119 Amendments of Martin HÄUSLING related to 2018/0088(COD)
Amendment 64 #
Draft legislative resolution
Citation 2
Citation 2
– having regard to Article 294(2) and Articles 43, 114 and, 168(4)(b) and 192 (1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8- 0144/2018),
Amendment 75 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and, continuous and inclusive 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 within the risk analysis proces as well as all interested parties.
Amendment 78 #
Proposal for a regulation
Recital 5
Recital 5
(5) Particular emphasis should be placed on explaining in a coherent, appropriatmaking publicly available in a clear, objective and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevantdetailed information on the elaboration, discussion and adoption of risk management decisions.
Amendment 83 #
Proposal for a regulation
Recital 8
Recital 8
(8) The general plan should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process. It 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 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 mechanisms to ensure coherenteffective risk communication.
Amendment 87 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Consumer confidence in food safety has been eroded by a series of widespread incidents. There is a need to improve public information on such incidents, including when they result from possible intentional violations of applicable Union legislation perpetrated through fraudulent or deceptive practices.
Amendment 90 #
Proposal for a regulation
Recital 9
Recital 9
(9) The lack of transparency of the risk assessment process has contributesd to the Authority acquiring greaterlosing legitimacy in the eyes of the consumers and general public in pursuing its mission, increaseseroded their confidence in its work and ensures thatfailed to make the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to maintainrebuild the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisafunctioning and independence of the Authority and transparency.
Amendment 92 #
Proposal for a regulation
Recital 10
Recital 10
(10) IWhilst maintaining a clear separation between risk assessment and risk management, 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 . __________________ 22 https://europa.eu/european- union/sites/europaeu/files/docs/body/joint_ statement_and_common_approach_2012_e n.pdf.
Amendment 99 #
Proposal for a regulation
Recital 13
Recital 13
(13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capabilcity of the Authority to maintain its high-level expertise. In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels. The system has thus to be strengthened and Member States should take a more active roleMember States should support the dissemination of the Authority’s calls for expressions of interest for membership of the Scientific Panels and Scientific Committee, to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise.
Amendment 103 #
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 nominaselection 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 criteria, such as the absence of any links to industry, 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 alsoMeasures, including proper financial compensation, should be put in place to ensure that scientific experts have the means to act independently and to dedicate sufficient time to their risk assessment work for the Authority.
Amendment 107 #
Proposal for a regulation
Recital 15
Recital 15
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. By 36 months after the entry into force of this regulation, the Commission should evaluate the impact of these pre-submission meetings on the functioning of the Authority. It should particularly evaluate their impact on the allocation of the Authority’s resources and its independence.
Amendment 119 #
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 outthe institution carrying them out, e.g. laboratories, institutes or universities, 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 transparency.
Amendment 127 #
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 makesIf there is a new application, the Authority shall always conduct searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment, and demand additional studies if needed. 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 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 whenimmediately after the studies submitted by industry included in an application for authorisation arehave been made public, under the transparency rules of this Regulation.
Amendment 134 #
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 Commission should be resThis exceptional verification tool should remain proportionate and should not replace the application of the precautionary principle in the presence of scientific uncertainty. The Commission, the Member States and the European Parliament should have the ponssible for triggering theility to ask the Authority to 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 141 #
Proposal for a regulation
Recital 23
Recital 23
(23) The Fitness Check of the General Food Law demonstrated that although the Authority has made considerable progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the agri-food chain, is not always perceived as fully transparent. This is also partly due to the different transparency and confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in other Union legislative acts covering the agri-food chain. Their interplay can impact on the acceptability of the risk assessment by the general publicremains insufficiently transparent.
Amendment 143 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) The Aarhus Convention establishes a number of rights of the public with regard to the environment. The Convention provides for the right of everyone to receive environmental information that is held by public authorities, the right to participate in environmental decision-making, and the right to review procedures to challenge public decisions that have been made without respecting the two aforementioned rights or environmental law in general.
Amendment 144 #
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 152 #
Proposal for a regulation
Recital 27
Recital 27
(27) To determine what level of proactive disclosure strikes the appropriate balance, the relevant rights of the public toneed to ensure transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002.
