Activities of Eleftherios SYNADINOS related to 2016/0261(COD)
Plenary speeches (1)
Criminal acts and penalties in the field of illicit drug trafficking - Information exchange on, and an early warning system and risk assessment procedure for, new psychoactive substances I (debate) EL
Amendments (16)
Amendment 16 #
Proposal for a regulation
Recital 1
Recital 1
(1) New psychoactive substances can pose serious cross border threatrisks to health and result in life-threatening consequences, which makes it necessary to enhance identification, monitoring, early warning and combating of those threats.
Amendment 17 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) A new psychoactive substance should be defined as a new narcotic or psychotropic drug, in pure form or in preparation, that is not covered by the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and the 1971 United Nations Convention on Psychotropic Substances, but which may pose a public health threat comparable to that posed by substances listed in those Conventions. A psychoactive substance should be defined as any substance which affects a person's mental functioning, emotional state, or behavioural output when there is intention that it will be consumed for its psychoactive effects.
Amendment 18 #
Proposal for a regulation
Recital 2
Recital 2
(2) During the past years, Member States have notified an progressively increasing number of new psychoactive substances via the mechanism for rapid exchange of information which was established by Joint Action 97/396/JHA adopted by the Council on the basis of Article K.3 of the Treaty on European Union concerning the information exchange, risk assessment and the control of new synthetic drugs13 and was further strengthened by Council Decision 2005/387/JHA14 . _________________ 13 Council Joint Action 97/396/JHA of 16 June 1997 concerning the information exchange, risk assessment and control of new synthetic drugs (OJ L 167, 25.6.1997, p. 1). 14 Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances (OJ L 127, 20.5.2005, p. 32).
Amendment 19 #
Proposal for a regulation
Recital 3
Recital 3
(3) New psychoactive substances that pose health and social risks across the Union shcould be addressed at the Union level within the scope of synergistic provisions and by tackling common threats to public health and public order. This Regulation has therefore to be read in conjunction with Council Framework Decision 2004/757/JHA15 [as amended by Directive (EU) …/…] since both acts are designed to replace the mechanism established by Council Decision 2005/387/JHA. _________________ 15 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).
Amendment 20 #
Proposal for a regulation
Recital 5
Recital 5
(5) Any Union action on new psychoactive substances should be based on sound, unbiased and well-founded scientific evidence.
Amendment 21 #
Proposal for a regulation
Recital 7
Recital 7
(7) NoA framework should be adopted for targeted risk assessment shs that could be conducted on a new psychoactive substance ifeven where it is subject to an assessment under international law, or ifwhere it is an active substance in a medicinal product or in a veterinary medicinal product, based on scientific evidence, reporting from Member States and needs across the Union.
Amendment 23 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5a – paragraph 1
Article 5a – paragraph 1
Each Member State shall ensure that its Reitox National Focal Points and the Europol National Unit provide timely and without any undue delay to the Centre and Europol theall available information on new psychoactive substances. The information shall be related to the detection and identification, use and patterns of use, potential and identified risks, manufacture, extraction, distribution, trafficking, commercial, as well as medical and scientific use of these substances.
Amendment 24 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5a – paragraph 1 a (new)
Article 5a – paragraph 1 a (new)
The Reitox National Focal Points may also provide information on new trends in the use of existing substances and/or new combinations of psychoactive substances.
Amendment 27 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5b – paragraph 2 – point a
Article 5b – paragraph 2 – point a
(a) a first indication of the nature or scale of health and social risks associated with the new psychoactive substance, newly misused on the market;
Amendment 30 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5b – paragraph 9
Article 5b – paragraph 9
9. The Centre shall respect the conditions on use of the information, which are communicated to the Centre, including conditions on information and data security and, protection of confidential business information, and provisions on intellectual property.
Amendment 32 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5c – paragraph 3 – point a
Article 5c – paragraph 3 – point a
(a) information on the chemical and physical properties of the new psychoactive substance, the methods and the precursors used for its manufacture or extraction, and derivatives;
Amendment 33 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5c – paragraph 3 – point b
Article 5c – paragraph 3 – point b
(b) information on the pharmacological and toxicological properties of the new psychoactive substance and a reference to known analogues, similar in pharmacological activity and similar in chemical structure;
Amendment 34 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5c – paragraph 3 – point c
Article 5c – paragraph 3 – point c
(c) an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and its physical, mental, emotional and behavioural effects;
Amendment 35 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5c – paragraph 3 – point d
Article 5c – paragraph 3 – point d
(d) an analysis of the social risks associated with the new psychoactive substance, in particular its impact on social functioning, groups of the population targeted or particularly affected, public order and criminal activities, the involvement of criminal groups in the manufacture and distribution of the new psychoactive substance;
Amendment 37 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5c – paragraph 4 – subparagraph 2
Article 5c – paragraph 4 – subparagraph 2
The European Parliament, the Commission, the Centre, Europol and the European Medicines Agency shall each have the right to nominate two observers.
Amendment 38 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1920/2006
Article 5d – paragraph 3 – introductory part
Article 5d – paragraph 3 – introductory part
3. NUnless there is a strong indication that there are significant health and/or social risks or a major potential impact on public order, no risk assessment shall be carried out where the new psychoactive substance is: