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Annex 5
to Decision Section 71,
3.3.2005
Draft Order
amending the Order (1999:58) banning certain products that are
harmful to health
issued on xx June 2005.
The government lays down1 the following in respect of the Order (1999:58) banning
certain products that are harmful to health:
- Section 12 shall be worded as set out below,
- a new section, Section 4, and, immediately preceding Section 4, a new heading shall
be inserted, worded as set out below.
Licence-issuing authority
Section 4 The Medical Products Agency shall issue licences and may issue provisions in
accordance with Section 3 of the Act (1999:42) banning certain products that are harmful
to health.
_______________
This Order shall enter into force on 1 July 2005.
On behalf of the Swedish Government
MORGAN JOHANSSON
Björn Reuterstrand
(Ministry of Health and Social Affairs)
Annex2
List of products that are to be regarded as harmful to health in accordance with the
Act banning certain products that are harmful to health
N-methyl-1-(3,4-methylenedioxyphenyl)-2-butylamine (MBDB)
1-(3,4-methylenedioxyphenyl)-2-butylamine (BDB)
N-benzylpiperazine
4-chloro-2,5-dimethoxyamphetamine (DOC).
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT)
5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)
5-methoxy-alphamethyltryptamine (5-MeO-AMT)
2,5-dimethoxy-4-ethylphenethylamine (2C-E)
1
See Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations (OJ L 204,
21.7.1998, p.37, Celex 398L0034), amended by European Parliament and Council Directive 98/48/EC (OJ
L 217, 5.8.1998, p.18, Celex 398L0048).
2
Most recent wording 2005:26.
alpha-methyltryptamine (AMT)
2,5-dimethoxy-4-chlorophenethylamine (2C-C)
2,5-dimethoxy-4-methylphenethylamine (2C-D)
4-acetoxy-N,N-diisopropyltryptamine (4-AcO-DIPT)
4-hydroxy-N,N-diisopropyltryptamine (4-HO-DIPT)
gamma-butyrolactone (GBL)
1,4-butanediol (1,4-BD)
Salts of the substances where these can occur.
Memorandum
Annex 1
to Decision Section 71,
3.3.2005
21.2.2005
Ministry of Health and Social
Affairs
Public Health Department
Angela Öst
Telephone +46 8 405 24 13
E-mail angela.ost@social.ministry.se
General remarks on the Act banning certain products that are harmful to health
The Act (1999:42) banning certain products that are harmful to health entered into force
on 1 January 1999. The aim of the Act was to put into place a more effective control
procedure for new synthetic drugs and create a set of regulations that were more
restricted but had a wider area of application than narcotics legislation. The Act is
accompanied by the Order (1999:58) banning certain products that are harmful to health.
The Order specifies the products that are to be regarded as harmful to health in
accordance with the Act. Some of the products which were previously included in the
Order have been transferred to the system of control provided by the narcotics control
legislation. One example of this is the substance 4-MTA. This has meant that it has
sometimes been regarded as a “waiting list law” prior to classification as a narcotic.
A product which is classified as harmful to health must not be imported into Sweden,
passed on, manufactured, acquired with the intention of passing it on, offered for sale or
be in anyone’s possession without a special licence.
A ban carrying penal sanctions prohibiting manufacture and other types of handling
without a licence of a substance classified as harmful to health together with the
possibility of withdrawal of a licence that has been issued and of forfeiting the
confiscated substance contributes to making the legislation effective. Only wilful
contraventions of the provisions of the Act are punishable.
When the Act was introduced it was the intention that the products that could be covered
by the Act would lack a more general area of application, within science or healthcare for
example, but it was nevertheless not considered an option to fail to provide for the
possibility of dispensation in certain cases. Consequently, the Act states that the Medical
Products Agency may, in specific cases, grant a licence for handling the substance for
scientific or industrial purposes.
Proposed amendments to the statute
In accordance with the draft Act, the government or the authority designated by the
government may issue a licence to handle products which are harmful to health for
scientific or industrial purposes. The licence can have conditions attached and may be
withdrawn if it is no longer utilised, if the licence holder has committed a significant
violation of a specified condition or if he has not complied with the provisions of the Act.
The government or the authority designated by the government may issue provisions
concerning exceptions to the requirement for a licence in order, among other things, to
allow the use of preparations containing such products.
The nature of the draft amendment to the Act is not such as to cause a barrier to trade. On
the contrary, the draft will facilitate the free trade in substances classified as products
harmful to health, as the government or an authority is given the authority to issue
provisions concerning exceptions to the requirement for a licence.
In accordance with the draft Order, GBL and 1,4-butanediol are classified as products
that are harmful to health. The Medical Products Agency is appointed as the authority
that is to issue licences and provisions.
Classification of substances as products harmful to health is a barrier to trade. However,
under certain circumstances such a barrier is justified.
The Medical Products Agency intends to issue provisions containing exceptions to the
requirement for a licence. However, it is not yet possible to present a draft of such
provisions.
Reason for the draft
The Act banning certain products that are harmful to health has been effective as a result
of it having led to a more rapid control primarily of new synthetic drugs than was
possible solely on the basis of the narcotics legislation. However, it has not been possible
to utilise either this Act or the narcotics legislation to classify products having extensive
and desirable areas of application within industry, for example. In Sweden, the abuse of
GBL and 1,4-butanediol in particular has increased in recent years. Both substances are
used fairly extensively in industry in Sweden: around 239 tonnes per year of GBL and
around 121 tonnes per year of 1,4-butanediol. GBL is used as a solvent, cleaning agent
and is incorporated into various products. 1,4-butanediol is a synthetic chemical used in
the manufacture of plastics. Both substances are environmentally sound and neither
substance can as yet be replaced by equivalent substances having the same benign effect
on the environment. However, after uptake in the human body both substances are also
converted to the drug gamma-hydroxy-butyrate (GHB), which is classified as a narcotic.
