Activities of Kyriacos TRIANTAPHYLLIDES related to 2013/0305(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on new psychoactive substances PDF (439 KB) DOC (526 KB)
Amendments (49)
Amendment 21 #
Proposal for a regulation
Recital 5
Recital 5
(5) RAs conditions and circumstances differ in Member States with regard to psychoactive substances, restriction measures vary significantaccordingly in different Member States, meaning that economic operators that use them in the production of various goods must comply, in the case of the same new psychoactive substance, with different requirements, such as pre-export notification, export authorisation, or import and export licences. Consequently, the differences between the Member States' laws, regulations and administrative provisions on new psychoactive substances hindercould potentially hinder to some extent the functioning of the internal market, by causing obstacles to trade, market fragmentation, lack of legal clarity and of an even level playing field for economic operators, making it more difficult for companies to operate across the internal market.
Amendment 22 #
Proposal for a regulation
Recital 6
Recital 6
(6) Restriction measures could not only cause barriers to trade in the case of new psychoactive substances that already have commercial, industrial or scientific uses, but canould also impede the development of such uses, and are likely to cause obstacles to trade for economic operators that seek to develop such uses, by making access to those new psychoactive substances more difficult.
Amendment 23 #
Proposal for a regulation
Recital 7
Recital 7
(7) The disparities between the various restriction measures applied to new psychoactive substances can, while they are legitimate since they respond to each Member State's particularities with regard to psychoactive substances, could also lead to displacement of harmful new psychoactive substances between the Member States, hampering efforts to restrict their availability to consumers and undermining consumer protection across the Union, if efficient information exchange and coordination among Member States is not strengthened.
Amendment 25 #
Proposal for a regulation
Recital 8
Recital 8
(8) Such disparities are expected to increascontinue as Member States continue to pursueadopt divergent approaches to addressing challenges with regard to new psychoactive substances. Therefore, the obstacles to trade and market fragmentation, and the lack of legal clarity and of a level playing field are expected to increascontinue, further hindering the functioning of the internal market if Member States do not coordinate and cooperate more efficiently.
Amendment 26 #
Proposal for a regulation
Recital 9
Recital 9
(9) ThosWhere distortions to the functioning of the internal market are identified they should be eliminataddressed and, to that end, the rules relating to new psychoactive substances that are of concern at Union level should be approximated, while, at the same time, ensuring a high level of health, safety and consumer protection. and a flexibility for Member States to respond to local situations.
Amendment 27 #
Proposal for a regulation
Recital 10
Recital 10
(10) New psychoactive substances and mixtures should be able to move freely in the Union when intended for commercial and industrial use, as well as for scientific research and development. This Regulation should establish rules for introducing rest, by duly authorised persons in establishments which are directly under the control of Member States' authorictions to this free movementes or specifically approved by them.
Amendment 30 #
Proposal for a regulation
Recital 14
Recital 14
(14) No risk assessment should be conducted under this Regulation on a new psychoactive substance if it is subject to an assessment under international law, or if it is an active substance in a medicinal product or in a veterinary medicinal product, provided that the substance used is not liable to have ill effects and is transformed in such a condition that it cannot be abused or recovered.
Amendment 32 #
Proposal for a regulation
Recital 18
Recital 18
(18) No restriction measures should be introduced at Union level on new psychoactive substances which pose low health, social and safety risks. , but Member States may introduce further measures that are deemed appropriate or necessary depending on the specific risks that the substance poses in their territories taking into account national circumstances and any social, economic, legal, administrative or other factor they may consider relevant.
Amendment 37 #
Proposal for a regulation
Recital 21
Recital 21
(21) This Regulation should provide for exceptions in order to ensure the protection of human and animal health, to facilitate scientific research and development, and to allow the use of new psychoactive substances in industry, provided that they are not liable to have ill effects and that they cannot be abused or recovered.
Amendment 46 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) Information on new psychoactive substances provided by and exchanged among Member States is crucial for their national health policies, both in terms of drug prevention and of the treatment for psychoactive drug users in recovery services. Member States should make use of all the available information in an effective manner and monitor the relevant developments.
Amendment 50 #
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure uniform conditions for the implementation of temporary and permanent market restrictions, implementingdelegated powers should be conferred on the Commission. Those powers should be exercised in accIt is of particular impordtance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers23 . __________________ 23 OJ L 55, 28.02.2011, p.13that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 51 #
Proposal for a regulation
Recital 32
Recital 32
(32) The Commission should adopt immediately applicable implementingdelegated acts where, in duly justified cases relating to a rapid increase in the number of reported fatalities in several Member States associated with the consumption of the new psychoactive substance concerned, imperative grounds of urgency so require.
