With this consultation the Commission seeks the views of stakeholders on the Supplementary Protection Certificates (SPC) and patent research exemption of SPCs. Citizens and stakeholders are invited to provide feedback on their experience and knowledge, which the Commission will carefully analyse before deciding whether and to what extent it should take further action. SPCs are a unique intellectual property right that constitute an extension (of up to 5 years) to the term of a patent right (of 20 years). SPCs apply to innovative pharmaceutical and plant protection products that have been authorised by regulatory authorities. They aim to offset the loss of effective patent protection that occurs due to the compulsory and lengthy testing and clinical trials that products require prior to obtaining regulatory marketing approval.
Website: https://ec.europa.eu/
EFSA Public Consultation on The Active Substance Carvone
The European Food Safety Authority (EFSA) will assess all comments from interested parties regarding the active substance Carvone. 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: 6 November 2017
Website: http://www.efsa.europa.eu/
Public Consultation on The Revision of The Policy on Monitoring, Reporting and Verification of CO2 Emissions from Maritime Transport
Regulation on monitoring, reporting and verification of carbon dioxide emissions from maritime transport was adopted and entered into force in 2015. It sets an EU wide scheme for reporting monitored and verified data on shipping CO2 emissions (EU MRV) applying to activities carried out after January 2018. At the international level, the International Maritime Organisation (IMO) has completed the legal framework for its global data collection system (IMO DCS) with the adoption in July 2017 of guidelines on data verification and database management. Considering these recent developments, the Commission is now reviewing the situation with a view to align the EU MRV with the IMO DCS and it will table, if appropriate, a legislative proposal to amend the EU MRV accordingly in 2018. In this context, a stakeholder consultation will ensure that all relevant parties are given the opportunity to express their opinions and to contribute to the analysis on the effectiveness and potential impacts of such alignment.
Deadline: 1 December 2017
Website: https://ec.europa.eu/
Public Consultation on the Evaluation of the Batteries Directive
The Batteries Directive lays down rules on placing batteries and accumulators on the market and their treatment in the EU. The evaluation is the first step of a review process, in which the Commission assesses whether this Directive meets its objectives and contributes to the general objectives of the EU environmental policy. Preliminary research results have served as a basis for understanding the various issues at hand as well as for identifying areas where data gaps in aspects under evaluation still remain. This consultation offers any interested individual, group or company an opportunity to give their opinion and provide information. The consultation aims to capture views, experience and ideas of relevant stakeholders on achieving the Directive’s objectives, and invites them to provide relevant information for assessing the Directive’s performance and suitability.
Deadline: 28 November 2017
Website: https://ec.europa.eu/
Feedback: Alignment of Compositional Requirements and Quality Characteristics of Milk and Milk Products Under Public Intervention
The 2013 reform of the Common Agricultural Policy (the “CAP”) has confirmed that the system of public intervention and aid for private storage should continue as two of the main market measures of the CAP. EU legislation sets out the methods to be applied in assessing whether milk and milk products comply with the eligibility requirements laid down in those Regulations for public intervention and aid for private storage. In the light of technical developments in the methodology used in the analysis and quality evaluation of milk and milk products, substantial changes should be made in order to simplify and to provide for updated references to ISO standards.
Deadline: 6 October 2017
Website: https://ec.europa.eu/; https://ec.europa.eu/
Public Consultation to Support the Evaluation of the European Environment Agency and its European Environment Information and Observation Network
The European Environment Agency (EEA) is an agency of the European Union, which relies on a network of several hundred organisations across EU member States and other member and co-operating countries, the European Environment Information and Observation Network (EIONET). The objective of the EEA and EIONET, as set out in the founding regulation, is to provide the Community and the Member States with objective, reliable and comparable information at European level.
The findings of the evaluation will be used to assess how well the Agency is performing and, in particular, to assess how far the core missions of the EEA and EIONET match current policy demands, some 26 years after the founding of the Agency.
Deadline: 23 October 2017
Website: https://ec.europa.eu/
Public Consultation on Aluminium in Toys
The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) have launched a public consultation on the preliminary Opinion Tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys. The Commission has requested SCHEER to review the currently available data on the toxicity of aluminium, taking into account the acceptable levels established by the European Food Safety Authority (EFSA) in 2008 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2011. The preliminary Opinion presents recommendation for a tolerable intake level for aluminium based on most recent data, including exposure to aluminium from sources other than toys.
Deadline: 10 September 2017
Website: https://ec.europa.eu/
Public Consultation of the Draft Opinion “Reflection on Interpretation of Some Aspects Related to Genotoxicity Assessments”
In line with the European Food Safety Authority (EFSA) policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched public consultations on the draft document “Reflection on Interpretation of Some Aspects Related to Genotoxicity Assessments”.
