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 comply testing facilities in the Union and in third with relevant standards for carrying out countries, 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 be organised in with the competent authorities of the cooperation with the competent authorities Member States. of the concerned countries

Or. en

Justification

In order to ensure the quality and a level playing field, these controls and audits should be inside and outside the EU, such as with other agri-food chain products and installations.

Amendment 304 Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

AM\1163538EN.docx 7/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

Verification studies deleted 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 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.;

Or. en

Amendment 305 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation, the Commission, in exceptional circumstances, may request the exceptional circumstances, may request the Authority to commission scientific studies Authority to commission scientific studies with the objective of verifying evidence with the objective of verifying evidence used in its risk assessment process. The used in its risk assessment process. The studies commissioned may have a wider studies commissioned may have a wider scope than the evidence subject to scope than the evidence subject to verification.; verification. The power of initiative for the commissioning of verification studies, shall also be given to the citizens under the same conditions as the European Citizen’s Initiative. Once the conditions

PE627.946v01-00 8/151 AM\1163538EN.docx EN are fulfilled and verified, the Commission shall consult with the initiators and the Authority, about the specifications of the studies and the process of the commissioning will start immediately. The studies many have a wider scope than the evidence subject to verification or the demand of the Citizens’ verification initiative, but the scope shall correspond at least to the request(s) and shall have the approval of the initiators. For this purpose the Commission shall create the platform and the mechanism that allow the public to submit their request for commissioning of verification studies;

Or. en

Justification

This way the public participation would be enhanced and it would be given to the citizens the right to indicate to the decision-makers where their concerns are focused and to have the public money spend serving public requests.

Amendment 306 Michel Dantin, Angélique Delahaye

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation, the Commission, the exceptional circumstances, may request the European Parliament and the Member Authority to commission scientific studies States, in exceptional circumstances, may with the objective of verifying evidence request the Authority to commission used in its risk assessment process. The scientific studies with the objective of studies commissioned may have a wider verifying evidence used in its risk scope than the evidence subject to assessment process. The studies verification.”; commissioned may have a wider scope

AM\1163538EN.docx 9/151 PE627.946v01-00 EN than the evidence subject to verification.” Where it considers necessary, the Authority may also order verification studies after consulting its Management Board. A quadripartite selection panel comprising the Commission, the Member States, the EFSA and the European Parliament shall be set up. Its mission shall be to identify and prioritise requests for verification studies.

Or. fr

Justification

The amendment proposes that verification studies be carried out in as wide and open a supervisory context as possible encompassing not only the Commission but also Parliament, the Member States and the EFSA. These studies are launched at the behest of a multipartite selection committee. Finally, the funding thereof is already provided for under the additional EFSA allocation proposed by Commission.

Amendment 307 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation and without prejudice to the exceptional circumstances, may request the application of the precautionary principle Authority to commission scientific studies in presence of scientific uncertainty, the with the objective of verifying evidence Commission, the Member States or the used in its risk assessment process. The European Parliament may, in exceptional studies commissioned may have a wider circumstances, request the Authority to scope than the evidence subject to commission scientific studies with the verification.; objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.

PE627.946v01-00 10/151 AM\1163538EN.docx EN Verification studies shall be funded via the contributions of applicants to a common fund. The Commission shall adopt a delegated act in accordance with Article 57a to determine the modalities of this fund.

Or. en

Justification

The reference to the precautionary principle (PP) is important in order to make sure that the verification studies are not conducted instead of applying the PP, i.e. they should not be commissioned to keep a product on the market if gaps have been identified. Public money shall not be used in order to safety test products of companies.

Amendment 308 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation, the Commission, the exceptional circumstances, may request the European Parliament and Member States, Authority to commission scientific studies in exceptional circumstances, can request with the objective of verifying evidence the Authority to commission scientific used in its risk assessment process. The studies with the objective of verifying studies commissioned may have a wider evidence used in its risk assessment scope than the evidence subject to process. The studies commissioned may verification.; have a wider scope than the evidence subject to verification. When deemed necessary and after consulting its Board members, the Authority may also request verification studies.

Or. en

AM\1163538EN.docx 11/151 PE627.946v01-00 EN Amendment 309 Pavel Poc, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation and without prejudice to the exceptional circumstances, may request the application of the precautionary principle Authority to commission scientific studies in presence of scientific uncertainty, the with the objective of verifying evidence Commission, the Member States or the used in its risk assessment process. The European Parliament, in exceptional studies commissioned may have a wider circumstances, may request the Authority scope than the evidence subject to to commission scientific studies with the verification.; objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.

Or. en

Justification

EFSA can only assess regulated products on the basis of the authorisation dossiers submitted by applicants. It cannot commission additional studies to verify the safety of a given substance or product. The verification studies foreseen in the Commission proposal could therefore be a positive element in case of a scientific uncertainty if they are not used instead of the precautionary principle.

Amendment 310 Annie Schreijer-Pierik

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

PE627.946v01-00 12/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation, the Commission, in exceptional circumstances, may request the exceptional circumstances and after Authority to commission scientific studies careful consultation, may request the with the objective of verifying evidence Authority to commission scientific studies used in its risk assessment process. The with the objective of verifying evidence studies commissioned may have a wider used in its risk assessment process. The scope than the evidence subject to studies commissioned may have a wider verification.”; scope than the evidence subject to verification.”

Or. nl

Amendment 311 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation, the Authority may, in exceptional circumstances, may request exceptional circumstances, when there are the Authority to commission scientific data gaps or scientific uncertainty, studies with the objective of verifying commission scientific studies with the evidence used in its risk assessment objective of verifying evidence used in its process. The studies commissioned may risk assessment process. The studies have a wider scope than the evidence commissioned may have a wider scope subject to verification. than the evidence subject to verification.

Or. en

Amendment 312 Piernicola Pedicini, Eleonora Evi

AM\1163538EN.docx 13/151 PE627.946v01-00 EN Proposal for a regulation Article 1 – paragraph 1 – point 4 Regulation (EC) No 178/2002 Article 32 e

Text proposed by the Commission Amendment

Without prejudice to the obligation of Without prejudice to the obligation of applicants for authorisations under food applicants for authorisations under food law to demonstrate the safety of a subject law to demonstrate the safety of a subject matter submitted to a system of matter submitted to a system of authorisation, the Commission, in authorisation, the Commission, in exceptional circumstances, may request exceptional circumstances, may the Authority to commission scientific commission independent scientific studies studies with the objective of verifying with the objective of verifying evidence evidence used in its risk assessment used in its risk assessment process. The process. The studies commissioned may studies commissioned may have a wider have a wider scope than the evidence scope than the evidence subject to subject to verification. verification.

Or. en

Amendment 313 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 4 a (new) Regulation (EC) No 178/2002 Article 32 e a (new)

Text proposed by the Commission Amendment

(4a) The following Article 32ea is inserted: “Safety Mandatory Tests Safety testing of chemicals shall be paid for by the applicant of a substance and shall be managed by EFSA in cooperation with independent laboratories. EFSA shall define the set of mandatory laboratory tests based on legal requirements and additional concerns for hazards observed in scientific literature and put forward in public consultation.”

PE627.946v01-00 14/151 AM\1163538EN.docx EN Or. en

Amendment 314 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 a (new) Regulation (EC) No 178/2002 Article 32 e a (new)

Text proposed by the Commission Amendment

(4b) The following Article 32ea is inserted: “Safety testing Safety testing of products falling within EFSA’s remit shall be based on a set of mandatory tests defined by the Authority. Any studies based on so-called good laboratory practice need to be complemented and verified by other, independent research.”

Or. en

Amendment 315 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 a (new) Regulation (EC) No 178/2002 Article 33 – paragraph 1 – point d a (new)

Text proposed by the Commission Amendment

(4a) In Article 33(1), the following point is inserted: (da) combinatorial and accumulated effects.

Or. en

AM\1163538EN.docx 15/151 PE627.946v01-00 EN Amendment 316 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 a (new) Regulation (EC) No 178/2002 Article 33 – paragraph 2

Text proposed by the Commission Amendment

(4a) In Article 33, paragraph 2 is replaced by the following: “For the purposes of paragraph 1, the Authority shall work in close cooperation with all independent organisations operating in the field of data collection, including those from applicant countries, third countries or international bodies.”

Or. en

Justification

new word: “independent “It is not desirable that EFSA relies on non-independent organisations for its data collection activities.

Amendment 317 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 b (new) Regulation (EC) No 178/2002 Article 36 – paragraph 1

Text proposed by the Commission Amendment

(4b) In Article 36, paragraph 1 is replaced by the following: “1. The Authority shall promote the European networking of independent organisations operating in the fields within the Authority’s mission. The aim of such networking is, in particular, to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information,

PE627.946v01-00 16/151 AM\1163538EN.docx EN the development and implementation of joint projects, the exchange of expertise and best practices in the fields within the Authority’s mission.”

Or. en

Justification add “independent “It is not desirable that EFSA coordinate a network where non- independent organisations could be affiliated.

Amendment 318 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 c (new) Regulation (EC) No 178/2002 Article 36 – paragraph 2

Text proposed by the Commission Amendment

(4c) In Article 36, paragraph 2 is replaced by the following: “2. The Management Board, acting on a proposal from the Executive Director, shall draw up a list to be made public of competent independent organisations and public research institutes designated in the Member States by the Commission which may assist the Authority, either individually or in networks, with its mission. The Authority may entrust to these organisations certain tasks, in particular preparatory work for scientific opinions, scientific studies, scientific and technical assistance, collection of data and identification of emerging risks. Some of these tasks may be eligible for financial support.”

Or. en

AM\1163538EN.docx 17/151 PE627.946v01-00 EN Justification

insert: independent; public research institutes; “in the MS” by the “Commission”; “scientific studies “It is desirable that EFSA has a list of public research institutes with which it may collaborate for the realisation on scientific studies, if necessary. The Commission should draw that list, rather than the Member States.

Amendment 319 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 4 d (new) Regulation (EC) No 178/2002 Article 36 – paragraph 3

Text proposed by the Commission Amendment

(4d) In Article 36, paragraph 3 is replaced by following: “3. The Commission shall, after consulting the Authority, adopt delegated acts in accordance with Article 57a in order to supplement this Regulation by laying down rules establishing the criteria for inclusion of a public research institute on the list of competent independent organisations, arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. 3a. The Commission shall, after consulting the Authority, by means of implementing acts lay down implementing rules for the application of paragraphs 1 and 2. Those implementing acts shall be adopted in accordance with Article 58(2).”

Or. en

Justification

new: a public research before institute; independent. It is desirable that EFSA has a network of public research institutes with which it may collaborate for the realisation on scientific studies, if necessary.

PE627.946v01-00 18/151 AM\1163538EN.docx EN Amendment 320 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The Authority shall carry out its activities The Authority shall carry out its activities with a high level of transparency. It shall in with a high level of transparency and particular make public without delay: proactively publish the information in its possession, in line with the Aarhus Convention and Regulation 1367/2006, in particular Article 4. It shall in particular make public without delay:

Or. en

Amendment 321 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The Authority shall carry out its activities The Authority shall ensure a high level of with a high level of transparency. It shall in transparency, in line with the Aarhus particular make public without delay: Convention and Regulation 1367/2006, providing for an active and systematic dissemination to the public of environmental information. It shall in particular make public without delay:

Or. en

Amendment 322 Anja Hazekamp

AM\1163538EN.docx 19/151 PE627.946v01-00 EN Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The Authority shall carry out its activities The Authority shall carry out its activities with a high level of transparency. It shall in with a high level of transparency in line particular make public without delay: with the Aarhus Convention and without prejudice to Regulations (EC) No 1049/2001 and (EC) No 1367/2006 and Directive 2003/4/EC. It shall in particular make public without delay:

Or. en

Justification

The new proposal should enhance transparency, therefore it should not limit the rights deriving from existing EU legislation and International Conventions.

Amendment 323 Pavel Poc, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The Authority shall carry out its activities The Authority shall actively disseminate with a high level of transparency. It shall in the information it possesses to ensure high particular make public without delay: level of transparency in line with the Aarhus Convention and Regulation (EC) No 1367/2006. It shall in particular make public without delay:

Or. en

Amendment 324 Martin Häusling

PE627.946v01-00 20/151 AM\1163538EN.docx EN Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) agendas and minutes of the (a) agendas and minutes of the Scientific Committee and the Scientific Managing Board, the Advisory Panels and their Working Groups; Committee, the Scientific Committee and the Scientific Panels and their Working Groups;

Or. en

Justification

There is no reason for exempting the Managing Board and the Advisory Committee from the transparency requirements on their agendas and minutes.

Amendment 325 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) agendas and minutes of the (a) agendas, participants, observers Scientific Committee and the Scientific and minutes of the Scientific Committee Panels and their Working Groups; and the Scientific Panels and their Working Groups;

Or. en

Amendment 326 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point a

AM\1163538EN.docx 21/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(a) agendas and minutes of the (a) agendas, participants lists, and Scientific Committee and the Scientific minutes of the Scientific Committee and Panels and their Working Groups; the Scientific Panels and their Working Groups;

Or. en

Amendment 327 Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) agendas and minutes of the (a) agendas, participant lists and Scientific Committee and the Scientific minutes of the Scientific Committee and Panels and their Working Groups; the Scientific Panels and their Working Groups;

Or. en

Amendment 328 Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) scientific data, studies and other (c) scientific data, studies and other information supporting applications for information supporting applications for authorisation under Union food law, authorisation under Union food law, including supplementary information including supplementary information supplied by applicants, as well as other supplied by applicants, as well as other scientific data and information supporting scientific data and information supporting requests from the European Parliament, the requests from the European Parliament, the Commission and the Member States for a Commission and the Member States for a

PE627.946v01-00 22/151 AM\1163538EN.docx EN scientific output, including a scientific scientific output, including a scientific opinion, taking into account protection of opinion, taking into account the overriding confidential information and protection of public interest in disclosure and the personal data in accordance with Articles protection of confidential information and 39 to 39f. protection of personal data in accordance with Articles 39 to 39f.

Or. en

Amendment 329 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) scientific data, studies and other (c) scientific data, studies and other information supporting applications for information supporting applications for authorisation under Union food law, authorisation under Union food law, including supplementary information including supplementary information supplied by applicants, as well as other supplied by applicants, as well as other scientific data and information supporting scientific data and information supporting requests from the European Parliament, the requests from the European Parliament, the Commission and the Member States for a Commission and the Member States for a scientific output, including a scientific scientific output, including a scientific opinion, taking into account protection of opinion, in accordance with Regulations confidential information and protection of (EC) No 1049/2001 and (EC) No personal data in accordance with Articles 1367/2006. 39 to 39f.

Or. en

Amendment 330 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point d

AM\1163538EN.docx 23/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(d) the information on which its (d) the information on which its scientific outputs, including scientific scientific outputs, including scientific opinions are based, taking into account opinions, conclusions of pesticides peer protection of confidential data and reviews and reasoned opinions are based, protection of personal data in accordance taking into account protection of with Articles 39 to 39f; confidential data and protection of personal data in accordance with Articles 39 to 39f;

Or. en

Justification

Scientific opinions are produced by scientific panels and scientific committee, but there are others scientific outputs produced by EFSA staff.