Amendment 57 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
If a Member State has information relating to what appears to be a new psychoactive substance or mixture, its National Focal Points within the European Information Network on Drugs and Drug Addiction (‘Reitox’) and Europol National Units shall provide to the EMCDDA and Europol the available information on the consumption, possible risks, manufacture, extraction, importation, trade, distribution, trafficking, commercial and scientific use of that substances that appear to be new psychoactive substances or mixtures.
Amendment 63 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Amendment 64 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Where the EMCDDA and Europol, or the Commission, considers, that the information shared on a new psychoactive substance notified by several Member States gives rise to concerns across the Union because of the health, social and safety risks that the new psychoactive substance may pose, the EMCDDA and Europol shall draw up a joint report on the new psychoactive substance.
Amendment 66 #
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. The joint report shall contain the following information:
Amendment 67 #
Proposal for a regulation
Article 6 – paragraph 2 – point e
Article 6 – paragraph 2 – point e
Amendment 68 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The EMCDDA and Europol shall request the National Focal Points and, the Europol National Units to provide additional information on the new psychoactive substanceand Europol to provide information on the new psychoactive substance and in particular on the involvement of criminal groups in the manufacture, distribution or trade in the new psychoactive substance, and any use of the new psychoactive substance in the manufacture of narcotic drugs or psychotropic substances. They shall provide that information within four weeks from receipt of the request.
Amendment 69 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
4. The EMCDDA and Europol shall request the European Medicines Agency and the national competent authorities for medicines of Member States to provide information on whether, in the Union or in any Member State, the new psychoactive substance is:
Amendment 70 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
6. The EMCDDA and Europol shall submit the joint report to the Commission within eight weeks from the request for additional information referred to in paragraph 3.
Amendment 71 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Within four weeks from the receipt of the joint report referred to in Article 6, the Commission may request the EMCDDA to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report. The risk assessment shall be conducted by the Scientific Committee of the EMCDDA.
Amendment 73 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Scientific Committee of the EMCDDA shall assess the risks during a special meeting. The Committee may be extended by not more than five experts, representing the scientific fields relevant for ensuring a balanced assessment of the risks of the new psychoactive substance. The Director of the EMCDDA shall designate them from a list of experts. The Management Board of the EMCDDA shall approve the list of experts every three years. TEuropean Parliament, the Council, the Commission, the EMCDDA, Europol and the European Medicines Agency shall each have the right to nominate two observers.
Amendment 79 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. No risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the United Nations system, namely once the World Health Organisation expert committee on drug dependence has published its critical review together with a written recommendation, except where there is significant and concrete information that is new or of particular relevance for the Union and that has not been taken into account by the United Nations system, which is to be mentioned in the assessment report.
Amendment 81 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. No risk assessment shall be carried out where the new psychoactive substance has been assessed within the United Nations system, but it has been decided not to schedule it under the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or the 1971 Convention on Psychotropic Substances, except where there is significant and concrete information that is new or of particular relevance for the Union, the reasons for which shall be indicated in the assessment report.
Amendment 83 #
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1
Article 9 – paragraph 2 – subparagraph 1
The Commission shall adopt the Decision referred to in paragraph 1 by means of implementingdelegated acts. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 19(21).
Amendment 84 #
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
On duly justified imperative grounds of urgency relating to a rapid increase in the number of reported fatalities in several Member States associated with the consumption of the new psychoactive substance concerned, the Commission shall adopt immediately applicable implementingdelegated acts in accordance with the urgency procedure laid down in Article 19(32).
Amendment 85 #
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 1 – point b
Article 10 – paragraph 2 – subparagraph 1 – point b
(b) the social harm caused to individuals and to society, in particularbased on its impact on social functioning, public order and criminal activities, organised crime activity associated with the new psychoactive substance, illicit profits generated by the production, trade and distribution of the new psychoactive substance, and associated economic costs of the social harm;
Amendment 86 #
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 1 – point c
Article 10 – paragraph 2 – subparagraph 1 – point c
(c) the risks to safety, in particularbased on the spread of diseases, including transmission of blood borne viruses, the consequences of physical and mental impairment on the ability to drive, the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment.
Amendment 93 #
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) the social harm caused to individuals and to society is limited, in particular regarding its impact on social functioning andbased on its impact on public order, criminal activities associated with the new psychoactive substance is low, illicit profits generated by the production, trade and distribution of the new psychoactive substance and associated economic costs are non-existent or negligible;
Amendment 95 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) the risks to safety are limited, in particularbased on a low risk of spread of diseases, including transmission of blood borne viruses, non- existent or low consequences of physical and mental impairment on the ability to drive, and the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment is low.