Amendment 153 #
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27a) The provisions on active dissemination laid down in this Regulation are not intended to limit in any manner the scope of the rights given by Regulations 1049/2001 and 1367/2006.
Amendment 157 #
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 exhaustive 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 disclosich could be kept confidential on the grounds that their disclosure would significantly undermine the protection of commercial interests (“general horizontal list of confidential items”). To request confidentiality, the company in question must prove, with justification, that the proactive disclosure of the information item would significantly undermine its commercial interests. However, where disclosure of the information is of overriding public interest, confidentiality cannot be granted.
Amendment 163 #
Proposal for a regulation
Recital 33
Recital 33
(33) Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commissionconduct an independent evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost- effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.
Amendment 165 #
Proposal for a regulation
Recital 36
Recital 36
Amendment 170 #
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36a) The Fitness Check of the General Food Law also highlighted a lack of transparency of the risk management process. There is a need to better inform the public on the risk management options under consideration, the level of protection to consumer and animal health and the environment that each of these options would achieve, as well as on the factors, other than the results of the risk assessment, which are taken into account by the risk managers, and how they are weighed up against each other in the decision-making process.
Amendment 172 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to further strengthen the link betweenimprove the interactive exchange of information, throughout the risk analysis process, amongst the risk assessors and risk managers at Union and national levels, as well as the coherence and consistency of risk commuwith economic operators of the food chain, consumer and other civil society organicsations, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 174 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) In addition, the general plan on risk communication should lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process.
Amendment 183 #
Proposal for a regulation
Article 1 – paragraph 1 – point -1a (new)
Article 1 – paragraph 1 – point -1a (new)
Regulation (EC) No 178/2002
Article 6 – paragraph 1
Article 6 – paragraph 1
(-1a) Article 6 paragraph 1 is amended as follows: “1. In order to achieve the general objective of a high level of protection of human health and life as well as of the environment, food law shall be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure."
Amendment 184 #
Proposal for a regulation
Article 1 – paragraph – point -1 a (new)
Article 1 – paragraph – point -1 a (new)
(-1a) In Article 6, paragraph 2 is replaced as follows: 2. "Risk assessment shall be based on all available scientific evidence and undertaken in an independent, objective and transparent manner." (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 185 #
Proposal for a regulation
Article 1 – paragraph 1 – point -1a (new)
Article 1 – paragraph 1 – point -1a (new)
Regulation (EC) No 178/2002
Article 7 – paragraph 1
Article 7 – paragraph 1
(-1a) In Article 7, paragraph 1 is replaced as follows: 1. "In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, risk management measures necessary to ensure the high level of health protection chosen in the Community shall be adopted, pending further scientific information for a more comprehensive risk assessment."
Amendment 191 #
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 options and recommendations;
Amendment 198 #
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 c a (new)
Article 8 a – point c a (new)
(ca) the risk management options considered including, as appropriate, the possibility to adopt provisional measures within the meaning of Article 7 of this Regulation;
Amendment 199 #
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 c b (new)
Article 8 a – point c b (new)
(cb) the extent to which the various risk management options under consideration reflect the degree of uncertainty of the risk assessment, and the level of consumer and animal health and environmental protection each of these options would achieve;
Amendment 200 #
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 c c (new)
Article 8 a – point c c (new)
(cc) as foreseen under Article 6(3) of this Regulation, the factors, other than the results of the risk assessment, which were considered by the risk managers, and how these factors were weighed up against each other;
Amendment 203 #
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 e
Article 8 a – point e
(e) promote appropriatethe balanced involvement of all interested parties, including economic operators of the food chain, consumer and other civil society organisations; and,
Amendment 205 #
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
Article 8 a – point f
(f) ensure appropriattransparent and equitable exchange of information with these interested parties in relation to risks associated with the agri- food chain.
