Activities of Karin KADENBACH related to 2018/0088(COD)
Plenary speeches (1)
Transparency and sustainability of the EU risk assessment in the food chain (debate) DE
Amendments (51)
Amendment 73 #
Proposal for a regulation
Recital 18
Recital 18
(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, private and public institutes and unversities 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 transparency.
Amendment 77 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and, continuous and inclusive risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherenceprevalence of public interest, accuracy and consistency within the risk analysis process.
Amendment 79 #
Proposal for a regulation
Recital 5
Recital 5
(5) Particular emphasis should be placed on explaining in a coherent, appropriatlear, objective and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.
Amendment 83 #
Proposal for a regulation
Recital 8
Recital 8
(8) The general plan should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process. It 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 coherenteffective risk communication.
Amendment 91 #
Proposal for a regulation
Recital 9
Recital 9
(9) Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increases their confidence in its work and ensures that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to maintainrebuild the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.
Amendment 99 #
Proposal for a regulation
Recital 13
Recital 13
(13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capabilcity 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 active roleMember States should support the dissemination of the Authority’s calls for expressions of interest for membership of the Scientific Panels and Scientific Committee, 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 15
Recital 15
(15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise. It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority’s Scientific Panels. In particular, the Authority should organise the preparatory work supporting the Panels’ tasks, 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 the Panels. This should be without prejudice to the independence of the Authority’s scientific assessments.
Amendment 120 #
Proposal for a regulation
Recital 18
Recital 18
(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 or renewal 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 transparency.
Amendment 131 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 156 #
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 general horizontal exhaustive 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 However, this information can only be kept secret if the applicant opposing its disclosure proves, with verifiable justifications, that proactive disclosure would significantly harm the commercial interests concerned. The exceptions to the principle of transparency must be interproetect human health, animal health or the environment, such information should be disclosedd strictly. In any event, even when the publication of the information is considered to undermine the commercial interests, the information cannot be kept secret if disclosure is requested and is of overriding public interest.
Amendment 171 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to further strengthen the link between risk assessors and risk managers at Union and national levels, as well as the coherence and consistency of risk communicwith other stakeholders in the food chain such as economic operators, consumer and other civil society organisations, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. IThe general plan on risk communication shall lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process. Therefore, it is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 191 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point b
Article 8 a – point b
(b) promote consistency and transparency in formulating risk management options and recommendations;
Amendment 193 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point b
Article 8 a – point b
(b) promote consisttransparency and transparencclarity in formulating risk management options and recommendations;
Amendment 194 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c
Article 8 a – point c
(c) provide a soundcientific basis for understanding risk management decisions;, including information on:
Amendment 198 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c a (new)
Article 8 a – point c a (new)
(ca) the risk management options considered including, as appropriate, the possibility to adopt provisional measures within the meaning of Article 7 of this Regulation;
Amendment 199 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c b (new)
Article 8 a – point c b (new)
(cb) the extent to which the various risk management options under consideration reflect the degree of uncertainty of the risk assessment, and the level of consumer and animal health and environmental protection each of these options would achieve;
Amendment 200 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point c c (new)
Article 8 a – point c c (new)
(cc) as foreseen under Article 6(3) of this Regulation, the factors, other than the results of the risk assessment, which were considered by the risk managers, and how these factors were weighed up against each other;
Amendment 202 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
(d) foster public understanding of the risk analysis process so as to enhance confidenceaccountability in its outcome;
Amendment 204 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point e
Article 8 a – point e
(e) promote appropriatebalanced involvement of all interested parties, including economic operators of the food chain, consumer and other civil society organisations; and,
Amendment 208 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point a
Article 8 b – point a
(a) ensure that accurate, appropriacomplete and timely information is interactively exchanged, including with all interested parties, based on the principles of transparency, openness, and responsiveness;
Amendment 212 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point e
Article 8 b – point e
(e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
Amendment 218 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point b
Article 8 c – paragraph 2 – point b
(b) identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and, to ensure the balanced involvements of all interested parties including economic operators of the food chain, consumer-, health-, and other civil society organisations;
Amendment 222 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point d a (new)
Article 8 c – paragraph 2 – point d a (new)
(da) lay down the practical arrangements and timeline for making the following information available to the public:
Amendment 223 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point d b (new)
Article 8 c – paragraph 2 – point d b (new)
(db) the agendas and detailed minutes of the meetings of the Authority’s Scientific Committee, Scientific Panels and working groups;
Amendment 224 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point d c (new)
Article 8 c – paragraph 2 – point d c (new)
(dc) at an early stage of the risk management process, the draft risk management measures under consideration;
Amendment 225 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point d e (new)
Article 8 c – paragraph 2 – point d e (new)
(de) the agendas and detailed minutes of the meetings of the working groups of governmental experts where the risk management measures are discussed;
Amendment 226 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point d f (new)
Article 8 c – paragraph 2 – point d f (new)
(df) the agendas and detailed summary reports of the meetings of the regulatory committees where the risk management measures are discussed and put to a vote, including an explanation of the votes by individual Member States and the information referred to under Article 8a(c).