Amendment 331 Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) the information on which its (d) the information on which its scientific outputs, including scientific scientific outputs, including scientific opinions are based, taking into account opinions are based, taking into account the protection of confidential data and overriding public interest in disclosure protection of personal data in accordance and the protection of confidential data and with Articles 39 to 39f; protection of personal data in accordance with Articles 39 to 39f;

Or. en

Amendment 332 Renate Sommer

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

PE627.946v01-00 24/151 AM\1163538EN.docx EN Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point h a (new)

Text proposed by the Commission Amendment

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

Or. en

Amendment 333 Lukas Mandl

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – point i

Text proposed by the Commission Amendment

(i) advice provided by the Authority to (i) the general advice provided by the potential applicants at pre-submission Authority to potential applicants at pre- phase pursuant to Article 32a and 32c. submission phase pursuant to Article 32a and 32c.

Or. de

Justification

In order to support the competitiveness and capacity for innovation of SMEs, it is essential for them to receive advice before they lodge an application. The crucial source of costs is often the studies required for the authorisation process. The advice should therefore also cover these aspects in order to avoid unnecessary or misdirected studies.

Amendment 334 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Those items referred to in the first Those items referred to in the first

AM\1163538EN.docx 25/151 PE627.946v01-00 EN subparagraph shall be made public on a subparagraph shall be made public on a dedicated section of the Authority’s dedicated section of the Authority’s website. That section shall be publicly website. That section shall be publicly available and easily accessible. The available and easily accessible subject to relevant items shall be available to clear undertakings recorded electronically download, print and search through in an by those accessing it and subject to electronic format.”, 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 points (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.

Or. en

Justification

The Commission proposal is not sufficiently robust it its protection against commercial use of disclosed information. It is possible to improve transparency and sustainability of the EU risk assessment process without facilitating misuse by commercial parties of information for their own commercial ends. Such unfair competition would be inconsistent with recent EU policy to create “A renewed EU Industrial Policy Strategy”, COM(2017) 479 final .

Amendment 335 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 2

PE627.946v01-00 26/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

Those items referred to in the first Those items referred to in the first subparagraph shall be made public on a subparagraph shall be made public on a dedicated section of the Authority’s dedicated section of the Authority’s website. That section shall be publicly website. That section shall be publicly available and easily accessible. The available and easily accessible. The relevant items shall be available to relevant items shall be available to download, print and search through in an download, print watermarked for electronic format.”, tractability and search through in an electronic format. The dedicated section of the Authority’s website will include necessary measures to protect against non-permitted use, such as for commercial purposes. Measures and penalties which are effective and proportionate should be introduced in cases of non-permitted use of documents. Protective measures will be designed to protect effectively against commercial use both within in the Union and in third- countries.”

Or. en

Justification

The disclosure of information should ensure easy access to information whilst ensuring that the data provider is protected against non-permitted use of this data by competitors. Sanctions for misuse should also be enforceable.

Amendment 336 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Those items referred to in the first Those items referred to in the first subparagraph shall be made public on a subparagraph shall be made public in a dedicated section of the Authority’s structured way on a dedicated section of website. That section shall be publicly the Authority’s website. That section shall

AM\1163538EN.docx 27/151 PE627.946v01-00 EN available and easily accessible. The be publicly available, easily accessible, relevant items shall be available to and regularly updated. The relevant items download, print and search through in an shall be available to download, print and electronic format.”, search through in an electronic format, which is “machine-readable.”

Or. en

Amendment 337 Pavel Poc, Nicola Caputo, Jytte Guteland, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point a Regulation (EC) No 178/2002 Article 38 – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Those items referred to in the first Those items referred to in the first subparagraph shall be made public on a subparagraph shall be made public on a dedicated section of the Authority’s dedicated section of the Authority’s website. That section shall be publicly website. That section shall be publicly available and easily accessible. The available and easily accessible. The relevant items shall be available to relevant items shall be available to download, print and search through in an download, print and search through in an electronic format. electronic and as appropriate machine- readable format.

Or. en

Amendment 338 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1

Text proposed by the Commission Amendment

The disclosure of the information The disclosure of the information mentioned in paragraph (1)(c) to the public mentioned in paragraph (1)(c) to the public shall be without prejudice: shall take into account the Union’s interest to promote access to environmental information in accordance

PE627.946v01-00 28/151 AM\1163538EN.docx EN with Regulation (EC) No 1367/2002 on the application of the provisions of the Aarhus Convention, in particular when information relates to emissions in the environment.

Or. en

Amendment 339 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – introductory part

Text proposed by the Commission Amendment

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

Or. en

Justification

For readability: (c) authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests, (d) the information on which its scientific outputs, including scientific opinions are based, (i) advice provided by the Authority to potential applicants at pre- submission phase pursuant to Article 32a and 32c.

Amendment 340 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – introductory part

Text proposed by the Commission Amendment

The disclosure of the information The disclosure of the information mentioned in paragraph (1)(c) to the public mentioned in paragraph (1)(c), (d) and (i)

AM\1163538EN.docx 29/151 PE627.946v01-00 EN shall be without prejudice: to the public shall be without prejudice:

Or. en

Amendment 341 Lukas Mandl

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – introductory part

Text proposed by the Commission Amendment

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

Or. de

Amendment 342 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1 – point a

Text proposed by the Commission Amendment

(a) to any intellectual property right deleted which may exist over documents or their content; and,

Or. en

Justification

There is no reason to put the whole disclosure requirements with reservation as regards intellectual property rights (IPR). Moreover, there is no need to refer to IPR at this point: ‘Hard IPRs’, such as patents, copyrights or trademarks will already be protected under Article 38.1a (b). ‘Soft IPRs’ (trade secrets) will be covered by Article 39(2).

PE627.946v01-00 30/151 AM\1163538EN.docx EN Amendment 343 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1 – point a

Text proposed by the Commission Amendment

(a) to any intellectual property right deleted which may exist over documents or their content; and,

Or. en

Amendment 344 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1 – point a

Text proposed by the Commission Amendment

(a) to any intellectual property right deleted which may exist over documents or their content; and,

Or. en

Justification

Article 39(2) is meant to be an exhaustive list of information which may be claimed confidential because commercially sensitive. Thus, leaving Article 38(1a)a in the text may lead to misinterpretation.

Amendment 345 Anja Hazekamp

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

AM\1163538EN.docx 31/151 PE627.946v01-00 EN Regulation (EC) No 178/2002 Article 38 – paragraph 1a – subparagraph 1 – point a

Text proposed by the Commission Amendment

(a) to any intellectual property right deleted which may exist over documents or their content; and,

Or. en

Amendment 346 Lukas Mandl

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1 – point a

Text proposed by the Commission Amendment

(a) to any intellectual property right (a) to any intellectual property right, which may exist over documents or their and the protection of business secrets as content; and, referred to in Directive (EU) 2016/943, which may exist in relation to documents or their content; and,

Or. de

Justification

Business secrets as referred to in Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure must not be allowed to enter the public domain. The intellectual property of SMEs, in particular, is often inadequately protected. Business secrets as referred to in Directive (EU) 2016/943 should therefore be protected as fully as possible, both in connection with the publication of studies and in the provision of advice.

Amendment 347 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1 – point b

PE627.946v01-00 32/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

(b) any provisions set out in Union deleted food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules’).

Or. en

Amendment 348 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 1 – point b

Text proposed by the Commission Amendment

(b) any provisions set out in Union (b) any provisions set out in Union food law protecting the investment made food law giving the temporary right of the by innovators in gathering the owner of a test or study report to prevent it information and data supporting relevant being used for the benefit of another applications for authorisations (‘data applicant (‘data exclusivity rules’). exclusivity rules’).

Or. en

Amendment 349 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 2

Text proposed by the Commission Amendment

The disclosure to the public of the The disclosure to the public of the information mentioned in paragraph (1)(c) information mentioned in paragraph (1)(c), shall not be considered as an explicit or (d) and (i) shall not be considered as an implicit permission or license for the explicit or implicit permission or license

AM\1163538EN.docx 33/151 PE627.946v01-00 EN relevant data and information and their for the relevant data and information and content to be used, reproduced, or their content to be used, reproduced, or otherwise exploited and its use by third otherwise exploited and its use by third parties shall not engage the responsibility parties shall not engage the responsibility of the European Union. 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.

Or. en

Justification

See above.

Amendment 350 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 2

Text proposed by the Commission Amendment

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

PE627.946v01-00 34/151 AM\1163538EN.docx EN Or. en

Justification

For readability: (c) authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests, (d) the information on which its scientific outputs, including scientific opinions are based, (i) advice provided by the Authority to potential applicants at pre- submission phase pursuant to Article 32a and 32c.

Amendment 351 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point b Regulation (EC) No 178/2002 Article 38 – paragraph 1 a – subparagraph 2

Text proposed by the Commission Amendment

The disclosure to the public of the The disclosure to the public of the information mentioned in paragraph (1)(c) information mentioned in paragraph (1)(c) shall not be considered as an explicit or shall not be considered as an explicit or implicit permission or license for the implicit permission or license for the relevant data and information and their relevant data and information and their content to be used, reproduced, or content to be used, reproduced, or otherwise exploited and its use by third otherwise exploited for commercial parties shall not engage the responsibility purposes and its use by third parties shall of the European Union. not engage the responsibility of the European Union.

Or. en

Justification

It must be possible for independent scientists to use relevant data or reproduce relevant studies. To be 100% safe, it could be discussed (EMA example) to apply a watermark to the published information to emphasise the prohibition of its use for commercial purposes.

Amendment 352 Renate Sommer

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

AM\1163538EN.docx 35/151 PE627.946v01-00 EN Regulation (EC) No 178/2002 Article 38 – paragraph 1 b (new)

Text proposed by the Commission Amendment

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.

Or. en

Justification

Feedback should be provided on the effectiveness of measures and penalties within a relatively short period so that any necessary amendments to the system of disclosure and confidential business information (“CBI”) protection can be amended as appropriate.

Amendment 353 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 5 – point c a (new) Regulation (EC) No 178/2002 Article 38 – paragraph 3 a (new)

Text proposed by the Commission Amendment

(ca) The following paragraph is added: “3a. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information justification and to Regulation (EC) No 1049/2001 and Regulation (EC) No 1367/2006.”

PE627.946v01-00 36/151 AM\1163538EN.docx EN Or. en

Amendment 354 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 5 a (new) Regulation (EC) No 178/2002 Article 38 a (new)

Text proposed by the Commission Amendment

(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

AM\1163538EN.docx 37/151 PE627.946v01-00 EN 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.”

Or. en

Justification

The author introduces a three-step-approach in order to improve transparency of the risk assessment procedure based on the guidelines on EFSA Consultations that the authority already uses for substances that are not subject to an official application procedure (e.g. aspartame, BPA, caffeine). Using this method provides a good balance between the need to protect commercial interests of applicants and the need to increase transparency, visibility and openness of the scientific risk assessment towards stakeholders.

Amendment 355 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – title

PE627.946v01-00 38/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

Confidentiality Limitations to transparency

Or. en

Amendment 356 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 1

Text proposed by the Commission Amendment

1. By way of derogation from Article 1. By way of derogation from Article 38, the Authority shall not make public 38 and without prejudice to Regulation information for which confidential (EC) No 1049/2001, the Authority shall treatment has been requested under the not make public information for which conditions laid down in this Article. confidential treatment has been requested under the conditions laid down in this Article.

Or. en

Amendment 357 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 1

Text proposed by the Commission Amendment

1. By way of derogation from Article 1. By way of derogation from Article 38, the Authority shall not make public 38, the Authority shall not make public information for which confidential information for which confidential treatment has been requested under the treatment has been granted under the conditions laid down in this Article. conditions laid down in this Article.

Or. en

AM\1163538EN.docx 39/151 PE627.946v01-00 EN Amendment 358 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – introductory part

Text proposed by the Commission Amendment

2. The Authority may only accept to 2. The Authority may accept to provide confidential treatment in relation to provide confidential treatment, unless the following information, the disclosure there is an overriding public interest in of which may be deemed, upon verifiable disclosure, if in relation to the following justification, to significantly harm the information, the request for confidential interests concerned: treatment from the applicant demonstrates, for each item of information, with adequate and verifiable justification, that the publication would significantly, specifically and actually harm the commercial interest concerned,

Or. en

Amendment 359 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – introductory part

Text proposed by the Commission Amendment

2. The Authority may only accept to 2. The Authority may only accept to provide confidential treatment in relation to provide confidential treatment in relation to the following information, the disclosure the following information, and provided of which may be deemed, upon verifiable that the request for confidential treatment justification, to significantly harm the demonstrates, with adequate and interests concerned: verifiable justification, that disclosure would significantly, specifically and actually, harm the commercial interest of the applicant:

Or. en

PE627.946v01-00 40/151 AM\1163538EN.docx EN Amendment 360 Pavel Poc, Jytte Guteland, Nicola Caputo, Martin Häusling, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – introductory part

Text proposed by the Commission Amendment

2. The Authority may only accept to 2. The Authority may only accept to provide confidential treatment in relation to provide confidential treatment in relation to the following information, the disclosure the following information, and provided of which may be deemed, upon verifiable that the request for confidential treatment justification, to significantly harm the demonstrates, with adequate and interests concerned: verifiable justification, that disclosure would specifically and significantly harm the commercial interest of the applicant:

Or. en

Amendment 361 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – introductory part

Text proposed by the Commission Amendment

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

Or. en

Justification

The Commission proposal reverses the burden proof for certain key pieces of information

AM\1163538EN.docx 41/151 PE627.946v01-00 EN which have long been acknowledged to constitute confidential business information (“CBI”), in EU sectoral legislation falling within Union food law. It does so without providing an explanation of this significant change. This unjustified reversal should be corrected.

Amendment 362 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – introductory part

Text proposed by the Commission Amendment

2. The Authority may only accept to 2. The Authority may only accept to provide confidential treatment in relation to provide confidential treatment in relation to the following information, the disclosure of the following information, the disclosure of which may be deemed, upon verifiable which it concludes, upon verifiable justification, to significantly harm the justification, would significantly harm the interests concerned: interests concerned:

Or. en

Amendment 363 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1

Text proposed by the Commission Amendment

(1) the method and other technical deleted 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;

Or. en

PE627.946v01-00 42/151 AM\1163538EN.docx EN Amendment 364 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1

Text proposed by the Commission Amendment

(1) the method and other technical and (1) the method and other technical and industrial specifications relating to that industrial specifications relating to that method, used to manufacture or produce method, used to manufacture or produce the subject matter of the request for a the subject matter of the request for a scientific output, including a scientific scientific output, including a scientific opinion; opinion, provided that the applicant demonstrates with verifiable justification that such method does not entail information about emissions in the environment and about impacts on health and environment;

Or. en

Amendment 365 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1

Text proposed by the Commission Amendment

(1) the method and other technical and (1) the method and other technical and industrial specifications relating to that industrial specifications relating to that method, used to manufacture or produce method, used to manufacture or produce the subject matter of the request for a the subject matter of the request for a scientific output, including a scientific scientific output, including a scientific opinion; 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;

Or. en

AM\1163538EN.docx 43/151 PE627.946v01-00 EN Amendment 366 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1

Text proposed by the Commission Amendment

(1) the method and other technical and (1) the method and other technical and industrial specifications relating to that industrial specifications relating to that method, used to manufacture or produce method, used to manufacture or produce the subject matter of the request for a the subject matter of the request for a scientific output, including a scientific scientific output, including a scientific opinion; opinion, except when relevant to understanding the potential effects on health and the environment;

Or. en

Amendment 367 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 1

Text proposed by the Commission Amendment

(1) the method and other technical and (1) the method and other technical and industrial specifications relating to that industrial specifications relating to that method, used to manufacture or produce method, used to manufacture or produce the subject matter of the request for a the subject matter of the request for a scientific output, including a scientific scientific output; opinion;

Or. en

Amendment 368 Anja Hazekamp

PE627.946v01-00 44/151 AM\1163538EN.docx EN Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 2

Text proposed by the Commission Amendment

(2) commercial links between a deleted producer or importer and the applicant or the authorisation holder, where applicable;

Or. en

Amendment 369 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 3

Text proposed by the Commission Amendment

(3) commercial information revealing deleted sourcing, market shares or business strategy of the applicant; and,

Or. en

Amendment 370 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 3

Text proposed by the Commission Amendment

(3) commercial information revealing (3) commercial information revealing sourcing, market shares or business sourcing, market shares, innovative strategy of the applicant; and, product ideas or business strategy and trade secrets of the applicant in the meaning of Article 2 (1) of Directive (EU)

AM\1163538EN.docx 45/151 PE627.946v01-00 EN 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.

Or. en

Justification

Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure applies to trade secrets and should be fully applied in the context of the decision for keeping certain information eligible for confidential treatment.

Amendment 371 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 4

Text proposed by the Commission Amendment

(4) quantitative composition of the deleted subject matter of the request for a scientific output, including a scientific opinion.

Or. en

Amendment 372 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 4

Text proposed by the Commission Amendment

(4) quantitative composition of the deleted

PE627.946v01-00 46/151 AM\1163538EN.docx EN subject matter of the request for a scientific output, including a scientific opinion.

Or. en

Amendment 373 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 4

Text proposed by the Commission Amendment

(4) quantitative composition of the (4) quantitative composition of the subject matter of the request for a scientific subject matter of the request for a scientific output, including a scientific opinion. output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment.

Or. en

Amendment 374 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 – point 4

Text proposed by the Commission Amendment

(4) quantitative composition of the (4) quantitative composition of the subject matter of the request for a scientific subject matter of the request for a scientific output, including a scientific opinion. output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment.

Or. en

AM\1163538EN.docx 47/151 PE627.946v01-00 EN Amendment 375 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 2 a (new)

Text proposed by the Commission Amendment

2a. These derogations shall be construed restrictively.

Or. en

Amendment 376 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 3

Text proposed by the Commission Amendment

3. The list of information referred to 3. The list of information referred to in paragraph 2 shall be without prejudice to in paragraph 2 shall not preclude a request any specific Union food law. 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.

Or. en

Justification

The Commission proposal reduces the information for which confidential treatment may be requested to an exhaustive list of information. The effect is that it no longer allows decisions on disclosure taken by EFSA to consider the individual circumstances of each case. This contrasts sharply with Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and Commission documents - which also applies to documents held by EFSA.

PE627.946v01-00 48/151 AM\1163538EN.docx EN Amendment 377 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – introductory part

Text proposed by the Commission Amendment

4. Notwithstanding paragraphs 2 and 4. The Authority shall not provide 3, the following information shall confidential treatment to the following nevertheless be made public: information:

Or. en

Amendment 378 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) Where there is an overriding protect public health, animal health or the public interest in disclosure, environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,

Or. en

Amendment 379 Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

AM\1163538EN.docx 49/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) Information relating to human protect public health, animal health or the health, animal health or the environment, environment, such as in emergency including emergency situations, or situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,

Or. en

Amendment 380 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) Information that may be deemed protect public health, animal health or the essential to protect public health, animal environment, such as in emergency health or the environment, such as in situations, the Authority may disclose the emergency situations information referred to paragraphs 2 and 3; and,

Or. en

Amendment 381 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) Where urgent action is essential to protect public health, animal health or the protect public health, animal health or the environment, such as in emergency environment, such as in emergency situations, the Authority may disclose the situations, the Authority may disclose the

PE627.946v01-00 50/151 AM\1163538EN.docx EN information referred to paragraphs 2 and 3; information referred to paragraphs 2 and 3; and, or,

Or. en

Amendment 382 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) Where timely action is essential to protect public health, animal health or the protect public health, animal health or the environment, such as in emergency environment, the Authority shall disclose situations, the Authority may disclose the the information referred to paragraphs 2 information referred to paragraphs 2 and 3; and 3; and, and,

Or. en

Amendment 383 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) Where action is essential to protect protect public health, animal health or the public health, animal health or the environment, such as in emergency environment, including in emergency situations, the Authority may disclose the situations, the Authority will disclose any information referred to paragraphs 2 and information necessary; 3; and,

Or. en

AM\1163538EN.docx 51/151 PE627.946v01-00 EN Amendment 384 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) Where urgent action is essential to (a) If circumstances so require in protect public health, animal health or the order to protect human health, animal environment, such as in emergency health or the environment, the Authority situations, the Authority may disclose the shall disclose the information referred to information referred to paragraphs 2 and 3; paragraphs 2 and 3; and, and,

Or. en

Justification

It is not acceptable that information relevant for health or environmental protection is only disclosed when an actual danger has already appeared. The current rules in both the GMO (“If circumstances so require in order to protect human health, animal health or the environment”) and in the Pesticides Regulation (“Where there is an overriding public interest in disclosure”) go much further than restricting the safeguard to emergency situations only. The new proposal would thus lead to a decreased level of transparency, which is not acceptable.

Amendment 385 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b

Text proposed by the Commission Amendment

(b) information which forms part of (b) information which forms part of conclusions of scientific outputs, including conclusions of scientific outputs, including scientific opinions, delivered by the scientific opinions, delivered by the Authority and which relate to foreseeable Authority and which relate to foreseeable health effects. (human and animal) health effects and/ or environmental impacts.

PE627.946v01-00 52/151 AM\1163538EN.docx EN Or. en

Amendment 386 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b

Text proposed by the Commission Amendment

(b) information which forms part of (b) information which forms part of conclusions of scientific outputs, including conclusions of scientific outputs, including scientific opinions, delivered by the scientific opinions, delivered by the Authority and which relate to foreseeable Authority and which relate to foreseeable health effects. effects on human health, biodiversity or the environment.

Or. en

Amendment 387 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b

Text proposed by the Commission Amendment

(b) information which forms part of (b) information which forms part of conclusions of scientific outputs, including conclusions of scientific outputs, including scientific opinions, delivered by the scientific opinions, delivered by the Authority and which relate to foreseeable Authority and which relate to foreseeable health effects. human health, animal health, or environmental effects.

Or. en

Justification

The legislation covered by this proposal does not relate to human health only, but also to legislation in the fields of pesticides, GMOs or animal health.

AM\1163538EN.docx 53/151 PE627.946v01-00 EN Amendment 388 Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b

Text proposed by the Commission Amendment

(b) information which forms part of (b) information which forms part of conclusions of scientific outputs, including conclusions of scientific outputs, including scientific opinions, delivered by the scientific opinions, delivered by the Authority and which relate to foreseeable Authority. health effects.

Or. en

Amendment 389 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point ba (new)

Text proposed by the Commission Amendment

(ba) any information for which there is an overriding public interest in disclosure as per Article 4(2) of Regulation 1049/2001 and Article 6 of Regulation 1367/2006, in particular where the information relates to emissions into the environment.

Or. en

Amendment 390 Martin Häusling

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

PE627.946v01-00 54/151 AM\1163538EN.docx EN Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b a (new)

Text proposed by the Commission Amendment

(ba) where an overriding public interest in disclosure exists.

Or. en

Justification

This provision is, already today, included in the pesticides Regulation, and should not be abolished.

Amendment 391 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b a (new)

Text proposed by the Commission Amendment

(ba) when an overriding public interest in the disclosure exists.

Or. en

Amendment 392 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 – point b a (new)

Text proposed by the Commission Amendment

(ba) information relating to potential emissions in the environment.

Or. en

AM\1163538EN.docx 55/151 PE627.946v01-00 EN Amendment 393 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 6 Regulation (EC) No 178/2002 Article 39 – paragraph 4 a (new)

Text proposed by the Commission Amendment

4a. This provision is without prejudice to Directive 2003/4/EC and Regulations (EC) No 1049/2001 and (EC) No 1367/2006.

Or. en

Amendment 394 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 a – paragraph 1

Text proposed by the Commission Amendment

1. When submitting an application deleted 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 request shall be accompanied by verifiable justification demonstrating how making public the information concerned significantly harms the interests concerned in accordance with paragraphs 2 and 3 of Article 39.

Or. en

PE627.946v01-00 56/151 AM\1163538EN.docx EN Amendment 395 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 a – paragraph 1

Text proposed by the Commission Amendment

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

Or. en

Amendment 396 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 a – paragraph 2

Text proposed by the Commission Amendment

2. Where an applicant submits a 2. Where an applicant submits a request for confidentiality, it shall provide request for confidentiality, it shall provide a non-confidential version and a a non-confidential version and a confidential version of the information confidential version of the information submitted in accordance with standard data submitted in accordance with standard data formats, where they exist, pursuant to formats, where they exist, pursuant to Article 39f. The non-confidential version Article 39f. The non-confidential version shall be without the information the shall be without the information the applicant deems confidential in accordance applicant requests confidential treatment with paragraphs 2 and 3 of Article 39. The for in accordance with paragraphs 2 and 3

AM\1163538EN.docx 57/151 PE627.946v01-00 EN confidential version shall contain all of Article 39. This information shall be information submitted, including garbled by black bars. The confidential information the applicant deems version shall contain all information confidential. Information requested to be submitted, including information the treated as confidential in the confidential applicant considers confidential. version shall be clearly marked. The Information requested to be treated as applicant shall clearly indicate the grounds confidential in the confidential version on the basis of which confidentiality is shall be clearly marked. The applicant shall requested for the different pieces of clearly indicate the verifiable justifications information. on the basis of which confidentiality is requested for each of the different pieces of information.

Or. en

Justification

It is important to state how the information the applicant considers to be confidential must be treated. Using black bars is an easy and acknowledged way and permits to assess at least the amount of information which is to be kept confidential.

Amendment 397 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 a – paragraph 2

Text proposed by the Commission Amendment

2. Where an applicant submits a 2. Where an applicant submits a request for confidentiality, it shall provide request for confidentiality, it shall provide a non-confidential version and a a non-confidential version and a confidential version of the information confidential version of the information submitted in accordance with standard data submitted in accordance with standard data formats, where they exist, pursuant to formats, where they exist, pursuant to Article 39f. The non-confidential version Article 39f. The non-confidential version shall be without the information the shall redact with back bars the information applicant deems confidential in accordance the applicant requests the confidential with paragraphs 2 and 3 of Article 39. The treatment of, in accordance with confidential version shall contain all paragraphs 2 and 3 of Article 39. The information submitted, including confidential version shall contain all information the applicant deems information submitted, including confidential. Information requested to be information the applicant considers treated as confidential in the confidential confidential. Information requested to be

PE627.946v01-00 58/151 AM\1163538EN.docx EN version shall be clearly marked. The treated as confidential in the confidential applicant shall clearly indicate the grounds version shall be clearly marked. The on the basis of which confidentiality is applicant shall clearly indicate the requested for the different pieces of verifiable justifications and evidence on information. the basis of which confidentiality is requested for each of the different pieces of information.

Or. en

Amendment 398 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 a – paragraph 2

Text proposed by the Commission Amendment

2. Where an applicant submits a 2. Where an applicant submits a request for confidentiality, it shall provide request for confidentiality, it shall provide a non-confidential version and a a non-confidential version and a confidential version of the information confidential version of the information submitted in accordance with standard data submitted in accordance with standard data formats, where they exist, pursuant to formats, where they exist, pursuant to Article 39f. The non-confidential version Article 39f. The non-confidential version shall be without the information the shall hide in black the information the applicant deems confidential in accordance applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39. The with paragraphs 2 and 3 of Article 39. The confidential version shall contain all confidential version shall contain all information submitted, including information submitted, including information the applicant deems information the applicant deems confidential. Information requested to be confidential. Information requested to be treated as confidential in the confidential treated as confidential in the confidential version shall be clearly marked. The version shall be clearly marked. The applicant shall clearly indicate the grounds applicant shall clearly indicate the grounds on the basis of which confidentiality is on the basis of which confidentiality is requested for the different pieces of requested for the different pieces of information. information.

Or. en

Justification

In order to have a continuity and understanding of the rest of the text, only the confidential

AM\1163538EN.docx 59/151 PE627.946v01-00 EN parts shall be hidden.

Amendment 399 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 a – paragraph 2 a (new)

Text proposed by the Commission Amendment

2a. The Authority shall keep a record of requests for confidentiality received, and annually publish statistics about the amounts and categories of information for which confidentiality has been requested. It shall specify amounts and categories of information for which confidentiality request have been granted as well as for which it has been rejected, including the grounds on the basis of which confidentiality has been granted or rejected.

Or. en

Amendment 400 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) inform the applicant in writing of (c) inform the applicant in writing of its intention to disclose information and the its intention to disclose information and the reasons for it, before the Authority reasons for it, before the Authority formally takes a decision on the formally takes a decision on the confidentiality request. If the applicant confidentiality request. If the applicant disagrees with the assessment of the disagrees with the assessment of the Authority it may state its views or Authority it may (1) state its views, (2) withdraw its application within two weeks withdraw its application, or (3) request a

PE627.946v01-00 60/151 AM\1163538EN.docx EN from the date on which it was notified of review to the EFSA Board of Appeal the Authority’s position. within four weeks from the date on which it was notified of the Authority’s position. The applicant may provide written notice to the Authority that he wishes to request a re-examination of the opinion to the EFSA Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the EFSA Board of Appeal shall re-examine its opinion.

Or. en

Justification

Both EMA and EFSA has a Board of Appeal of some sort. This is to provide the applicant the possibility for a re-examination of the opinion. The Commission should, by means of a delegated act, set up this same possibility in EFSA.

Amendment 401 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) make public any additional data (e) publish non-confidential data and and information for which the information relating to the application confidentiality request has not been only once a final decision has been taken accepted as justified not earlier than two in respect of the confidentiality request weeks after the notification of its decision pursuant to this Article and the Authority to the applicant has taken place, pursuant has published its draft scientific opinion to point (d). 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

AM\1163538EN.docx 61/151 PE627.946v01-00 EN on the application for authorisation.

Or. en

Justification

Scientific data and studies and any other information supporting applications should be made public only once the Authority publishes its draft scientific opinion in accordance with Article 38. Otherwise, there is a risk that competitors gain access to information about innovative product ideas or manufacturing processes. Moreover, there would be the danger of political interference in the risk assessment process. If a company withdraws its application there is no need to publish all the information.

Amendment 402 Christofer Fjellner

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) make public any additional data (e) make public non-confidential data and information for which the and information relating to the application confidentiality request has not been only once a final decision has been taken accepted as justified not earlier than two in respect of the confidentiality request weeks after the notification of its decision pursuant to this Article and the Authority to the applicant has taken place, pursuant has published its scientific opinion. to point (d). 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.

Or. en

Amendment 403 Guillaume Balas

PE627.946v01-00 62/151 AM\1163538EN.docx EN Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) make public any additional data and (e) make public any additional data and information for which the confidentiality information for which the confidentiality request has not been accepted as justified request has not been accepted as justified not earlier than two weeks after the not earlier than two weeks and no later notification of its decision to the applicant than four weeks after the notification of its has taken place, pursuant to point (d). decision to the applicant has taken place, pursuant to point (d).

Or. en

Amendment 404 Fredrick Federley

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) make public any additional data and (e) make public any additional data and information for which the confidentiality information for which the confidentiality request has not been accepted as justified request has not been accepted as justified not earlier than two weeks after the not earlier than four weeks after the notification of its decision to the applicant notification of its decision to the applicant has taken place, pursuant to point (d). has taken place, pursuant to point (d).