Amendment 208 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point a
Article 8 b – point a
(a) ensure that accurate, appropriacomplete and timely information is interactively exchanged, including with all interested parties, based on the principles of transparency, openness, and responsiveness;
Amendment 210 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point c
Article 8 b – point c
(c) take into account risk perceptionthe imbalance in the representation of various interests;
Amendment 214 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 b – point e
Article 8 b – point e
(e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
Amendment 219 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point b
Article 8 c – paragraph 2 – point b
(b) identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and, to ensure the balanced involvements of all interested parties including economic operators of the food chain, consumer and other civil society organisations;
Amendment 220 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point c
Article 8 c – paragraph 2 – point c
(c) establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties., including by systematically acknowledging and explaining, where they exist, divergences in scientific assessment or in the appreciation of the acceptable level of risk
Amendment 221 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 2 – point c a (new)
Article 8 c – paragraph 2 – point c a (new)
(ca) lay down the practical arrangements and timeline for making the information referred to in Article 55a paragraph 1 available to the public.
Amendment 227 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8 c – paragraph 3
Article 8 c – paragraph 3
3. The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and, experience gained. and societal expectations;
Amendment 229 #
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 9
Article 9
Amendment 230 #
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 10
Article 10
Amendment 237 #
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 b
Article 25 – paragraph 1 a – point b
(b) ontwo members and two alternate members appointed by the European Parliament, with the right to vote.
Amendment 241 #
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) four members with the right to vote representing civil society and food chain interests namely, onetwo from consumers organisations, one and two from environmental non-governmental organisations, one from farmers organisations and one from industry organisations. 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 243 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point c
Article 1 – paragraph 1 – point 2 – point c
Regulation (EC) No 178/2002
Article 25 – paragraph 2
Article 25 – paragraph 2
2. The term of office of members and alternate members shall be four years. However, the term of office of the members referred to in paragraph 1a(a) and (b) shall not be limited in duration. The term of office of the members referred to in paragraph 1a(c) may be renewable only once.”,
Amendment 244 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 178/2002
Article 26 – paragraph 2 – point h a (new)
Article 26 – paragraph 2 – point h a (new)
2a. In Article 26, paragraph 2 the following point is added: "(ha) the absence of conflict of interests within the Authority and the full application of the principles governing risk analysis, as laid down in Article 6 of the present Regulation."
Amendment 245 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 178/2002
Article 27 – paragraph 4 – point d
Article 27 – paragraph 4 – point d
(2a) Article 27, paragraph 4, point d is replaced by the following: "(d) where the Authority or a Member State identifies an emerging risk or the possibility of a risk. In that case, and where there is a shared competence on the risk analysis of a product, that emerging risk or possibility of a risk shall not remain unassessed and duly managed, either by the Authority or by the competent bodies of Member States."
Amendment 246 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point -a (new)
Article 1 – paragraph 1 – point 3 – point -a (new)
Regulation (EC) No 178/2002
Article 28 – paragraph 3
Article 28 – paragraph 3
(-a) The following sentence is added at the end of paragraph 3: "The scientific experts shall be scientists who are actively conducting research, and publishing their research findings in peer- reviewed scientific journals."
Amendment 247 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point -a (new)
Article 1 – paragraph 1 – point 3 – point -a (new)
Regulation (EC) No 178/2002
Article 28 – paragraph 4 – introductory part
Article 28 – paragraph 4 – introductory part
(-a) The introductory sentence of paragraph 4 is amended as follows: "The Scientific Panels shall be composed of independent scientists who are actively conducting research, and publishing their research findings in peer-reviewed scientific journals."
Amendment 253 #
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 5 a – point b
Article 28 – paragraph 5 a – point b
(b) Member States shallmay then nominate experts with a view tofor the fields indicated but must do so on the basis of a coallectively reach the number indicated by the Executive Director. Each Member State shall nominate at least 12 for expressions of interest. The experts nominated shall be scientists who are actively conducting research, and publishing their research findings in peer-reviewed scientific expertjournals. Member States may nominate nationals of other Member States.
Amendment 255 #
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 5 a – point b a (new)
Article 28 – paragraph 5 a – point b a (new)
(ba) In addition to the experts possibly nominated by the Member States, the Authority shall publish a call for expressions of interest in the Official Journal of the European, in relevant leading scientific publications, and on the Authority’s website, and shall actively approach the relevant academic institutions in the different fields of expertise. Member States shall ensure the broad dissemination of the call for expressions of interest across the scientific community.
