Activities of Renate WEBER 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 (10)
Amendment 28 #
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, unless at Union level there is sufficient data available to suggest the need for a joint report of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol.
Amendment 38 #
Proposal for a regulation
Recital 23
Recital 23
(23) The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) established by Regulation 1920/2006/EC of the European Parliament and of the Council of 12 December 200618 should have a central role in the exchange and coordination of information on new psychoactive substances and in the assessment of the health, social and safety risks that they pose. Given that under the scope of this Regulation there is an increase in the amount of information expected to be collected and managed by the agency, specific support should be envisaged and provided. __________________ 18 OJ L 376, 27.12.2006, p. 1.
Amendment 45 #
Proposal for a regulation
Recital 25
Recital 25
(25) Information from Member States is crucial for the effective functioning of the procedures leading to decision on market restriction of new psychoactive substances. Therefore, Member States should monitor and collect, on a regular basis, data on the use of any new psychoactive substances, related health, safety and social problems and policy responses, in accordance with the EMCDDA framework for data collection for the key epidemiological indicators and other relevant data. They should share this data notably with the EMCDDA, Europol and the European Commission.
Amendment 53 #
Proposal for a regulation
Recital 33
Recital 33
(33) In the application of this Regulation, the Commission should consult Member States' experts, relevant Union agencies, civil society and, economic operators and any other relevant stakeholder.
Amendment 54 #
Proposal for a regulation
Recital 36
Recital 36
(36) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union and of the European Convention of Human Rights, including the freedom to conduct a business, the right to property and the right to an effective remedy, the right of access to preventive healthcare and the right to benefit from medical treatment,
Amendment 58 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
National Focal Points within the European Information Network on Drugs and Drug Addiction (‘Reitox’) and Europol National Units shall providegather continuously and provide in a timely manner to the EMCDDA and Europol the available information on the consumption, possible riskdetection, identification, consumption, patterns of use, dosage, use disorder, possible risks, non-fatal intoxication, deaths, social harms, manufacture, extraction, importation, trade, distribution, trafficking, commercial and scientific use of substances that appear to be new psychoactive substances or mixtures.
Amendment 76 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. The Scientific Committee of the EMCDDA shall carry out the risk assessment on the basis of information on the risks of the substance and on its uses, like its patterns and dosage, including commercial and industrial uses, provided by the Member States, the Commission, the EMCDDA, Europol, the European Medicines Agency, the European Chemicals Agency, the European Food Safety Authority and on the basis of any other relevant scientific evidence. It shall take into consideration all opinions held by its members. The EMCDDA shall support the risk assessment and shall identify information needs, including targeted studies or tests.
Amendment 82 #
Proposal for a regulation
Article 8 – paragraph 4 (new)
Article 8 – paragraph 4 (new)
4. However, the risk assessment shall be carried if at the Union level there is sufficient data available to suggest the need for a joint report of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol.
Amendment 107 #
Proposal for a regulation
Article 13 – paragraph 1 a (new)
Article 13 – paragraph 1 a (new)
1a. By means of delegated acts, the Commission shall adopt a Decision to supplement or further specify the exhaustive criteria based on which the Decision referred to in paragraph 1 will be taken.
Amendment 125 #
Proposal for a regulation
Article 22
Article 22
By [five years after the entry into force of this Regulation] at the latest and every five years thereafter, the Commission shall assess the implementation, application and effectiveness of this Regulation and publish a report. In this respect, the Commission, the EMCDDA and Europol shall conduct post-risk assessments based on epidemiological and sociological studies of new psychoactive substances.