Chemical name: Oxirane Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Legislative or administrative measures: Bolivarian Republic of Venezuela, Ministry of People's Power for Planning and Finance, through the National Integrated Service of Customs and Tax Administration, G.O. N°. 6,097, Decree N°. 9,430, 03/19/2013. Art. 1. In order to classify goods according to the tariff, the Common Customs Tariff Nomenclature of the MERCOSUR Member States (NCM) is adopted, based on the Harmonized System of Designation and Coding of Merchandise (HS) of the Customs Cooperation Council (C.C.A). The import of Ethylene oxide is found in the Commom Customs Tariff under tariff code No. 2910.10.00.00, according to Decree 4,944, relative to Customs Tariffs of 04-24-2024, published in Official Gazette N°. 6,804 04-25-2024, where in article 21 on the Legal Regime applicable to the import or export of merchandise under Note 10 is established, being the Ministry of Popular Power for Ecosocialism the entity in charge of establishing the requirements for the import according to article 27 of Decree N°. 2,635 on the "Standards for the Control of the Recovery of Hazardous Materials and the Management of Hazardous Waste" of 22 July 22 1998, published in the Official Gazette of the Republic of Venezuela No 5,245. Extraordinary dated 3 August 1998, for which this institution, once the requirements have been met and the technical inspection has been carried out by the General Directorate of Environmental Quality Management, which grants the import or export authorization, with a validity of one fiscal year according to the industrial chemical product or pesticide where the quantities, country of origin and use that will have in the country are reflected. In Venezuela, Ethylene oxide is used in the pharmaceutical sector for the sterilization of medical supplies and equipment. This product is in the pesticide category. Its capacity for chemical reaction makes it widely used as an intermediate product in the chemical industry and as an effective pesticide, according to the Decision Guidance Document, Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, Rome - Geneva, February 2001.The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: Health problems due to inhalation, poisoning due to high exposures, and carcinogenic effects. Expected effect of the final regulatory action in relation to human health: Regulations for the correct handling in the storage, transportation, and use of Ethylene oxide in sterilization activities in order to reduce the risks due to exposures. Date of entry into force of the final regulatory action: 24/04/2024 |