Current international regulatory status of 1,4-butanediol 1,4-Butanediol is not restricted under the European legislation on cosmetics (EU, 1976), not classified as a dangerous substance in Annex I to Directive 67/548/EEC, and it is not listed in a priority list (under Council Regulation EEC No. 793/93) on the evaluation and control of the risks of existing substances. The chemical is not subject to the key UN convention that covers precursor chemicals; however its metabolite, (GHB), is subject to γ-hydroxybutyrate international controls in accordance with the 1971 UN convention on psychotropic substances. In May 1999, the USA FDA issued a public warning products containing 1,4 butanediol and declared the chemical to be a Class I Health Hazard (i.e. potentially life-threatening). Although this classification imposes no legal restrictions on the manufacture, distribution or possession of 1,4 butanediol, Garcia and Catterton (2003) state that when 1,4 butanediol is distributed for human consumption it meets the definition of a substance analogue’ and can therefore be prosecuted ‘controlled as a Schedule 1 substance. This definition is supported by the US Court as at least 3 people have been prosecuted and found guilty of distributing a controlled substance analogue of GHB in violation of the Controlled Substance Analogue Enforcement Act of 1986 (“the Analogue Act”), 21 U.S.C. §§ 802 and 813. Others have concluded that the extensive industrial use of 1,4 butanediol, in combination with anonymous marketing via the Internet (see Exposure’), ensures a continued ‘Public supply that is almost impossible to regulate (Zvosec et al., 2001).
Current international regulatory status of 1,4-butanediol 1,4-Butanediol is not restricted under the European legislation on cosmetics (EU, 1976), not classified as a dangerous substance in Annex I to Directive 67/548/EEC, and it is not listed in a priority list (under Council Regulation EEC No. 793/93) on the evaluation and control of the risks of existing substances. The chemical is not subject to the key UN convention that covers precursor chemicals; however its metabolite, γ-hydroxybutyrate (GHB), is subject to international controls in accordance with the 1971 UN convention on psychotropic substances. In May 1999, the USA FDA issued a public warning products containing 1,4 butanediol and declared the chemical to be a Class I Health Hazard (i.e. potentially life-threatening). Although this classification imposes no legal restrictions on the manufacture, distribution or possession of 1,4 butanediol, Garcia and Catterton (2003) state that when 1,4 butanediol is distributed for human consumption it meets the definition of a ‘controlled substance analogue’ and can therefore be prosecuted as a Schedule 1 substance. This definition is supported by the US Court as at least 3 people have been prosecuted and found guilty of distributing a controlled substance analogue of GHB in violation of the Controlled Substance Analogue Enforcement Act of 1986 (“the Analogue Act”), 21 U.S.C. §§ 802 and 813. Others have concluded that the extensive industrial use of 1,4 butanediol, in combination with anonymous marketing via the Internet (see ‘Public Exposure’), ensures a continued supply that is almost impossible to regulate (Zvosec et al., 2001).
butandediol-hazard-assessment.docx