Amendment 258 #
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 5 a – point d – point i
Article 28 – paragraph 5 a – point d – point i
(i) A high level of scientific expertise; this includes at least that the expert is actively conducting research, and publishing their research findings in peer- reviewed scientific journals;
Amendment 261 #
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 5 b
Article 28 – paragraph 5 b
5b. When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5. Such additional members may be appointed for a short term of office, including for collaborating to the risk analysis of a single application.
Amendment 264 #
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 5 c a (new)
Article 28 – paragraph 5 c a (new)
5ca. The reasons for appointing the members of the panels shall be made available to be public on a dedicated page of the EFSA website, referring to the selection criteria laid down in Article 28 paragraph 5a (d).
Amendment 265 #
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 5 d
Article 28 – paragraph 5 d
5d. The Member States shall put in place measures ensuring that the members of the Scientific Panels shall 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 PanelsThey shall 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, shall not receive any instruction at any national level, and that their independent scientific contribution to the risk assessment system at Union level ishall be recognised as a priority task for the protection of the safety of the food chain.
Amendment 266 #
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 5 e
Article 28 – paragraph 5 e
5e. As appropriate, Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided forwhich are necessary to ensure that the conditions referred to in paragraph 5d are met.
Amendment 267 #
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 5 f
Article 28 – paragraph 5 f
Amendment 271 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 a (new)
Article 1 – paragraph 1 – point 3 a (new)
(3a) The following sentence is added at the end of Article 29 paragraph 6: "They shall not allow a priori exclusion of certain scientific evidences, especially when these have been published after a peer-review process.";
Amendment 273 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a
Article 32 a
At the request of a potential applicant for a food law authorisation, the staff of the Authority shallmay, in written form, advise on the relevant provisions and the required content of the application for authorisation. 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. staff of the Authority providing the advice referred to in paragraph 1 shall not be involved in any scientific work, including within the meaning of Article 28 (5f), that is directly or indirectly relevant to the application that is the subject of the advice. The advice provided by the staff of the Authority shall be documented and be published on the Authority’s website immediately after it has been provided. It shall contribute to the development of a Frequently Asked Questions document, in order to develop more comprehensive guidelines for applicants and reduce the need for individual correspondence. The advice provided shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. Within [36 months after the entry into force of this regulation], the Commission shall assess the impact of this article on the functioning of the Authority. Particular attention shall be paid to the additional workload and mobilisation of staff, and whether it has led to any shift in the allocation of the Authority’s resources, at the expense of activities of public interest.
Amendment 284 #
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 1
Article 32 b – paragraph 1
1. A Union register of studies commissioned by business operators to obtain an authorisation under Union food law is hereby established. Business operators shall notify, without delay, to the Authority the subject matter and main research questions of any study commissioned to support a future application for an authorisation under Union food law. The register shall be managed by the Authority.
Amendment 286 #
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 2
Article 32 b – paragraph 2
2. The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studany institution carrying out the studies, including laboratories, institutes or universities.
Amendment 289 #
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 ain a structured way, on a dedicated page of the Agency’s website in a Public register of studies corresponding application for authorisation has been received and immediately after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f. The publication shall always include the names of the authors of the studies, except for natural persons involved in testing on vertebrate animals. The notified information shall be made public in a structured way, on a dedicated page of the Agency’s website in a Public register of studies corresponding application for authorisation has been received and immediately after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f. The publication shall always include the names of the authors of the studies, except for natural persons involved in testing on vertebrate animals.
Amendment 292 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
3a. Where the Authority requests and receives additional data by an applicant, this data is, marked as such, also added to the Union register and made available to the public.
Amendment 294 #
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 4
Article 32 b – paragraph 4
4. The Authority shall lay down in its internal rules the practical arrangements for implementing the notification obligations laid down in paragraphs 1 and 2, including consequences of non-compliance with the notification obligation. Those arrangements shall however be in accordance with the present Regulation and other Union sectoral food law.
Amendment 296 #
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 4 a (new)
Article 32 b – paragraph 4 a (new)
4a. Non-compliance with notification obligation shall lead to the rejection of the authorisation pursued.