Amendment 96 #
Proposal for a regulation
Article 11 – paragraph 1 – point c a (new)
Article 11 – paragraph 1 – point c a (new)
(ca) Member States may introduce further measures that are deemed appropriate or necessary with regard to a new psychoactive substance, depending on the specific risks that the substance poses in their territories taking into account national circumstances and any social, economic, legal, administrative or other factor they may consider relevant;
Amendment 97 #
Proposal for a regulation
Article 11 – paragraph 1 – point c b (new)
Article 11 – paragraph 1 – point c b (new)
(cb) In case the decision to not adopt restriction measures on a new psychoactive substance that is considered to pose overall low health, social and safety risk was based on a partial or total lack of evidence, it shall include an appropriate mention in its classification.
Amendment 98 #
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. The Commission shall, by means of a Decision, without undue delay, prohibit the making available on the market to consumers of the new psychoactive substance if, based on existing evidence, it poses, overall, moderate health, social and safety risks, in particular based on the following criteria:
Amendment 100 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) the social harm caused to individuals and to society is moderate, in particular regarding its impact on social functioning andbased on its impact on public order, producing public nuisance; criminal activities and organised crime activity associated with the substance are sporadic, illicit profits and economic costs are moderate;
Amendment 101 #
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) the risks to safety are moderate, in particularbased on a sporadic spread of diseases, including transmission of blood borne viruses, moderate consequences of physical and mental impairment on the ability to drive, and the manufacture, transport and disposal of the new psychoactive substance and associated waste materials results in environmental nuisance.
Amendment 102 #
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The Commission shall adopt the Decision referred to in paragraph 1 by means of implementingdelegated acts. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 19(21).
Amendment 103 #
Proposal for a regulation
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. Member States may introduce further measures that are deemed appropriate or necessary with regard to a new psychoactive substance, depending on the specific risks that the substance poses in their territories taking into account national circumstances and any social, economic, legal, administrative or other factor they may consider relevant.
Amendment 105 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) the social harm caused to individuals and to society is severe, in particular regarding its impact on social functioning and public order, resulting in public order disruption, violent and anti-social behaviour causing damage to the user, to others and to property; criminal activities and organised crime activity associated with the new psychoactive substance are systematic, illicit profits, and economic costs are high;
Amendment 106 #
Proposal for a regulation
Article 13 – paragraph 1 – point c
Article 13 – paragraph 1 – point c
(c) the risks to safety are severe, in particular significantbased on a spread of diseases, including transmission of blood borne viruses, severe consequences of physical and mental impairment on the ability to drive, and the manufacture, transport and disposal of the new psychoactive substance and associated waste materials result in environmental harm.
Amendment 109 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The Commission shall adopt the Decision referred to in paragraph 1 by means of implementingdelegated acts. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 19(21).
Amendment 111 #
Proposal for a regulation
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) for scientific research and development purposes, by duly authorised persons in establishments which are directly under the control of Member States' authorities or specifically approved by them;
Amendment 112 #
Proposal for a regulation
Article 14 – paragraph 2 – point d
Article 14 – paragraph 2 – point d
(d) for use in the manufacture of substances and products provided that the new psychoactive substances are transformed in such a condition that they cannot be abused or recovered, that they are not liable to have ill effects and that the amount of each substance used is included in the information about the substance or the product.
Amendment 113 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. Products containing new psychoactive substances shall include directions for use, including cautions, warnings and contraindications with other substances, to be either indicated on the label or included in the accompanying leaflet for the safety of the user.
Amendment 115 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
The EMCDDA and Europol, with the support of Reitox, shall monitor all new psychoactive substances on which a joint report has been drawn up.
Amendment 116 #
Proposal for a regulation
Article 19 – title
Article 19 – title
Amendment 117 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. adopt the Decision referred to in paragraphs 9(2), 12(2) and 13(2) by means of delegated act subject to the conditions laid down in this Article. The delegation of power shall be conferred on the Commission for a period of 5 years from the date of entry into force of the Regulation. The delegation of power 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. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. A delegated act adopted shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 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 2 months at the initiative of the European Parliament or the Council.
Amendment 118 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply, in the case of duly justified cases relating to a rapid increase in the number of reported fatalities in several Member States associated with the consumption of a new psychoactive substance and imperative grounds of urgency so require, an emergency procedure shall apply to delegated acts. Delegated acts adopted under an emergency procedure shall enter into force without delay and shall apply as long as no objection is expressed in accordance with third subparagraph . The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 19(1). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council.
Amendment 119 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
Amendment 123 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
The EMCDDA and Europol shall report annually on the implementation of this Regulation.