15 Amendments of Eleonora EVI related to 2018/0088(COD)
Amendment 148 #
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 of a high level of protection of human life and health, the protection of consumers' interests, as well as the protection of animal health and welfare, plant health and the environment.
Amendment 158 #
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 or the environment, and where there is an overriding public interest such information should be disclosed.
Amendment 168 #
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 rights of commercial applicants against the obligation to proactive disclosure of the information held by EU authorities and 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 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, together with the right to access documents upon request as per Regulation 1049/2001 and Regulation 1367/20046 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.s interpreted by the Court.35 __________________ 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 239 #
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 276 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
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. The Authority shall also offer pre-submission meetings with EFSA staff, or scientific experts not involved in the relevant product evaluation, to discuss the information required to support an application, including the necessary tests, studies and clinical trials, giving priority to SMEs. 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 312 #
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, in exceptional circumstances, may request the Authority to commissioncommission independent 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 330 #
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 d
Article 38 – paragraph 1 – point d
(d) the information on which its scientific outputs, including scientific opinions, conclusions of pesticides peer reviews and reasoned opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;
Amendment 344 #
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 382 #
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 urgenttimely action is essential to protect public 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 389 #
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 ba (new)
Article 39 – paragraph 4 – point ba (new)
(ba) any information for which there is an overriding public interest in disclosure as per Article 4(2) of Regulation 1049/2001 and Article 6 of Regulation 1367/2006, in particular where the information relates to emissions into the environment.
Amendment 427 #
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)
(9a) The following Article 55a is inserted after Article 55: “Article 55a Transparency of risk management 1. The Commission shall carry out its activities with a high level of transparency. It shall in particular make public without delay which other factors legitimate to the matter under consideration according to Article 6(3) of Regulation (EC) No 178/2002 were taken into account in analysing the opinion of the Authority and its application of the precautionary principle according to Article 7(1) of Regulation (EC) No 178/2002. 2. The Member States shall carry out their activities with a high level of transparency. They shall in particular make public without delay: (a) agendas and minutes of the meetings of the Council working groups in which the risk management measures are discussed; (b) agendas and minutes of the meetings of the Standing Committees, included but not limited to the Appeal Committee, as well as the votes for each Member state. Those items referred to in the first and second subparagraph shall be made public on a dedicated section of the Commission’s website. That section shall be publicly available and easily accessible. The relevant items shall be available to download, print and search through in an electronic format.
Amendment 490 #
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
(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 use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results;
Amendment 492 #
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
Amendment 493 #
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 c
Article 20 – paragraph 2 – point c
Amendment 519 #
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 – point c
Article 63 – paragraph 2 – point c