15 Amendments of Anthea McINTYRE related to 2018/0088(COD)
Amendment 81 #
Proposal for a regulation
Recital 24
Recital 24
Amendment 83 #
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. Directive (EU) 2016/943 should be fully taken into account.
Amendment 85 #
Proposal for a regulation
Recital 27
Recital 27
(27) To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to 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, the principle of proportionality and the TRIPS Agreement and Directive (EU) 2016/943.
Amendment 86 #
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, in line with the current provisions governing the protection of confidential items”)nformation. Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.
Amendment 96 #
Proposal for a regulation
Recital 36
Recital 36
(36) To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention35 , against the rights of commercial applicants, taking into account Directive(EU) 2016/943, the specific objectives of sectoral Union legislation as well as experienced gained. Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. _________________ 35 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 129 #
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 advise on the relevant provisions and the required content of the application for authorisation during a pre- submission meeting. 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, and should ensure the protection of any confidential business information and any personal data it contains.
Amendment 156 #
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, without prejudice to Directive (EU) 2016/943. It shall in particular make public without delay:
Amendment 160 #
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 – sub–paragraph 2 a (new)
Article 38 – paragraph 1 – sub–paragraph 2 a (new)
Member States shall put in place all necessary measures to prevent any breach of the undertakings given by those accessing the dedicated section of the Authority's website. Measures and penalties shall be effective, proportionate and dissuasive against any non-permitted use.
Amendment 164 #
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 – point a
Article 38 – paragraph 1 a – point a
(a) to any intellectual property right which may exist over documents or their content, in accordance with the TRIPS Agreement; and,
Amendment 165 #
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 – point b
Article 38 – paragraph 1 a – point b
(b) any provisions set out in Union food law protecting the investment made by innovators in gathering the information, in line with Directive (EU) 2016/943 and data supporting relevant applications for authorisations (‘data exclusivity rules’).
Amendment 166 #
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 – sub–paragraph 2 a (new)
Article 38 – paragraph 1a – sub–paragraph 2 a (new)
This article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council on public access to environmental information, 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, and 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.
Amendment 168 #
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 ofshall not divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified, except for information which mayust be deemed, upon verifiable justification, to significantly harm the interests concerned:made public if circumstances so require, in order to protect public health.
Amendment 182 #
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 d
Article 39 b – paragraph 1 – point d
(d) adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, as appropriate, of its decision; data contained in the application dossier shall not be disclosed before the decision on a first European Union authorisation or re-authorisation of a marketable product has been made; and,
Amendment 222 #
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. It shall provide verifiable justification 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 223 #
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
Article 63 – paragraph 2
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 respect to the followingthe Authority shall not divulge to third parties confidential information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned:at it receives for which confidential treatment has been requested and justified, except for information which must be made public if circumstances so require, in order to protect public health.