Amendments to Framework Decision 2004/757/JHA
Article 1
Framework Decision 2004/757/JHA is amended as follows:
1. Article 1 is amended as follows:
  1. point 1 is replaced by the following:
    1. “drug” means any of the following:
      1. a substance covered by the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or by the 1971 United Nations Convention on Psychotropic Substances;
      2. any of the substances listed in the Annex;
;
  2. the following points are added:
    1. “new psychoactive substance” means a substance in pure form or in a preparation that is not covered by the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or by the 1971 United Nations Convention on Psychotropic Substances but may pose health or social risks similar to those posed by the substances covered by those Conventions;
    2. “preparation” means a mixture containing one or more new psychoactive substances.
;
2. the following Articles are inserted:

Procedure for including new psychoactive substances in the definition of “drug”
Article 1a
1
Based on a risk assessment or combined risk assessment carried out pursuant to Article 5c of Regulation (EC) No 1920/2006 of the European Parliament and of the Council , and in accordance with the criteria set out in paragraph 2 of this Article, the Commission shall, without undue delay, adopt a delegated act in accordance with Article 8a amending the Annex to this Framework Decision in order to add the new psychoactive substance or substances to it and provide that the new psychoactive substance or substances pose severe public health risks and, where applicable, severe social risks at Union level, and that it is or they are included in the definition of “drug”.
2
When considering whether to adopt a delegated act as referred to in paragraph 1, the Commission shall take into account whether the extent or patterns of use of the new psychoactive substance and its availability and potential for diffusion within the Union are significant, and whether the harm to health caused by the consumption of the new psychoactive substance, associated with its acute or chronic toxicity and abuse liability or dependence-producing potential, is life-threatening. The harm to health is considered life-threatening if the new psychoactive substance is likely to cause death or lethal injury, severe disease, severe physical or mental impairment or a significant spread of diseases, including the transmission of blood-borne viruses.
In addition, the Commission shall take into account whether the social harm caused by the new psychoactive substance to individuals and to society is severe, and, in particular, whether the impact of the new psychoactive substance on social functioning and public order is such as to disrupt public order, or cause violent or anti-social behaviour, resulting in harm to the user or to other persons or damage to property, or whether criminal activities, including organised crime, associated with the new psychoactive substance are systematic, involve significant illicit profits or entail significant economic costs.
3
If, within six weeks of the date of receipt of the risk assessment report or the combined risk assessment report in accordance with Article 5c(6) of Regulation (EC) No 1920/2006, the Commission considers that it is not necessary to adopt a delegated act to include the new psychoactive substance or substances in the definition of “drug”, it shall present a report to the European Parliament and to the Council explaining the reasons for not doing so.
4
As regards new psychoactive substances added to the Annex to this Framework Decision, Member States which have not yet done so shall bring into force the laws, regulations and administrative provisions necessary to apply the provisions of this Framework Decision to those new psychoactive substances as soon as possible but no later than six months after the entry into force of the delegated act amending the Annex. They shall immediately inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Framework Decision or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

National control measures
Article 1b
Without prejudice to the obligations imposed on the Member States under this Framework Decision, Member States may maintain or introduce in their territories, with regard to new psychoactive substances, any national control measures that they consider appropriate.
;
3. the following Article is inserted:

Exercise of the delegation
Article 8a
1
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2
The power to adopt delegated acts referred to in Article 1a shall be conferred on the Commission for a period of five years from 22 November 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3
The delegation of power referred to in Article 1a may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making .
5
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6
A delegated act adopted pursuant to Article 1a shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
;
4. an Annex, as set out in the Annex to this Directive, is added.
Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p. 1).’;
OJ L 123, 12.5.2016, p. 1.’;