68 Amendments of Annie SCHREIJER-PIERIK related to 2018/0088(COD)
Amendment 11 #
Proposal for a regulation
Recital 17
Recital 17
(17) Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.
Amendment 12 #
(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparencyly submitted and the Authority has published its scientific opinion.
Amendment 17 #
Proposal for a regulation
Recital 28
Recital 28
(28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures. It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.Does not affect the English version.)
Amendment 21 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point f a (new)
Article 8 a – point f a (new)
(fa) combat sources of false information and its dissemination.
Amendment 24 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) No 178/2002
Article 8 d (new)
Article 8 d (new)
(1a) Transparency of risk communication 1. The European Commission, the Authority and the Member States shall carry out their tasks as regards risk communication in relation to food law with a high level of transparency. When preparing their approaches and measures to ensure transparency of risk communication, they shall take into account the general principles of risk communication laid down in Article 8b of this Regulation and shall consult in advance with all relevant stakeholders, where applicable including the primary producers within the chain. 2. In order to comply with the requirements set out in paragraph 1, the European Commission and the Authority shall adopt relevant guidelines.
Amendment 26 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1 a – point c
Article 25 – paragraph 1 a – point c
(c) foursix members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and, one from industry organisationsfisheries and aquaculture organisations, one from the agrochemical industry and one from the food industry. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Amendment 32 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a – paragraph 1
Article 32 a – paragraph 1
The Authority shall publish a guidance document, including a list of questions and answers, regarding all the administrative and scientific requirements applicable to an application for authorisation. At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions andlso offer consultation sessions to explain the required content ofand the application for authorisationmode of implementation of the various tests and studies in order to prove the quality, safety and efficacy of the planned product. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels.
Amendment 34 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 3
Article 32 b – paragraph 3
3. The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies and its scientific opinion in accordance with Article 38 and Articles 39 to 39f and has published its scientific opinion.
Amendment 42 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point c
Article 38 – paragraph 1 – subparagraph 1 – point c
Amendment 43 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point d
Article 38 – paragraph 1 – subparagraph 1 – point d
Amendment 44 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point i
Article 38 – paragraph 1 – subparagraph 1 – point i
Amendment 45 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a a (new)
Article 1 – paragraph 1 – point 5 – point a a (new)
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a (new)
Article 38 – paragraph 1 a (new)
(aa) The following new paragraph 1a is inserted: “1a. At the time of publication of its scientific opinion, the Authority shall also make the following public: (a) scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f; (b) the information on which its scientific outputs, including scientific opinions, are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f; (c) information concerning the consultation sessions with potential applicants conducted by the Authority pursuant to Article 32a and 32c prior to their applications.";
Amendment 48 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 3
Article 39 – paragraph 2 – point 3
(3) commercial information revealing sourcing, market shares, innovative product ideas or business strategy of the applicant; and,
Amendment 50 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point a
Article 39 b – paragraph 1 – point a
Amendment 51 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point e
Article 39 b – paragraph 1 – point e
(e) make public any additionnon-confidential data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d)concerning the application for authorisation only when a decision has been taken in accordance with this article on the confidentiality request and the Authority has published its scientific opinion. 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.
Amendment 53 #
Amendment 54 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 2
Article 39 d – paragraph 2
2. The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive and its scientific opinion has been published. 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.
Amendment 55 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 3
Article 39 d – paragraph 3
3. If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public theany information for which confidentiality has been requestedrelating to the planned application.
Amendment 56 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 e – paragraph 2
Article 39 e – paragraph 2
2. Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available, unless there is an overriding public interest.
Amendment 60 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Directive 2001/18/EC
Article 28 – paragraph 4
Article 28 – paragraph 4
4. Where the relevant Scientific Committee is consulted under paragraph 1, it shall make public the notification/application, relevant supporting information and any supplementary information supplied by the notifier/applicant, as wellt the same time as its scientific opinions, in accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and Article 25 of this Directive..
Amendment 62 #
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
Regulation (EC) No 1829/2003
Article 29 – paragraph 1
Article 29 – paragraph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, at the same time as its scientific opinion, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation.
