The Authority shall, in accordance with Article 38(1) of Regulation (EC) No 178/2002, make its opinion public, after the 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. Renewable energies. doc. 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. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.; Public access to the information for renewal. Those arrangements shall be in accordance with this Regulation and other relevant Union law. Where the Authority may be requested to provide a scientific output, it should have knowledge of all studies performed by an applicant with a view to supporting an application under Union law. At the summit, the leaders agreed to strengthen ties by: EU and AU leaders agreed to boost peace and security cooperation. This will help us improve your experience. Those fact-finding missions would allow the Commission to identify, and to aim at correcting, possible weaknesses in the systems and non-compliance and to provide an additional level of guarantees to reassure the general public on the quality of studies. They will intensify their cooperation on security, including cybersecurity. This website is the official website of the Council of the EU and the European Council. Sign up to receive our email and SMS alerts. Nature protection package. 2. ", (*2)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJL295, 21.11.2018, p.39).;". The Authority shall ensure that clear undertakings or signed statements are given to that effect by those who access the relevant information prior to its disclosure.; paragraph 3 is replaced by the following: 3. This website is the official website of the Council of the EU and the European Council. The new rules strengthen the EU's legal framework to prevent terrorist attacks and address the phenomenon of foreign terrorist fighters. Any personal data made public pursuant to Article 38 of this Regulation and this Article shall only be used to ensure the transparency of the risk assessment under this Regulation and shall not be further processed in a manner that is incompatible with these purposes, in accordance with point (b) of Article5(1) of Regulation (EU) 2016/679 and point (b) of Article 4(1) of Regulation (EU) 2018/1725, as the case may be. The term of office of members and alternate members shall be four years and may be renewed. In December 2020, EU leaders reaffirmed their unity in the fight against radicalisation, terrorism and violent extremism. 2. Two of the meetings are generally devoted exclusively to employment and social policy topics. The members and alternate members thus nominated shall be appointed by the Council and have the right to vote.; 1a. It shall forthwith transmit that opinion to the Commission, Member States and the authorisation-holder. 1. 3. (15)Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJL327, 11.12.2015, p.1). That dedicated section shall be publicly available and easily accessible. News article | 7 November 2022 Continuously open call for applications for the selection of members of the expert group 'Single European Railway Area Forum' Radicalisation is not a new phenomenon, but it has become a more serious threat in recent years. Where the Authority detects, during its risk assessment, that studies notified in accordance with paragraph 2 or 3 are not included in the corresponding application or notification in full, and in the absence of a valid justification of the applicant or notifier to that effect, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended. 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. There are certain public concerns about the Authority's assessment in the area of authorisation procedures being primarily based on industry studies. The EU is currently working on new rules to ensure a more efficient mechanism for cross-border access to e-evidence. 3. (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). Authorisation procedures are based on the principle that it is for the applicant or the notifier to prove that the subject matter of an application or notification complies with Union requirements. Council adopts Conclusions on the EU biodiversity strategy for 2030 . This Article is without prejudice to Directive 2003/4/EC(*7) and Regulations (EC) No 1049/2001(*8) and (EC) No 1367/2006(*9) of the European Parliament and of the Council. 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. Where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health due to non-compliance resulting from intentional violations of applicable Union law perpetrated through fraudulent or deceptive practices, public authorities, identifying to the fullest extent possible the products concerned and the risk that they may present, should inform the public accordingly as soon as possible. 2. The public may make comments to the Commission within 30 days of such publication.; in Article 23(2), the introductory wording is replaced by the following: in Article 29, paragraphs 1 and 2 are replaced by the following: 1. The leaders committed to follow up on the implementation of the engagements undertaken during the summit. 2019, the European Council adopted conclusions on 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. Furthermore, the ministers approved Council Conclusions on Research Infrastructures and on the New European Innovation Agenda. To get more information about these cookies, how and why we use them and how you can change your settings, check our cookies policy page. WebIn line with the conclusions of the European Council of 17 June 2010, whereby the Union strategy for smart, sustainable and inclusive growth was adopted, the Union and Member States should implement the delivery of smart, sustainable and inclusive growth, while promoting harmonious development of the Union and reducing regional disparities. The members of the Management Board should be selected and appointed in such a way as to secure the highest standards of competence and the broadest range of relevant experience available. The public may make comments to the Commission within 30 days of such publication.; in Article 22, paragraph 1 is replaced by the following: 1. In March 2017, the EU adopted a directive on combating terrorism. Fighting terrorism is a top priority for the EU. In duly justified cases, where there is a risk that the results of the public consultation performed in accordance with this paragraph cannot be given proper consideration because of the applicable time limits within which the Authority is required to deliver its scientific output, those time limits may be extended for a maximum period of seven weeks. European Council conclusions, 30-31 May 2022. 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. While maintaining the principle that the burden to prove compliance with Union requirements is on the industry, it is important to establish an additional verification tool, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment to address specific cases of high societal importance where there are serious controversies or conflicting results. What can professional societies and non-governmental organisations (NGOs) do to maximise the benefits, that may arise from the conclusions? 