Or. en

Amendment 405 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1– point e a (new)

AM\1163538EN.docx 63/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(ea) In case the Authority considers that the applicant misuses of the confidentiality claims, a proportionate, effective and dissuasive fine maybe charged for the additional administrative burden creating by respective application.

Or. en

Amendment 406 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Decisions taken by the Authority pursuant deleted to this Article may be subject to an action before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively.

Or. en

Amendment 407 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Decisions taken by the Authority pursuant Decisions taken by the Authority pursuant to this Article may be subject to an action to this Article may be subject to an action before the Court of Justice of the European before the Authority Board of Appeal, Union, under the conditions laid down in which will be established by means of

PE627.946v01-00 64/151 AM\1163538EN.docx EN Articles 263 and 278 of the Treaty delegated acts. Those delegated acts shall respectively. be adopted in accordance with Article 57a of this Regulation. A submission of an appeal pursuant to this paragraph shall have suspensive effect. The applicant may provide written notice to the Authority that he wishes to request a re-examination of the opinion to the EFSA Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the EFSA Board of Appeal shall re-examine its opinion. In case of a contesting decision taken by the EFSA Board of appeal, a case may be brought before the Court of Justice of the European Union under the conditions laid down in Articles 263 of the Treaty.

Or. en

Justification

Both EMA and EFSA has a Board of Appeal of some sort. This is to provide the applicant the possibility for a re-examination of the opinion. The Commission should, by means of a delegated act, set up this same possibility in EFSA. This will render the system more efficient than waiting for a decision by the CoJ.

Amendment 408 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Decisions taken by the Authority pursuant Decisions taken by the Authority pursuant to this Article may be subject to an action to this Article may be subject to an action before the Court of Justice of the European of any natural or legal person before the Union, under the conditions laid down in Court of Justice of the European Union, Articles 263 and 278 of the Treaty under the conditions laid down in Articles respectively. 263 and 278 of the Treaty respectively.

AM\1163538EN.docx 65/151 PE627.946v01-00 EN Or. en

Justification

Any decisions might be appealed before the ECJ, both by companies, as well as by any natural person with regard to EFSA’s decision on confidentiality requests.

Amendment 409 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 b – paragraph 1 – subparagraph 2

Text proposed by the Commission Amendment

Decisions taken by the Authority pursuant The Authority may charge a fine for the to this Article may be subject to an action unnecessary burden created by abusive before the Court of Justice of the confidentiality claims from the applicant. European Union, under the conditions The fine should be effective, laid down in Articles 263 and 278 of the proportionate and dissuasive. Treaty respectively.

Or. en

Amendment 410 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 c

Text proposed by the Commission Amendment

Before the Authority issues its scientific Before the Authority issues its scientific outputs, including scientific opinions, it outputs, including scientific opinions, it shall review whether information that has shall review whether information that has been previously accepted as confidential been previously accepted as confidential may nevertheless be made public in shall nevertheless be made public in accordance with paragraph 4(b) of Article accordance with paragraph 4(b) and (c) of 39. Should that be the case, the Authority Article 39. Should that be the case, the shall follow the procedure laid down in Authority shall follow the procedure laid Article 39b, which shall apply mutatis down in Article 39b, which shall apply

PE627.946v01-00 66/151 AM\1163538EN.docx EN mutandis. mutatis mutandis.

Or. en

Amendment 411 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 d – paragraph 2

Text proposed by the Commission Amendment

2. The Commission and the Member 2. The Commission and the Member States shall take the necessary measures so States shall take the necessary measures so that information received by them under that information received by them under Union food law for which confidential Union food law for which confidential treatment has been requested is not made treatment has been requested is not made public until a decision on the public until a decision on the confidentiality request has been taken by confidentiality request has been taken by the Authority and has become definitive. the Authority and has become definitive, The Commission and the Member States except for when access to information is shall also take the necessary measures so requested in accordance with directive that information for which confidential 2003/4/EC or national law on access to treatment has been accepted by the documents. The Commission and the Authority is not made public. 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, except for when access to information is requested in accordance with directive 2003/4/EC or national law on access to documents.

Or. en

Justification

Clarification needs to be made regarding when EFSA:s obligation to confidentiality decision applies, notably only when the authorities proactively publish information. When access to information is requested, an individual assessment must be made, even if the institution previously have decided on confidentiality.

AM\1163538EN.docx 67/151 PE627.946v01-00 EN Amendment 412 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 d – paragraph 2

Text proposed by the Commission Amendment

2. The Commission and the Member 2. The Commission and the Member States shall take the necessary measures so States shall take the necessary measures so that information received by them under that information received by them under Union food law for which confidential Union food law for which confidential treatment has been requested is not made treatment has been requested is not made public until a decision on the public until a decision on the confidentiality request has been taken by confidentiality request has been taken by the Authority and has become definitive. the Authority and has become definitive, The Commission and the Member States unless it concerns information that may shall also take the necessary measures so be deemed essential to protect public that information for which confidential health, animal health or it is clear that treatment has been accepted by the such information relates to emissions in Authority is not made public. the environment. 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.

Or. en

Amendment 413 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 d – paragraph 2

Text proposed by the Commission Amendment

2. The Commission and the Member 2. The Commission and the Member States shall take the necessary measures so States shall take the necessary measures so that information received by them under that information received by them under Union food law for which confidential Union food law for which confidential treatment has been requested is not made treatment has been requested is not made public until a decision on the public until a decision on the

PE627.946v01-00 68/151 AM\1163538EN.docx EN confidentiality request has been taken by confidentiality request has been taken by the Authority and has become definitive. the Authority and its draft scientific The Commission and the Member States opinion has been published in line with shall also take the necessary measures so Article 38. The Commission and the that information for which confidential Member States shall also take the treatment has been accepted by the necessary measures so that information for Authority is not made public. which confidential treatment has been accepted by the Authority is not made public.

Or. en

Amendment 414 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 d – paragraph 3

Text proposed by the Commission Amendment

3. If an applicant in the context of an 3. If an applicant in the context of an authorisation procedure withdraws or has authorisation procedure withdraws or has withdrawn an application, the Authority, withdrawn an application, the Authority, the Commission and the Member States the Commission and the Member States shall respect the confidentiality of shall respect the confidentiality of commercial and industrial information as commercial and industrial information as accepted by the Authority in accordance accepted by the Authority in accordance with Articles 39to 39f. The application with Articles 39to 39f. The application shall be considered withdrawn as of the shall be considered withdrawn as of the moment the written request is received by moment the written request is received by the competent body that had received the the competent body that had received the original application. Where the withdrawal original application. The Authority shall of the application takes place before the not publish any information, confidential Authority has decided on the relevant or non-confidential, should an applicant confidentiality request, the Authority, the decide to withdraw its application. Commission and the Member States shall not make public the information for which confidentiality has been requested.

Or. en

Amendment 415 Anja Hazekamp

AM\1163538EN.docx 69/151 PE627.946v01-00 EN Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 e – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) the names of all participants in (c) the names of all participants and meetings of the Scientific Committee and observers in meetings of the Scientific the Scientific Panels and their Working Committee and the Scientific Panels, their Groups. Working Groups and any other ad hoc Group meeting on the subject..

Or. en

Amendment 416 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 e – paragraph 2

Text proposed by the Commission Amendment

2. Notwithstanding paragraph 1, 2. Notwithstanding paragraph 1, disclosure of names and addresses of disclosure of names and addresses of natural persons involved in testing on natural persons involved in testing on vertebrate animals or in obtaining vertebrate animals shall be deemed to toxicological information shall be deemed significantly harm the privacy and the to significantly harm the privacy and the integrity of those natural persons and shall integrity of those natural persons and shall not be made publicly available, unless not be made publicly available, unless there is an overriding public interest. there is an overriding public interest.

Or. en

Amendment 417 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 e – paragraph 2

PE627.946v01-00 70/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

2. Notwithstanding paragraph 1, 2. Notwithstanding paragraph 1, disclosure of names and addresses of disclosure of names and addresses of natural persons involved in testing on natural persons involved in testing on vertebrate animals or in obtaining vertebrate animals shall be deemed to toxicological information shall be deemed significantly harm the privacy and the to significantly harm the privacy and the integrity of those natural persons and shall integrity of those natural persons and shall not be made publicly available, unless not be made publicly available, unless there is an overriding public interest. there is an overriding public interest.

Or. en

Justification

Including persons involved in obtaining toxicological information would enlarge the exemption enormously. In particular, it must be clear that the name of authors of the toxicological studies can never be kept confidential. There is no reason to include them; on the contrary, in order to foster excellent research it is necessary to identify authors of studies.

Amendment 418 Renate Sommer

Proposal for a regulation Article 1 – paragraph 1 – point 7 Regulation (EC) No 178/2002 Article 39 f – paragraph 2 a (new)

Text proposed by the Commission Amendment

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.

Or. en

Amendment 419 Anja Hazekamp

AM\1163538EN.docx 71/151 PE627.946v01-00 EN Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1

Text proposed by the Commission Amendment

(9) in Article 41, the following deleted sentence is added at the end of paragraph 1: ‘Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply.; ‘ ______39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).

Or. en

Justification

Adding the phrase might be interpreted as the rest of the Regulation 1367/2006 shall not apply. This would be contrary to the spirit of the proposal, of that Regulation, of our International Obligation and of the Courts rulings on access to documents, such as C-280/11, Council v. Access Info Europa.par.30)

Amendment 420 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 9 – introductory part Regulation (EC) No 178/2002 Article 41 – paragraph 1

PE627.946v01-00 72/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

(9) in Article 41, the following (9) Article 41 is amended as follows: sentence is added at the end of paragraph 1: 1. The Authority shall ensure wide access to the documents which it possesses, in accordance with Regulations (EC) No 1049/2001 and No 1367/2006 of the European Parliament and of the Council. 2. The Management Board, acting on a proposal from the Executive Director, shall adopt the provisions applicable to access to the documents referred to in paragraph 1, in accordance with the general principles and conditions governing the right of access to the Community institutions’ documents. 3. The proactive disclosure mechanisms set out in Articles 38 and 39 are without prejudice to the rights to access conferred on the public by Regulations (EC) 1049/2001 and No 1367/2006 of the European Parliament and of the Council.

Or. en

Amendment 421 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1

Text proposed by the Commission Amendment

(9) in Article 41, the following (9) in Article 41, paragraph 1 is sentence is added at the end of paragraph replaced by the following: 1: Where environmental information is “The Authority shall ensure wide access concerned, Articles 6 and Article 7 of upon request to the documents which it

AM\1163538EN.docx 73/151 PE627.946v01-00 EN Regulation (EC) No 1367/2006 of the possesses. Regulation 1049/2001 of the European Parliament and of the Council39 European Parliament and the Council shall also apply.; and 1367/2006 of the European Parliament and of the Council shall apply.” ______39 Regulation (EC) No 1367/2006 of the 39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of European Parliament and of the Council of 6 September 2006 on the application of the 6 September 2006 on the application of the provisions of the Aarhus Convention on provisions of the Aarhus Convention on Access to Information, Public Participation Access to Information, Public Participation in Decision-making and Access to Justice in Decision-making and Access to Justice in Environmental Matters to Community in Environmental Matters to Community institutions and bodies (OJ L 264, institutions and bodies (OJ L 264, 25.9.2006, p. 13). 25.9.2006, p. 13).

Or. en

Amendment 422 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1

Text proposed by the Commission Amendment

Where environmental information is deleted concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply.; ______39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).

Or. en

PE627.946v01-00 74/151 AM\1163538EN.docx EN Amendment 423 Guillaume Balas

Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1

Text proposed by the Commission Amendment

Where environmental information is For the purpose of ensuring an efficient concerned, Articles 6 and Article 7 of access to documents that it possesses, the Regulation (EC) No 1367/2006 of the Authority shall answer requests to access European Parliament and of the Council39 information. Where environmental shall also apply.; information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply. Upon request, information found confidential under the proactive disclosure procedures set out in Article 38 and 39 shall be disclosed , if the conditions for disclosure are met under Regulation (EC) No 1367/2006 and Regulation 1949/2001. ______39 Regulation (EC) No 1367/2006 of the 39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of European Parliament and of the Council of 6 September 2006 on the application of the 6 September 2006 on the application of the provisions of the Aarhus Convention on provisions of the Aarhus Convention on Access to Information, Public Participation Access to Information, Public Participation in Decision-making and Access to Justice in Decision-making and Access to Justice in Environmental Matters to Community in Environmental Matters to Community institutions and bodies (OJ L 264, institutions and bodies (OJ L 264, 25.9.2006, p. 13). 25.9.2006, p. 13).

Or. en

Amendment 424 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1

AM\1163538EN.docx 75/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

Where environmental information is Where environmental information is concerned, Articles 6 and Article 7 of concerned, Regulation (EC) No 1367/2006 Regulation (EC) No 1367/2006 of the of the European Parliament and of the European Parliament and of the Council39 Council39 shall also apply. Articles 38 to shall also apply.; 39d of this Regulation shall apply without prejudice to the application of Regulation 1049/2001 and Regulation 1367/2006.; ______39 Regulation (EC) No 1367/2006 of the 39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of European Parliament and of the Council of 6 September 2006 on the application of the 6 September 2006 on the application of the provisions of the Aarhus Convention on provisions of the Aarhus Convention on Access to Information, Public Participation Access to Information, Public Participation in Decision-making and Access to Justice in Decision-making and Access to Justice in Environmental Matters to Community in Environmental Matters to Community institutions and bodies (OJ L 264, institutions and bodies (OJ L 264, 25.9.2006, p. 13). 25.9.2006, p. 13).

Or. en

Amendment 425 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 178/2002 Article 41 – paragraph 1

Text proposed by the Commission Amendment

Where environmental information is Where environmental information is concerned, Articles 6 and Article 7 of concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 European Parliament and of the Council39, shall also apply.; as well as the provisions of the Arhus convention, shall also apply.; ______39 Regulation (EC) No 1367/2006 of the 39 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of European Parliament and of the Council of 6 September 2006 on the application of the 6 September 2006 on the application of the provisions of the Aarhus Convention on provisions of the Aarhus Convention on Access to Information, Public Participation Access to Information, Public Participation

PE627.946v01-00 76/151 AM\1163538EN.docx EN in Decision-making and Access to Justice in Decision-making and Access to Justice in Environmental Matters to Community in Environmental Matters to Community institutions and bodies (OJ L 264, institutions and bodies (OJ L 264, 25.9.2006, p. 13). 25.9.2006, p. 13).

Or. en

Amendment 426 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 9 a (new) Regulation (EC) No 178/2002 Article 55 a (new)

Text proposed by the Commission Amendment

(9a) The following Article 55a is inserted after Article 55: ‘Article 55a Transparency of risk management 1. The Commission and the Member States shall carry out their risk management activities in the context of food law with a high level of transparency. They shall in particular make public without delay: (a) at an early stage of the risk management process, the draft risk management measures under consideration; (b) the agendas and the detailed minutes of meetings of the Member States working groups in which the risk management measures are discussed; and (c) 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 the results of votes in the committees in which regulatory proposals are adopted, and an explanation of the votes by individual Member States.

AM\1163538EN.docx 77/151 PE627.946v01-00 EN 2. The Commission shall attach to each regulatory proposal an explanatory statement comprising: (a) the reasons for and objectives of the measure, (b) the justification of the measure taking into consideration both need and proportionality, (c) the impact of the measure on public health, animal health and the environment, on the society and on food manufacturers as indicated by the impact assessment, and (d) the results of the public consultation pursuant to Article 9.’;

Or. en

Justification

Based on amendment 48 by the Rapporteur.

