24 Amendments of Molly SCOTT CATO related to 2018/0088(COD)
Amendment 87 #
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 112 #
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) onetwo members appointed by the European Parliament, with the right to vote.
Amendment 118 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a – point c
Article 25 – paragraph 1a – point c
(c) fourthree members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, and 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 132 #
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 shall provide written advisce 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.
Amendment 133 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32 a – subparagraph 1a (new)
Article 32 a – subparagraph 1a (new)
All correspondence between potential applicants for a food law authorisation and the staff of the Authority shall be publicly available on the EFSA website immediately, and before the publication of the relevant EFSA decision, and 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
Amendment 146 #
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 the Parliament, 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 modalities of which shall be determined via delegated act;
Amendment 155 #
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 sentence
Article 38 – paragraph 1 – introductory sentence
The Authority shall carry out its activities with a high level of transparency, proactively disseminating the information it possesses. It shall in particular make public without delay:
Amendment 162 #
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 1a
Article 38 – paragraph 1a
Amendment 167 #
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 sentence
Article 39 – paragraph 2 – introductory sentence
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 concernedprovided that the request for confidential treatment demonstrates, with adequate and verifiable justification, that the disclosure would significantly, specifically and actually harm the commercial interests of the applicant:
Amendment 170 #
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, provided that the applicant demonstrates that such method does not entail emissions in the environment and has no harmful impacts on health and environment;
Amendment 175 #
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 environment.
Amendment 178 #
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 essentialrequired to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,
Amendment 179 #
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 healthpotential human or animal health effects or environmental effects.
Amendment 195 #
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 196 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – introductory part
Article 1 – paragraph 1 – point 9 – introductory part
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Article 41 – paragraph 1
(9) in Article 41, the following sentence is addparagraph 1 is replaced atby the end of paragraph 1following:
Amendment 197 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 178/2002
Article 41
Article 41
Amendment 199 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive No 2001/18/EC
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
1 a. In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential: - general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses; - methods and plans for monitoring of the GMO or GMOs and for emergency response; - environmental risk assessment.
Amendment 200 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive No 2001/18/EC
Article 25 – paragraph 2
Article 25 – paragraph 2
Amendment 206 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10 – introductory part
Article 3 – paragraph 1 – point 10 – introductory part
Regulation (EC) No 1829/2003
Article 30
Article 30
(10) Article 30 is replaced by the following: 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. Without prejudice to paragraph 3, the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision. 3. Information relating to the following shall not be considered confidential:(a) name and composition of the GMO, food or feed referred to in Articles 3(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;(c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);(d) 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;(e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;(f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);(g) information on waste treatment and emergency response. 4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession. 5. 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. 6. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment. 7. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information as to the confidentiality of which the Commission and the applicant disagree.
Amendment 208 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – introductory part
Article 4 – paragraph 1 – point 2 – introductory part
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 to39f 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. The following information shall not be considered confidential: (a) name and composition of the feed additive and, where appropriate, indication of the production strain; (b) physico-chemical and biological characteristics of the feed additive; (c) the conclusions of the study results on effects of the feed additive on human and animal health and on the environment; (d) the conclusions of the study results on effects of the feed additive on the characteristics of animal products and its nutritional properties; (e) methods for detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring. 4. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents when handling applications for access to documents held by the Authority. 5. The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.
Amendment 210 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 218 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2
Article 20 – paragraph 2
Amendment 219 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2 – point a
Article 20 – paragraph 2 – point a
Amendment 220 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation (EC) No 1935/2004
Article 20 – paragraph 2 – point b
Article 20 – paragraph 2 – point b