BETA

Activities of Renate SOMMER related to 2018/0088(COD)

Plenary speeches (3)

2016/11/22
Dossiers: 2018/0088(COD)

2016/11/22
Dossiers: 2018/0088(COD)

2016/11/22
Dossiers: 2018/0088(COD)

Amendments (32)

Proposal for a regulation
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 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 and the Authority has published its draft scientific opinion in accordance with the applicable rules on transparency.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 178/2002
Article 8 b – point e

(e) be accessible, including to those not directly involved in the process, while taking into account confidentiality of data and intellectual property and protection of personal data.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b

Regulation (EC) No 178/2002
Article 25 – paragraph 1 a – point b

(b) ontwo members and the alternate members appointed by the European Parliament and representing the European Parliament, with the right to vote.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point c a (new)

Regulation (EC) No 178/2002
Article 28 – paragraph 9 a (new)

(ca) the following point is inserted in paragraph 9 after point 9: (9a) the possibility for applicants to address, in a maximum period of 6 months unless otherwise agreed with EFSA, and previous to the publication of the draft opinion of the Authority, critical areas of concern by new data.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 178/2002
Article 32 b – paragraph 3

3. The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies and published its draft scientific opinion in accordance with Article 38 and Articles 39 to 39f.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a

(ha) information on the name of the applicant and the title of the application;

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a

Regulation (EC) No 178/2002
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,~~ subject to clear undertakings recorded electronically by those accessing it and subject to measures and penalties which are effective, proportionate and dissuasive against any non-permitted use, such as commercial. The relevant items shall be available to search through in an electronic format. The dedicated section of the Authority`s website will include all necessary measures to protect against the use by those accessing it of items referred to in proint ~~and search through in an electronic format.”,~~s (c), (d) and (i) of the first subparagraph, for commercial purposes. These measures will focus on the commercial use of documents (their submission) and use of the information contained therein (without being submitted as such). Such protective measures will be designed to protect effectively against commercial use both within the Union and in third-countries.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b

Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – introductory part

The disclosure of the information mentioned in paragraph (1)(c), (d) and (i) to the public shall be without prejudice:

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b

Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 2

The disclosure to the public of the information mentioned in paragraph (1)(c), (d) and (i) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union. Member States shall put in place all necessary measures to address any breach of the undertakings given by those accessing the dedicated section of the Authority`s website. Measures and penalties shall be effective, proportionate and dissuasive against any non-permitted use, such as commercial use.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b

1b. By [30 months after the entry into force] Member States shall submit to the Commission a report, on the basis of experience gained with the application of this Regulation, on any breach of measures and penalties and their effectiveness. On this basis, by [6 months later] the Commission shall submit to the European Parliament and the Council a report on the extent to which this Regulation requires amending.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) No 178/2002
Article 38 a (new)

(5a) The following Article 38a is inserted: “Article 38a Following the EFSA guidelines on consultations that aim at increasing the transparency of the risk assessment the authority follows a three-step-procedure. First it publishes a draft scientific opinion. At the same time of the publication of the draft scientific opinion the Authority makes public the following information: (a) scientific date, studies and other information supporting applications for authorization 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 opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f. (b) the full application document taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f. (c) the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Article 39 to 39f. (d) information concerning the consultation sessions with applicants conducted by the Authority pursuant to Article 32a and 32c prior to their applications. After the publication of its draft opinion the Authority shall, within six weeks, consult stakeholders and the public regarding the studies supporting applications for authorisation in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation. The results of the consultation including comments provided by stakeholders shall be made public in a technical report that will be attached to the final scientific opinion of the Authority. In its final scientific opinion the authority shall indicate how the comments made by stakeholders were addressed.”

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 2 – introductory part

2. The Authority ~~may only~~shall accept to provide confidential treatment in relation to the following information, the disclosure of which ~~may be~~is deemed~~, upon verifiable justification,~~ to significantly harm the interests concerned unless this is proven not to be the case:

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 3

(3) commercial information revealing sourcing, market shares ~~or business strategy of the applicant; and,~~ , innovative product ideas or business strategy and trade secrets of the applicant in the meaning of Article 2 (1) of Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 3

3. The list of information referred to in paragraph 2 shall not preclude a request for confidentiality being submitted for other information which does not benefit from presumption of confidentiality in paragraph 2 of this Article and shall be without prejudice to any specific Union food law.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7

