1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on the rules applicable to, and the content required for, the application or notification, prior to its submission. Rotating presidency; Council configurations Justice and Home Affairs Council, 8-9 December 2022 Statistics Explained is an official Eurostat website presenting statistical topics in an easily understandable way. To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process against the rights of applicants or of notifiers, taking into account the specific objectives of sectoral Union law as well as experience gained. 5f. The public may make comments to the Commission within 30 days of such publication.; in Article 10, paragraph 1 is replaced by the following: 1. Based on the conclusions of such fact-finding missions, the Commission could propose appropriate legislative measures aimed at improving compliance with the relevant standards. Learning from the current health crisis, we are committed to supporting the full-fledged African health sovereignty, in order for the continent to respond to future public health emergencies. 8 June 2022, 13:50. (17)Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30May 2001 regarding public access to European Parliament, Council and Commission documents (OJL145, 31.5.2001, p.43). Regulation (EC) No 1107/2009 is amended as follows: in paragraph 1, the first subparagraph is replaced by the following: An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation. 18 September 2020. Append an asterisk (, Other sites managed by the Publications Office. Climate change and environmental degradation are an existential threat to Europe and the world. Regulation (EC) No 1831/2003 is amended as follows: 1. 3. Remarks by President Charles Michel at the final press conference of the special meeting Charles Michel, President of the European Council, Paschal Donohoe, President of the Eurogroup, EU response to Russia's invasion of Ukraine, The EU's work to combat human trafficking, Food for the world: What EU countries are doing to mitigate the impact of Russias war. Studies, including tests, submitted by business operators in support of applications usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. Since 2011, the EEAS carries out the EUs Common Foreign and Security Policy to promote peace, prosperity, security, and the interests of Europeans across the globe. 8. We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. The existing trade agreements between the EU and some African countries have contributed to the strengthening and deepening of trade and economic development between the two continents. the number of members in each Scientific Panel but no more than the maximum number provided for in paragraph 5f.; an identification of the parts of the application and any other supplementary information that the applicant requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002;; a summary of the dossier in a standardised form.; an identification of the parts of the application and any other supplementary information that the applicant requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 30 of this Regulation and Articles 39 to 39e of Regulation (EC) No 178/2002;; make public the application and any information supplied by the applicant, in accordance with Article 18.; http://data.europa.eu/eli/reg/2019/1381/oj, Portal of the Publications Office of the EU. Brussels, 23.2.2022. Member States and employers of the members of the Scientific Committee and of the Scientific Panels shall refrain from giving those members, or the external experts participating in the working groups of the Scientific Committee or the Scientific Panels, any instruction which is incompatible with the individual tasks of those members and experts, or with the tasks, responsibilities and independence of the Authority. (3)Position of the European Parliament of 17April 2019 (not yet published in the Official Journal) and the decision of the Council of 13June 2019. Furthermore, in order to assess the effectiveness and efficiency of the different legal provisions applicable to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority. It is therefore appropriate for the Commission to carry out fact-finding missions to assess the application by laboratories and other testing facilities of the relevant standards for carrying out tests and studies submitted to the Authority as part of an application. 30 % of them have already returned to their home countries. In this respect, they welcomed a number of international initiatives, including: Leaders reiterated their commitment to keep global trade in food commodities free of unjustified trade barriers, enhance solidarity towards the most vulnerable countries and increase local sustainable food production. The applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification, upon submission of the application. The list drawn up by the Commission shall be forwarded to the European Parliament by the Council, together with the relevant background documents. With your permission, we will use AT internet and Hotjar cookies to produce aggregated, anonymous data about our visitors' browsing and behaviour on our website. In this new context, recalling the Versailles Declaration and the European Council conclusions of 24-25 March 2022, EU leaders stressed the importance of resolutely implementing the Strategic Compass, reinforcing the EU's partnerships, enhancing its resilience and increasing its security and defence capacity through more and better investments, focusing on identified strategic shortfalls. It complements this legislation, including: Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles 11; Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on They will put the packaging sector on track for climate neutrality by 2050. Members of Scientific Panels shall have access to comprehensive training on the risk assessment.; in paragraph 9, point (b) is replaced by the following: 1. contribute to the fight against the dissemination of false information and the sources thereof. 