53 Amendments of Emil RADEV related to 2018/0088(COD)
Amendment 91 #
Proposal for a regulation
Recital 3
Recital 3
(3) The evaluation of Regulation (EC) No 178/200221, (“Fitness Check of the General Food Law”), found that risk communication is overall, not considered to be effective enough, which has an direct impact on consumers’ confidence on the outcome of the risk analysis process. _________________ 21 Commission Staff Working Document, Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)”, SWD(2018)38 final, dated 15.1.2018.
Amendment 93 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherence and, consistency and transparency within the risk analysis process.
Amendment 95 #
Proposal for a regulation
Recital 6
Recital 6
(6) To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers and the need to ensure their independence.
Amendment 96 #
Proposal for a regulation
Recital 7
Recital 7
(7) Based on these general objectives and principles, a general plan on risk communication in real time should be established in close cooperation with the Authority and the Member States, and following the holding of the relevant public consultations.
Amendment 98 #
Proposal for a regulation
Recital 8
Recital 8
(8) The general plan should identify the key factors to be taken into account when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health and environmental impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate and timely mechanisms to ensure coherent risk communication.
Amendment 100 #
Proposal for a regulation
Recital 10
Recital 10
(10) It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 201222, while also taking into account the withdrawal of the United Kingdom from the EU and the legal effects of this. _________________ 22 https://europa.eu/european- union/sites/europaeu/files/docs/body/joint_ statement_and_common_approach_2012_e n.pdf.
Amendment 102 #
Proposal for a regulation
Recital 11
Recital 11
(11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States in the Management Board of the Authority, while providing that those representatives should have considerable experience in particular on risk assessment, after they have made a declaration of an absence of conflict of interests.
Amendment 109 #
Proposal for a regulation
Recital 14
Recital 14
(14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict, transparent criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently of the Member States by whom they are appointed.
Amendment 111 #
Proposal for a regulation
Recital 16
Recital 16
(16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health isand the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
Amendment 113 #
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 115 #
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 transparencysubmitted and the Authority has published its official opinion.
Amendment 117 #
Proposal for a regulation
Recital 20
Recital 20
(20) There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of non- interested third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
Amendment 119 #
Proposal for a regulation
Recital 21
Recital 21
(21) Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance. It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests wouldare to be verified by the Commission.
Amendment 121 #
Proposal for a regulation
Recital 22
Recital 22
(22) Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the CommissionAuthority should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Amendment 125 #
Proposal for a regulation
Recital 25
Recital 25
(25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner. Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process. However, this process should be without prejudice to existing intellectual property rights or to any provisions of Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations.
Amendment 137 #
Proposal for a regulation
Recital 32
Recital 32
(32) Having regard to the fact that the Authority would be required to store scientific data, including confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security and in full compliance with the Data Protection Regulation.
Amendment 140 #
Proposal for a regulation
Recital 35
Recital 35
(35) For the purposes of ensuring the transparency and independence of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.
Amendment 150 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/202
Article 8a – point fa (new)
Article 8a – point fa (new)
fa) combat sources and dissemination of false and misleading information;
Amendment 154 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8b – point d
Article 8b – point d
Amendment 158 #
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 1a – point b
Article 25 – paragraph 1a – point b
b) onetwo members and their substitutes appointed by the European Parliament, with the right to vote.
Amendment 160 #
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 1a – point c
Article 25 – paragraph 1a – 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 organisationsthe 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 164 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5a – point a
Article 28 – paragraph 5a – point a
а) The Executive Director, after consulting the Management Board, shall send to the Member States the request for the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts to be nominated by the Member Statesrequired. The Executive Director shall notify the Member States of the Authority’s independence policy and implementing rules applicable to Scientific Panels’ members. Member States shall launch a call for interest as a basis for their nominations. The Executive Director shall inform the Management Board of the requests sent to the Member States.
Amendment 165 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5a – point b
Article 28 – paragraph 5a – point b
b) Member States shallmay nominate experts with a view to collectively reach the numberfor the fields indicated byon the Executive Director. Each Member State shall nominate at least 12 scientific expertsbasis of a call for expressions of interest. Member States may also nominate nationals of other Member States.
