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03 January 2018

Bulgaria has liberalised the legal requirements on mixtures containing 1,4-Butanediol and y-Butyrolactone

On 20 December 2017, the Bulgarian parliament voted on a legislative amendment that will allow the marketing of risky substances containing mixtures intended for industry use.

The currently applicable Bulgarian legislation

The Bulgarian Narcotic Substances and Precursors Control Act (NSPCA) regulates "social relations with regard to the control of narcotic substances and precursors". According to the NSPCA, the procedures for classifying plants and substances as narcotics are set forth in an Ordinance (a secondary legislative act; the Ordinance), which divides plants and substances into three lists (Lists):

  1. plants and substances presenting a high risk to public health due to the harmful effect of abuse thereof, which are prohibited for use in human and veterinary medicine; 
  2. substances presenting a high risk, which are in use in human and veterinary medicine;
  3. risky substances.

1,4-butanediol (BD) and γ-Butyrolactone (GBL) are chemicals related to Gamma-Hydroxybutyrate (an anaesthetic with sedating properties, also known as "liquid ecstasy"). They are often used as industrial solvents by the synthesis of polymers and plastics needed in the construction and automotive industries.

According to the Ordinance, BD and GBL are risky substances (it. (iii) above). In light of this and of the definition of "drug" under the NSPCA (which includes all substances from all Lists), products containing BD and GBL are "preparations" under the NSPCA and are subject to the same control measures as narcotic substances. This has led to a ban on the placing on the market of both pure substances and mixtures containing BD and GBL.

Non liquet

In Bulgaria, risky substances like BD and GBL are regulated only by the NSPCA, whose implementation is within the competence of the Ministry of Health. The NSPCA defines the use of BD and GBL for human consumption or for medical and veterinary purposes only. The Ministry of Health has no legal ground to issue a licence under the NSPCA for products containing BD and GBL intended for industrial use.

Legislative amendment

On 21 April 2017, the Bulgarian National Drug Council adopted a working group proposal to enable liberalisation of the drug legislation. According to its decision, BD and GBL shall not be subject to control when:

  1. they are included in multi-component mixtures intended for the manufacture of polymers for industrial use;
  2. their content does not exceed 20 % of the relevant mixture; and
  3. the mixtures are formulated in such a manner that BD and GBL cannot be used and/or extracted with readily available or economically viable means.

Eight months later, on 20 December 2017, the Bulgarian parliament voted to amend the NSPCA. It does not affect the status of pure substances – marketing of BD and GBL is still prohibited in Bulgaria. But the marketing of mixtures containing risky substances intended for industrial use will be admissible upon notification to the Ministry of Economy.

The detailed terms and conditions for carrying out the relevant activities, maximum percentages of risky substances in mixtures and the notification procedure will be regulated in detail by a new ordinance, which the Ministry of Economy must approve within two months of the amendment of the NSPCA (i.e. by March 2018). Currently only one of the requisites for mixtures whose use has been liberalised is clear. They must be formulated in such a manner that the risky substance cannot be used directly and/or extracted with readily available or economically viable means.