1. These companies must provide a report on their ESG impacts, namely on environmental, social and governance impacts, as defined in this directive. On the first day of the summits during the discussion on Ukraine, EU leaders were joined by Ukraine's President, Volodymyr Zelenskyy, via video conference. However, points 4 and 5 of Article 1 shall apply from 1July 2022. Moreover, two days ago the European Council re-elected Charles Michel as President for a second term of two and a half years, from June 1st, 2022 to November 30th, 2024. The Authority shall publish such a call for expression of interest after having informed the Member States about the necessary criteria and fields of expertise. In accordance with Directive 2010/63/EU of the European Parliament and of the Council(5), tests on animals should be replaced, reduced or refined. The obligation to notify such studies should also apply to the laboratories and other testing facilities carrying them out. These features are still under development; they are not fully tested, and might reduce EUR-Lex stability. After transmission of the draft legislative act to the national parliaments. When preparing those implementing acts, the Commission shall consult the Authority. European Council President's speeches and statements, General approach proposal for a directive on corporate sustainability reporting, Commission proposal for a directive on corporate sustainability reporting (21April 2021), Directive of the European Parliament and the Council as regards corporate sustainability reporting (CSRD) - link added on 30 June 2022, send your request to the public information service, 1 January 2024 for companies already subject to the non-financial reporting directive, 1 January 2025 for large companies that are not presently subject to the non-financial reporting directive, 1 January 2026 for listed SMEs, small and non-complex credit institutions and captive insurance undertakings. any provisions set out in Union law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (data exclusivity rules). To that end, it is necessary and appropriate that, when business operators commission or carry out studies with a view to submitting an application or notification, they notify those studies to the Authority. Judicial Atlas Identification of the locally competent authority; Compendium Drafting requests for judicial cooperation; Fiches Belges Practical information on specific sets of measures; List of Contact Points Contact details of the EJN Contact Points; Judicial Library Documents related to the EU legal instruments; Cooperation outside the EU The Commission shall make a summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.; 3. We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. EU leaders invited member states to accelerate work on the solidarity lanes put forward by the European Commission to facilitate food exports from Ukraine. To close the legal loopholes which allowed terrorists to use reconverted weapons, in 2017 the Council adopted new rules on control of the acquisition and possession of weapons. Certain cookies are used to obtain aggregated statistics about website visits to help us constantly improve the site and better serve your needs. 3. EU leaders also underlined the importance of the common agriculture policy (CAP) in the EUs contribution to food security and called for the swift adoption of the CAP strategic plans. Should that be the case, the Authority shall follow the procedure laid down in Article 39b, which shall apply mutatis mutandis. Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of the obligation of professional secrecy pursuant to Article 339 TFEU. EU heads of state and government welcomed the establishment of a joint investigation team coordinated by Eurojust and the ongoing operational support provided by Europol. The meeting was co-chaired by the President of the European Council, Charles Michel and the President of Those standard data formats shall: ensure interoperability with existing data submission approaches to the extent possible; be user-friendly and adapted for the use by small and medium-sized enterprises. It is necessary, therefore, to ensure transparent, continuous and inclusive risk communication throughout the risk analysis, involving Union and national risk assessors and risk managers. An application for an authorisation as provided for in Article 4 of this Regulation shall be sent to the Commission, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. published in June 2022. It is thus appropriate to include representatives of all Member States, of the European Parliament and of the Commission as well as of civil society and industry organisations in the Management Board, while providing that those representatives should have experience and expertise not only in the fields of food chain law and policy, including risk assessment, but also in the fields of managerial, administrative, financial and legal matters and ensuring that they act independently in the public interest. The atrocities being committed by Russian forces and the suffering and destruction being inflicted are unspeakable. The Authority shall assess, without delay, any confidentiality request and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and granted by the Authority pursuant to Article 63. in Article 63, paragraphs 1, 2 and 3 are replaced by the following: 1. Within two weeks of the notification of the Authority's decision on the confidentiality request to the applicant pursuant to paragraph 1, the applicant may submit a confirmatory application asking the Authority to reconsider its decision. Reporting must be certified by an accredited independent auditor or certifier. The European Union remains committed to continue bolstering Ukraines ability to defend its territorial integrity and sovereignty. Your life online: How is the EU making it easier and safer for you? Striving to be the first climate-neutral continent. The leaders reaffirmed their commitment to work together to promote effective multilateralism within the rules-based international order, with the UN at its core. This document is an excerpt from the EUR-Lex website, Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (Text with EEA relevance. the equivalent of 400 million vaccine doses) to the Covax Facility and to vaccination on the African continent. More information onDelivering the European Green Deal. Two of the meetings are generally devoted exclusively to employment and social policy topics. Charles Michel, President of the European Council, Paschal Donohoe, President of the Eurogroup, EU response to Russia's invasion of Ukraine, The EU's work to combat human trafficking, Food for the world: What EU countries are doing to mitigate the impact of Russias war. In addition to members and alternate members referred to in paragraph 1, the Management Board shall include: two members and two alternate members appointed by the Commission as its representatives, with the right to vote; two members appointed by the European Parliament, with the right to vote; four members and four alternate members with the right to vote as representatives of civil society and food chain interests, namely one member and one alternate member from consumer organisations, one member and one alternate member from environmental non-governmental organisations, one member and one alternate member from farmers organisations, and one member and one alternate member from industry organisations. Where the Commission requests an opinion from the European Food Safety Authority (the Authority), the Authority shall make public the application in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health.; in Article 15, paragraph 2 is replaced by the following: 2. of 24 June 2021. laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for Where the Commission does not request the Authority's opinion pursuant to Articles 10 and 16 of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant. 5. Through joint action and capacity-building, including with dedicated African migration institutions, the two Unions will aim at: The EU and the AU will deepen their cooperation in finding durable solutions for asylum seekers, refugees and vulnerable migrants in need of international protection. These rules make it difficult to hide illegal funds under layers of fictitious companies, and strengthen checks on risky third countries. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis. For the industry, they will create new business opportunities and make Europe less dependent on primary resources and external suppliers. Your life online: How is the EU making it easier and safer for you? Where studies have not been previously notified in accordance with paragraph 2 or 3, and where a valid justification has not been provided, an application or notification may be re-submitted, provided that the applicant or notifier notifies to the Authority those studies, in particular their title and their scope, the laboratory or testing facility carrying them out as well as their starting and planned completion dates. The coordinator is in charge of coordinating counter-terrorism work within the EU, monitoring implementation of the EU counter-terrorism strategy and improving communication between EU and non-EU countries. That dedicated section shall be publicly available and easily accessible. Sign up to receive our email and SMS alerts. Conclusions on 17 June 2022 the Council recalled the discussion on 1. The EU is currently working on new rules to ensure a more efficient mechanism for cross-border access to e-evidence. 6. The notifier may submit a request to the competent authority to treat certain parts of the information submitted under this Directive as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6. The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the Authority).; in paragraph 2, point (c) is replaced by the following: 1. make public the non-confidential version of the application as submitted by the applicant without delay once that application has been considered valid or admissible; proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article; inform the applicant in writing of its intention to disclose information and the reasons for that, before the Authority formally takes a decision on the confidentiality request. The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.; The Authority shall without delay make the dossiers referred to in Article 8, including any supplementary information supplied by the applicant, available to the public, with the exception of any information to which the rapporteur Member State has granted confidential treatment pursuant to Article 63.; In Article 15, paragraph 1 is replaced by the following: 1. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION. The Authority shall make public the additional information supplied by the applicant in accordance with Articles 11 and 12.; Where the Commission requests the opinion of the Authority in accordance with Article 3(2) of this Regulation, the Authority shall make public without delay the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002. 13)..". This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.. The reporting of non-European companies must also be certified, either by a European auditor or by one established in a third country. They pledged to work more closely together in multilateral fora to: They committed to providing political support to achieve the necessary reform of the WTO and to improve its functioning in order to strengthen the multilateral trading system. 2. By 28March 2026, and every five years thereafter, the Commission shall evaluate the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. Accordingly, it is necessary to make specific amendments to Regulations (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC in order to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. Such shortcomings hinder the transition to a sustainable economy. The outcome of these fact-finding missions shall be presented in an overview report. The European Commission and the High Representative put forward an Action Plan on Military Mobility 2.0 and a Joint Communication on an EU cyber defence policy. Information referred to in the first subparagraph shall be made public without delay, with the exception of the information referred to in point (c) thereof, as far as applications are concerned, and in point (i) thereof, which shall be made public without delay once an application has been considered valid or admissible. In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree: where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the novel food subject to the authorisation, and detailed information on the nature