Deadline: 6 September 2017
Website: http://www.efsa.europa.eu/
Public Consultation on Draft Bisphenol A Hazard Assessment Protocol
The European Food Safety Authority (EFSA) Unit on Food Ingredients and Packaging has launched an open consultation on the draft Bisphenol A (BPA) hazard assessment protocol. This protocol details a priori the strategy and methodology for data collection, study inclusion, evidence appraisal and integration that will be applied in the future EFSA’s re-evaluation of BPA hazard identification and characterisation.
Deadline: 3 September 2017
Website: http://www.efsa.europa.eu/en/consultations/call/170630
Roadmap: Fitness check of the EU Ambient Air Quality Directives
Air quality has improved across Europe over the past decades, as emissions of many pollutants were curbed successfully. Nevertheless, significant compliance gaps for some key pollutants prevail – most noteworthy exceedances are for particulate matter, nitrogen dioxide and to a certain extent the ozone target values. This fitness check will look at the performance of the two complementary EU Ambient Air Quality (AAQ) Directives (Directives 2008/50/EC and 2004/107/EC).
Website: https://ec.europa.eu/
Public Consultation Investigating Options for Reducing Releases to the Environment of Microplastics
The European Commission is launching this consultation to collect the views of stakeholders and citizens with regard to the policy options to reduce microplastics entering the marine environment. The objectives of the consultation are 1) to inform stakeholders and to enable their input on the concern around microplastics emissions and possible options for reduction; and 2) to gather information and data that cannot be found through desk research and additional sources of evidence as regards to the sources and policy options for the reduction of microplastics emissions.
Deadline: 26 October 2017
Website: https://ec.europa.eu/
Inception Impact Assessment: Commission Delegated Regulation establishing the Innovation Fund
The initiative should mobilize the development and implementation of low-carbon investments demonstrating innovative technologies in the relevant sectors while ensuring the effective use of public funds and crowding-in additional public and private resources; offer effective and attractive financing products fitting the market needs and risk profiles; and provide for an effective operational structure with limited administrative burden.
Deadline: 21 July 2017
Website: https://ec.europa.eu/
Draft Regulation: Amendments following Article 15 of the cosmetic Regulation 1223/2009
These draft amendments concern the restrictions of use in cosmetics of substances which are carcinogenic, mutagenic or toxic for reproduction (CMR).
Deadline: 26 July 2017
Website: https://ec.europa.eu/
Roadmap: Evaluation of the Ozone Regulation
The evaluation will look into the implementation of the Regulation on substances that deplete the ozone layer (ODS), which ensures compliance with the obligations set out in the Montreal Protocol regarding ozone-depleting substances. The current EU Regulation includes additional requirements and is more ambitious than the Montreal Protocol by envisaging quicker phase-out schedules and by controlling more ozone-depleting substances and more uses. It controls substances not just in bulk, but also contained in products and equipment. Legislation in this area was expected to bring technological leadership in finding alternatives to ozone-depleting substances and increased competitiveness and sustainability of EU businesses on the global market.
Deadline for feedback: 11 August 2017
Website: https://ec.europa.eu/
Public Consultation on the Draft Scientific Opinion of The PPR Panel on The Follow-up of The Findings of The External Scientific Report “Literature Review of Epidemiological Studies Linking Exposure to Pesticides and Health Effects”
EFSA’s Pesticides Unit has launched an open consultation on the follow-up of the findings of the External Scientific Report “Literature review of epidemiological studies linking exposure to pesticides and health effects”. The methodological limitations affecting the quality of epidemiological studies on pesticides have been assessed in the document and specific recommendations on how to improve them. In addition, this document proposes a methodology for the integration of epidemiological evidence with data from experimental toxicology to delineate the potential contributions of epidemiological studies that complement classical toxicological studies conducted in laboratory animal species in the area of pesticide risk assessment.
Deadline: 28 July 2017
Website: http://www.efsa.europa.eu/
Feedback on Draft Regulation on the Application of Control & Mitigation Measures to Reduce the Presence of Acrylamide in Food
Acrylamide is a contaminant as defined in EU legislation and as such, it is a chemical hazard in the food chain. The mitigation measures set out in this draft Regulation are based on current scientific and technical knowledge and they have proven to result in lower levels of acrylamide without adversely affecting the quality and microbial safety of the product. Those mitigation measures have been established following extensive consultation of organisations representing affected food business operators, consumers and experts from competent authorities of Member States.
Deadline: 7 July 2017
Website: https://ec.europa.eu/
Public Consultation: Guidance on The Risk Assessment of GMO at Low Level
EFSA has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms (GMOs) present at low levels in food and feed material and not intended for import into the European Union. The presence of a GMO at a maximum of 0.9% per ingredient in any food and/or feed can be the unintentional result of unavoidable technical circumstances. The guidance document refers to genetically modified plants only.
