(1)

New psychoactive substances can pose serious cross-border threats to health, in particular due to the large number and diversity of those substances and the speed with which they appear. In order to develop responses for addressing those threats, it is necessary to enhance monitoring and the early warning system and to assess the health and social risks associated with new psychoactive substances.

(2)

Vulnerable groups, especially young people, are particularly exposed to the health and social risks associated with new psychoactive substances.

(3)

In recent years, Member States have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information on such substances, which was established by Council Joint Action 97/396/JHA (3) and further strengthened by Council Decision 2005/387/JHA (4).

(4)

New psychoactive substances that pose public health and, where applicable, social risks across the Union should be addressed at Union level. This Regulation should therefore be read in conjunction with Directive (EU) 2017/2103 of the European Parliament and of the Council (5) because both acts are designed to replace the mechanism established by Decision 2005/387/JHA.

(5)

A small number of new psychoactive substances can have commercial and industrial uses and can be used for scientific research and development.

(6)

Provisions concerning information exchange on, and the early warning system and risk assessment procedure for, new psychoactive substances should be included in Regulation (EC) No 1920/2006 of the European Parliament and of the Council (6). Provisions concerning the early warning of new psychoactive substances should, in particular, be strengthened and the procedures for drawing up an initial report and organising the risk assessment should be made more efficient. Substantially shortened deadlines for all stages of those procedures should be set.

(7)

Any Union action on new psychoactive substances should be based on scientific evidence and be subject to a specific procedure.

(8)

An initial report should be drawn up on a new psychoactive substance where information provided by the Member States on that new psychoactive substance gives rise to concerns that it might pose health or social risks at Union level. The initial report should allow the Commission to make an informed decision regarding the launch of the risk assessment procedure. The risk assessment procedure at Union level should be undertaken rapidly.

(9)

Following the risk assessment procedure, the Commission should determine whether the new psychoactive substance in question should be included in the definition of ‘drug’ in accordance with the procedure provided for in Council Framework Decision 2004/757/JHA (7). With a view to ensuring the continuous functioning of the mechanism for information exchange and of the reporting and risk assessment procedures set out in Decision 2005/387/JHA and in this Regulation, this Regulation should apply from the same date as the deadline for transposition of Directive (EU) 2017/2103, which is also the date on which Decision 2005/387/JHA is to be repealed.

(10)

In principle, no risk assessment should be carried out on a new psychoactive substance if it is subject to an assessment under international law. No risk assessment should be carried out on a new psychoactive substance if it is an active substance in a medicinal product for human use or in a veterinary medicinal product.

(11)

Regulation (EC) No 1920/2006 should therefore be amended accordingly,

(1)

in Article 2, the following point is added:

(*1)  Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8).’;"

(2)

in Article 5(2), the second subparagraph is deleted;

(3)

the following Articles are inserted:

(*2)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67)."

(*3)  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1)."

(*4)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1)."

(*5)  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).’;"

(4)

in Article 13(2), the fourth subparagraph is replaced by the following:

‘For the purpose of assessing the risks posed by the new psychoactive substance or group of new psychoactive substances, the Scientific Committee may be extended following the procedure laid down in Article 5c(4).’.

(1)

Directive 2011/65/EU of the European Parliament and of the Council (3) on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE) contains a request that the Commission examine the need to amend the scope of that Directive in respect of the EEE covered therein and, if appropriate, present a legislative proposal with respect to any additional exclusions related to that EEE.

(2)

Secondary market operations for EEE, which involve repair, replacement of spare parts, refurbishment and reuse, and retrofitting, should be facilitated to promote a circular economy in the Union. A high level of protection of human health and the environment should be ensured, including through the environmentally sound recovery and disposal of waste EEE. Any unnecessary administrative burden on market operators should be avoided. Directive 2011/65/EU allows EEE that fell outside the scope of the previous Directive 2002/95/EC of the European Parliament and of the Council (4), but which would not comply with Directive 2011/65/EU, to continue to be made available on the market until 22 July 2019. After that date, however, both the first placing on the market and secondary market operations of non-compliant EEE are prohibited. Such prohibition of secondary market operations is inconsistent with the general principles underlying Union measures for the approximation of laws relating to products and should therefore be removed.