and composition of the specific foods or food categories in which the applicant intends to use that novel food, except for information which is relevant to the assessment of safety; where applicable, detailed analytical information on the variability and stability of individual production batches, except for information which is relevant to the assessment of safety. In particular, there has been a decrease in the number of candidates applying to be members of the Authority's Scientific Panels. If you are not a journalist, please send your request to the public information service. For the purposes of point (c) of Article 38(1) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats shall be adopted in accordance with paragraph 2 of this Article to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union law. In particular, the Authority should organise the preparatory work supporting the tasks of the Scientific Panels, including by requesting the Authority's staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by those Scientific Panels. 3. 3. Contributing to this and complementing the actions of the AVATT, Team Europe has provided more than USD 3 billion (i.e. The European Green Deal will improve the well-being and health of citizens and future generations by providing: fresh air, clean water, healthy soil and biodiversity, cleaner energy and cutting-edge clean technological innovation, longer lasting products that can be repaired, recycled and re-used, future-proof jobs and skills training for the transition, globally competitive and resilient industry, Affordable, secure and sustainable energy for Europe, Becoming the first climate neutral continent by 2050, Protecting our biodiversity and ecosystems, A healthy food system for people and the planet, Providing efficient, safe and environmentally friendly transport, An industrial strategy for a competitive, green and digital Europe, Its role in driving transformative change, Sustainable investments to deliver the European Green Deal, A creative and interdisciplinary initiative that connects the European Green Deal to our living spaces and experiences, Circular Economy: Packaging and Packaging Waste Regulation, Proposal for a first EU-wide voluntary framework to reliably certify high-quality carbon removals, Proposal for new Euro 7 standards to reduce pollutant emissions from vehicles and improve air quality, Biodiversity: Stronger measures against wildlife trafficking, The Council and the European Parliament reach a provisional political agreement on stricter CO2 emission performance standards for new cars and vans, Commission proposesstronger rules for cleaner air and water, Proposal for anemergency market interventionto reduce energy bills for Europeans, REPowerEU plan: affordable, secure and sustainable energy for Europe, The European Commission joins the European Climate Pact and pledges to make its operations climate neutral by 2030, Proposals to phase down fluorinated greenhouse gases and ozone depleting substances, Proposals to modernise EU industrial emissions rules to steer large industry in long-term green transition, Proposals to make sustainable products the norm in the EU, boost circular business models and empower consumers for the green transition, Options to mitigate high energy prices with common gas purchases and minimum gas storage obligations, REPowerEU: Joint European action for more affordable, secure and sustainable energy, Proposal of a new EU framework to decarbonise gas markets, promote hydrogen and reduce methane emissions, Commission proposals to remove, recycle and sustainably store carbon, New transport proposals target greater efficiency and more sustainable travel, Proposals to stop deforestation, innovate sustainable waste management and make soils healthy, New European Bauhaus: new actions and funding, New EU strategy on adaptation to climate change, Presentation of the2030 Climate Target Plan, Adoption of theEU strategies for energy system integration and hydrogento pave the way towards a fully decarbonised, more efficient and interconnected energy sector, Presentation of theEU Biodiversity Strategy for 2030to protect the fragile natural resources on our planet, Presentation of the Farm to fork strategy to make food systems more sustainable, Proposal of aCircular Economy Action Planfocusing on sustainable resource use, Adoption of theEuropean Industrial Strategy, a plan for a future-ready economy, Proposal for aEuropean climate lawto ensure a climate neutral European Union by 2050, Public consultation (open until 17 June 2020) on theEuropean Climate Pactbringing together regions, local communities, civil society, businesses and schools, Presentation of theEuropean Green Deal Investment Planand theJust Transition Mechanism, Factsheets on Delivering the European Green Deal, A clear and complete repository of the thematic areas that are shaping the European Green Deal, Putting an end to wasteful packaging, boosting reuse and recycling, net greenhouse gas emissions by 2030, compared to 1990 levels, additional trees to be planted in the EU by 2030, Communication and roadmap on the European Green Deal, This site is managed by the Directorate-General for Communication, Follow the European Commission on social media. Where the studies which have previously been notified in accordance with paragraph 2 or 3 were not included in the application or notification, and where a valid justification has not been provided, an application or notification may be resubmitted, provided that the applicant or notifier submits all the studies that were notified in accordance with paragraph 2 or 3. European Council conclusions from 2004 onwards are available in the public register of official documents. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.. Where there is a risk that the results of a public consultation cannot be given proper consideration because of the applicable deadlines, it is appropriate to provide for a limited extension of those deadlines. It is of utmost importance that the Authority carry out searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. This website is the official website of the Council of the EU and the European Council. On the second day of the summit, they were joined by Chairperson of the African Union, Macky Sall, via video conference during the discussion on food security. where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to in paragraphs 2 and 3; information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable effects on human health, animal health or the environment, shall nevertheless be made public.; 1. It is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers, while guaranteeing their independence. The leaders committed to follow up on the implementation of the engagements undertaken during the summit. The Russian war of aggression against Ukraine is having a direct impact on global food security and affordability. 3. With respect to requests for scientific outputs, including scientific opinions under Union law, the Authority shall always make public: the names of authors of published or publicly available studies supporting such requests; and. : ST 9145/22 Subject: Council Conclusions on the Dev elopment of Sustainable Public RECALLING the European Council conclusions of 21 July 2020 stating that the plan for European The directive includes measures to enhance traceability and stricter rules for the acquisition and possession of the most dangerous firearms. The European Council also supported further options in line with EU and international law being actively explored, including options aimed at using frozen Russian assets to support Ukraines reconstruction. It closed on 3 September 2021. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public. EU heads of state and government welcomed the establishment of a joint investigation team coordinated by Eurojust and the ongoing operational support provided by Europol. Other cookies are used to boost performance and guarantee security of the website. 2. The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission's initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. WebBrussels , 10 June 2022 (OR. For the purpose of increased transparency and in order to ensure that requests for scientific outputs received by the Authority are processed in an effective manner, standard data formats should be developed. EU leaders took note of the preparation of the Commissions opinions on the application for EU membership of Ukraine, the Republic of Moldova and Georgia, and said they will return to this matter at their June meeting. In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree: any information provided in detailed descriptions of starting substances and mixtures used to manufacture the substance subject to the authorisation, the composition of mixtures, materials or articles in which the applicant intends to use that substance, the manufacturing methods of those mixtures, materials or articles, impurities, and migration testing results, except for information which is relevant to the assessment of safety; the trademark under which the substance shall be marketed as well as the tradename of the mixtures, material or articles in which it shall be used, where applicable; and. 3. Where the Commission requests the opinion of the Authority in accordance with Article 10(3) and Article 16 of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles38 to 39e of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. In order to provide an additional level of guarantee to ensure that the Authority can have access to all relevant scientific data and studies available on a subject matter of an application or a notification for an authorisation or a renewal of an authorisation or an approval, it is appropriate to provide for consultation of third parties in order to identify whether other relevant scientific data or studies are available. There are certain public concerns about the Authority's assessment in the area of authorisation procedures being primarily based on industry studies. The leaders supported Africas hosting of COP 27 in Egypt in 2022, as well as an ambitious global biodiversity framework. WebThis is a list of meetings of the European Council (informally referred to as EU summits); the meetings of the European Council, an institution of the European Union (EU) comprising heads of state or government of EU member states.They started in 1975 as tri-annual meetings. The list is reviewed regularly, at least every 6 months. The Authority shall make available, upon request, to the Commission and the Member States all information in its possession relating to an application or to a request by the European Parliament, by the Commission or by the Member States for a scientific output, including a scientific opinion, unless otherwise indicated in Union law. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.. If the applicant disagrees with the assessment of the Authority, the applicant may state its views or withdraw its application within two weeks of the date on which it was notified of the Authority's position; adopt a reasoned decision on the confidentiality request, taking into account the observations of the applicant, within 10 weeks of the date of receipt of the confidentiality request with respect to applications and without delay in the case of supplementary data and information; notify the applicant of its decision and provide information on the right to submit a confirmatory application in accordance with paragraph 2; and inform the Commission and the Member States, where appropriate, of its decision; and. In particular, for the purpose of ensuring the transparency and to avoid conflicts of interest, it is necessary to publish the names of the participants and observers in certain meetings of the Authority. In June 2019, the Council adopted new rules to limit the availability of explosives precursors to the general public and ensure the appropriate reporting of suspicious transactions throughout the supply chain. Certain cookies are used to obtain aggregated statistics about website visits to help us constantly improve the site and better serve your needs. According to EU law, terrorist offences are acts committed with the aim of: It is estimated that 4 000 to 5 000 EU nationals have travelled or attempted to travel to conflict zones - mainly in Iraq and Syria - since 2011 to join terrorist groups such as ISIL/Da'esh. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2); the Authority shall make the standard data formats, as adopted, available on its website; where standard data formats have been adopted pursuant to this Article, applications as well as requests for a scientific output, including a scientific opinion by the European Parliament, by the Commission and by the Member States, shall only be submitted in accordance with those standard data formats. That evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Scientific Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests. Other cookies are used to boost performance and guarantee security of the website. 2. 3. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 30 of this Regulation. European The Council's attention was drawn to food security issues i n mid -2008, as the . 22 June 2022. The European Council adopted conclusions on Ukraine, food security, security and defence and energy. The corporate sustainability reporting directive amends the 2014 non-financial reporting directive. We want to hear your feedback about our website. 3. Information about the notified studies should be made public only once a corresponding application has been made public in accordance with the applicable rules on transparency. Sign up to receive our email and SMS alerts. This will help us improve your experience. This forum brought the Allies together with their Central European, Eastern European, and Central We want to hear your feedback about our website. Regulations (EU) 2016/679 and (EU) 2018/1725 shall apply to the processing of personal data carried out pursuant to this Regulation. Your life online: How is the EU making it easier and safer for you? WebStatistics Explained, your guide to European statistics. The meeting was co-chaired by the President of the European Council, Charles Michel and the President of Senegal and the Chairperson of the AU, Macky Sall. 5. WebThe European Council (informally EUCO) is a collegiate body that defines the overall political direction and priorities of the European Union.It is composed of the heads of state or government of the EU member states, the President of the European Council, and the President of the European Commission.The High Representative of the Union for Where the relevant Scientific Committee is consulted in accordance with paragraph 1 of this Article, it shall make public without delay the notification, relevant supporting information and any supplementary information supplied by the notifier, as well as its scientific opinions, with the exception of any information to which the competent authority has granted confidential treatment in accordance with Article 25.. To ensure that companies comply with the reporting rules, an independent auditor or certifier must ensure that the sustainability information complies with the certification standards that have been adopted by the EU. In case of sudden interruptions of supply, emergency measures will be introduced to ensure security of supply. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply. In its conclusions of 20 June 2017 the Council confir med the commitment of the Union and its Member States to the implementation of the 2030 Agenda in a full, coherent, comprehensive, integrated and effective manner, in close cooperation with par tners and other stakeholders. Where the opinion of the Authority is requested in relation to applications or notifications submitted under Union law, and having regard to its obligation to ensure public access to all supporting information with respect to the provision of its scientific outputs, the Authority should have responsibility for assessing confidentiality requests. WebThe European Political Community (EPC) is an intergovernmental forum for political and strategic discussions about the future of Europe, established in 2022 after the Russian invasion of Ukraine. 2. In a spirit of European solidarity, leaders called for greater EU preparedness for possible major supply disruptions, in particular through bilateral solidarity agreements and a coordinated European contingency plan, which should ensure that major supply disruptions are mitigated. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of information as granted by the Authority in accordance with Articles 39 to39e. WebThe European Stability Mechanism (ESM) is an intergovernmental organization located in Luxembourg City, which operates under public international law for all eurozone member states having ratified a special ESM intergovernmental treaty.It was established on 27 September 2012 as a permanent firewall for the eurozone, to safeguard and provide The EU will support Africa in its transition to foster just and sustainable pathways towards climate neutrality. Taking into account the respective roles of risk assessors and risk managers, risk communication shall: ensure that accurate and all appropriate information is exchanged in an interactive and timely manner with all interested parties, based on the principles of transparency, openness, and responsiveness; provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions, including information on how risk management decisions were reached and which factors were considered; take into account risk perceptions of all interested parties; facilitate understanding and dialogue amongst all interested parties; and. Amendments to Regulation (EC) No 1829/2003. Infographic - How dependent are EU member states on energy imports? COM(2022) 68 final. (7)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJL119, 4.5.2016, p.1). (10)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22September 2003 on additives for use in animal nutrition (OJL268, 18.10.2003, p.29). Proper financial compensation of the experts should be ensured. WebThe European External Action Service (EEAS) is the European Unions diplomatic service. It is managed by the General Secretariat of the Council, the body of staff responsible for assisting the Council of the EU and the European Council. The Authority shall establish and manage a database of studies commissioned or carried out by business operators to support an application or notification in relation to which Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion. We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. (5)Directive 2010/63/EU of the European Parliament and of the Council of 