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En En Amendments European Parliament 2014-2019 Committee on the Environment, Public Health and Food Safety 2018/0088(COD) 21.9.2018 AMENDMENTS 297 - 539 Draft report Renate Sommer (PE623.765v02-00) Transparency and sustainability of the EU risk assessment in the food chain Proposal for a regulation (COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)) AM\1163538EN.docx PE627.946v01-00 EN United in diversity EN AM_Com_LegReport PE627.946v01-00 2/151 AM\1163538EN.docx EN Amendment 297 Fredrick Federley, Ulrike Müller, Jan Huitema Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 c – paragraph 1 Text proposed by the Commission Amendment 1. Where Union food law provides 1. Where Union food law provides that an authorisation may be renewed, the that an authorisation may be renewed, the potential applicant for the renewal shall potential applicant for the renewal shall notify the Authority of the studies it notify the Authority of the studies it intends to perform for that purpose. intends to perform for that purpose. Following this notification, the Authority Following this notification, the Authority shall launch a consultation of stakeholders shall launch a consultation of stakeholders and the public on the intended studies for and the public on the intended studies for renewal and shall provide advice on the renewal and shall provide advice on the content of the intended renewal application content of the intended renewal application taking into account the received comments. taking into account the received comments The advice provided by the Authority shall which are relevant for the risk assessment be without prejudice and non-committal as of the intended renewal. The advice to the subsequent assessment of the provided by the Authority shall be without applications for renewal of authorisation by prejudice and non-committal as to the the Scientific Panels. subsequent assessment of the applications for renewal of authorisation by the Scientific Panels. Or. en Amendment 298 Martin Häusling Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 c – paragraph 2 Text proposed by the Commission Amendment 2. The Authority shall consult 2. The Authority shall consult stakeholders and the public regarding the stakeholders and the public regarding the studies supporting applications for studies supporting applications for authorisation once they are made public by authorisation once they are made public by the Authority in accordance with Article 38 the Authority in accordance with Article 38 AM\1163538EN.docx 3/151 PE627.946v01-00 EN and Articles 39 to 39f in order to identify and Articles 39 to 39f in order to identify whether other relevant scientific data or whether other relevant scientific data or studies are available on the subject matter studies are available on the subject matter concerned by the application for concerned by the application for authorisation. This provision does not authorisation, and such without prejudice apply to the submission of any to the Authority’s own obligations under supplementary information by the Article 33. This provision does not apply to applicants during the risk assessment the submission of any supplementary process. information by the applicants during the risk assessment process. Or. en Justification Public consultation should not be seen as the panacea for good quality and exhaustive risk assessment. Indeed public consultations generally touch a very narrow audience. This responsibility lies with the EFSA. The rigorous identification of relevant scientific data should be done by the Authority itself, as laid down in Article 33. Public consultation should not exempt EFSA from this obligation. Amendment 299 Fredrick Federley, Ulrike Müller, Jan Huitema Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 c – paragraph 2 Text proposed by the Commission Amendment 2. The Authority shall consult 2. The Authority shall consult stakeholders and the public regarding the stakeholders and the public regarding the studies supporting applications for studies supporting applications for authorisation once they are made public by authorisation once they are made public by the Authority in accordance with Article 38 the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify and Articles 39 to 39f in order to identify whether other relevant scientific data or whether other relevant scientific data or studies are available on the subject matter studies that have been carried out in concerned by the application for accordance with international guidelines authorisation. This provision does not and Good Laboratory Practices (GLP) are apply to the submission of any available on the subject matter concerned supplementary information by the by the application for authorisation. This applicants during the risk assessment provision does not apply to the submission process. of any supplementary information by the applicants during the risk assessment PE627.946v01-00 4/151 AM\1163538EN.docx EN process. Or. en Amendment 300 Anja Hazekamp Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 c – paragraph 2 Text proposed by the Commission Amendment 2. The Authority shall consult 2. The Authority shall, within four stakeholders and the public regarding the months, consult stakeholders and the studies supporting applications for public regarding the studies supporting authorisation once they are made public by applications for authorisation once they are the Authority in accordance with Article 38 made public by the Authority in and Articles 39 to 39f in order to identify accordance with Article 38 and Articles 39 whether other relevant scientific data or to 39f in order to identify whether other studies are available on the subject matter relevant scientific data or studies are concerned by the application for available on the subject matter concerned authorisation. This provision does not by the application for authorisation. This apply to the submission of any provision does not apply to the submission supplementary information by the of any supplementary information by the applicants during the risk assessment applicants during the risk assessment process. process Or. en Justification Sufficient time should be given to all stakeholders and the public to submit other relevant available data. Amendment 301 Martin Häusling Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 d AM\1163538EN.docx 5/151 PE627.946v01-00 EN Text proposed by the Commission Amendment The Commission experts shall perform The Commission experts shall perform controls, including audits, to obtain controls, including audits, on a regular assurance that testing facilities comply basis to obtain assurance that testing with relevant standards for carrying out facilities comply with relevant standards tests and studies submitted to the Authority for carrying out tests and studies submitted as part of an application for an to the Authority as part of an application authorisation under Union food law. These for an authorisation under Union food law. controls shall be organised in cooperation These controls shall also include checks if with the competent authorities of the the raw data complies with the outcome of Member States. safety studies. These controls shall be unannounced and organised in cooperation with the competent authorities of the Member States. Or. en Amendment 302 Michel Dantin, Angélique Delahaye Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 d Text proposed by the Commission Amendment The Commission experts shall perform The Commission experts shall perform controls, including audits, to obtain controls, including audits, to obtain assurance that testing facilities comply assurance that testing facilities established with relevant standards for carrying out in the Union or in a third country comply tests and studies submitted to the Authority with relevant standards for carrying out as part of an application for an tests and studies submitted to the Authority authorisation under Union food law. These as part of an application for an controls shall be organised in cooperation authorisation under Union food law. Those with the competent authorities of the controls shall be organised in cooperation Member States. with the competent authorities of the Member States and the third countries in which the facilities concerned are established. Or. fr PE627.946v01-00 6/151 AM\1163538EN.docx EN Justification The purpose of this amendment is to provide the legal bases necessary to allow the Commission to check laboratories located in third countries that are carrying out studies submitted in support of authorisation applications. If no checks were carried out in third countries, laboratories located in the EU would not be treated in the same way as those located elsewhere, meaning that the laboratories could not provide a uniform level of guarantee. This would be unacceptable for the European public. Amendment 303 Anja Hazekamp Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 d Text proposed by the Commission Amendment The Commission experts shall perform The Commission experts shall perform controls, including audits, to obtain controls, including audits, to ensure that assurance that testing facilities
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