ANSES proposes undertaking a restriction procedure for gamma-butyrolactone and 1,4-butanediol to prohibit their sale to the public at European level
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News of 13/01/2012
Since 2005, several hundred cases of poisoning and one death have been reported following the deliberate or accidental absorption of gamma-butyrolactone or 1,4-butanediol, which are most often consumed by young adults for their euphoriant properties. At the request of the Directorate General for Health, and in agreement with the Directorate General for Labour and the Directorate General for Risk Prevention, the competent authority for the REACh Regulation, ANSES was asked to conduct an analysis of the best option for managing the risks associated with these substances. Following this analysis and in order to reinforce the effectiveness of the national ban on the sale of these substances to the public, ANSES is recommending the preparation of a dossier proposing use restrictions within the framework of the REACh Regulation, which would extend the ban to European level. It would then be up to the competent authority, in association with the Ministerial partners and stakeholders, to validate this recommendation.
Gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD) are inexpensive industrial chemicals widely used in industry, primarily as solvents in various formulations or as feedstocks in the manufacture of polyurethane, drugs, plant protection products, polymers, etc. Both substances are precursors of gamma-hydroxybutyrate, more commonly known as GHB or the "date rape" drug, classified as a narcotic since 1999. Since this date, there has been a perceptible increase in the recreational use of these two precursors that are rapidly metabolised into GHB in the body after ingestion, causing similar sensations and enabling the law on GHB to be circumvented. Considering in particular that these substances are easy to obtain and can be sold to the general public for various uses (solvents, automotive cleaners, etc.) including at high concentrations, France decided to prohibit the supply and sale to the public of GBL and 1,4-BD either as raw materials, or in manufactured goods containing a concentration greater than 10% and a volume of more than 100 mL. This ban has been effective since 2 September 2011.
What are the risks associated with these substances?
The deliberate ingestion of GBL or 1,4-BD can cause respiratory problems, consciousness disorders, loss of consciousness and impairment of vital functions, that may lead to coma and even death. Cases of self-induced intoxication mainly concern young adults who consume these products at various recreational venues, and also at home. Ingestion of these substances is particularly dangerous because of the small difference between the "euphoriant" dose and the potentially lethal dose, which is dependent on multiple factors: beverages (mainly alcohol) or drugs consumed concomitantly, body mass, physical fitness of the individual, etc.
Since 2005, just over 200 cases of poisoning and one death linked to the consumption of GBL have been recorded in France by the toxicant monitoring network (CAPTV)(1) and the addiction monitoring network (CEIP)(2). This trend has also been observed in many other European countries. According to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), overdose cases account for a significant proportion of emergencies related to illicit drug use in several major European cities.
How are these substances regulated?
In January 2010, the Directorate General of Health called on the Regulated Products Department at ANSES to examine all the possible regulatory channels, especially at European level, that would limit the risks to human health of self-induced ingestion of GBL and 1,4-BD.
At the same time, a Ministry of Health Order, effective since 2 September 2011, has prohibited the supply and sale to the public of gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD) both as raw materials and in manufactured products containing a concentration greater than 10% and a volume of more than 100 mL.
Given the many European countries affected by this issue (Germany, Norway, Finland, Netherlands, Denmark, Spain, Italy, Sweden, Great Britain and France) and considering the free movement of goods within the European territory, European regulatory action would enable management of this risk to be harmonised within the European Union. ANSES therefore recommends reinforcing the effectiveness of the national ban by extending it to European level, and to this end is proposing to compile a dossier of proposed restrictions in the framework of REACh (3) which would amend Annex XVII of this Regulation.
Furthermore, ANSES considers it desirable to enhance communication measures and target them to the people concerned by the risks involved in the consumption of GBL or 1,4-BD. This would focus on the risks associated with ingestion of these substances and on the increased risks in the event of simultaneous consumption of alcohol or other drugs. As GBL and 1,4-BD can also be used for drug-induced incapacitation, this communication campaign could help to promote the other precautions to be taken (monitoring one's drink in recreational venues, closed glasses, etc.).
(1) Poison Control and Monitoring Centres
(2) Centre for Evaluation and Information on Drug Dependence
(3) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006