11 Amendments of Răzvan POPA related to 2018/0088(COD)
Amendment 103 #
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 but also representatives of the industry in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.
Amendment 107 #
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. The system has thus to be strengthened and Member States should take a more transparent and 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 108 #
Proposal for a regulation
Recital 14
Recital 14
(14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should alshave to be put in place to ensure that scientific experts have the means to act independently. To this effect, it is necessary to implement new and adequate budgetary measures.
Amendment 110 #
Proposal for a regulation
Recital 16
Recital 16
(16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health isand the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the players in the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
Amendment 118 #
Proposal for a regulation
Recital 20
Recital 20
(20) There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
Amendment 120 #
Proposal for a regulation
Recital 21
Recital 21
(21) Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, issues ofnon- compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.
Amendment 123 #
Proposal for a regulation
Recital 23
Recital 23
(23) The Fitness Check of the General Food Law demonstrated that although the Authority has made considerable progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the agri-food chain, is not always perceived asyet fully transparent. This is also partly due to the different transparency and confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in other Union legislative acts covering the agri-food chain. Their interplay can impact on the acceptability of the risk assessment by the general public.
Amendment 126 #
Proposal for a regulation
Recital 25
Recital 25
(25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner in order to ensure the liability of the Authority. Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process. However, this process should be without prejudice to existing intellectual property rights or to any provisions of Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations.
Amendment 127 #
Proposal for a regulation
Recital 26
Recital 26
(26) Where the opinion of the Authority is requested in relation to authorisation procedures under Union food 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 shouldmust have responsibility for assessing confidentiality requests.
Amendment 133 #
Proposal for a regulation
Recital 28
Recital 28
(28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures. It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.
Amendment 134 #
Proposal for a regulation
Recital 30
Recital 30
(30) It is also necessary to set out specific requirements with respect to the protection and the confidentiality of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council24 and Regulation (EU) 2016/679 of the European Parliament and of the Council25 . 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. _________________ 24 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 25 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 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) (OJ L 119, 4.5.2016, p. 1).