Amendment 230 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) No 178/2002
Article 10
Article 10
Amendment 236 #
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 – paragraph 1 a – point b
Article 25 – paragraph 1 a – point b
(b) ontwo members and two substitute members appointed by the European Parliament, with the right to vote.
Amendment 242 #
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 – paragraph 1 a – point c
Article 25 – paragraph 1 a – point c
(c) fourive members with the right to vote representing civil society and food chain workers interests namely, one from health organisations, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Amendment 274 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a
Article 32 a
Amendment 280 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a – paragraph 1 a (new)
Article 32 a – paragraph 1 a (new)
Amendment 281 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a – paragraph 1 a (new)
Article 32 a – paragraph 1 a (new)
Within 36 months after the entry into force of this regulation, the Commission shall assess the impact of this article on the functioning of the Authority. Particular attention shall be paid to the additional workload and mobilisation of staff, and whether it has led to any shift in the allocation of the Authority’s resources, at the expense of activities of public interest.
Amendment 282 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 1
Article 32 b – paragraph 1
1. A Union register of studies commissioned by business operators seeking to obtain an authorisation or renewal under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter of anyll study commissioneies and research terms of reference commissioned within the EU and beyond to support a future application for an authorisation or renewal under Union food law. The register shall be managed by the Authority.
Amendment 295 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 4 a (new)
Article 32 b – paragraph 4 a (new)
4a. The Commission shall establish, as part of a delegated act, penalties for breaches of the notification obligation.
Amendment 304 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 e
Article 32 e
Amendment 309 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 e
Article 32 e
Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission and without prejudice to the application of the precautionary principle in presence of scientific uncertainty, the Commission, the Member States or the European Parliament, in exceptional circumstances, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.;
Amendment 323 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – introductory part
Article 38 – paragraph 1 – introductory part
The Authority shall carry out its activities with a high level of transparencyactively disseminate the information it possesses to ensure high level of transparency in line with the Aarhus Convention and Regulation (EC) No 1367/2006. It shall in particular make public without delay:
Amendment 327 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point a
Article 38 – paragraph 1 – point a
(a) agendas, participant lists and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
Amendment 328 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
(c) scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account the overriding public interest in disclosure and the protection of confidential information and protection of personal data in accordance with Articles 39 to 39f.
Amendment 331 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point d
Article 38 – paragraph 1 – point d
(d) the information on which its scientific outputs, including scientific opinions are based, taking into account the overriding public interest in disclosure and the protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;
Amendment 337 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 2
Article 38 – paragraph 1 – subparagraph 2
Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority’s website. That section shall be publicly available and easily accessible. The relevant items shall be available to download, print and search through in an electronic and as appropriate machine- readable format.
Amendment 357 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 1
Article 39 – paragraph 1
1. By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requesgranted under the conditions laid down in this Article.
Amendment 360 #
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 – introductory part
Article 39 – paragraph 2 – introductory part
2. The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concernedand provided that the request for confidential treatment demonstrates, with adequate and verifiable justification, that disclosure would specifically and significantly harm the commercial interest of the applicant:
Amendment 365 #
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 1
Article 39 – paragraph 2 – point 1
(1) the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion; provided that the applicant demonstrates that such method does not entail emissions in the environment and has no harmful impacts on health and environment;
Amendment 374 #
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 4
Article 39 – paragraph 2 – point 4
(4) quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment.
Amendment 379 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Article 39 – paragraph 4 – point a
(a) Where urgent action is essential to protect publicInformation relating to human health, animal health or the environment, such as including emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,or
Amendment 381 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Article 39 – paragraph 4 – point a
(a) Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; andor,
Amendment 388 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b
Article 39 – paragraph 4 – point b
(b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects.
Amendment 432 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 2
Article 61 – paragraph 2
2. Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’sAuthority jointly with the Commission shall commission an independent evaluation of their performance in relation to itstheir objectives, mandates, tasks, procedures and location, in accordance with Commission guidelines. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification. The evaluation shall take into account the views of the stakeholders, at both Community and national level.
Amendment 434 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 2 a (new)
Article 61 – paragraph 2 a (new)
2a. The Management Board of the Authority shall examine the conclusions of the evaluation and issue to the Commission such recommendations as may be necessary regarding changes in the Authority.