Amendment 298 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 c – paragraph 2
Article 32 c – paragraph 2
2. The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation, and such without prejudice to the Authority’s own obligations under Article 33. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process.
Amendment 301 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 d
Article 32 d
The Commission experts shall perform controls, including audits, on a regular basis to obtain assurance that testing facilities comply with relevant 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 bealso include checks if the raw data complies with the outcome of safety studies. These controls shall be unannounced and organised in cooperation with the competent authorities of the Member States.
Amendment 307 #
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 and without prejudice to the application of the precautionary principle in presence of scientific uncertainty, the Commission, the Member States or the European Parliament may, 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.; 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.
Amendment 314 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EC) No 178/2002
Article 32 e a (new)
Article 32 e a (new)
(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.”
Amendment 315 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EC) No 178/2002
Article 33 – paragraph 1 – point d a (new)
Article 33 – paragraph 1 – point d a (new)
(4a) In Article 33(1), the following point is inserted: (da) combinatorial and accumulated effects.
Amendment 316 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EC) No 178/2002
Article 33 – paragraph 2
Article 33 – paragraph 2
(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.”
Amendment 317 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 b (new)
Article 1 – paragraph 1 – point 4 b (new)
Regulation (EC) No 178/2002
Article 36 – paragraph 1
Article 36 – paragraph 1
(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, the development and implementation of joint projects, the exchange of expertise and best practices in the fields within the Authority’s mission.”
Amendment 318 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 c (new)
Article 1 – paragraph 1 – point 4 c (new)
Regulation (EC) No 178/2002
Article 36 – paragraph 2
Article 36 – paragraph 2
(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.”
Amendment 319 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 d (new)
Article 1 – paragraph 1 – point 4 d (new)
Regulation (EC) No 178/2002
Article 36 – paragraph 3
Article 36 – paragraph 3
(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).”
Amendment 321 #
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 – introductory part
Article 38 – paragraph 1 – introductory part
The Authority shall carry out its activities with a high level of transparencyensure a high level of transparency, in line with the Aarhus 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:
Amendment 324 #
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 a
Article 38 – paragraph 1 – point a
(a) agendas and minutes of the Managing Board, the Advisory Committee, the Scientific Committee and the Scientific Panels and their Working Groups;
Amendment 336 #
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 2
Article 38 – paragraph 1 – subparagraph 2
Those items referred to in the first subparagraph shall be made public in a structured way on a dedicated section of the Authority’s website. That section shall be publicly available and, easily accessible, and regularly updated. The relevant items shall be available to download, print and search through in an electronic format, which is “machine-readable.”,
Amendment 342 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 1 – point a
Article 38 – paragraph 1 a – subparagraph 1 – point a
Amendment 348 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 1 – point b
Article 38 – paragraph 1 a – subparagraph 1 – point b
(b) any provisions set out in Union food law protectgiving the investment made by innovators in gathering the information and data supporting relevant applications for authorisationstemporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant (‘data exclusivity rules’).
Amendment 351 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 2
Article 38 – paragraph 1 a – subparagraph 2
The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited for commercial purposes and its use by third parties shall not engage the responsibility of the European Union.
Amendment 353 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point c a (new)
Article 1 – paragraph 1 – point 5 – point c a (new)
Regulation (EC) No 178/2002
Article 38 – paragraph 3 a (new)
Article 38 – paragraph 3 a (new)
(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.”
Amendment 359 #
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 – introductory part
Article 39 – paragraph 2 – introductory part
2. The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concernedand provided that the request for confidential treatment demonstrates, with adequate and verifiable justification, that disclosure would significantly, specifically and actually, harm the commercial interest of the applicant:
Amendment 360 #
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 – introductory part
Article 39 – paragraph 2 – introductory part
2. The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concernedand provided that the request for confidential treatment demonstrates, with adequate and verifiable justification, that disclosure would specifically and significantly harm the commercial interest of the applicant:
Amendment 366 #
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 1
Article 39 – paragraph 2 – point 1
(1) the method and other technical 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, except when relevant to understanding the potential effects on health and the environment;
Amendment 373 #
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 4
Article 39 – paragraph 2 – point 4
(4) quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion, except when relevant to understanding the potential effects on health and the environment.