Amendment 427 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 1 – paragraph 1 – point 9 a (new) Regulation (EC) No 178/2002 Article 55 a (new)

Text proposed by the Commission Amendment

(9a) The following Article 55a is inserted after Article 55: “Article 55a Transparency of risk management 1. The Commission shall carry out its activities with a high level of transparency. It shall in particular make public without delay which other factors legitimate to the matter under consideration according to Article 6(3) of Regulation (EC) No 178/2002 were taken

PE627.946v01-00 78/151 AM\1163538EN.docx EN into account in analysing the opinion of the Authority and its application of the precautionary principle according to Article 7(1) of Regulation (EC) No 178/2002. 2. The Member States shall carry out their activities with a high level of transparency. They shall in particular make public without delay: (a) agendas and minutes of the meetings of the Council working groups in which the risk management measures are discussed; (b) agendas and minutes of the meetings of the Standing Committees, included but not limited to the Appeal Committee, as well as the votes for each Member state. Those items referred to in the first and second subparagraph shall be made public on a dedicated section of the Commission’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 format.

Or. en

Justification

Risk managers should be accountable for their decisions.

Amendment 428 Pilar Ayuso

Proposal for a regulation Article 1 – paragraph 1 – point 9 a (new) Regulation (EC) No 178/2002 Article 50 – paragraph 1 a (new)

Text proposed by the Commission Amendment

(9a) Article 50 is amended as follows:

AM\1163538EN.docx 79/151 PE627.946v01-00 EN Paragraph 1a is inserted: Article 50 Rapid alert system 1. A rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed is hereby established as a network. It shall involve the Member States, the Commission and the Authority. The Member States, the Commission and the Authority shall each designate a contact point, which shall be a member of the network. 1a. The Commission shall, by delegated act, amend Regulation 16/2011 to develop a harmonised food alert network management system between the Commission and the Member States

Or. es

Justification

Regulation (EC) No 178/2002 (Articles 50 to 54), establishes the RASFF, together with its basic provisions, scope and operation. Weaknesses were subsequently identified, requiring rectification through the adoption of Regulation (EU) No 16/2011 which did not include harmonised procedures to be followed by all MS or the necessary enhancement of the Commission’s powers for dealing with alerts. A joint, compulsory and enhanced procedure for managing food alerts is necessary.

Amendment 429 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 10 Regulation (EC) No 178/2002 Article 57 a – paragraph 2

Text proposed by the Commission Amendment

2. The powers to adopt delegated acts 2. The powers to adopt delegated acts referred to in Article 8(c) shall be referred to in Article 8(c) and 32c shall be conferred upon the Commission for an conferred upon the Commission for a indeterminate period of time from [date of period of five years from [date of entry into entry into force of this Regulation]. force of this Regulation].

PE627.946v01-00 80/151 AM\1163538EN.docx EN Or. en

Amendment 430 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 2

Text proposed by the Commission Amendment

2. Not later than five years after the 2. Not later than five years after the date referred to in Article [entry into force date referred to in Article [entry into force of the Regulation amending the GFL], and of the Regulation amending the GFL], and every five years thereafter, the every five years thereafter, the Authority Commission shall assess the Authority’s jointly with the Commission shall performance in relation to its objectives, commission an independent external mandate, tasks, procedures and location, evaluation of its achievements and in accordance with Commission performance in relation to its objectives, guidelines. The evaluation shall address mandates, tasks, procedures and locations. the possible need to modify the mandate The evaluation shall be based on the terms of the Authority, and the financial of reference issued by the Management implications of any such modification. Board in agreement with the Commission, and will assess the working practices and the impact of the Authority. The evaluation shall take into account the views of all stakeholders, at both Community and national level.

Or. en

Justification

Based on amendment 49 by the Rapporteur.

Amendment 431 Michel Dantin, Angélique Delahaye

Proposal for a regulation Article premier – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 2

AM\1163538EN.docx 81/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

2. Not later than five years after the 2. Not later than five years after the date referred to in Article [entry into force date referred to in Article [entry into force of the Regulation amending the GFL], and of the Regulation amending the GFL], and every five years thereafter, the every five years thereafter, the Commission shall assess the Authority’s Commission shall assess the Authority’s performance in relation to its objectives, performance in relation to its objectives, mandate, tasks, procedures and location, in mandate, tasks, procedures and location, in accordance with Commission guidelines. accordance with Commission guidelines. The evaluation shall address the possible That evaluation shall address the possible need to modify the mandate of the need to modify the mandate of the Authority, and the financial implications of Authority, especially when it comes to any such modification. coordinating and dovetailing the Agency’s activities more closely with those of the competent bodies in the Member States and other Union agencies and the financial implications of any such modification.

Or. fr

Amendment 432 Pavel Poc, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 2

Text proposed by the Commission Amendment

2. Not later than five years after the 2. Not later than five years after the date referred to in Article [entry into force date referred to in Article [entry into force of the Regulation amending the GFL], and of the Regulation amending the GFL], and every five years thereafter, the every five years thereafter, the Authority Commission shall assess the Authority’s jointly with the Commission shall performance in relation to its objectives, commission an independent evaluation of mandate, tasks, procedures and location, in their performance in relation to their accordance with Commission guidelines. objectives, mandates, tasks, procedures The evaluation shall address the possible and location. The evaluation shall address need to modify the mandate of the the possible need to modify the mandate of Authority, and the financial implications of the Authority, and the financial any such modification. implications of any such modification. The evaluation shall take into account the views of the stakeholders, at both

PE627.946v01-00 82/151 AM\1163538EN.docx EN Community and national level.

Or. en

Amendment 433 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 2

Text proposed by the Commission Amendment

2. Not later than five years after the 2. Not later than five years after the date referred to in Article [entry into force date referred to in Article [entry into force of the Regulation amending the GFL], and of the Regulation amending the GFL], and every five years thereafter, the every five years thereafter, the Commission shall assess the Authority’s Commission shall commission an performance in relation to its objectives, independent external evaluation of the mandate, tasks, procedures and location, in Authority’s achievements and accordance with Commission guidelines. performance in relation to its objectives, The evaluation shall address the possible mandate, tasks, procedures and location, in need to modify the mandate of the accordance with Commission guidelines Authority, and the financial implications of and the Management Board’s work any such modification. programme. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.

Or. en

Justification

The current Reg. foresees and independent external evaluation. This provision should remain in order to strengthen transparency and accountability of the process.

Amendment 434 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu, Karin Kadenbach

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 2 a (new)

AM\1163538EN.docx 83/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

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.

Or. en

Amendment 435 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 3

Text proposed by the Commission Amendment

3. Where the Commission considers deleted that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.

Or. en

Justification

This paragraph would give undue power to the Commission.

Amendment 436 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 3

PE627.946v01-00 84/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

3. Where the Commission considers 3. Where the Management Board that the continuation of the Authority is no considers that the continuation of the longer justified with regard to its assigned Authority is no longer justified with regard objectives, mandate and tasks, it may to its assigned objectives, mandate and propose that the relevant provisions of this tasks, it may propose to the Commission to Regulation be amended accordingly or initiate the legislative process so that the repealed. relevant provisions of this Regulation be amended accordingly or repealed

Or. en

Amendment 437 Anja Hazekamp

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 4

Text proposed by the Commission Amendment

4. The Commission shall report to the 4. The external evaluator shall report European Parliament, the Council and the to the Commission, the European Management Board on the evaluation Parliament, the Council and the findings. The findings of the evaluation Management Board on the evaluation shall be made public. findings. The findings of the evaluation shall be made public

Or. en

Amendment 438 Martin Häusling

Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 178/2002 Article 61 – paragraph 4

Text proposed by the Commission Amendment

4. The Commission shall report to the 4. The evaluations and European Parliament, the Council and the recommendations referred to in

AM\1163538EN.docx 85/151 PE627.946v01-00 EN Management Board on the evaluation paragraphs 1 and 2 shall be forwarded to findings. The findings of the evaluation the Council and the European Parliament, shall be made public. and be made public.

Or. en

Amendment 439 Martin Häusling

Proposal for a regulation Article 2 – paragraph 1 – point 2 a (new) Directive 2001/18/EC Article 24 – paragraph 3 a (new)

Text proposed by the Commission Amendment

(2a) In Article 24, the following paragraph is inserted: “3a. The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 25 below, and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.”

Or. en

Amendment 440 Martin Häusling

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25

Text proposed by the Commission Amendment

(3) Article 25 is replaced by the (3) Article 25 is replaced by the following: following: “Article 25 “Article 25

PE627.946v01-00 86/151 AM\1163538EN.docx EN Confidentiality Confidentiality 1. In accordance with the conditions 1. In accordance with the conditions and the procedures laid down in Article 39 and the procedures laid down in Article 39 to 39f of Regulation (EC) No 178/2002, to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and which shall apply mutatis mutandis, and this article, this article, (a) the notifier/applicant may request (a) the notifier/applicant may request certain information submitted under this certain information submitted under this Directive to be kept confidential, Directive to be kept confidential, accompanied by verifiable justification; accompanied by verifiable justification; and, and, (b) the competent authority shall assess (b) the competent authority shall assess the confidentiality request submitted by the the confidentiality request submitted by the notifier/applicant. notifier/applicant. 2. In addition to Article 39(2) of 2. In no case may the following Regulation (EC) No 178/2002 and information when submitted according to pursuant to Article 39(3) thereof, which Articles 6, 7, 8, 13, 17, 20 or 23 be kept shall apply mutatis mutandis, confidential confidential: treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except – general description of the GMO or for sequences used for the purpose of GMOs, name and address of the notifier, detection, identification and purpose of the release, location of release quantification of the transformation and intended uses; event; and, (b) breeding patterns and strategies.”; – methods and plans for monitoring of the GMO or GMOs and for emergency response; – environmental risk assessment.”

Or. en

Justification

Paragraph 2 simply reinstates the current wording of Directive 2001/18/EC. If the aim of the proposal is to strengthen transparency, then, instead of enlarging the list of information which can be kept confidential, the current provisions relating to information that can never be kept confidential must be kept.

AM\1163538EN.docx 87/151 PE627.946v01-00 EN Amendment 441 Anja Hazekamp

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) the notifier/applicant may request (a) the notifier/applicant may request certain information submitted under this certain information, the disclosure of Directive to be kept confidential, which could harm his/her competitive accompanied by verifiable justification; position and submitted under this Directive and, to be kept confidential, accompanied by verifiable justification; and,

Or. en

Amendment 442 Anja Hazekamp

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 1 – point b a (new)

Text proposed by the Commission Amendment

(ba) In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential: – general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses; – methods and plans for monitoring of the GMO or GMOs and for emergency response; – environmental risk assessment.

Or. en

PE627.946v01-00 88/151 AM\1163538EN.docx EN Amendment 443 Anja Hazekamp

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, which shall apply mutatis mutandis, confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (b) breeding patterns and strategies.;

Or. en

Amendment 444 Guillaume Balas

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, which shall apply mutatis mutandis, confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the

AM\1163538EN.docx 89/151 PE627.946v01-00 EN interests concerned: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (b) breeding patterns and strategies.;

Or. en

Amendment 445 Anja Hazekamp

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, which shall apply mutatis mutandis, confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (b) breeding patterns and strategies.

Or. en

Justification

Dir. 2001/18 had foreseen that some data, should not be deemed confidential. Not including that same list, not only does it put in doubt the pursuit of high level of transparency, but will also create legal uncertainty and administrative burden to both applicants and the EC.

PE627.946v01-00 90/151 AM\1163538EN.docx EN Amendment 446 Anja Hazekamp

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) DNA sequence information, except deleted for sequences used for the purpose of detection, identification and quantification of the transformation event; and,

Or. en

Amendment 447 Anja Hazekamp

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 2 – point b

Text proposed by the Commission Amendment

(b) breeding patterns and strategies.; deleted

Or. en

Amendment 448 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 2 – paragraph 1 – point 3 Directive 2001/18/EC Article 25 – paragraph 2 a (new)

Text proposed by the Commission Amendment

The provisions on active dissemination

AM\1163538EN.docx 91/151 PE627.946v01-00 EN laid down in Article 24 and 25 of this Directive, and Article 38 and 39 of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulation 1049/2001 and 1367/2006.

Or. en

Amendment 449 Renate Sommer

Proposal for a regulation Article 2 – paragraph 1 – point 4 Directive 2001/18/EC Article 28 – paragraph 4

Text proposed by the Commission Amendment

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

Or. en

Amendment 450 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 1 – point b Regulation (EC) No 1829/2003 Article 5 – paragraph 3 – point e

Text proposed by the Commission Amendment

(l) an identification of the parts of the (l) an identification of the parts of the

PE627.946v01-00 92/151 AM\1163538EN.docx EN application and any other supplementary application and any other supplementary information that the applicant requests to information that the applicant requests to be kept confidential, accompanied by be kept confidential, accompanied by verifiable justification, pursuant to Articles verifiable justification on how the 30 of this Regulation and Article 39 of disclosure of those would have his/hers Regulation (EC) No 178/2002; ; competitive advantage, pursuant to Articles 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002;

Or. en

Amendment 451 Renate Sommer

Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1

Text proposed by the Commission Amendment

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

Or. en

Amendment 452 Martin Häusling

Proposal for a regulation Article 3 – paragraph 1 – point 9 Regulation (EC) No 1829/2003 Article 29 – paragraph 1

AM\1163538EN.docx 93/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

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

Or. en

Justification

This provision is taken from the current Regulation 1829/2003, Article 29.

Amendment 453 Martin Häusling

Proposal for a regulation Article 3 – paragraph 1 – point 9 a (new) Regulation (EC) No 1829/2003 Article 29 – paragraph 1 a (new)

Text proposed by the Commission Amendment

(9a) In Article 29, the following paragraph 1a is inserted: “1a. The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 30 below, and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.”

Or. en

PE627.946v01-00 94/151 AM\1163538EN.docx EN Amendment 454 Martin Häusling

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30

Text proposed by the Commission Amendment

(10) Article 30 is replaced by the (10) Article 30 is replaced by the following: following: “Article 30 “Article 30 Confidentiality Confidentiality 1. In accordance with the conditions 1. In accordance with the conditions and the procedures laid down in Article 39 and the procedures laid down in Article 39 to 39f of Regulation (EC) No 178/2002 and to 39f of Regulation (EC) No 178/2002 and this article, this article, (a) the applicant may request certain (a) the applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification; accompanied by verifiable justification; and, and, (b) the Authority shall assess the (b) the Authority shall assess the confidentiality request submitted by the confidentiality request submitted by the applicant. applicant. 2. In addition to Article 39(2) and 2. Information relating to the pursuant to Article 39(3) of Regulation following shall not be considered (EC) No 178/2002, the Authority may also confidential: accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except (a) name and composition of the for sequences used for the purpose of GMO, food or feed referred to in Articles detection, identification and 3(1) and 15(1) and, where appropriate, quantification of the transformation indication of the substrate and the micro- event; and, organism; (b) breeding patterns and strategies. (b) general description of the GMO and the name and address of the authorisation-holder; (ba) physico-chemical and biological

AM\1163538EN.docx 95/151 PE627.946v01-00 EN characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1); (bb) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environment; (bc) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties; (bd) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1); (bf) information on waste treatment and emergency response. 3. The use of the detection methods 3. The use of the detection methods and the reproduction of the reference and the reproduction of the reference materials, provided under Article 5(3) and materials, provided under Article 5(3) and 17(3) for the purpose of applying this 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to Regulation to the GMOs, food or feed to which an application refers, shall not be which an application refers, shall not be restricted by the exercise of intellectual restricted by the exercise of intellectual property rights or otherwise.” property rights or otherwise.”

