30 Amendments of Fredrick FEDERLEY related to 2018/0088(COD)
Amendment 80 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) There is no definition of 'other legitimate factors' in the General Food Law in relation to its objective. This principle should always be applied on a case-by-case basis, but as there are no general guidelines on the application and interpretation of the principle, there is a lack of consistency in its application. The Commission should therefore draft general guidelines on the application of this principle.
Amendment 112 #
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 is 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 and validated studies, including tests that have been carried out in accordance with international standards and Good Laboratory Practices (GLP), to demonstrate the safety and in some cases the efficacy of a subject matter.
Amendment 124 #
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 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. The scientific data and studies submitted within the consultation process should be taken into account provided that they are validated, relevant, in line with international standards and Good Laboratory Practices (GLP).
Amendment 135 #
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 shouldAuthority should in case of controversy on safety issues, data gaps and/or scientific uncertainty 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 135 #
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 of any study commissioned within and outside the EU to support a future application for an authorisation under Union food law. The register shall be managed by the Authority.
Amendment 141 #
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, 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 be organised in cooperation with the competent authorities of the Member States. These controls shall be coordinated with OECD Good Laboratory Practices (GLP) auditing programmes, which currently audit each Member State monitoring authority every 10 years.
Amendment 146 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) Using the Board of Appeal of the European Chemicals Agency as its model, as set out in Articles 89 to 93 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), an EFSA Board of Appeal should be established by means of delegated acts.
Amendment 159 #
Proposal for a regulation
Recital 28
Recital 28
(28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures. It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health and welfare or the environment, such information should be disclosed.
Amendment 173 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) The type of information that should be made public are without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of30 May 2001, regarding access to European Parliament, Council and Commission documents, national or union law regarding public access to official documents.
Amendment 173 #
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 or, business strategy of the applicant, or innovative product ideas; and,
Amendment 181 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point c
Article 39 b – paragraph 1 – point c
(c) inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority it may (1) state its views or, (2) withdraw its application, or (3) request a review within twofour weeks from the date on which it was notified of the Authority’s position.
Amendment 186 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point e
Article 39 b – paragraph 1 – point e
(e) make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than twofour weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment 187 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point e a (new)
Article 39 b – paragraph 1 – point e a (new)
(e a) The Authority shall not publish any information from the concerned application when the applicant has decided to withdraw it's application.
Amendment 209 #
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, appropriate, relevant and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness;
Amendment 211 #
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 address risk perceptions and misperceptions;
Amendment 217 #
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 a (new)
Article 8 b – point e a (new)
(ea) formulate approaches to better communicate the difference between hazard and risk.
Amendment 297 #
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 1
Article 32 c – paragraph 1
1. Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose. Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments which are relevant for the risk assessment of the intended renewal. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels.
Amendment 299 #
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 that have been carried out in accordance with international guidelines and Good Laboratory Practices (GLP) are available on the subject matter concerned by the application for authorisation. This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process.
Amendment 311 #
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 CommissionAuthority may, in exceptional circumstances, may request the Authority towhen there are data gaps or scientific uncertainty, 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 335 #
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 on a dedicated section of the Authority’s website. That section shall be publicly available and easily accessible. The relevant items shall be available to download, print watermarked for tractability and search through in an electronic format. The dedicated section of the Authority’s website will include necessary measures to protect against non-permitted use, such as for commercial purposes. Measures and penalties which are effective and proportionate should be introduced in cases of non-permitted use of documents. Protective measures will be designed to protect effectively against commercial use both within in the Union and in third- countries.”,
Amendment 339 #
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 – introductory part
Article 38 – paragraph 1 a – introductory part
The disclosure of the information mentioned in paragraph (1)(c), (d) and (i) to the public shall be without prejudice:
Amendment 350 #
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), (d) and (i) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union. Member States shall put in place necessary measures and penalties to address non-permitted use by those accessing the dedicated section of the Authority’s website. These measures and penalties shall be effective and proportionate.
Amendment 400 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point c
Article 39 b – paragraph 1 – point c
(c) inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority it may (1) state its views or, (2) withdraw its application, or (3) request a review to the EFSA Board of Appeal within twofour weeks from the date on which it was notified of the Authority’s position. The applicant may provide written notice to the Authority that he wishes to request a re-examination of the opinion to the EFSA Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the EFSA Board of Appeal shall re-examine its opinion.
Amendment 404 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 b – paragraph 1 – point e
Article 39 b – paragraph 1 – point e
(e) make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than twofour weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment 407 #
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 before the Authority Board of Appeal, which will be established by means of delegated acts. Those delegated acts shall be adopted in accordance with Article 57a of this Regulation. A submission of an appeal pursuant to this paragraph shall have suspensive effect. The applicant may provide written notice to the Authority that he wishes to request a re-examination of the opinion to the EFSA Board of Appeal. In that case the applicant shall forward to the Authority the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days after receipt of the grounds for the request, the EFSA Board of Appeal shall re-examine its opinion. In case of a contesting decision taken by the EFSA Board of appeal, a case may be brought before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively.
Amendment 411 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 2
Article 39 d – paragraph 2
2. The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive, except for when access to information is requested in accordance with directive 2003/4/EC or national law on access to documents. 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, except for when access to information is requested in accordance with directive 2003/4/EC or national law on access to documents.
Amendment 414 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39 d – paragraph 3
Article 39 d – paragraph 3
3. If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f. The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application. Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public the information for which confidentiality has been requestedThe Authority shall not publish any information, confidential or non-confidential, should an applicant decide to withdraw its application.
Amendment 425 #
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
Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39, as well as the provisions of the Arhus convention, 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 510 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 1
Article 63 – paragraph 1
1. In accordance with the conditions and the procedures laid down in Article 39 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. The justification shall include verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.
Amendment 515 #
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 2 – introductory part
Article 63 – paragraph 2 – introductory part
2. In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3), confidential treatment may be accepted with respectthe Authority shall provide confidential treatment in relation to the following information, if the disclosure of which may beis deemed, upon verifiable justification, to significantly harm the interests concerned until proven otherwise: