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3 Consultations and Roadmaps, BNU November 2017, Brussels News Updates

EFSA Public Consultation on The Active Substance Pyrimethanil

The European Food Safety Authority (EFSA) will assess all comments from interested parties regarding the active substance Pyrimethanil. Input is requested on the following: physical/chemical properties; details of uses and further information; methods of analysis; mammalian toxicology; residues; and environmental fate and behaviour.
Deadline: 8 January 2018
Website: http://www.efsa.europa.eu/

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3 Consultations and Roadmaps, BNU November 2017, Brussels News Updates

Evaluation of EU Pesticide Legislation – Stakeholder Survey

This survey is part of an evaluation of the EU legislation on plant protection products and pesticide residues. The scope of this survey includes the provisions of Regulation (EC) No 396/2005 on maximum residue levels (MRLs) of pesticides, and Regulation (EC) No 1107/2009, concerning the placing of plant protection products (PPPs) on the market. This survey seeks to collect information on how well the rules governing the approval of active substances, authorisation of plant protection products, and the setting of MRLs of pesticides in the EU work in practice. The questions explore in detail the impact of these provisions on businesses, the environment, and consumers in the EU. The survey aims at identifying strengths and weaknesses of the PPP and MRL Regulations, and gathers information on how the situation has changed after the entry into force of the Regulations. The results of the survey will feed into the evaluation performed independently on behalf of DG SANTE.
Deadline (for stakeholders): 31 December 2017
Website (for stakeholders): https://s.chkmkt.com/
Deadline (for citizens): 12 February 2018
Website (for citizens): https://ec.europa.eu/

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3 Consultations and Roadmaps, BNU November 2017, Brussels News Updates

Draft Delegated Regulation – Scheduling of ANPP and NPP in the EU Drug Precursor Legislation

Drug precursors are chemicals which may be used for the illicit manufacture of narcotic drugs or psychotropic substances. Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the EU, while Regulation (EC) No 111/2005 governs trade in drug precursors between the EU and third countries. Both Regulations jointly implement the obligations stemming from Article 12 of the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (the 1988 UN Convention) in the EU. By its decisions 60/12 and 60/13, taken at its sixtieth session on 16 March 2017, the Commission on Narcotic Drugs of the United Nations decided to include, respectively, 4-anilino-N-phenethylpiperidine (ANPP) and N-phenethyl-4-piperidone (NPP) in Table I of the 1988 UN Convention. The Commission is asking for feedback on the Draft delegated regulation on the scheduling of these substances in the EU Drug Precursor legislation.
Deadline: 13 December 2017
Website: https://ec.europa.eu/

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3 Consultations and Roadmaps, BNU November 2017, Brussels News Updates

Draft Regulation – Methodological Principles for the Risk Assessment and Risk Management Recommendations for the Maximum Residue Limits

This Regulation sets out the methodological principles for the scientific risk assessment and risk management recommendations referred to in Articles 6 and 7 of Regulation (EC) No 470/2009 that shall be applied by the European Medicines Agency when preparing opinions on the maximum residue limits of pharmacologically active substances which may be permitted in food of animal origin.
Deadline: 13 December 2017
Website: https://ec.europa.eu/

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3 Consultations and Roadmaps, BNU November 2017, Brussels News Updates

Evaluation of the General Union Environment Action Programme to 2020

The purpose of this evaluation is to assess the 7th Environment Action Programme (EAP) and submit a report based on this evaluation to the European Parliament and to the Council. The focus of the evaluation will be on the structure and strategic role played by the 7th EAP: that is its multi-layered approach, dual focus and the joint responsibility to deliver. Essentially it will ask if this agreed framework is really helping us to deliver the nine priority objectives in a smart way. Evaluating the structure will require a basic assessment of the link between the structure and the actions undertaken under the 7th EAP and the progress towards achieving the 7th EAP’s different sub-objectives. In doing so, the evaluation will consider the impact of relevant actions taken at Union and Member State level given their shared responsibility for the 7th EAP.
Deadline: 6 December 2017
Website: https://ec.europa.eu/

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3 Consultations and Roadmaps, BNU November 2017, Brussels News Updates

Draft Regulation – Definition of the Concept “Similar Medicinal Product”

Commission Regulation (EC) No 847/20002 provides a definition of the concept “similar medicinal product”, which includes specific cases defining what kind of products are to be regarded as similar for the purposes of the application of Regulation (EC) No 141/2000. That definition should be updated in the light of new scientific and technical knowledge, in particular, due to major developments in the field of biological medicines, and especially advanced therapy medicinal products, and in the light of experience gained with regard to the designation and regulation of orphan medicinal products. In addition, there is a need for a clear definition of the concept ‘principal molecular structural features’, which is used within the definition of the concept ‘similar active substance’, which is in turn used within the definition of the concept ‘similar medicinal products’.
Deadline: 27 November 2017
Website: https://ec.europa.eu/

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