15 Amendments of Daniel BUDA related to 2018/0088(COD)
Amendment 89 #
Proposal for a regulation
Recital 2
Recital 2
(2) Regulation (EC) No 178/2002 defines “risk analysis” as a process consisting of three distinct but interconnected components: risk assessment, risk management and risk communication. 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. Risk communication is an essential part of the risk analysis process and presupposes the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions amongst risk assessors, risk managers, consumers, feed and food businesses, the academic community, including the explanation of risk assessment findings and the basis of risk management decisions.
Amendment 94 #
Proposal for a regulation
Recital 6
Recital 6
(6) To this effect, 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.
Amendment 99 #
Proposal for a regulation
Recital 8
Recital 8
(8) The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent, comprehensive and prompt risk communication.
Amendment 101 #
Proposal for a regulation
Recital 11
Recital 11
(11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States, including representatives of civil society and industry, in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment and have no conflict of interest with the applicants.
Amendment 106 #
Proposal for a regulation
Recital 13
Recital 13
(13) 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. In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels, with two- thirds of the experts of the scientific groups coming from six Member States in this instance. 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.
Amendment 112 #
Proposal for a regulation
Recital 17
Recital 17
(17) Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.
Amendment 116 #
(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparencysubmitted and the Authority has published its scientific opinion.
Amendment 144 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to enable the Authority, Member States and the business operators to adapt to the new requirements and to ensure a balance between, on the one hand, benefits for citizens, Member States and interested parties and, on the other hand, an negligible impact on innovation and industry as a whole, while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.
Amendment 145 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Chapter II – SECTION 1a – Article 8a(b)
Chapter II – SECTION 1a – Article 8a(b)
(b) promote consistency and, transparency in formulating risk management recommendations;and measures to ensure a high level of health protection in formulating risk management recommendations; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 149 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Chapter II – SECTION 1a – Article 8a(b)
Chapter II – SECTION 1a – Article 8a(b)
(f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri- food chain. and strategies to avoid them. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 155 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Chapter II – SECTION 1a – Article 8b(e)
Chapter II – SECTION 1a – Article 8b(e)
(e) be accessible, including to those not directly involved in the process, while taking into accountrespecting confidentiality and protection of personal data. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 162 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25(1b)
Article 25(1b)
1b. The members of the Management Board and where relevant, the alternate members shall be appointed taking into account high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy, and relevant managerial, administrative and budgetary/financial skills.”,
Amendment 173 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32a – paragraph 1
Article 32a – paragraph 1
With a view to ensuring transparency and facilitating access for those concerned, the Authority shall publish a guide setting out the requirements and the details to be included in the application for authorisation. At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and, giving details of the required content of the application for authorisation and the accompanying studies or documentation. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 197 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 3
Article 39 – paragraph 2 – point 3
(3) commercial information revealing sourcing, innovative ideas for the product/substance, market shares or business strategy of the applicant; and(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 213 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 3d – paragraph 3
Article 3d – paragraph 3
3. If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public theany information for which confidentiality has been requested.relating to the planned application. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)