8. EU rules on non-financial information apply to all large companies and all companies listed on regulated markets. Where the withdrawal of the notification takes place before the competent authority has decided on the relevant confidentiality request, Member States, the Commission and the relevant Scientific Committee(s) shall not make public the information for which confidentiality has been requested.; in Article 28, the following paragraph is added: 4. The EU will support Africa in its transition to foster just and sustainable pathways towards climate neutrality. This paragraph is without prejudice to the Authority's obligations under Article 33 and does not apply to the submission of any supplementary information by the applicants or notifiers during the risk assessment process. 4. It should also allow for the necessary flexibility and should not deal with situations specifically covered by the general plan for crisis management. Such requirements would prevent major German and other European firms from scaling their businesses or operating outside of the EU to ensure The Authority should systematically provide advice to the applicants or to the notifiers on the content of the intended renewal application or notifications, as well as on the design of studies, taking into account the comments received. Risk communication should place particular emphasis on explaining in an accurate, clear, comprehensive, coherent, appropriate and timely manner not only risk assessment findings themselves but also how such findings are used to help inform risk management decisions along with other legitimate factors, where relevant. 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. any other information deemed confidential within the specific procedural rules referred to in point (n) of Article5(1) of this Regulation. The Authority shall publish general guidance on its website regarding the rules applicable to, and the content required for, applications and notifications, including, where appropriate, general guidance on the design of required studies. The new rules oblige member states to carry out systematic checks against relevant databases on all persons crossing the external borders, including EU citizens and members of their families. In 1991 as in 1949, NATO was to be the foundation stone for a larger, pan-European security architecture. 3. 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. If you are not a journalist, please send your request to the public information service. 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. 5. 1. These companies are also responsible for assessing the information at the level of their subsidiaries. Remarks by President Charles Michel at the final press conference of the special meeting (12)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJL338, 13.11.2004, p.4). Before the Authority issues its scientific outputs, including scientific opinions, it shall review whether information that has been previously accepted as confidential may nevertheless be made public in accordance with point (b) of Article 39(4). Last reviewed on 31 August 2022. 6. It is therefore necessary to strengthen the transparency of the risk assessment in a proactive manner. 18 September 2020. EU an AU leaders will also boost regional and continental economic integration, particularly through the African Continental Free Trade Area. Leaders stressed that international humanitarian law, including the Geneva Convention relative to the treatment of prisoners of war, should be fully respected. That principle is based on the premise that human health, animal health and, where relevant, the environment are better protected where the burden of proof is on the applicant or the notifier since it has to prove that the subject matter of its application or notification is safe prior to its placing on the market, instead of the public authorities having to prove that that subject matter is unsafe in order to be able to ban it from the market. 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.. The use of the detection methods and the reproduction of the reference materials, provided under Articles5(3) and 17(3) for the purpose of applying this Regulation to GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise. 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. Russia is using food as a weapon of war. If you are not a journalist, please send your request to the public information service. 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. It shall notify the applicant of that decision within three weeks of submitting the confirmatory application and shall include in that notification information on the available remedies, namely an action before the Court of Justice of the European Union (the Court of Justice) against the Authority pursuant to paragraph 3. European Council conclusions from 2004 onwards are available in the public register of official documents. Accordingly, no personal data should be made publicly available under this Regulation, unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interests. 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. European Council President's speeches and statements, EU directive on passenger name record (PNR) data, Fight against money laundering and terrorist financing, Why counter-terrorism is a top priority for the EU, Measures to stop foreign terrorist fighters, Statement by the members of the European Council on the fight against terrorism (12 February 2015), Joint statement by the EU home affairs ministers on the recent terrorist attacks in Europe (13 November 2020), European Council conclusions (10-11 December 2020), Prevention of radicalisation (background information), EU terrorist list (background information), IT systems to fight crime and secure EU borders (background information), EU Counter-Terrorism Coordinator (background information), Fight against money laundering and terrorist financing (background information), EU strengthens control of the acquisition and possession of firearms (press release, 25 April 2017), EU reinforces rules on marketing and use of explosive precursors (press release, 14 June 2019), Better access to e-evidence to fight crime (background information), Digital Europe: Council adopts new rules to modernise judicial cooperation (press release, 4 November 2020), Judicial counter-terrorism register (Eurojust), Fight against terrorism: definitions of terrorist crimes and support to victims, EU strengthens rules to prevent new forms of terrorism (press release, 7 March 2017), Schengen borders code: Council adopts regulation to reinforce checks at external borders (press release, 7 March 2017), Strengthening EU external borders (background information), Preventing and countering terrorism and violent extremism: Council adopts conclusions on EU external action (press release, 16 June 2020), Foreign affairs & international relations, preventing radicalisation and safeguarding values, unduly compelling a government or international organisation to perform or abstain from performing any act, seriously destabilising or destroying the fundamental political, constitutional, economic or social structures of a country or an international organisation, undertaking training or travelling for terrorist