Amendment 63 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
Regulation (EC) No 1831/2003
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) ensure public access to the application and any information supplied by the applicant, at the same time as its scientific opinion is published, in accordance with Article 18.;
Amendment 64 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
Amendment 65 #
Proposal for a regulation
Article 5 – paragraph 1 – point 1 – point a
Article 5 – paragraph 1 – point 1 – point a
Regulation (EC) No 2065/2003
Article 7 – paragraph 2 – point c – indent ii
Article 7 – paragraph 2 – point c – indent ii
(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15, at the same time as its scientific opinion is published.;
Amendment 66 #
Proposal for a regulation
Article 5 – paragraph 1 – point 2
Article 5 – paragraph 1 – point 2
Regulation (EC) No 2065/2003
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002.;
Amendment 67 #
Proposal for a regulation
Article 6 – paragraph 1 – point 1 – point a
Article 6 – paragraph 1 – point 1 – point a
Regulation (EC) No 1935/2004
Article 9 – paragraph 1 – point c – indent ii
Article 9 – paragraph 1 – point c – indent ii
(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20, at the same time as its scientific opinion is published.;
Amendment 68 #
Proposal for a regulation
Article 6 – paragraph 1 – point 2
Article 6 – paragraph 1 – point 2
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as wellt the same time as its scientific opinions is published, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and Article 20 of this Regulation. ;
Amendment 69 #
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11 – paragraph 1
Article 11 – paragraph 1
“Where the Commission requests its opinion in accordance with Article 3(2) of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39to 39f and Article 40 of Regulation (EC) No 178/2002. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.;
Amendment 70 #
Proposal for a regulation
Recital 17
Recital 17
(17) Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.
Amendment 70 #
Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point b
Article 9 – paragraph 1 – point 1 – point b
Regulation (EC) No 2015/2283
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Where the Commission requests an opinion from, the European Food Safety Authority (‘the Authority’), the Authority shall ensure that the public has access to the application in accordance with Article 23 and shall givesimultaneously with the publication of its opinion as to whether the update is liable to have an effect on human health.;
Amendment 71 #
Proposal for a regulation
Article 9 – paragraph 1 – point 3 – point b
Article 9 – paragraph 1 – point 3 – point b
Regulation (EC) No 2015/2283
Article 16 – paragraph 2 – final paragraph
Article 16 – paragraph 2 – final paragraph
The Authority shall ensure that the public has access to the application, relevant supporting information and any supplementary information supplied by the applicantnon-confidential data of the application in accordance with Article 23 at the same time as the publication of its scientific advice, as well as to the notification on safety issues in accordance with Article 2315.;
Amendment 72 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, simultaneously with the publication of its opinion on the application, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article.
Amendment 74 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparencyly submitted and the Authority has published its scientific opinion.
Amendment 89 #
Proposal for a regulation
Recital 28
Recital 28
(28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures. It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in very limited and exceptional circumstances relating to foreseeable health effectwhen there is and urgent needs to protect human health, animal health or the environment, such information should be disclosed.
Amendment 104 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point f b (new)
Article 8 a – point f b (new)
(fa) combat sources of false information and its dissemination.
Amendment 109 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c a (new)
Article 8 c a (new)
Rule 8ca Transparency of risk communication 1. The European Commission, the Authority and the Member States shall carry out their tasks as regards risk communication in relation to food law with a high level of transparency. When preparing their approaches and measures to ensure transparency of risk communication, they shall take into account the general principles of risk communication laid down in Article 8b of this Regulation and shall consult in advance with all relevant stakeholders, where applicable including the primary producers within the chain. In order to comply with the requirements set out in paragraph 1, the European Commission and the Authority must adopt relevant guidelines.
Amendment 116 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1 a – point c
Article 25 – paragraph 1 a – point c
(c) fourive members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations, one from the agrochemical industry and one from the food industry. Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Amendment 121 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. Information about theall notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparencysubmitted and the Authority has published its scientific opinion.
Amendment 128 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation No 178/2002
Article 32 a
Article 32 a
The Authority shall publish a guidance document, including a list of questions and answers, regarding all the administrative and scientific requirements applicable to an application for authorisation. At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and the required content of the application for authorisationlso offer consultation sessions to explain what information is required and how the various tests and studies necessary to prove the quality, safety and efficacy of the planned product are to be carried out. The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels.
Amendment 137 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 b – paragraph 3
Article 32 b – paragraph 3
3. The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f and has published its scientific opinion.
Amendment 157 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragrah 1 – point c
Article 38 – paragrah 1 – point c
Amendment 158 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point d
Article 38 – paragraph 1 – point d
Amendment 159 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point i
Article 38 – paragraph 1 – point i
Amendment 161 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a a (new)
Article 1 – paragraph 1 – point 5 – point a a (new)
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a (new)
Article 38 – paragraph 1 a (new)
(aa) The following paragraph 1a shall be added: “1a.At the time of publication of its scientific opinion, the Authority shall also make the following public: (a) scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f; (b) the information on which its scientific outputs, including scientific opinions, are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f; (c) information concerning the consultation sessions with potential applicants conducted by the Authority pursuant to Article 32a and 32c prior to their applications.";
Amendment 172 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph – point 3
Article 39 – paragraph – point 3
(3) commercial information revealing sourcing, market shares, innovative product ideas or business strategy of the applicant; and,
Amendment 180 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point a
Article 39 b – paragraph 1 – point a
Amendment 183 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point e
Article 39 b – paragraph 1 – point e
(e) make public any additionnon-confidential data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d)concerning the application for authorisation only when a decision has been taken in accordance with this article on the confidentiality request and the Authority has published its scientific opinion. 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.