Regulation (EC) No 178/2002
Article 39 a – paragraph 1

1. When submitting an application for an authorisation, supporting scientific data and other supplementary information in accordance with Union food law, the applicant may request certain parts of the information submitted to be kept confidential in accordance with paragraphs 2 and 3 of Article 39. ~~This~~A request ~~shall be accompanied by verifiable justification~~pursuant to paragraph 3 of Article 39 shall be accompanied by a reasoned statement, with appropriate verifiable evidence, demonstrating how making public the information concerned smig~~nificantly harms~~ht undermine the interests concerned ~~in accordance with paragraphs 2 and 3 of Article 39~~.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7

Regulation (EC) No 178/2002
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 after the notification of its decision to the applicant has taken place, pursuant to point (d). publish non-confidential data and information relating to the application only once a final decision has been taken in respect of the confidentiality request pursuant to this Article and the Authority has published its draft scientific opinion in line with Article 38. Where an applicant withdraws the application pursuant to Article 39(c) because the applicant deems the publication of the information planned by the Authority to be too comprehensive, the Authority, the Commission and the Member States shall refrain from publishing any information on the application for authorisation.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7

Regulation (EC) No 178/2002
Article 39 d – paragraph 2

2. The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and ~~has become definitive~~its draft scientific opinion has been published in line with Article 38. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7

Regulation (EC) No 178/2002
Article 39 f – paragraph 2 a (new)

2a. The standard data formats and data packages shall only apply to data generated after adoption of the implementing acts in accordance with paragraph 2(b) of this Article.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – point 4

Directive 2001/18/EC
Article 28 – paragraph 4

4. Where the relevant Scientific Committee is consulted under paragraph 1, it shall make public the notification/application, relevant supporting information and any supplementary information supplied by the notifier/applicant, a~~s well~~t the same time as its draft scientific opinions, in accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and Article 25 of this Directive..

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 9

Regulation (EC) No 1829/2003
Article 29 – paragraph 1

1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, at the same time as its draft scientific opinion, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b

Regulation (EC) 1831/2003
Article 7 – paragraph 2 – point c

(c) ensure public access to the application and any information supplied by the applicant, at the same time as the Authority publishes its draft scientific opinion, in accordance with Article 18.;

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 1 – point 2

Regulation (EC) No 1831/2003
Article 18 – paragraph 1

1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, a~~s well~~t the same time as its draft scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 5 – paragraph 1 – point 1 – point a

Regulation (EC) No 2065/2003
Article 7 – paragraph 2 – point c – point ii

(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant when it publishes its draft scientific opinion, in accordance with Articles 14 and 15.;

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 5 – paragraph 1 – point 2

Regulation (EC) No 2065/2003
Article 14 – paragraph 1

1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant a~~s well~~t the same time as its draft scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 1 – point 1 – point a

Regulation (EC) No 1935/2004
Article 9 – paragraph 1 – point c – point ii

(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, at the same time as it publishes its draft scientific opinion, in accordance with Articles 19 and 20.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 1 – point 2

Regulation (EC) No 1935/2004
Article 19 – paragraph 1

1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, a~~s well~~t the same time as its draft scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and Article 20 of this Regulation.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 1 – point 2

Regulation (EC) No 1331/2008
Article 11

Where the Commission requests its opinion in accordance with Article 3(2) of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, a~~s well as its~~t the same time as it publishes its draft scientific opinions, in accordance with Article 38, Articles 39to 39f and Article 40 of Regulation (EC) No 178/2002. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.;

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point b

Regulation (EC) No 2015/2283
Article 10 – paragraph 3

3. Where the Commission requests an opinion from, the European Food Safety Authority (‘the Authority’), the Authority shall ensure public access to the application in accordance with Article 23 a~~nd shall give its opinion as to~~t the same time as it publishes its draft opinion in response to the question whether the update is liable to have an effect on human health;

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 1 – point 2

Regulation (EC) No 2015/2283
Article 15 – paragraph 1 – last sentence

The Authority shall ensure public access to the notification pursuant to Article 23 when it publishes its technical report.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 1 – point 3 – point b

Regulation (EC) No 2015/2283
Article 16 – paragraph 2 - last sentence

The Authority shall ensure public access to the non-confidential elements of the application, relevant supporting information and any supplementary information supplied by the applicant as well as to the notification concerning safety concerns at the same time as it publishes its draft scientific opinion and in accordance with Article 23.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 1 – point 4

Regulation (EC) No 2015/2283
Article 23 – paragraph 1

1. Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, a~~s well~~t the same time as its draft scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article.

2018/09/21
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 1 – point 4

Regulation (EC) No 2015/2283
Article 23 – paragraph 4 a (new)

4a. The Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 4 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).

2018/09/21
Committee: ENVI