22September 2010 on the protection of animals used for scientific purposes (OJL276, 20.10.2010, p.33). We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. This agreement is excellent news for all European consumers. European Council President's speeches and statements, Remarks by President Charles Michel at the final press conference following the European Union-African Union summit, Informal meeting of the members of the European Council, Sixth European Union - African Union Summit: A Joint Vision for 2030, EU-Africa relations (background information), On the path to a deeper and stronger partnership, living up to the European and African aspirations: Council adopts conclusions on Africa (press release, 30 June 2020), Africa-EU Partnership (European Commission, DG International Partnerships), Intervention du prsident Charles Michel lors de l'vnement ddi au transfert de technologie ARNm, Speech by President Charles Michel at the opening ceremony of the EU-AU summit, Joint article by Macky Sall, President of Senegal and Chairperson of the African Union, and Charles Michel, President of the European Council, send your request to the public information service, Foreign affairs & international relations, mobility and employability of students, young graduates and skilled workers, promoting exchanges for young citizens, volunteers and students, through the expanded Erasmus+ programme, developing partnerships between universities, facilitating cultural exchanges and the movement of artists and artworks, strengthen and scale up autonomous peace operations of African defence and security forces, including through EU missions and assistance measures. Such request shall be accompanied by verifiable justification that demonstrates how making public the information concerned significantly harms the interests concerned in accordance with Article 39(2) and (3). That suspension shall end six months after the submission of all data of those studies. Those findings shall be made public.; Commission experts shall perform fact-finding missions in Member States to assess the application, by laboratories and by other testing facilities, of the relevant standards for carrying out tests and studies submitted to the Authority as part of an application, as well as compliance with the notification obligation set out in Article 32b(3), by 28March 2025. Notwithstanding the dates of application referred to in Article 11, the procedure for nomination and appointment of members to the Management Board set out in point 4 of Article 1 shall apply for the purposes of allowing the members appointed under those rules to start their term of office on 1July 2022. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation. They also aim to improve the business and investment climate by reforming governance, supporting African entrepreneurship. Articles 39, 39a and 39d of Regulation (EC) No 178/2002 and paragraph 3 of this Article shall apply mutatis mutandis. The EU contributes to the protection of its citizens by acting as the main forum for cooperation and coordination among member states. The aims of the partnership are solidarity, security, peace and sustainable and sustained economic development and prosperity for the citizens of the two Unions today and in the future, bringing together people, regions and organisations. This website is the official website of the Council of the EU and the European Council. The leaders agreed to support local and regional mechanisms for procurement, as well as the allocation and deployment of medical products. With this text, Europe is at the forefront of the international race to standards, setting high standards in line with our environmental and social ambitions. Member States, the Commission and the relevant Scientific Committee(s) shall take the necessary measures to ensure that confidential information notified or exchanged under this Directive is not made public. In the margins of the summit, the World Health Organization announced the first six countries that will receive the technology needed for the production of mRNA vaccines on the African continent: Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia. 2. The European Commission has adopted a set of proposals to make the EU's climate, energy, transport and taxationpolicies fit for reducing net greenhouse gas emissions by at least 55% by 2030, compared to 1990 levels. The EU and the AU will also work to leverage and facilitate transparent remittances, notably by reducing the transaction costs. This means more transparency for citizens, consumers and investors. There are usually four EPSCO meetings a year. The investment package aims to boost public and private investment in a number of areas: In addition, the package will be complemented with specific instruments supporting: To implement the package, the EU and the AU will leverage public funds to stimulate private investments by mobilising innovative financing instruments. The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise. The summit was held in an innovative format, where EU and AU leaders participated in a series of thematic roundtables, which allowed for dynamic and frank exchanges on the challenges but also possible solutions and joint actions. If you are not a journalist, please send your request to the public information service. 43). Rotating presidency; Council configurations 9 December 2022; 13 March 2023; 14 March 2023; 12 June 2023; See also. Those arrangements shall be in accordance with this Regulation and other relevant Union law. They recognised that Africa's energy transition is vital for its industrialisation and to bridge the energy gap. All scientific data and information supporting requests for authorisations or for approvals under Union law as well as other requests for scientific output should be made publicly available in a proactive manner and be easily accessible as early as possible in the risk assessment process. The leaders also agreed to keep working to address the root causes of irregular migration and forced displacement, and enhance cooperation on tackling all migration-related issues. It provides, inter alia, that food law is to be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure. 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