Human chemical repellent：It is used for mosquito control on human skin with active ingredients of chemical substances, such as DEET, Picaridin (Icaridin), Imok (IR3535), etc.
Exemption Substances
1) Single component solutions of hypochlorous acid and its salts, sodium chlorite with concentrations of less than 6%.
2) Bleaching agents with chlorine concentrations of 40% or less.
3) Technical grade agents of hypochlorous acid and its salts, Sodium chlorite, chlorine dioxide, sodium borate (boric acid) raw materials.
Circumstances Where Permits Are not Issued
1) Containing ingredients whose manufacture, processing, import, export, sale or use are prohibited by the central competent authority (Environmental agents are prohibited).
2) The toxicity of the environmental agent is categorized as highly toxic or extremely toxic according to the WHO Pesticide Oral and Dermal Toxicity Classification (Attachment 4 of Working Standards for Environmental Agent Permit Application and Issuance). However, rodenticides and pollution control agents are not subject to this restriction.
3) The applicant already has a permit covering the same components and said components are sourced from the same manufacturer.
4) The environmental agent includes two or more components with the same efficacy. However, germicides and components that are proven to add functionality are not subject to this restriction.
5) The environmental agent product name already exists or the Chinese name of the active component in the environmental agent is the product name. However, those manufacturing or importing technical grade agents using the Chinese name of the active ingredient as the product name are not subject to this restriction.
6) The competent authority has determined that there is cause for concern that an environmental agent may be hazardous to humans or to the environment.
Obligations
1) Permit: According to Article 9 of the Environmental Agents Control Act, those that intend to manufacture, process, or import environmental agents shall apply to the central competent authority for checking and registration by submitting markings and a sample together with the product's name, components, performance data, key aspects of the manufacturing process, analytical methods, toxicology report, efficacy (potency) report, and other relevant information or documentation. Manufacture, processing, or import may begin only after a permit is issued. Customs shall order those persons obligated to pay tax to return within a limited time period any imported environmental agents that have not received the central competent authority's permission or approval.
2) Natural substance product application：Natural substance products used as environmental pest repellants, rodent repellants or attracting purposes, and not as pesticides, provided with certification of biological effects and components. The applicant should check the documents and data of Attachment 3 for examination and approval by the central competent authority and be exempted from applying for a permit. However, natural substances with natural pyrethrum extracts require application for a permit.
3) Record: Environmental agents manufacturing enterprises, environmental agents vendors shall record the quantities of environmental agents manufactured, processed, exported, imported, sold, and used before the 20th of January, April, July and October each year by network transmission.
The recorded data in the foregoing paragraph shall be preserved for three years. When necessary, the competent authority may order an enterprise to submit said records.