purposes, providing or collecting funds related to terrorist groups or activities, cooperation with key partners will be strengthened, new projects to support capacity building will be launched, action to counter radicalisation and violent extremism will be intensified, geographic regions, including the Western Balkans, North Africa, the Middle East, the Sahel region and the Horn of Africa, thematic areas, including human rights, the rule of law, the prevention of radicalisation leading to violent extremism, terrorism financing. It called for specific measures, focusing on three areas: In November 2020, following the terrorist attacks in France, Germany and Austria, EU home affairs ministers agreed to further strengthen their joint efforts in the fight against terrorism, without compromising the EUs common values such as democracy, justice and freedom of speech. Infographic - How dependent are EU member states on energy imports? (11)Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10November 2003 on smoke flavourings used or intended for use in or on foods (OJL309, 26.11.2003, p.1). Sign up to receive our email and SMS alerts. 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 to39e of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and with Article 20 of this Regulation.; 1. For the purposes of paragraph 1, business operators shall, without delay, notify the Authority of the title and the scope of any study commissioned or carried out by them to support an application or a notification, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates. 6. 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 proposal aims to address shortcomings in the existing rules on disclosure of non-financial information, which was of insufficient quality to allow it to be properly taken into account by investors. The Commission shall report to the European Parliament, to the Council and to the Management Board on the findings of its reviews and evaluations under this Article. Please take a few minutes to complete a survey at the end of your visit. Where Member States assess confidentiality requests under this Regulation, the following requirements and procedures apply: confidentiality treatment may only be granted with respect to information listed in paragraph 2; where the Member State has decided which information is to be treated as confidential, it shall inform the applicant of its decision; Member States, the Commission and the Authority shall take the necessary measures so that information for which confidential treatment has been granted is not made public; Article 39e of Regulation (EC) No 178/2002 shall apply mutatis mutandis; notwithstanding paragraph 2 and points (c) and (d) of this paragraph: where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the Member State may disclose the information referred to in paragraph 2; information which forms part of the conclusions of the scientific outputs delivered by the Authority and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. The Council adopted its negotiating mandate on MiCA on 24 November 2021. Other cookies are used to boost performance and guarantee security of the website. One third of the 1.8 trillioninvestments from the NextGenerationEU Recovery Plan, and the EUs seven-year budget will finance the European Green Deal. More efforts are needed to prevent money laundering. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:; in Article 17, paragraph 3 is amended as follows: The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:; in Article 18, paragraph 7 is replaced by the following: 7. en ) 13948 / 18 CULT 137 NOTE From: General Secretariat of the Council To: Council No. Commission adopts proposal for a Nature Restoration Law 23 October 2020 . 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. 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. 4. ), OJ L 231, 6.9.2019, p. 128 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. Such shortcomings hinder the transition to a sustainable economy. The information systems operated by the Authority to store its data, including confidential and personal data shall be designed in a way that guarantees that any access to it is fully auditable and that the highest standards of security appropriate to the security risks at stake are attained, taking into account Articles 39 to 39f. For the purposes of risk assessment at Union level, it establishes the European Food Safety Authority (the Authority), as the responsible Union risk assessment body in matters relating to food and feed safety. Applicants or notifiers and in particular small and medium-sized enterprises do not always have a clear understanding of those specifications. Certain cookies are used to obtain aggregated statistics about website visits to help us constantly improve the site and better serve your needs. Regulation (EC) No 178/2002 of the European Parliament and of the Council(4) lays down the general principles and requirements of food law, so as to form a common basis for measures governing food law at both Union and national level. 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. Based on the conclusions of such fact-finding missions, the Commission could propose appropriate legislative measures aimed at improving compliance with the relevant standards. They also encouraged more EU member states to contribute to this global effort. The leaders announced an Africa-Europe Investment Package of EUR 150 billion that will support a common ambition for 2030 and AU Agenda 2063. EU and AU leaders welcomed the USD 55 billion that have been pledged already from the new allocation of special drawing rights (SDRs), including USD 13 billion from EU countries. They will put the packaging sector on track for climate neutrality by 2050. 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. There are usually four EPSCO meetings a year. The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level. The list drawn up by the Commission shall be forwarded to the European Parliament by the Council, together with the relevant background documents. where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the substance subject to the authorisation, and detailed information on the nature and composition of the materials or products in which the applicant intends to use the substance subject to the authorisation, 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 of the substance subject to the authorisation, except for information which is relevant to the assessment of safety. We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply. Your life online: How is the EU making it easier and safer for you? We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. 3. 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. European Council Conclusions (24 and 25 March 2022) Communication on REPowerEU: Joint European Action for more affordable, secure and sustainable energy, COM(2022) 108 final, (8.3.2022) See the complete list of actions in Annex 1 Flash Eurobarometer 506: EU's response to the war in Ukraine, 5 May 2022. 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). (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). 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