Or. en

Justification

Paragraph 2 simply reinstates the current wording of Regulation 1829/2003. If the aim of the proposal is to strengthen transparency, then, instead of enlarging the list of information which can be kept confidential, the current provisions relating to information that can never be kept confidential must be kept.

Amendment 455 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2

PE627.946v01-00 96/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

2. In addition to Article 39(2) and deleted pursuant to Article 39(3) of Regulation (EC) No 178/2002, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (b) breeding patterns and strategies.

Or. en

Amendment 456 Guillaume Balas

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) and deleted pursuant to Article 39(3) of Regulation (EC) No 178/2002, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and, (b) breeding patterns and strategies.

AM\1163538EN.docx 97/151 PE627.946v01-00 EN Or. en

Amendment 457 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) and 2. Information relating to the pursuant to Article 39(3) of Regulation following shall not be considered (EC) No 178/2002, the Authority may also confidential: accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) DNA sequence information, except (a) name and composition of the for sequences used for the purpose of GMO, food or feed referred to in Articles detection, identification and 3(1) and 15(1) and, where appropriate, quantification of the transformation indication of the substrate and the micro- event; and, organism; (b) breeding patterns and strategies. (b) general description of the GMO and the name and address of the authorisation-holder; (c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and15(1); (d) effects of the GMO, food or feed referred to in Articles 3(1) and15(1) on human and animal health and on the environment; (e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties; (f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles

PE627.946v01-00 98/151 AM\1163538EN.docx EN 3(1) and 15(1); (g) information on waste treatment and emergency response.

Or. en

Justification

The current list provides for certainty, predictability and transparency both for assessors and applicants. It should be expanded instead of being deleted

Amendment 458 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) DNA sequence information, except deleted for sequences used for the purpose of detection, identification and quantification of the transformation event; and,

Or. en

Amendment 459 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) DNA sequence information, except deleted for sequences used for the purpose of detection, identification and quantification of the transformation event; and,

AM\1163538EN.docx 99/151 PE627.946v01-00 EN Or. en

Amendment 460 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) 1829/2003 Article 30 – paragraph 2 – point b

Text proposed by the Commission Amendment

(b) breeding patterns and strategies. deleted

Or. en

Amendment 461 Anja Hazekamp

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 2 – point b

Text proposed by the Commission Amendment

(b) breeding patterns and strategies. deleted

Or. en

Amendment 462 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003 Article 30 – paragraph 4 a (new)

Text proposed by the Commission Amendment

4a. The provisions on active dissemination laid down in Article 29 and 30 of this Directive, and Article 38 and 39

PE627.946v01-00 100/151 AM\1163538EN.docx EN of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulation 1049/2001 and 1367/2006.

Or. en

Amendment 463 Renate Sommer

Proposal for a regulation Article 4 – paragraph 1 – point 1 – point b Regulation (EC) 1831/2003 Article 7 – paragraph 2 – point c

Text proposed by the Commission Amendment

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

Or. en

Amendment 464 Martin Häusling

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) Regulation (EC) No 1831/2003 Article 17 – paragraph 2 a (new)

Text proposed by the Commission Amendment

(1a) In Article 17, the following paragraph is inserted: “2a. The obligation to proactively disseminate information set out in this Article and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation

AM\1163538EN.docx 101/151 PE627.946v01-00 EN 1367/2006.”

Or. en

Amendment 465 Martin Häusling

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18

Text proposed by the Commission Amendment

(2) Article 18 is replaced by the (2) Article 18 is replaced by the following: following: “Article 18 “Article 18 Transparency and confidentiality Transparency and confidentiality 1. The Authority shall make public the 1. The Authority shall make public the application for authorisation, relevant application for authorisation, relevant supporting information and any supporting information and any supplementary information supplied by the supplementary information supplied by the applicant, as well as its scientific opinions, applicant, as well as its scientific opinions, in accordance with Article 38, Articles 39 in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis No 178/2002, which shall apply mutatis mutandis. mutandis. 2. In accordance with the conditions 2. In accordance with the conditions and the procedures laid down in Articles 39 and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and to 39f of Regulation (EC) No 178/2002 and this Article, the applicant may request this Article, the applicant may request certain information submitted under this certain information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification; accompanied by verifiable justification; and, the Authority shall assess the and, the Authority shall assess the confidentiality request submitted by the confidentiality request submitted by the applicant. applicant.

3. In addition to Article 39(2) of 3. The following information shall Regulation (EC) No 178/2002 and not be considered confidential: pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of

PE627.946v01-00 102/151 AM\1163538EN.docx EN which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) the study plan for studies (a) name and composition of the feed demonstrating the efficacy of a feed additive and, where appropriate, additive in terms of the aims of its indication of the production strain; intended use as defined in Article 6(1) and Annex I to this Regulation; and, (b) specifications of the impurities of (b) physico-chemical and biological the active substance and the relevant characteristics of the feed additive; methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.”. (ba) the conclusions of the study results on effects of the feed additive on human and animal health and on the environment; (bb) the conclusions of the study results on effects of the feed additive on the characteristics of animal products and its nutritional properties; (bc) methods for detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring. 3a. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council when handling applications for access to documents held by the Authority. 3b. The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of

AM\1163538EN.docx 103/151 PE627.946v01-00 EN Regulation (EC) No 1049/2001.”

Or. en

Justification

Paragraph 3 simply reinstates the current wording of Regulation 1831/2003 . If the aim of the proposal is to strengthen transparency, then, instead of enlarging the list of information which can be kept confidential, the current provisions relating to information that can never be kept confidential must be kept. Likewise, paragraphs 4 and 5 simply keep the current text of Regulation 1831/2003.

Amendment 466 Renate Sommer

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 1

Text proposed by the Commission Amendment

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

Or. en

Amendment 467 Anja Hazekamp

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 2

PE627.946v01-00 104/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

2. In accordance with the conditions 2. In accordance with the conditions and the procedures laid down in Articles 39 and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and to 39f of Regulation (EC) No178/2002 and this Article, the applicant may request this Article, the applicant may request certain information submitted under this certain information which might Regulation to be kept confidential, significantly harm his competitive accompanied by verifiable justification; position submitted under this Regulation to and, the Authority shall assess the be kept confidential, accompanied by confidentiality request submitted by the verifiable justification; and, the Authority applicant. shall assess the confidentiality request submitted by the applicant.

Or. en

Justification

In the current Reg. it is clearly named that there must exist verifiable reasons which might harm significantly. In order to allow for legal certainty and predictability to the evaluators and the applicant, the current language should remain

Amendment 468 Guillaume Balas

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3

Text proposed by the Commission Amendment

3. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and

AM\1163538EN.docx 105/151 PE627.946v01-00 EN Annex I to this Regulation; and, (b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment..

Or. en

Amendment 469 Anja Hazekamp

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3

Text proposed by the Commission Amendment

3. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and, (b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment..

Or. en

PE627.946v01-00 106/151 AM\1163538EN.docx EN Amendment 470 Anja Hazekamp

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 - introductory part

Text proposed by the Commission Amendment

3. In addition to Article 39(2) of 3. Confidential treatment may not be Regulation (EC) No 178/2002 and accepted with respect to the following pursuant to Article 39(3) of that information, in light of their relevance for Regulation, the Authority may also accept the protection of public and animal to provide confidential treatment to the health: following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned:

Or. en

Amendment 471 Anja Hazekamp

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) 1831/2003 Article 18 – paragraph 3 – point b

Text proposed by the Commission Amendment

(b) specifications of the impurities of (b) specifications of the impurities of the active substance and the relevant the active substance and the relevant methods of analysis developed internally methods of analysis developed internally by the applicant, except for impurities that by the applicant. may have adverse effects on animal health, human health, or the environment.

Or. en

AM\1163538EN.docx 107/151 PE627.946v01-00 EN Amendment 472 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraph 3 a (new)

Text proposed by the Commission Amendment

3a. The provisions on active dissemination laid down in this Article, and in Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation 1049/2001.

Or. en

Amendment 473 Anja Hazekamp

Proposal for a regulation Article 4 – paragraph 1 – point 2 Regulation (EC) No 1831/2003 Article 18 – paragraphs 3 a to 3 e (new)

Text proposed by the Commission Amendment

3a. Notwithstanding paragraph 2, the following information shall not be considered confidential: (a) name and composition of the feed additive and, where appropriate, indication of the production strain; (b) physico-chemical and biological characteristics of the feed additive; (c) the conclusions of the study results on effects of the feed additive on human and animal health and on the environment; (d) the conclusions of the study results on effects of the feed additive on the characteristics of animal products and its nutritional properties;

PE627.946v01-00 108/151 AM\1163538EN.docx EN (e) methods for detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring. 3b. Notwithstanding paragraph 2, the Authority shall, on request, supply the Commission and Member States with all information in its possession, including any identified as confidential pursuant to that paragraph. 3c. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council 1a when handling applications for access to documents held by the Authority. 3d. The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraphs 2 and 3 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001. 3e. If an applicant withdraws or has withdrawn an application, the Member States, the Commission and the Authority shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the Commission and the applicant disagree as to its confidentiality. ______1a Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

AM\1163538EN.docx 109/151 PE627.946v01-00 EN Or. en

Justification

In order to maintain at least the same level of transparency and legal objectivity and predictability, the list of non-confidential information should continue to exist and well as the rest of the information on access to document, unless it is covered on the final text of Reg. 178/2002 as it will be amended.

Amendment 474 Renate Sommer

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

Text proposed by the Commission Amendment

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

Or. en

Amendment 475 Anja Hazekamp

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

Text proposed by the Commission Amendment

(ii) ensure public access to the (ii) ensure public access to the application, relevant supporting application, relevant supporting information and any supplementary information and any supplementary information supplied by the applicant, in information supplied by the applicant, the accordance with Articles 14 and 15. principles of Regulation 1049/2001.

PE627.946v01-00 110/151 AM\1163538EN.docx EN Or. en

Justification

Regulation 1049/2001 provided the legal base for access to documents. The current Regulation 2065/2003 on art. 7 (2) clearly reconfirms it and if we wish to keep the same of access and transparency, this provision should remain.

Amendment 476 Renate Sommer

Proposal for a regulation Article 5 – paragraph 1 – point 2 Regulation (EC) No 2065/2003 Article 14 – paragraph 1

Text proposed by the Commission Amendment

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

Or. en

Amendment 477 Martin Häusling

Proposal for a regulation Article 5 – paragraph 1 – point 2 a (new) Regulation (EC) No 2065/2003 Article 14 – paragraph 1a (new)

Text proposed by the Commission Amendment

(2a) In Article 14, the following paragraph is inserted: “1a. The obligation to proactively disseminate information set out in paragraph 1 of this Article and Articles 38

AM\1163538EN.docx 111/151 PE627.946v01-00 EN and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.”

Or. en

Amendment 478 Anja Hazekamp

Proposal for a regulation Article 5 – paragraph 1 – point 3 Regulation (EC) No 2065/2003 Article 15

Text proposed by the Commission Amendment

(3) Article 15 is replaced by the deleted following: ‘Article 15 Confidentiality In accordance with the conditions and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002, (a) the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and, (b) the Authority shall assess the confidentiality request submitted by the applicant. ‘

Or. en

Justification

The current list of items is a more transparent, objective and predictable way on assessing the confidentiality claims. It should not be replaced.

PE627.946v01-00 112/151 AM\1163538EN.docx EN Amendment 479 Martin Häusling

Proposal for a regulation Article 5 – paragraph 1 – point 3 Regulation (EC) No 2065/2003 Article 15

Text proposed by the Commission Amendment

(3) Article 15 is replaced by the (3) Article 15 is replaced by the following: following: “Article 15 “Article 15 Confidentiality Confidentiality In accordance with the conditions and the 1. In accordance with the conditions procedures laid down in Articles 39 to 39f and the procedures laid down in Articles 39 of Regulation (EC) No 178/2002, to 39f of Regulation (EC) No 178/2002, (a) the applicant may request certain (a) the applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification; accompanied by verifiable justification; and, and, (b) the Authority shall assess the (b) the Authority shall assess the confidentiality request submitted by the confidentiality request submitted by the applicant.”. applicant. 1a. Without prejudice to Article 39(3) of Regulation (EC) No 178/2002, information relating to the following shall not be considered confidential: (a) the name and address of the applicant and the name of the product; (b) in the case of an opinion in favour of authorising the evaluated product, the particulars mentioned in Article 6(2); (c) information of direct relevance to the assessment of the safety of the product; (d) the analytical method referred to in point 4 of Annex II.”

Or. en

AM\1163538EN.docx 113/151 PE627.946v01-00 EN Justification

Paragraph 2 simply reinstates the current wording of Regulation 2065/2003. If the aim of the proposal is to strengthen transparency, then, instead of enlarging the list of information which can be kept confidential, the current provisions relating to information that can never be kept confidential must be kept.

Amendment 480 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 5 – paragraph 1 – point 3 Regulation (EC) No 2065/2003 Article 15 – paragraph 1 a (new)

Text proposed by the Commission Amendment

1a. The provisions on active dissemination laid down in Articles 14 and 15 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.

Or. en

Amendment 481 Renate Sommer

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

Text proposed by the Commission Amendment

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

PE627.946v01-00 114/151 AM\1163538EN.docx EN Or. en

Amendment 482 Renate Sommer

Proposal for a regulation Article 6 – paragraph 1 – point 2 Regulation (EC) No 1935/2004 Article 19 – paragraph 1

Text proposed by the Commission Amendment

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

Or. en

Amendment 483 Martin Häusling

Proposal for a regulation Article 6 – paragraph 1 – point 2 a (new) Regulation (EC) No 1935/2004 Article 19 – paragraph 2 a (new)

Text proposed by the Commission Amendment

(2a) In Article 19, the following paragraph is inserted: “(2a) The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 20 below, and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001

AM\1163538EN.docx 115/151 PE627.946v01-00 EN and Regulation 1367/2006.”

Or. en

Amendment 484 Martin Häusling

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20

Text proposed by the Commission Amendment

(3) Article 20 is replaced by the (3) Article 20 is replaced by the following: following: “Article 20 “Article 20 Confidentiality Confidentiality 1. In accordance with the conditions 1. In accordance with the conditions and the procedures laid down in Articles 39 and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and to 39f of Regulation (EC) No 178/2002 and this article: this article: (a) the applicant may request certain (a) the applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification; accompanied by verifiable justification; and, and, (b) the Authority shall assess the (b) the Authority shall assess the confidentiality request submitted by the confidentiality request submitted by the applicant. applicant. 2. In addition to Article 39(2) of 2. Information relating to the Regulation (EC) No 178/2002 and following shall not be considered pursuant to Article 39(3) of that confidential: Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) any information provided in (a) the name and address of the detailed descriptions of starting applicant and the chemical name of the substances and preparations used to substance; manufacture the substance subject to the authorisation, the composition of

PE627.946v01-00 116/151 AM\1163538EN.docx EN preparations, materials or articles in which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results; (b) the trademark under which the (b) information of direct relevance to substance, shall be marketed as well as the assessment of the safety of the the tradename of the preparations, substance; material or articles in which it shall be used, where applicable; and, (c) any other information deemed (c) the analytical method or methods.” confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation.”.