(3)

Certain niche product groups should be excluded from the scope of Directive 2011/65/EU as their inclusion would bring negligible environmental or health benefits and introduce unresolvable compliance problems or market distortions that cannot effectively be addressed through the exemption mechanism provided for in that Directive.

(4)

Pipes in organs are built using a specific type of lead-based alloy, for which no alternative has been found so far. Most pipe organs are kept in the same place for centuries and their turnover rate is negligible. Pipe organs should therefore be excluded from the scope of Directive 2011/65/EU as their inclusion would bring negligible benefit in terms of the substitution of lead.

(5)

Directive 2011/65/EU does not apply to non-road mobile machinery with an on-board power source, which is made available exclusively for professional use. However, for certain types of non-road mobile machinery, two versions are produced in the same production line, with the power source (either on-board or external) being the only difference. Those versions should be treated in the same way under that Directive. Non-road mobile machinery with a traction drive powered by an external power source should therefore also be excluded from the scope of Directive 2011/65/EU.

(6)

For all relevant EEE categories, as set out in Annex I to Directive 2011/65/EU, the conditions for the exemption of reused spare parts, recovered from EEE, should be clearly specified. Likewise, since exemptions from the restriction of the use of certain hazardous substances should have a limited duration, the maximum validity period for existing exemptions should also be clearly specified for all relevant EEE categories, including for category 11.

(7)

When an application for renewal of an exemption is submitted, the Commission is required to take a decision no later than 6 months before the expiry date of the existing exemption, unless specific circumstances justify a different deadline. No deadline is specified for the Commission to take a decision on applications for new exemptions. According to the report of 18 April 2016 from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2011/65/EU, that deadline has proven to be unfeasible in practice, due to the need to follow several mandatory procedural steps for the evaluation of an application for renewal of an exemption. While the deadline brings no additional value to the existing procedure for the evaluation of applications for renewal, it entails uncertainties for businesses and other stakeholders due to its impracticability. On the other hand, business continuity is ensured since market operators are able to rely on an existing exemption remaining valid until a decision is taken on the application for renewal. Therefore, the provision related to the deadline should be removed. However, the Commission should provide to the applicant, the Member States and the European Parliament, shortly after the receipt of an application, a timeline for the adoption of its decision on the application. Furthermore, the general review of Directive 2011/65/EU to be carried out by the Commission no later than 22 July 2021 should include the specification of a realistic deadline for a decision by the Commission on an application for renewal of an exemption before the expiry of the relevant exemption.

(8)

Since the objectives of this Directive, which are to contribute to the protection of human health and the environmentally sound recovery and disposal of waste EEE by means of the restriction of the use of hazardous substances in EEE, cannot be sufficiently achieved by the Member States because disparities between the laws or administrative measures adopted by the Member States could create barriers to trade and distort competition in the Union and thus have a direct impact on the internal market, but can rather, by reason of the scale of the problem and its implications in respect of other Union legislation on recovery and disposal of waste and areas of common interest, such as human health protection, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

(1)

Article 2 is amended as follows:

(2)

in Article 3, point (28) is replaced by the following:

(3)

Article 4 is amended as follows:

(4)

Article 5 is amended as follows:

(1)

Council Framework Decision 2004/757/JHA (3) provides for a common approach to tackle illicit drug trafficking, which poses a threat to the health, safety and quality of life of citizens of the Union, to the legal economy and to the stability and security of the Member States. Framework Decision 2004/757/JHA sets out minimum common rules on the definition of drug trafficking offences and penalties in order to avoid problems arising in the cooperation between the judicial authorities and law enforcement agencies of Member States owing to the fact that the offence or offences in question are not punishable under the laws of both the requesting and the requested Member State.