Deadline: 13 June 2017
Website: http://www.efsa.europa.eu/
Roadmap: Strategic Approach to Pharmaceuticals in the Environment
The main objectives of the initiative, a European Commission communication foreseen for 2018, will be to 1) identify remaining knowledge gaps and uncertainties, and present possible solutions for filling them; and 2) explore how to address the challenge to protect the environment (and human health via the environment) and at the same time safeguard access to effective and appropriate pharmaceutical treatments for human patients and animals, considering inter alia the opportunities for innovation. The strategic approach will aim to address pharmaceuticals in the environment generally (water, soils). It could include policy options relating to a number of different areas, given that emissions of pharmaceutical substances to the environment occur during their whole lifecycle, i.e. from production through consumption to disposal. Existing legislation already provides a fairly comprehensive framework, but it might be appropriate to consider its effectiveness in relation to this specific issue. EuCheMS recently debated these issues at the workshop From Waste to Health.
Source: https://ec.europa.eu/
Survey on The Impacts of International Mobility and Cooperation in The Areas of Education and Training, Youth and Sport
The European Commission has launched an online survey to assess the added-value of the programme Erasmus+ for learners and staff. The survey will help the Commission in gaining a more specific understanding of the impact of the Erasmus+ programme by comparing the changes in attitudes, competences and behaviours of learners and staff as a result of mobility. The survey is intended for all learners and staff, also from those who have not participated in any international mobility or cooperation programme.
Source: http://ec.europa.eu/
Public Consultation on How EFSA Assures the Impartiality of Professionals Contributing to Its Operations
The European Food Safety Authority (EFSA) has launched an open consultation on its draft Policy on independence. This draft Policy represents the outcome of reflections carried out by a Working Group of EFSA’s Management Board set up specifically for this purpose, and has been endorsed for public consultation by EFSA’s Board.
Deadline: 5 May 2017
Source: http://www.efsa.europa.eu/
Public consultation on Guidance on The Use of the Weight of Evidence Approach in Scientific Assessments
The European Food Safety Authority (EFSA) Scientific Committee has developed a draft guidance document on the use of the weight of evidence approach in scientific assessments for use in all areas under EFSA’s remit. The guidance document addresses the use of the weight of evidence in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA’s remit are annexed to the guidance document to illustrate the applicability of the proposed approach. Following this public consultation, the scientific committee will review the contributions and consider them in developing the final version of the guidance document.
Deadline: 1 May 2017
Source: http://www.efsa.europa.eu/
Public consultation on Guidance on The Use of the Weight of Evidence Approach in Scientific Assessments
The European Food Safety Authority (EFSA) Scientific Committee has developed a draft guidance document on the use of the weight of evidence approach in scientific assessments for use in all areas under EFSA’s remit. The guidance document addresses the use of the weight of evidence in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA’s remit are annexed to the guidance document to illustrate the applicability of the proposed approach. Following this public consultation, the scientific committee will review the contributions and consider them in developing the final version of the guidance document.
Deadline: 1 May 2017
Source: http://www.efsa.europa.eu/
Roadmap: Development of a Monitoring Framework for the Circular Economy
The objective of the monitoring framework is to assess progress towards a more circular economy at EU and national level, through a limited set of keys, meaningful indicators that capture the main elements of the circular economy. This will also allow to assess the effectiveness of action at EU and national level, to identify best practices and differences of performances in specific areas, as well as the possible need for further action. The framework will be developed in close cooperation with the European Environment Agency and in consultation with Member States, and will aim to cover areas such as food waste, security of supply for key raw materials, repair and reuse, waste generation, waste management, trade in secondary raw materials in the EU and with non-EU countries, and the use of recycled materials in products.
Website: https://ec.europa.eu/
Impact Assessment: Optimising the Internal Market’s Industrial Property Legal Framework
This impact assessment will look into how to optimise the internal market’s industrial property legal framework relating to supplementary protection certificates (SPC) and patent research exemptions (particularly, Bolar exemptions) for sectors whose products are subject to regulated market authorisations. SPCs are an intellectual property right that constitute an extension (of up to five years) to the term of a patent right (of twenty years). They aim to offset the loss of effective patent protection that occurs due to the compulsory and lengthy testing and clinical trials that products require prior to obtaining regulatory marketing approval. The Bolar patent exemption aims at speeding up the entry of generic medicines into the market by allowing early preparatory development on generics to obtain pre-market regulatory approval even when the SPC of the reference medicine is still in force. The Commission will conduct an evaluation and impact assessment of all relevant provisions and options for modernising the SPC Regulations and the provisions of the Directives dealing with the Bolar exemption.
Website: http://ec.europa.eu/
Survey: How to Better Explain Uncertainty
The European Food and Safety Authority (EFSA) is currently running a survey on the topic of uncertainty, to improve the way that EFSA communicates and explains the scientific uncertainties related to its assessments. Even when there is strong evidence that something will happen, there will almost always be some uncertainty about the outcome, a point that should always be taken into consideration when taking decisions or making assessments. The survey should take about 10 minutes, and the participants are welcome to provide additional advice the topic.
Source: http://www.efsa.europa.eu/