Or. en

Amendment 485 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 a (new)

Text proposed by the Commission Amendment

2a. The provisions on active dissemination laid down in Articles 19 and 20 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.

Or. en

Amendment 486 Anja Hazekamp

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 1 – point b a (new)

AM\1163538EN.docx 117/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(ba) the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.

Or. en

Amendment 487 Anja Hazekamp

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) any information provided in detailed descriptions of starting substances and preparations used to manufacture the substance subject to the authorisation, the composition of preparations, materials or articles in which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results; (b) the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,

PE627.946v01-00 118/151 AM\1163538EN.docx EN (c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation..

Or. en

Amendment 488 Anja Hazekamp

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 – introductory part

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of 2. Confidential treatment may not be Regulation (EC) No 178/2002 and accepted with respect to the following pursuant to Article 39(3) of that information, when it may be deemed to Regulation, the Authority may also accept relate to emissions in the environment or to provide confidential treatment to the may be deemed relevant to protect public following information, the disclosure of health and/or animal health: which may be deemed, upon verifiable justification, to significantly harm the interests concerned:

Or. en

Amendment 489 Guillaume Balas

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation No 1935/2004 Article 20 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) any information provided in deleted detailed descriptions of starting substances and preparations used to manufacture the substance subject to the authorisation, the composition of preparations, materials or articles in

AM\1163538EN.docx 119/151 PE627.946v01-00 EN which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results;

Or. en

Amendment 490 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) any information provided in (a) any information provided in detailed descriptions of starting substances detailed descriptions of starting substances and preparations used to manufacture the and preparations used to manufacture the substance subject to the authorisation, the substance subject to the authorisation, the composition of preparations, materials or composition of preparations, materials or articles in which the applicant intends to articles in which the applicant intends to use this substance, the manufacturing use this substance, the manufacturing methods of these preparations, materials or methods of these preparations, materials or articles, impurities, and migration testing articles, impurities; results;

Or. en

Justification

The issue of migration is a healthcare matter. There is no reason why it should be confidential.

Amendment 491 Guillaume Balas

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation No 1935/2004 Article 20 – paragraph 2 – point b

PE627.946v01-00 120/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

(b) the trademark under which the deleted substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,

Or. en

Amendment 492 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 – point b

Text proposed by the Commission Amendment

(b) the trademark under which the deleted substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,

Or. en

Justification

There is no reason why there should be these additions to the list of confidential requirements already provided under Reg 178/2002.

Amendment 493 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 – point c

AM\1163538EN.docx 121/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(c) any other information deemed deleted confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation.

Or. en

Justification

There is no reason why there should be these additions to the list of confidential requirements already provided under Regulation 178/2002.

Amendment 494 Anja Hazekamp

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 a (new)

Text proposed by the Commission Amendment

2a. Information relating to the following shall not be considered confidential: (a) the name and address of the applicant and the chemical name of the substance; (b) information of direct relevance to the assessment of the safety of the substance; (c) the analytical method or methods.

Or. en

Justification

This reconfirm the existing legal framework. With the current proposal the analytical methods could be considered confidential. This would be detrimental for food safety reasons. As identified in the EPRS Implementation Assessment 5/2016 and expressed in the EP Resolution on the implementation of the FCM Regulation (2015/2259) INI, it is very difficult to identify

PE627.946v01-00 122/151 AM\1163538EN.docx EN and control the nanomaterials used and their organoleptic properties. Less information would lead to even higher risk.

Amendment 495 Anja Hazekamp

Proposal for a regulation Article 6 – paragraph 1 – point 3 Regulation (EC) No 1935/2004 Article 20 – paragraph 2 b (new)

Text proposed by the Commission Amendment

2b. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health.

Or. en

Justification

Currently par.5 of the Regulation.

Amendment 496 Martin Häusling

Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11

Text proposed by the Commission Amendment

(2) Article 11 is replaced by the (2) Article 11 is replaced by the following: following: “Where the Commission requests its “1. Where the Commission requests its opinion in accordance with Article 3(2) of opinion in accordance with Article 3(2) of this Regulation, the Authority shall make this Regulation, the Authority shall make public the application for authorisation, public the application for authorisation,

AM\1163538EN.docx 123/151 PE627.946v01-00 EN relevant supporting information and any relevant supporting information and any supplementary information supplied by the supplementary information supplied by the applicant, as well as its scientific opinions, applicant, as well as its scientific opinions, in accordance with Article 38, Articles in accordance with Article 38, Articles 39to 39f and Article 40 of Regulation (EC) 39to 39f and Article 40 of Regulation (EC) No 178/2002. It shall also make public any No 178/2002. It shall also make public any request for its opinion as well as any request for its opinion as well as any extension of period pursuant to Article 6(1) extension of period pursuant to Article 6(1) of this Regulation.”; of this Regulation. 1a. The obligation to proactively disseminate information set out in paragraph 1 of this Article, in Article 12 of this Regulation and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”

Or. en

Amendment 497 Anja Hazekamp

Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11

Text proposed by the Commission Amendment

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

Or. en

PE627.946v01-00 124/151 AM\1163538EN.docx EN Justification

Art. 3(2) allows the EC to update the lists of additives, enzymes and flavourings without asking the EFSA, if it deems that the updates are not liable to have an effect on human health. The condition that the Authority shall make public only where the EC, requests its opinion, will create less transparency, more pressure from industry, higher risk for human health and lesser democratisation of the process and it is contrary to the spirit of the transparency and the existing art 11.

Amendment 498 Renate Sommer

Proposal for a regulation Article 7 – paragraph 1 – point 2 Regulation (EC) No 1331/2008 Article 11

Text proposed by the Commission Amendment

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

Or. en

Amendment 499 Anja Hazekamp

Proposal for a regulation Article 7 – paragraph 1 – point 3 Regulation (EC) No 1331/2008 Article 12

AM\1163538EN.docx 125/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(3) Article 12 is replaced by the deleted following: ‘Article 12 Confidentiality 1. The applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification, upon submission of the application. 2. Where an opinion by the Authority is required in accordance with Article 3(2) of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39f of Regulation (EC) No 178/2002. 3. Where an opinion by the Authority is not required in accordance with Article 3(2) of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant. Articles 39 to 39f of Regulation (EC) No 178/2002 shall apply mutatis mutandis.; ‘

Or. en

Justification

The current art.12 provides more transparency and predictability and allow (par.5 the waiving of the confidentiality ‘if circumstances so require in order to protect human health, animal health or the environment’. It has of no use amending a regulation for reaching lower levels of transparency, risk for public health and criticism from the citizens.

Amendment 500 Martin Häusling

Proposal for a regulation Article 7 – paragraph 1 – point 3 Regulation (EC) No 1331/2008 Article 12

PE627.946v01-00 126/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

(3) Article 12 is replaced by the (3) Article 12 is replaced by the following: following: “Article 12 “Article 12 Confidentiality Confidentiality 1. The applicant may request certain 1. The applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification, accompanied by verifiable justification, upon submission of the application. upon submission of the application. 2. Where an opinion by the Authority 2. Where an opinion by the Authority is required in accordance with Article 3(2) is required in accordance with Article 3(2) of this Regulation, the Authority shall of this Regulation, the Authority shall assess the confidentiality request submitted assess the confidentiality request submitted by the applicant, in accordance with by the applicant, in accordance with Articles 39 to 39f of Regulation (EC) No Articles 39 to 39f of Regulation (EC) No 178/2002. 178/2002. 3. Where an opinion by the Authority 3. Where an opinion by the Authority is not required in accordance with Article is not required in accordance with Article 3(2) of this Regulation, the Commission 3(2) of this Regulation, the Commission shall assess the confidentiality request shall assess the confidentiality request submitted by the applicant. Articles 39 to submitted by the applicant. Articles 39 to 39f of Regulation (EC) No 178/2002 shall 39f of Regulation (EC) No 178/2002 shall apply mutatis mutandis.”; apply mutatis mutandis. 3a. Information relating to the following shall not, in any circumstances, be regarded as confidential: (a) the name and address of the applicant; (b) the name and a clear description of the substance; (c) the justification for the use of the substance in or on specific foodstuffs or food categories; (d) information that is relevant to the assessment of the safety of the substance; (e) where applicable, the analysis method(s). 3b. The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, take the necessary measures to

AM\1163538EN.docx 127/151 PE627.946v01-00 EN ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.”

Or. en

Justification

Paragraph 4 and 5 simply reinstate the current wording of Directive 2001/18/EC. If the aim of the proposal is to strengthen transparency, then, instead of enlarging the list of information which can be kept confidential, the current provisions relating to information that can never be kept confidential must be kept.

Amendment 501 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 7 – paragraph 1 – point 3 Regulation (EC) No 1331/2008 Article 12 – paragraph 3 a (new)

Text proposed by the Commission Amendment

3a. The provisions on active dissemination laid down in Articles 11 and 12 of this Regulation, and Articles 38 and 39 of Regulation (EC) No 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.

Or. en

Amendment 502 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 1 – point b Regulation (EC) No 1107/2009 Article 7 – paragraph 3 – subparagraph 1

PE627.946v01-00 128/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

When submitting the application, the When submitting the application, the applicant may pursuant to Article 63 applicant may pursuant to Article 63 request certain information, including request for certain information, including certain parts of the dossier, to be kept certain parts of the dossier that may confidential and shall physically separate significantly harm its commercial that information. interests, to be kept confidential and shall physically separate that information.

Or. en

Amendment 503 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 1 – point b Regulation (EC) No 1107/2009 Article 7 – paragraph 3 – subparagraph 2

Text proposed by the Commission Amendment

Member States shall assess the The Authority shall assess the confidentiality requests. Upon a request for confidentiality requests. Upon a request for access to information and after consultation access to information and after consultation with the Authority, the rapporteur Member between the Authority and the rapporteur States shall decide what information is to Member States it will be decided what be kept confidential, in accordance with information is to be kept confidential, in Article 63.; accordance with Article 63.;

Or. en

Justification

EFSA is the most appropriate player to identify which scientific parts could be commercially interesting and which not. This way, the assessment is more scientific-based and provides for equal treatment, as the assessment will be done for all application by EFSA based on the same criteria and not according to the Rapporteur MS

Amendment 504 Anja Hazekamp

AM\1163538EN.docx 129/151 PE627.946v01-00 EN Proposal for a regulation Article 8 – paragraph 1 – point 2 Regulation (EC) No 1107/2009 Article 10

Text proposed by the Commission Amendment

The Authority shall without delay make the The Authority shall without delay make the dossiers referred to in Article 8 of this dossiers referred to in Article 8 of this Regulation including any supplementary Regulation including any supplementary information supplied by the applicant, information supplied by the applicant, available to the public, excluding any available to the public, excluding any information in respect of which information in respect of which confidential treatment has been requested confidential treatment has been requested and accepted by the Authority pursuant to and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant shall apply mutatis mutandis and pursuant to Article 63 of this Regulation.; to Article 63 of this Regulation., unless there is an overriding public interest in its disclosure.

Or. en

Justification

The proposal 178/2002 as it stands, does not foresee the derogation for overriding public interest, as it is the case for the current art. 10 of Reg. 1107/2009. Therefore, it is necessary to re-insert it in order at least to maintain the current lever of public access;

Amendment 505 Martin Häusling

Proposal for a regulation Article 8 – paragraph 1 – point 4 Regulation (EC) No 1107/2009 Article 16

Text proposed by the Commission Amendment

The Authority shall assess, without delay, The Authority shall assess, without delay, any request for confidentiality and make any request for confidentiality and make available to the public the information available to the public the information provided by the applicant under Article 15 provided by the applicant under Article 15 as well as any other supplementary as well as any other supplementary information submitted by the applicant, information submitted by the applicant,

PE627.946v01-00 130/151 AM\1163538EN.docx EN except for information in respect of which except for information in respect of which confidential treatment has been requested confidential treatment has been requested and accepted by the Authority pursuant to and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant shall apply mutatis mutandis and pursuant to Article 63 of this Regulation.; to Article 63 of this Regulation, unless there is an overriding public interest in its disclosure.

Or. en

Justification

This provision is taken from the current Regulation 1107/2009, Article 16. There is no reason why the new rules should waive it.

Amendment 506 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 4 Regulation (EC) No 1107/2009 Article 16

Text proposed by the Commission Amendment

The Authority shall assess, without delay, The Authority shall assess, without delay, any request for confidentiality and make any request for confidentiality and make available to the public the information available to the public the information provided by the applicant under Article 15 provided by the applicant under Article 15 as well as any other supplementary as well as any other supplementary information submitted by the applicant, information submitted by the applicant, except for information in respect of which except for information in respect of which confidential treatment has been requested confidential treatment has been requested and accepted by the Authority pursuant to and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant shall apply mutatis mutandis and pursuant to Article 63 of this Regulation.; to Article 63 of this Regulation. unless there is an overriding public interest in its disclosure.

Or. en

AM\1163538EN.docx 131/151 PE627.946v01-00 EN Justification

For the moment, the EC proposal does not foresee the derogation based on overriding public interest, as the current Regulation foresees. Unless this derogation is inserting in the new articles of Regulation (EC) No 178/2002, then without this insertions, we head towards less transparent and accessibility from public even in cases of risk to health as foreseen in art. 4 (2) of 1049/2001 on public access to documents.

Amendment 507 Martin Häusling

Proposal for a regulation Article 8 – paragraph 1 – point 4 a (new) Regulation (EC) No 1107/2009 Article 23 – paragraph 1

Text proposed by the Commission Amendment

(4a) In Article 23, the last sentence of paragraph 1 is replaced by the following: “For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as an approved basic substance.”

Or. en

Justification

add: and “approved” This is an amendment of clarification, as many doubts remain on which substances may be considered as basic substances.

Amendment 508 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 – introductory part

Text proposed by the Commission Amendment

(5) in Article 63, paragraphs 1 and 2 (5) in Article 63, paragraphs 1, 2 and 3 are replaced by the following: are replaced by the following:

PE627.946v01-00 132/151 AM\1163538EN.docx EN Or. en

Amendment 509 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 – introductory part

Text proposed by the Commission Amendment

(5) in Article 63, paragraphs 1 and 2 (5) in Article 63, paragraph 1 is are replaced by the following: replaced by the following:

Or. en

Amendment 510 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 1

Text proposed by the Commission Amendment

1. In accordance with the conditions 1. In accordance with the conditions and the procedures laid down in Article 39 and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this of Regulation (EC) No 178/2002 and this article, the applicant may request certain article, the applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification. accompanied by verifiable justification. The justification shall include verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.

Or. en

Justification

This is a clarification, this is provided for in Article 63 of Regulation 1107/2009.

AM\1163538EN.docx 133/151 PE627.946v01-00 EN Amendment 511 Guillaume Balas

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 1

Text proposed by the Commission Amendment

1. In accordance with the conditions 1. In accordance with the conditions and the procedures laid down in Article 39 and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this of Regulation (EC) No 178/2002 and this article, the applicant may request certain article, except for information that is information submitted under this considered toxicologically, Regulation to be kept confidential, ecotoxicologically or environmentally accompanied by verifiable justification. relevant, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by adequate and verifiable justification.

Or. en

Amendment 512 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 1

Text proposed by the Commission Amendment

1. In accordance with the conditions 1. In accordance with the conditions and the procedures laid down in Article 39 and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this of Regulation (EC) No 178/2002 and this article, the applicant may request certain article, the applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential if the accompanied by verifiable justification. accompanied verifiable justification proves that the disclosure of those might undermine commercial interests, the protection of privacy and the integrity of the individual.