(2)

Framework Decision 2004/757/JHA applies to the substances covered by the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and to the substances covered by the 1971 United Nations Convention on Psychotropic Substances (‘UN Conventions’), as well as to the synthetic drugs subjected to control measures across the Union pursuant to Council Joint Action 97/396/JHA (4), which pose public health risks comparable to those posed by the substances scheduled under the UN Conventions.

(3)

Framework Decision 2004/757/JHA should also apply to the substances subjected to control measures and criminal penalties pursuant to Council Decision 2005/387/JHA (5), which pose public health risks comparable to those posed by the substances scheduled under the UN Conventions.

(4)

New psychoactive substances, which imitate the effects of substances scheduled under the UN Conventions, are emerging frequently and are spreading rapidly in the Union. Certain new psychoactive substances pose severe public health and social risks. Regulation (EU) 2017/2101 of the European Parliament and of the Council (6) provides the framework for the exchange of information on new psychoactive substances and for a risk assessment procedure based on an initial report and risk assessment report drawn up to evaluate whether a new psychoactive substance poses severe public health and social risks. To effectively reduce the availability of new psychoactive substances that pose severe public health risks and, where applicable, severe social risks, and to deter trafficking in those substances across the Union, as well as the involvement of criminal organisations, those substances should be included in the definition of ‘drug’ in accordance with the provisions of this Directive and underpinned by proportionate criminal law provisions.

(5)

The new psychoactive substances included in the definition of ‘drug’ should therefore be covered by the Union criminal law provisions on illicit drug trafficking. This would also help streamline and clarify the Union legal framework, as the same criminal law provisions would apply to substances covered by the UN Conventions and to the most harmful new psychoactive substances. The definition of ‘drug’ in Framework Decision 2004/757/JHA should therefore be amended.

(6)

This Directive should establish the essential elements of the definition of ‘drug’, as well as the procedure and the criteria for the inclusion of new psychoactive substances in that definition. Furthermore, in order to include in the definition of ‘drug’ psychoactive substances which are already subject to control measures by Council decisions adopted in accordance with Joint Action 97/396/JHA and Decision 2005/387/JHA, an Annex containing a list of those psychoactive substances should be added to Framework Decision 2004/757/JHA.

(7)

However, in order to swiftly address the emergence and spread of harmful new psychoactive substances in the Union, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amending that Annex to include new psychoactive substances in the definition of ‘drug’. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(8)

In order to swiftly address the emergence and spread of harmful new psychoactive substances in the Union, Member States should apply the provisions of Framework Decision 2004/757/JHA to new psychoactive substances which pose severe public health risks and, where applicable, severe social risks, as soon as possible but no later than six months from the entry into force of a delegated act amending the Annex to include them in the definition of ‘drug’. Member States should, to the extent possible, make every effort to shorten that deadline.

(9)

Since the objective of this Directive, namely to extend the application of the Union criminal law provisions that apply to illicit drug trafficking to new psychoactive substances posing severe public health risks and, where applicable, severe social risks, cannot be sufficiently achieved by the Member States acting alone, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(10)

This Directive respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, and in particular the right to an effective remedy and to a fair trial, the presumption of innocence and the right of defence, the right not to be tried or punished twice in criminal proceedings for the same criminal offence and the principles of legality and proportionality of criminal offences and penalties.

(11)

As this Directive together with Regulation (EU) 2017/2101, is designed to replace the mechanism established by Decision 2005/387/JHA, that Decision should be repealed.

(12)

In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified its wish to take part in the adoption and application of this Directive.

(13)

In accordance with Articles 1 and 2 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Directive and is not bound by it or subject to its application.

(14)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application.

(15)

Framework Decision 2004/757/JHA should therefore be amended accordingly,

(1)

Article 1 is amended as follows:

(2)

the following Articles are inserted:

(*1)  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).’;"

(3)

the following Article is inserted:

(*2)   OJ L 123, 12.5.2016, p. 1.’;"

(4)

an Annex, as set out in the Annex to this Directive, is added.