Amendment 375 #
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 a (new)
Article 39 – paragraph 2 a (new)
2a. These derogations shall be construed restrictively.
Amendment 384 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Article 39 – paragraph 4 – point a
(a) Where urgent action is essentialIf circumstances so require in order to protect publichuman health, animal health or the environment, such as in emergency situations, the Authority mayshall disclose the information referred to paragraphs 2 and 3; and,
Amendment 387 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b
Article 39 – paragraph 4 – point b
(b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable healthuman health, animal health, or environmental effects.
Amendment 390 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
(ba) where an overriding public interest in disclosure exists.
Amendment 393 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 a (new)
Article 39 – paragraph 4 a (new)
4a. This provision is without prejudice to Directive 2003/4/EC and Regulations (EC) No 1049/2001 and (EC) No 1367/2006.
Amendment 396 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 a – paragraph 2
Article 39 a – paragraph 2
2. Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall be without the information the applicant deemrequests confidential treatment for in accordance with paragraphs 2 and 3 of Article 39. This information shall be garbled by black bars. The confidential version shall contain all information submitted, including information the applicant deemconsiders confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the groundverifiable justifications on the basis of which confidentiality is requested for each of the different pieces of information.
Amendment 399 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 a – paragraph 2 a (new)
Article 39 a – paragraph 2 a (new)
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.
Amendment 408 #
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 – subparagraph 2
Article 39 b – paragraph 1 – subparagraph 2
Decisions taken by the Authority pursuant to this Article may be subject to an action of any natural or legal person before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively.
Amendment 417 #
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 421 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Article 41 – paragraph 1
(9) in Article 41, the following sentence is adparagraph 1 is replaced by the following: “The Authority shall ensure wided at the end of paragraph 1: Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) Noccess upon request to the documents which it possesses. Regulation 1049/2001 of the European Parliament and the Council and 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).
Amendment 426 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9 a (new)
Article 1 – paragraph 1 – point 9 a (new)
Regulation (EC) No 178/2002
Article 55 a (new)
Article 55 a (new)
Amendment 429 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 178/2002
Article 57 a – paragraph 2
Article 57 a – paragraph 2
2. The powers to adopt delegated acts referred to in Article 8(c) and 32c shall be conferred upon the Commission for an indeterminate period of timefive years from [date of entry into force of this Regulation].
Amendment 430 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 2
Article 61 – paragraph 2
2. Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority’sAuthority jointly with the Commission shall commission an independent external evaluation of its achievements and performance in relation to its objectives, mandates, tasks, procedures and location, in accordance with Commission guidelines. The evaluation shas. The evaluation shall be based on the terms of reference issued by the Management Board in agreement with the Commission, and will addrssess the possible need to modify the mandate of the Authority, and thworking practices and the impact of the Authority. The evaluation shall take financial implications of any such modificationto account the views of all stakeholders, at both Community and national level.
Amendment 438 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 4
Article 61 – paragraph 4
4. The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings. The findings of the evaluation shallevaluations and recommendations referred to in paragraphs 1 and 2 shall be forwarded to the Council and the European Parliament, and be made public.
Amendment 439 #
Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
Article 2 – paragraph 1 – point 2 a (new)
Directive 2001/18/EC
Article 24 – paragraph 3 a (new)
Article 24 – paragraph 3 a (new)
(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.”
Amendment 440 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25
Article 25
(3) Article 25 is replaced by the following: “Article 25 Confidentiality 1. In accordance with the conditions and the procedures laid down in Article 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and this article, (a) the notifier/applicant may request certain information submitted under this Directive to be kept confidential, accompanied by verifiable justification; and, (b) the competent authority shall assess the confidentiality request submitted by the notifier/applicant. 2. In addition to Article 39(2) of 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 strategiesno 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.”;
Amendment 452 #
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, monitoring reports as well 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 453 #
Proposal for a regulation
Article 3 – paragraph 1 – point 9 a (new)
Article 3 – paragraph 1 – point 9 a (new)
Regulation (EC) No 1829/2003
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
(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.”