Or. en

PE627.946v01-00 134/151 AM\1163538EN.docx EN Justification

Insertion to bring in line with the correct status

Amendment 513 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3), confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for these impurities; (b) results of production batches of the active substance including impurities; and, (c) information on the complete composition of a plant protection product.;

Or. en

Amendment 514 Martin Häusling

Proposal for a regulation Article 8 – paragraph 1 – point 5

AM\1163538EN.docx 135/151 PE627.946v01-00 EN Regulation (EC) No 1107/2009 Article 63 – paragraph 2

Text proposed by the Commission Amendment

2. In addition to Article 39(2) of deleted Regulation (EC) No 178/2002 and pursuant to Article 39(3), confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for these impurities; (b) results of production batches of the active substance including impurities; and, (c) information on the complete composition of a plant protection product.;

Or. en

Justification

As the aim of the proposal is to increase transparency, the addition of further information that may be kept confidential is not useful.

Amendment 515 Fredrick Federley, Ulrike Müller, Jan Huitema

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2 – introductory part

PE627.946v01-00 136/151 AM\1163538EN.docx EN Text proposed by the Commission Amendment

2. In addition to Article 39(2) of 2. In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant Regulation (EC)No 178/2002 and pursuant to Article 39(3), confidential treatment to Article 39(3), the Authority shall may be accepted with respect to the provide confidential treatment in relation following information, the disclosure of to the following information, if the which may be deemed, upon verifiable disclosure of which is deemed to justification, to significantly harm the significantly harm the interests concerned interests concerned: until proven otherwise:

Or. en

Amendment 516 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) the specification of impurity of the deleted active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for these impurities;

Or. en

Amendment 517 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2 – point b

AM\1163538EN.docx 137/151 PE627.946v01-00 EN Text proposed by the Commission Amendment

(b) results of production batches of deleted the active substance including impurities; and,

Or. en

Amendment 518 Guillaume Balas

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2 – point c

Text proposed by the Commission Amendment

(c) information on the complete deleted composition of a plant protection product.;

Or. en

Amendment 519 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2 – point c

Text proposed by the Commission Amendment

(c) information on the complete deleted composition of a plant protection product.;

Or. en

Amendment 520 Anja Hazekamp

PE627.946v01-00 138/151 AM\1163538EN.docx EN Proposal for a regulation Article 8 – paragraph 1 – point 5 Regulation (EC) No 1107/2009 Article 63 – paragraph 2 – point c

Text proposed by the Commission Amendment

(c) information on the complete deleted composition of a plant protection product.;

Or. en

Amendment 521 Anja Hazekamp

Proposal for a regulation Article 8 – paragraph 1 – point 5 a (new) Regulation (EC) No 1107/2009 Article 63 – paragraph 3

Text proposed by the Commission Amendment

(5a) in Article 63, paragraph 3 is replaced by the following: “3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents.”

Or. en

Amendment 522 Martin Häusling

Proposal for a regulation Article 8 – paragraph 1 – point 5 a (new)

AM\1163538EN.docx 139/151 PE627.946v01-00 EN Regulation (EC) No 1107/2009 Article 63 – paragraph 3

Text proposed by the Commission Amendment

(5a) in Article 63, paragraph 3 is replaced by the following: “3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and to Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”

Or. en

Amendment 523 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 8 – paragraph 1 – point 5 a (new) Regulation (EC) No 1107/2009 Article 63 – paragraph 3a (new)

Text proposed by the Commission Amendment

(5a) in Article 63, the following paragraph is added after paragraph 3: “3a. The provisions on active dissemination laid down in Article 63 of this Regulation, and Article 38 and 39 of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”

Or. en

Amendment 524 Anja Hazekamp

PE627.946v01-00 140/151 AM\1163538EN.docx EN Proposal for a regulation Article 9 – paragraph 1 – point 1 – point a Regulation (EC) No 2015/2283 Article 10 – paragraph 1

Text proposed by the Commission Amendment

1. The procedure for authorising the 1. The procedure for authorising the placing on the market within the Union of placing on the market within the Union of a novel food and updating of the Union list a novel food and updating of the Union list provided for in Article 9 of this Regulation provided for in Article 9 of this Regulation shall start either on the Commission’s shall start either on the Commission’s initiative or following an application to the initiative or following an application to the Commission by an applicant, in accordance Commission by an applicant, in accordance with standard data formats, where they with standard data formats, where they exist pursuant to Article 39f of Regulation exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall (EC) No 178/2002. The Commission shall make the application available to the make the application available to the Member States without delay; Member States and the summary of the application publicly available without delay;

Or. en

Justification

In order to ensure, at least, equal level of transparency, the amended Regulation should include access of the summary to the public, as it is currently foreseen in art.10 (1).

Amendment 525 Renate Sommer

Proposal for a regulation Article 9 – paragraph 1 – point 1 – point b Regulation (EC) No 2015/2283 Article 10 – paragraph 3

Text proposed by the Commission Amendment

3. Where the Commission requests an 3. Where the Commission requests an opinion from, the European Food Safety opinion from, the European Food Safety Authority (‘the Authority’), the Authority Authority (‘the Authority’), the Authority shall ensure public access to the shall ensure public access to the application in accordance with Article 23 application in accordance with Article 23 and shall give its opinion as to whether the at the same time as it publishes its draft update is liable to have an effect on human opinion in response to the question

AM\1163538EN.docx 141/151 PE627.946v01-00 EN health; whether the update is liable to have an effect on human health;

Or. en

Amendment 526 Anja Hazekamp

Proposal for a regulation Article 9 – paragraph 1 – point 1 – point b Regulation (EC) No 2015/2283 Article 10 – paragraph 3

Text proposed by the Commission Amendment

3. Where the Commission requests an 3. For every update, the Commission opinion from, the European Food Safety shall request from, the European Food Authority (‘the Authority’), the Authority Safety Authority (‘the Authority’) to give shall ensure public access to the its opinion as to whether the update is application in accordance with Article 23 liable to have an effect on human health. and shall give its opinion as to whether the The Authority shall ensure public access update is liable to have an effect on human to the application and its opinion in health; accordance with Article 23.

Or. en

Justification

In order to ensure food safety, EFSA should always ask for any update on novel foods. In order to enhance transparency and trust in the process, it is imperative to give public access to as many information as possible, as long as they are not covered by justified confidentiality restrictions;

Amendment 527 Renate Sommer

Proposal for a regulation Article 9 – paragraph 1 – point 2 Regulation (EC) No 2015/2283 Article 15 – paragraph 1 – last sentence

Text proposed by the Commission Amendment

The Authority shall ensure public access to The Authority shall ensure public access to

PE627.946v01-00 142/151 AM\1163538EN.docx EN the notification pursuant to Article 23. the notification pursuant to Article 23 when it publishes its technical report.

Or. en

Amendment 528 Renate Sommer

Proposal for a regulation Article 9 – paragraph 1 – point 3 – point b Regulation (EC) No 2015/2283 Article 16 – paragraph 2 - last sentence

Text proposed by the Commission Amendment

The Authority shall ensure public access to The Authority shall ensure public access to the application, relevant supporting the non-confidential elements of the information and any supplementary application, relevant supporting information supplied by the applicant in information and any supplementary accordance with Article 23. 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.

Or. en

Amendment 529 Martin Häusling

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23

Text proposed by the Commission Amendment

(4) Article 23 is replaced by the (4) Article 23 is replaced by the following: following: “Article 23 “Article 23 Transparency and confidentiality Transparency and confidentiality 1. Where the Commission requests its 1. Where the Commission requests its opinion in accordance with Articles 10(3) opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority and 16 of this Regulation, the Authority

AM\1163538EN.docx 143/151 PE627.946v01-00 EN shall make public the application for shall make public the application for authorisation, relevant supporting authorisation, relevant supporting information and any supplementary information and any supplementary information supplied by the applicant, as information supplied by the applicant, as well as its scientific opinions, in well as its scientific opinions, in accordance with Article 38, Articles 39 to accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article. 178/2002 and with this Article. 2. The applicant may request certain 2. The applicant may request certain information submitted under this information submitted under this Regulation to be kept confidential, Regulation to be kept confidential, accompanied by verifiable justification, accompanied by verifiable justification, upon submission of the application. upon submission of the application. 3. Where the Commission requests its 3. Where the Commission requests its opinion in accordance with Articles 10(3) opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority and 16 of this Regulation, the Authority shall assess the confidentiality request shall assess the confidentiality request submitted by the applicant, in accordance submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) with Articles 39 to 39e of Regulation (EC) No 178/2002. No 178/2002. 4. Where the Commission does not 4. Where the Commission does not request the Authority’s opinion pursuant to request the Authority’s opinion pursuant to Articles 10 and 16, the Commission shall Articles 10 and 16, the Commission shall assess the confidentiality request submitted assess the confidentiality request submitted by the applicant. Article 39 and 39a of by the applicant. Article 39 and 39a of Regulation (EC) No 178/2002 shall apply Regulation (EC) No 178/2002 shall apply mutatis mutandis.”. mutatis mutandis. 4a. Confidentiality shall not apply to the following information: (a) the name and address of the applicant; (b) the name and description of the novel food; (c) the proposed conditions of use of the novel food; (d) a summary of the studies submitted by the applicant; (e) the results of the studies carried out to demonstrate the safety of the food; (f) where appropriate, the analysis method(s); (g) any prohibition or restriction imposed in respect of the food by a third country.”

PE627.946v01-00 144/151 AM\1163538EN.docx EN Or. en

Amendment 530 Anja Hazekamp

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 1

Text proposed by the Commission Amendment

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

Or. en

Amendment 531 Renate Sommer

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 1

Text proposed by the Commission Amendment

1. Where the Commission requests its 1. Where the Commission requests its opinion in accordance with Articles 10(3) opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority and 16 of this Regulation, the Authority shall make public the application for shall make public the application for authorisation, relevant supporting authorisation, relevant supporting information and any supplementary information and any supplementary information supplied by the applicant, as information supplied by the applicant, at well as its scientific opinions, in the same time as its draft scientific accordance with Article 38, Articles 39 to opinion, in accordance with Article 38,

AM\1163538EN.docx 145/151 PE627.946v01-00 EN 39f and Article 40 of Regulation (EC) No Articles 39 to 39f and Article 40 of 178/2002 and with this Article. Regulation (EC) No 178/2002 and with this Article.

Or. en

Amendment 532 Anja Hazekamp

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 3

Text proposed by the Commission Amendment

3. Where the Commission requests its 3. The Authority shall assess the opinion in accordance with Articles 10(3) confidentiality request submitted by the and 16 of this Regulation, the Authority applicant, in accordance with Articles 39 to shall assess the confidentiality request 39e of Regulation (EC) No 178/2002. submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.

Or. en

Amendment 533 Anja Hazekamp

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4

Text proposed by the Commission Amendment

4. Where the Commission does not deleted request the Authority’s opinion pursuant to Articles 10 and 16, the Commission shall assess the confidentiality request submitted by the applicant. Article 39 and 39a of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Or. en

PE627.946v01-00 146/151 AM\1163538EN.docx EN Amendment 534 Pavel Poc, Jytte Guteland, Nicola Caputo, Daciana Octavia Sârbu

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 a (new)

Text proposed by the Commission Amendment

4a. The provisions on active dissemination laid down in Article 23 of this Regulation, and Articles 38 and 39 of Regulation 178/2002, are without prejudice to the right of access to documents upon request set in Regulation (EC) No 1049/2001.

Or. en

Amendment 535 Anja Hazekamp

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 a (new)

Text proposed by the Commission Amendment

4a. Confidentiality shall not apply to the following information: (a) the name and address of the applicant; (b) the name and description of the novel food; (c) the proposed conditions of use of the novel food; (d) a summary of the studies submitted by the applicant; (e) the results of the studies carried out to demonstrate the safety of the food;

AM\1163538EN.docx 147/151 PE627.946v01-00 EN (f) where appropriate, the analysis method(s); (g) any prohibition or restriction imposed in respect of the food by a third country. The Commission, the Member States and the Authority shall take necessary measures to ensure appropriate confidentiality of the information as referred to in paragraph 4, and received by them under this Regulation, except for information which is required to be made public in order to protect human health.

Or. en

Justification

Necessary insertion (identical to the current status) in order to avoid a backlash in transparency, accessibility and predictability.

Amendment 536 Renate Sommer

Proposal for a regulation Article 9 – paragraph 1 – point 4 Regulation (EC) No 2015/2283 Article 23 – paragraph 4 a (new)

Text proposed by the Commission Amendment

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).

Or. en

Justification

Regulation (EU) 2283/2015 foresaw in Article 23 (8) that the Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 6. This is

PE627.946v01-00 148/151 AM\1163538EN.docx EN required because of the specificities of Novel Foos that can cover aspects that are new and not known today. This provision must remain.

Amendment 537 Martin Häusling

Proposal for a regulation Article 9 – paragraph 1 – point 4 a (new) Regulation (EC) No 2015/2283 Article 25 – paragraph 1 a (new)

Text proposed by the Commission Amendment

(4a) In Article 25, the following paragraph is inserted: “1a. The obligation to proactively disseminate information set out in this Regulation and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulations (EC) No 1049/2001 and (EC) No 1367/2006.”

Or. en

Amendment 538 Michel Dantin

Proposal for a regulation Article 9 a (new) Directive 2001/110/EC Article 2

Text proposed by the Commission Amendment

Article 9a Amendments to Council Directive 2001/110/EC relating to honey Article 2 is amended as follows: (a) in paragraph 4, point (a), the first subparagraph is replaced by the following:

AM\1163538EN.docx 149/151 PE627.946v01-00 EN ‘The country or countries of origin where the honey has been harvested shall be indicated on the label. At least 75% of blended honeys must come from the indicated country or countries of origin’. (b) in paragraph 4, point (a), the second subparagraph is replaced by the following: ‘Furthermore, if the honey is a blend of honeys from more than one Member State or more than one third country, one of the following pieces of information may also appear on the label, as appropriate: – “blend of EU honeys”; – “blend of non-EU honeys”; – “blend of EU and non-EU honeys”. Such information is supplementary to, and shall not replace, the country of origin information referred to in the first subparagraph.’ (d) the following paragraph is added: « 5a. ‘Terms such as “contains honey” and “made with honey” may not be used in the designation of processed products, or in any graphic or non-graphic element, unless at least 20% of the (mono- and disaccharide) sugar content of the product in question originates from honey.’

Or. fr

Amendment 539 Marijana Petir, Norbert Erdős, Franc Bogovič

Proposal for a regulation Article 9a (new) Directive 2001/110/EC Article 2

Text proposed by the Commission Amendment

Article 9a Amendments to Directive 2001/110/EC on

PE627.946v01-00 150/151 AM\1163538EN.docx EN honey Directive 2001/110/EC is amended as follows: Article 2 is amended as follows: (a) in point 4, point (a) is replaced by the following: “(a) The country or countries of origin where the honey has been harvested shall be indicated on the label by which country or countries the honey used in the final product come from, and that these shall be listed in the order which corresponds to the percentage proportions used in the final product additionally stating the percentage by country in a given product;” (b) the following point is added: “5a. the use of the word ‘honey’ or the terms ‘containing honey’ or ‘made with honey’ in the designation of processed food products, or in any graphic or non- graphic element indicating that the product contains honey may only be used if at least 50 % of the sugar- content of the product originates from honey.”

Or. en

AM\1163538EN.docx 151/151 PE627.946v01-00 EN