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8 Amendments of Rosa D'AMATO related to 2018/0088(COD)

Amendment 9 #
Proposal for a regulation
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 is 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 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.deleted
2018/09/05
Committee: PECH
Amendment 13 #
Proposal for a regulation
Recital 20 a (new)
(20a) In order to increase public trust in the credibility of scientific studies, there is a need to ensure greater transparency by making sure that researchers and citizens have open access to all the information on which studies reported by EFSA are based; to the same end, the possibility should exist to launch consultations with third parties, including industry representatives, with a view to ascertaining whether other scientific data or studies are available for a given product.
2018/09/05
Committee: PECH
Amendment 14 #
Proposal for a regulation
Recital 22
(22) Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
2018/09/05
Committee: PECH
Amendment 16 #
Proposal for a regulation
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 should have responsibility for assessing confidentiality requests.deleted
2018/09/05
Committee: PECH
Amendment 18 #
Proposal for a regulation
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 direct and indirect health effects and urgent needs to protect human health, animal health or the environment, should such information should be disclosed.
2018/09/05
Committee: PECH
Amendment 65 #
Proposal for a regulation
Recital 14 a (new)
(14a) Since the Authority is responsible for assessing products in a variety of fields such as agriculture, food and health, it is vital to ensure that the members of the expert groups have the appropriate expertise to make a satisfactory assessment of the effectiveness and security of the product being analysed. In particular, the assessment should cover the specific characteristics of the substance being analysed and establish an appropriate methodology for its correct assessment, taking the approach best suited to that type of substance, and one which should therefore vary depending on whether it is a complex natural substance or a substance obtained through chemical synthesis.
2018/09/06
Committee: AGRI
Amendment 121 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5 a – subparagraph d – point iii a (new)
(iiia) Correspondence between the expertise available within the group responsible for a given assessment and the expertise required for that assessment, so as to ensure satisfactory understanding of the field in question and appropriate choice of methodology, depending on whether the substance is a complex natural substance or a product obtained through chemical synthesis.
2018/09/06
Committee: AGRI
Amendment 123 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragrah 5 b
5b. When the AuthorityManagement Board identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5.
2018/09/06
Committee: AGRI