Correspondence

Circular 004/2022: Gamma-Butyrolactone (GBL) and 1,4-Butanediol (1,4-BD): revocation of rescheduling

Published 14 June 2022

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This publication is available at https://www.gov.uk/government/publications/circular-0042022-gamma-butyrolactone-gbl-and-14-butanediol-14-bd-revocation-of-rescheduling/circular-0042022-gamma-butyrolactone-gbl-and-14-butanediol-14-bd-revocation-of-rescheduling

1. Introduction and summary

This circular draws attention to the contents of the below Statutory Instrument, which will come into force on 14 June 2022:

  • The Misuse of Drugs (Amendment) (Revocation) (England, Wales and Scotland) Regulations 2022 (SI 2022 No. 559) (“the 2022 Regulations”)

The 2022 Regulations revoke The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2021 (“the 2021 Regulations”). The 2021 Regulations placed two controlled drugs, Gamma-Butyrolactone (GBL) and 1,4-Butanediol (1,4-BD), which have legitimate uses in industry, under stricter control, meaning that industrial users would require a controlled drugs licence. The 2021 Regulations were due to come into force on 15 June 2022. The revocation will mean that, as is the case now, no business will require a Home Office controlled drugs licence to lawfully import, export, produce, supply or possess these drugs from 15 June 2022. GBL and 1,4-BD will remain controlled as Class B drugs under the Misuse of Drugs Act 1971 (“the 1971 Act”) [footnote 1].

The responsible Minister in Northern Ireland has made equivalent legislation in Northern Ireland to mirror this change.

The 2022 Regulations are available at www.legislation.gov.uk, at the following link:

The SI is also published by the Stationery Office. Telephone orders and general enquiries: 033 202 5070 or online at www.tso.co.uk.

2. Background

The Misuse of Drugs Regulations 2001 (“the 2001 Regulations”) provide access to controlled drugs for legitimate medicinal purposes (and exceptionally for industrial purposes) under the 1971 Act. Drugs are ordinarily placed into one of five Schedules to the 2001 Regulations. The Schedule into which a drug is placed is based on an assessment of its medicinal or therapeutic usefulness, the need for legitimate access as well as its potential for harm when used. The Schedule primarily dictates the circumstances under which it is lawful to import, export, produce, possess, supply and administer the drug. Schedule 1 drugs are considered to have no known medicinal use in the UK and are subject to the greatest restrictions, requiring a Home Office licence.

Section 7(3) of the 1971 Act requires the Secretary of State to make regulations to allow drugs controlled under the 1971 Act to be used for medicinal purposes. Section 7(3) does not apply to any drug which is “designated” by order under section 7(4). Controlled drugs are designated where the Secretary of State is of the opinion that it is in the public interest for the production, supply and possession of that drug to be either wholly unlawful or unlawful except for research or other special purposes under licence. Drugs are designated under the The Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 (“the 2015 Order”).

3. Status of GBL and 1,4-BD under the 2001 Regulations

GBL and 1,4-BD are Class B drugs under the 1971 Act and designated by the 2015 Order. Designated drugs are ordinarily placed in Schedule 1 to the 2001 Regulations. However, GBL and 1,4-BD were not placed in a schedule. Due to their legitimate industrial use, they are instead subject to a bespoke provision in regulation 4B of the 2001 Regulations under which it is lawful to import, export, produce, supply or possess them in circumstances where they were not intended to be used for the purposes of human ingestion (other than as a flavouring in food).

The Advisory Council on the Misuse of Drugs recommended that GBL and 1,4-BD should be placed in Schedule 1 to the 2001 Regulations and further recommended the removal of the exemption under regulation 4B of the 2001 Regulations, meaning that legitimate industrial users would require a controlled drugs licence [footnote 2]. The intention was to prevent the open supply of these substances as bogus industrial products. The Home Secretary accepted these recommendations, and they were implemented by the 2021 Regulations.

4. The 2022 Regulations

The Home Office considered the impact on legitimate industry in the impact assessment accompanying the 2021 Regulations, but the impact was significantly underestimated.

Therefore, the Government has revoked the 2021 Regulations and intends to consult with industry on how best to deliver the ACMD’s recommendation without causing disproportionate harm to business. The revocation will mean that, as is the case now, no business will require a Home Office controlled drugs licence to lawfully import, export, produce, supply or possess these drugs from 15 June 2022.

  1. Home Office Circular 001/2022 provides a summary of the control status of GBL, 1,4-BD and the related substance Gamma-Hydroxybutyric Acid (also known as GHB). The circular is available at the following link: Circular 001/2022: Reclassification of GHB and related substances - GOV.UK (www.gov.uk) ↩

  2. The ACMD report, An assessment of the harms of gamma-hydroxybutyric acid (GHB), gamma-butyrolactone (GBL), and closely related compounds, is available at the following link: ↩

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