Amendment 188 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 1
Article 39 d – paragraph 1
Amendment 190 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point b
Article 8 a – point b
(b) promote consistency and transparency in formulating risk management recommendations and decisions;
Amendment 190 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 2
Article 39 d – paragraph 2
2. The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and it has become definitivepublished its scientific opinion. 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.
Amendment 191 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 3
Article 39 d – paragraph 3
3. If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public theany information for which confidentiality has been requestedrelating to the planned application.
Amendment 194 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 e – paragraph 2
Article 39 e – paragraph 2
2. Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available, unless there is an overriding public interest.
Amendment 201 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point d
Article 8 a – point d
(d) foster public understanding of the risk analysis process so as to enhance confidence in its outcome, including the provision of clear and consistent information regarding the respective tasks, powers and responsibilities of risk assessors and risk managers;
Amendment 203 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Directive No 2001/18/EC
Article 28 – paragraph 4
Article 28 – paragraph 4
4. Where the relevant Scientific Committee is consulted under paragraph 1, it shall make public the notification/application, relevant supporting information and any supplementary information supplied by the notifier/applicant, as wellt the same time as its scientific opinions, in accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and Article 25 of this Directive..
Amendment 205 #
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
Regulation (EC) No 1829/2003
Article 29 – paragraph 1
Article 29 – paragraph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, at the same time as its scientific opinion, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and taking into account Article 30 of this Regulation.
Amendment 207 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 a – point f a (new)
Article 8 a – point f a (new)
(fa) seek to prevent the spread of incorrect information and the sources thereof.
Amendment 207 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
Regulation (EC) No 1831/2003
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) ensure public access to the application and any information supplied by the applicant, in accordance with Article 18., at the same time as its scientific opinion is published;
Amendment 209 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
Amendment 213 #
Proposal for a regulation
Article 5 – paragraph 1 – point 1 – point a
Article 5 – paragraph 1 – point 1 – point a
Regulation (EC) No 2065/2003
Article 7 – paragraph 2 – point c – point ii
Article 7 – paragraph 2 – point c – point ii
(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15., at the same time as its scientific opinion is published;
Amendment 215 #
Proposal for a regulation
Article 5 – paragraph 1 – point 2
Article 5 – paragraph 1 – point 2
Regulation (EC) No 2065/2003
Article 14 – paragaph 1
Article 14 – paragaph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002.;
Amendment 216 #
Proposal for a regulation
Article 6 – paragraph 1 – point 1 – point a
Article 6 – paragraph 1 – point 1 – point a
Regulation (EC) No 1935/2004
Article 9 – paragraph 1 – point c – point ii
Article 9 – paragraph 1 – point c – point ii
(ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20., at the same time as its scientific opinion is published;
Amendment 217 #
Proposal for a regulation
Article 6 – paragraph 1 – point 2
Article 6 – paragraph 1 – point 2
Regulation (EC) No 1935/2004
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and Article 20 of this Regulation. ”;
Amendment 221 #
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11 – paragraph 1
Article 11 – paragraph 1
“Where the Commission requests its opinion in accordance with Article 3(2) of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as wellt the same time as its scientific opinions, in accordance with Article 38, Articles 39to 39f and Article 40 of Regulation (EC) No 178/2002. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.;
Amendment 224 #
Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point b
Article 9 – paragraph 1 – point 1 – point b
Regulation (EC) No 2015/2283
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Where the Commission requests an opinion from, the European Food Safety Authority (‘the Authority’), the Authority shall ensure that the public has access to the application in accordance with Article 23 and shall givesimultaneously with the publication of its opinion as to whether the update is liable to have an effect on human health.;
Amendment 225 #
Proposal for a regulation
Article 9 – paragraph 1 – point 3 – point b
Article 9 – paragraph 1 – point 3 – point b
Regulation (EC) No 2015/2283
Article 16 – paragraph 2 – last sentence
Article 16 – paragraph 2 – last sentence
The Authority shall ensure that the public has access to the application, relevant supporting information and any supplementary information supplied bynon-confidential data of the application in accordance with Article 23, as well as to the notification on safety issues in accordance with Article 15, at the same time as the apppublicant in accordance with Article 23.;tion of its scientific opinion.
Amendment 226 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, simultaneously with the publication of its opinion on the application, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article.
Amendment 228 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) No 178/2002
Article 8 d (new)
Article 8 d (new)
Article 8d Objectives of risk communication 1. The European Commission, the Authority and the Member States shall carry out their tasks as regards risk communication in relation to food law with a high level of transparency. When preparing their approaches and measures to ensure transparency of risk communication, they shall adhere strictly to the general principles of risk communication laid down in Article 8b of this Regulation and shall consult in advance with all relevant stakeholders, including the primary producers within the chain where required. 2. In order to comply with the requirements set out in paragraph 1, the European Commission and the Authority must adopt relevant guidelines.
Amendment 310 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 e
Article 32 e
Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances and after careful consultation, 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.”;