39 Amendments of Maria Lidia SENRA RODRÍGUEZ related to 2018/0088(COD)
Amendment 5 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and continuous 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 coherence and consistency within the risk analysis process and application of the precautionary principle.
Amendment 6 #
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 maintain 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. and transparency of the Authority, which have been called into question in the wake of a number of complaints about conflicts of interest involving many of the Authority’s experts and the scandal surrounding the renewal of the authorisation for glyphosate, when the Authority took over the views presented by Monsanto;
Amendment 8 #
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, perhaps because in the performance of its work the Authority may be giving preference to criteria other than purely scientific ones. 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 10 #
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 (a principle threatened by free trade agreements the Union itself is promoting). 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.
Amendment 15 #
Proposal for a regulation
Recital 22
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, the Member States or the European Parliament 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).
Amendment 25 #
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 b
Article 25 b
(b) one member appoifrom each political group represented byin the European Parliament, with the right to vote.
Amendment 28 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 d ii
Article 28 d ii
(ii) IVerified independence and absence of conflict of interests in accordance with Article 37(2) and the Authority’s independence policy and implementing rules on the independence of the Scientific Panels’ members;
Amendment 29 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5 d
Article 28 – paragraph 5 d
5d. The Member States and the Commission shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests, making sure that they do not come from within the industries concerned, as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain.
Amendment 31 #
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 35 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 c – paragraph 1
Article 32 c – paragraph 1
1. Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels.
Amendment 37 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 d
Article 32 d
The Commission experts shall perform regular controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States.
Amendment 39 #
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, in exceptional circumstances, maythe European Parliament or a Member State shall 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 40 #
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, in exceptional circumstances, may shall 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 49 #
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
Amendment 52 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – point e
Article 39 b – point e
(e) make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks and no later than four weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment 55 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and continuous 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 coherence and consistency within the risk analysis process as well as to ensure that the precautionary principle is applied.
Amendment 57 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 178/2002
New Article
New Article
Amendment 58 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
Amendment 59 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2 – point b
Article 25 – paragraph 2 – point b
Amendment 60 #
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 the 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 maintain 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., independence and transparency of the Authority, which have been called into question in the wake of a number of complaints about conflicts of interest involving many of the Authority’s experts and the scandal surrounding the renewal of the authorisation for glyphosate, when the Authority took over the opinions provided by Monsanto;
Amendment 61 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Directive 2001/18/EC
Article 25 – point 4 a (new)
Article 25 – point 4 a (new)
4a. It shall be forbidden to intentionally release genetically modified organisms into the environment in contravention of the precautionary principle and when there is no scientific knowledge of the implications for each of the areas concerned (the environment, health, biodiversity, etc.).
Amendment 64 #
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, perhaps because developments in the Authority’s work may have led to an emphasis being placed on criteria other than purely scientific ones. 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 68 #
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 (a principle threatened by the free trade agreements that the Union itself is promoting). 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.
Amendment 77 #
Proposal for a regulation
Recital 22
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, the Member States or the European Parliament 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).
Amendment 111 #
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) one member appoifrom each political group represented byin the European Parliament, with the right to vote.
Amendment 117 #
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) four members with the right to vote representing civil society and food chain interests namely, one: one member from consumers’ organisations, one from environmental non-governmental organisations, one from farmers’ organisations and one from industry organisationsrepresenting each of the European farmers’ organisations, all with the right to vote. 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 120 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5 a – subparagraph d – point ii
Article 28 – paragraph 5 a – subparagraph d – point ii
(ii) IVerified independence and absence of conflict of interests in accordance with Article 37(2) and the Authority’s independence policy and implementing rules on the independence of the Scientific Panels’ members;
Amendment 124 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5 d
Article 28 – paragraph 5 d
5d. The Member States and the Commission shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests, and ensuring that they do not come from within the industries, as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain.
Amendment 126 #
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 139 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 c – paragraph 1
Article 32 c – paragraph 1
1. Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels.
Amendment 145 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 d
Article 32 d
The Commission experts shall perform regular controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States.
Amendment 152 #
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, in exceptional circumstances, maythe European Parliament or a Member State shall 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 153 #
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, in exceptional circumstances, may shall 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 174 #
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
Amendment 185 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point e
Article 39 b – paragraph 1 – point e
(e) make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks and no later than four weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment 198 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)
Article 1 – paragraph 1 – point 10 a (new)
Regulation (EC) No 178/2002
Article 57 b (new)
Article 57 b (new)
(10a) the following new Article 57a is inserted: Article 57b Authorisations The Commission shall not renew any authorisation, or grant any new authorisation, if there are scientific discrepancies, or without taking the precautionary principle into account.
Amendment 201 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive No 2001/18/EC
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
Amendment 202 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2 – point b
Article 25 – paragraph 2 – point b
Amendment 204 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Directive No 2001/18/EC
Article 28 – paragraph 4 a (new)
Article 28 – paragraph 4 a (new)
4a. It shall be forbidden to intentionally release genetically modified organisms into the environment in contravention of the precautionary principle, including where there is no scientific knowledge of the consequences for each different area (the environment, health, biodiversity, etc.).