Amendment 166 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5a – point c
Article 28 – paragraph 5a – point c
c) On the basis of the nominations made by Member Stateson the basis of the expressions of interest, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed. The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list. The Executive Director shall submit the list to the Management Board for appointment.
Amendment 169 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28(5d)
Article 28(5d)
5d. The Member States shall put in place measures ensuring that the members of the Scientific Panels nominated by them act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority’s internal measures. Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority. Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain.
Amendment 174 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 326 – paragraph 1a (new)
Article 326 – paragraph 1a (new)
1а. Any studies commissioned shall take account of Directive 2010/63/EU on the protection of animals used for scientific purposes.
Amendment 175 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 3
Article 32b – 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.
Amendment 177 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 4a (new)
Article 32b – paragraph 4a (new)
4а. This Article shall not be applicable to studies commissioned before [date of entry into force of this Regulation].
Amendment 179 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32d
Article 32d
The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant EU and external standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law. These controls shall be organised in cooperation with the competent authorities of the Member States and/or of the third countries concerned.
Amendment 182 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32d – paragraph 1
Article 32d – paragraph 1
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 toAuthority may, where the scientific data and findings conflict with one another, commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.
Amendment 186 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а
Article 1 – paragraph 1 – point 5 – point а
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
Amendment 187 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а
Article 1 – paragraph 1 – point 5 – point а
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point d
Article 38 – paragraph 1 – point d
d) 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;eleted
Amendment 188 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а
Article 1 – paragraph 1 – point 5 – point а
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point i
Article 38 – paragraph 1 – point i
Amendment 189 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а a (new)
Article 1 – paragraph 1 – point 5 – point а a (new)
(аа) The following paragraph 1 -a shall be added: (1-a) At the time of publication of its scientific opinion, the Authority shall also make the following public: (а) 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 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 applicants conducted by the Authority pursuant to Article 32a and 32c prior to their applications.
Amendment 198 #
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 206 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – point a
Article 39b – paragraph 1 – point a
Amendment 209 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – point e
Article 39b – paragraph 1 – point e
e) make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d)publish non-confidential data and information relating to the application only once a final decision has been taken in respect of the confidentiality request pursuant to this Article and the Authority has published its 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 210 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39d – paragraph 1
Article 39d – paragraph 1
Amendment 211 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39d – paragraph 2
Article 39d – 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 definitiveits 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 212 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39d – paragraph 3
Article 39d – 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 217 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39e (2)
Article 39e (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 230 #
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 231 #
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 wellt the same time as its scientific opinions and opinions from the competent authorities referred to in Article 4 of Directive 2001/18/EC, 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 236 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point б
Article 4 – paragraph 1 – point 1 – point б
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 to its scientific opinion, in accordance with Article 18.”;
Amendment 238 #
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 244 #
Proposal for a regulation
Article 5 – paragraph 1 – point 1 – point а
Article 5 – paragraph 1 – point 1 – point а
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, when it publishes its scientific opinion, in accordance with Articles 14 and 15.”;
Amendment 245 #
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, at the same time as its scientific opinion, the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant as well as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002.;
Amendment 249 #
Proposal for a regulation
Article 6 – paragraph 1 – point 1 – point а
Article 6 – paragraph 1 – point 1 – point а
Regulation (EC) No 1935/2004
Article 9 – paragraph 1 – point c – point ii
Article 9 – paragraph 1 – point c – point ii
Amendment 250 #
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 256 #
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Rule 11 – paragraph 1
Rule 11 – paragraph 1
Amendment 265 #
Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point б
Article 9 – paragraph 1 – point 1 – point б
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 public access to the application in accordance with Article 23 and shall givewhen it publishes its opinion as to the question of whether the update is liable to have an effect on human health.”;
Amendment 266 #
Proposal for a regulation
Article 9 – paragraph 1 – point 3 – point б
Article 9 – paragraph 1 – point 3 – point б
Regulation (EC) No 2015/2283
Article 16 – paragraph 2
Article 16 – paragraph 2
The Authority shall ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicantnon-confidential elements of the application, and to the notification concerning safety concerns under Article 15, at the same time as it publishes its scientific opinion in accordance with Article 23.”;
Amendment 267 #
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, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article, at the same time as it publishes its opinion concerning the application.