In this context it should be pointed out that GHB is classified as a narcotic in accordance
with List IV of the 1971 Convention on Psychotropic Substances and, when abused, GBL
and 1,4-butanediol are in practice the same substance. GBL is also a precursor to GHB,
but has not been listed as a narcotics precursor and therefore does not fall within this
control system, even though GBL is included on the voluntary list of substances, trade in
which the industry can voluntarily monitor.
The risks associated with the abuse of GBL and 1,4-butanediol are the same as those
involved with the abuse of GHB. Police and customs statistics relating to seizures
indicate that while the number of seizures of GHB fell after it was classified as a narcotic
in 2000, the number of seizures of GBL and 1,4-butanediol has risen. The increased
number of seizures indicates an increased amount of abuse, something that is also
confirmed by an increased number of deaths and serious poisonings as a result of the
abuse of GBL and 1,4-butanebiol and by reports from people working to prevent abuse
and investigations of drug habits that have been undertaken. It is therefore imperative that
the substances are placed under effective control as soon as possible. The development
towards increased abuse is not surprising in light of the fact that they are not currently
placed under any form of control in relation to abuse while at the same time they have the
same effect as taking GHB. The method of acquisition for abuse varies. All methods
occur ranging from home production, trade via the Internet and import to theft from
undertakings handling large quantities of chemicals. In this context it can be mentioned
that five litres of GBL constitutes a large quantity of substance for abuse, where an abuse
dose corresponds roughly to what can be held in the top of a normal PET bottle, but a
negligible amount in a vat for industrial use. The dose leading to acute and lifethreatening poisoning is also very small, which results in a serious risk of overdose and
death or serious injury among abusers.
With regard to the protection of life and health, it is important to place both chemicals
under controls. However, completely prohibiting both of these environmentally sound
substances that are used lawfully to a large extent within industry should not be an
option. Since both substances have the same effect as taking the drug GHB, which is
classified as a narcotic, it is natural to consider also classifying GBL and 1,4-butanediol
as narcotics. However, with regard to the fact that the useful industrial application of both
substances should not be prevented, such a measure would have to be preceded by an
extensive amendment to the Act (1992:860) on the control of narcotics. The possibilities
of issuing licences for the use of substances classified as narcotics are considerably more
limited than for substances classified as products harmful to health. For example, it is not
possible to issue a licence for industrial use of narcotics.
In order to get control over the non-intended handling of GBL and 1,4-butanediol, the
substances should therefore be classified as products harmful to health. As explained
above, this would lead, among other things, to it being unlawful for example to
manufacture and possess the substances without a special licence, unless an exception to
the requirement for a licence has been granted in provisions. It would also result in the
possibility of forfeiture where they are found in the possession of someone who does not
have the right to possess them. However, to have to apply for a licence for every single
instance of use would, for example, make it unacceptably more difficult for industry to
use the substances. Therefore, where it is possible to achieve a satisfactory level of
control without the need for a licence it is the intention to allow exceptions to the
requirement for a licence by means of provisions.
The licensing authority could thus lay down exceptions to the requirement for a licence
provided, for example, that the substance is held for its intended purpose, e.g. cleaning or
the manufacture of cleaning agents, or that it is denatured in a particular way. The
provisions may also contain rules relating, for example, to the storage of the substances
and the keeping of records in order to be able to control their use. It is the intention for
the provisions to allow as many exceptions as possible to the requirement for a licence to
handle the substances – in order, for example, not to make it unnecessarily more difficult
for industry to use the substances and also to reduce the workload and costs of the
competent authority in connection with the issuing of licences.
In accordance with the draft, fees shall not be charged for handling applications. The
Medical Products Agency has declared that applications will be dealt with promptly. The
industry’s trade organisations have not put forward any objections to the draft.
It is not deemed possible to use measures less radical than a requirement for a licence –
with the possibility of allowing exceptions to the requirement for a licence by means of
provisions – in order to attain adequate protection for human life and health. The
possibility of withdrawing an issued licence, for example, is a more effective sanction
having a greater deterrent effect than a punishment, and this possibility would not exist if
the requirement imposed on handling the substances consisted instead of registration or
notification. If registration or notification were a sufficient criterion for handling the
substances it would give rise to difficulties regarding proof, for example with regard to
forfeiture of the substances. A less far-reaching requirement than that laid down in the
Act banning certain substances that are harmful to health would therefore not be
sufficiently effective to be able to achieve adequate protection of life and health.
The proposed regulations aim to protect public health. They are general and do not entail
any form of discrimination or concealed restriction of trade between Member States. The
draft does not result in a ban on all use of the substances classified. On the contrary, they
will continue to be able to be used within industry, for example. The proposed regulations
will contribute to, and are necessary for, protecting public health. Less radical measures
would not protect life and health to the necessary extent. The draft is therefore
proportional with regard to the objectives sought, i.e. in balancing the protection of public
health against the free movement of goods and services. In this connection it can also be
mentioned that Italy has regulated GBL and Norway has regulated both GBL and 1,4butanediol.