Thailand’s Food and Drug Administration (FDA) recently opened a public consultation on removing citronella oil (CAS No. 8000-29-1) from Annex 4.1 of Thailand’s List of Hazardous Substances (hereinafter referred to as the List) under the Hazardous Substances Act B.E. 2535 (1992) (a.k.a. HSA).
Citronella oil, a kind of pure plant extract used as a mosquito and insect repellent (insecticides), is currently listed as a Type 1 hazardous substance and subject to the following obligations:
Manufacturers and importers should notify the production/import information to the FDA.
Business operators shall comply with the specified criteria and procedures, such as labeling, rules and conditions for manufacturing and storage.
However, according to Annex 4.3 of the List, insecticides are exempted from requirements under the HSA if meet all the followings:
Made from essential oils extracted from plants or animals as the main ingredient; and
Without any synthesized chemicals as active ingredients.
The inconsistency of regulatory requirements has confused stakeholders in terms of compliance. To determine whether the current control measures are appropriate, in the fiscal year 2022 – 2023, the FDA conducted a review on the toxicity data of citronella oil. Below are the results of the review.
There’s no clear evidence showing citronella oil has high risk of chronic toxicity or carcinogenicity to human health.
Although there’re reports stating that citronella oil has slight toxicity to aquatic animals, the exposure was found to be low.
Although users of insecticides containing citronella oil are inevitably exposed to it, its acute toxicity is of low level.
Considering the abovementioned facts, the FDA proposed to remove citronella oil (Entry No. 99) from Annex 4.1 of the List to address the inconsistency and eliminate unreasonable compliance burden. See the screenshot of the proposal below.
The period for comments ended on April 4, 2023. Once adopted, citronella oil will be exempted from the corresponding requirements under the HSA. ChemLinked will keep you updated.