Amendment 454 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30
Article 30
(10) Article 30 is replaced by the following: “Article 30 Confidentiality 1. In accordance with the conditions and the procedures laid down in Article 39 to 39f of Regulation (EC) No 178/2002 and this article, (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. 2. In addition to Article 39(2) and pursuantformation relating to the following shall not be considered confidential: (a) name and composition of the GMO, food or feed referred to in Articles 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. (1) and 15(1) and, where appropriate, indication of the substrate and the micro- organism; (b) general description of the GMO and the name and address of the authorisation-holder; (ba) physico-chemical and biological 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 and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.”
Amendment 464 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
Regulation (EC) No 1831/2003
Article 17 – paragraph 2 a (new)
Article 17 – paragraph 2 a (new)
Amendment 465 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18
Article 18
(2) Article 18 is replaced by the following: “Article 18 Transparency and confidentiality 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, in accordance with Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. 2. In accordance with the conditions and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and this Article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and, the Authority shall assess the confidentiality request submitted by the applicant. 3. In addition to Article 39(2) of 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 (a) demonstrating the efficacyThe following information shall not be considered confidential: 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; (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 athe feed additive ion 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 havhe 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 madverse effects on anie public in order to protect humaln health, huanimanl 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.”
Amendment 477 #
Proposal for a regulation
Article 5 – paragraph 1 – point 2 a (new)
Article 5 – paragraph 1 – point 2 a (new)
Regulation (EC) No 2065/2003
Article 14 – paragraph 1a (new)
Article 14 – paragraph 1a (new)
(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 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.”
Amendment 479 #
Proposal for a regulation
Article 5 – paragraph 1 – point 3
Article 5 – paragraph 1 – point 3
Regulation (EC) No 2065/2003
Article 15
Article 15
(3) Article 15 is replaced by the following: “Article 15 Confidentiality 1. 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. 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.”.
Amendment 483 #
Proposal for a regulation
Article 6 – paragraph 1 – point 2 a (new)
Article 6 – paragraph 1 – point 2 a (new)
Regulation (EC) No 1935/2004
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
(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 and Regulation 1367/2006.”
Amendment 484 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20
Article 20
(3) Article 20 is replaced by the following: “Article 20 Confidentiality 1. In accordance with the conditions and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and this article: (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. 2. In addition to Article 39(2) of 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 useformation relating to the following shall not be considered confidential: (a) the name and address of the applicant and the chemical name of thise 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, (c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation; (b) information of direct relevance to the assessment of the safety of the substance; (c) the analytical method or methods.”.
Amendment 496 #
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11
Article 11
Amendment 500 #
Proposal for a regulation
Article 7 – paragraph 1 – point 3
Article 7 – paragraph 1 – point 3
Regulation (EC) No 1331/2008
Article 12
Article 12
(3) Article 12 is replaced by the 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.”; 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 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.”
Amendment 505 #
Proposal for a regulation
Article 8 – paragraph 1 – point 4
Article 8 – paragraph 1 – point 4
Regulation (EC) No 1107/2009
Article 16
Article 16
The Authority shall assess, without delay, any request for confidentiality and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant to Article 63 of this Regulation, unless there is an overriding public interest in its disclosure.;
Amendment 507 #
Proposal for a regulation
Article 8 – paragraph 1 – point 4 a (new)
Article 8 – paragraph 1 – point 4 a (new)
Regulation (EC) No 1107/2009
Article 23 – paragraph 1
Article 23 – paragraph 1
(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.”
Amendment 514 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Amendment 522 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5 a (new)
Article 8 – paragraph 1 – point 5 a (new)
(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.”
Amendment 529 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23
Article 23
(4) Article 23 is replaced by the following: “Article 23 Transparency and confidentiality 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. 2. The applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification, upon submission of the application. 3. Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002. 4. Where the Commission does not 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. 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.”.
Amendment 537 #
Proposal for a regulation
Article 9 – paragraph 1 – point 4 a (new)
Article 9 – paragraph 1 – point 4 a (new)
Regulation (EC) No 2015/2283
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
(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.”