29 Amendments of Guillaume BALAS related to 2018/0088(COD)
Amendment 150 #
Proposal for a regulation
Recital 27
Recital 27
(27) To determine what level of disclosure strikes the appropriate balance, the relevanthe purpose of this Regulation is to give the fullest possible effect to the 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 ofaccess to documents of the Authority, encourage proactive publication, and must be read in conjunction with Regulation (EC)s No 178049/20021 and 1367/2006.
Amendment 154 #
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, after the submission of verifiable justifications - in each and every case and for each information item explaining the reason why the publication would significantly, specifically, and actually affect the protection of commercial interest - 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 beich could be kept consfidered to significantly harm the commercial interests concerned and should not therefore bntial upon request and after following the prerequisite diesclosed to the public,ribed above (“general horizontal list of confidential items”) . Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent neshould exemptions to the principle of transparency be made. Even when the publication of the information is considereds to protect human health, animal health or the environment, such information should be disclosundermine the commercial interests of an operator, the information cannot be kept secret if an access to document request fulfilling the conditions for disclosure under Regulation (EC) No 1367/2006 and Regulation No 1049/2001 has been filled.
Amendment 167 #
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 Convention35cluding, the right to benefit from proactive information related to the risk assessment process , 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 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002. Under no circumstances, the new provisions on active dissemination should limit the rights given by Regulations 1049/2001 and 1367/2006 to obtain information upon request. __________________ 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 176 #
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39a) Considering that the 7th European Action Plan for the Environment established as a priority the adoption of a common methodology to detect, analyse, and prevent "cocktail effects" in the use of chemicals, sufficient means should be allocated to study these effects and reinforce the cooperation between Members States agencies regarding this subject.
Amendment 187 #
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 a
Article 8 a – point a
(a) promote transparency, awareness and understanding of the specific issues under consideration during the entire risk analysis and management processes;
Amendment 189 #
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 consistencya high level of health and environmental protection, and transparency in formulating risk management recommendations;
Amendment 216 #
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 andthe protection of personal data.
Amendment 308 #
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, the European Parliament and Member States, in exceptional circumstances, maycan 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.; When deemed necessary and after consulting its Board members, the Authority may also request verification studies.
Amendment 320 #
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 transparency and proactively publish the information in its possession, in line with the Aarhus Convention and Regulation 1367/2006, in particular Article 4. It shall in particular make public without delay:
Amendment 326 #
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, participants lists, and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
Amendment 343 #
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 355 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – title
Article 39 – title
Amendment 358 #
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, unless there is an overriding public interest in disclosure, if in relation to the following information, the request for confidential treatment from the applicant demonstrates, for each item of information, with adequate and verifiable justification, that the publication would significantly, specifically and actually harm the commercial interests concerned:,
Amendment 364 #
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 with verifiable justification that such method does not entail information about emissions in the environment and about impacts on health and environment;
Amendment 371 #
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
Amendment 378 #
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 essential 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; andthere is an overriding public interest in disclosure,
Amendment 386 #
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 health effects on human health, biodiversity or the environment.
Amendment 397 #
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 withoutredact with back bars the information the applicant deemsrequests the confidential treatment of, in accordance with paragraphs 2 and 3 of Article 39. 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 groundsverifiable justifications and evidence on the basis of which confidentiality is requested for each of the different pieces of information.
Amendment 403 #
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 two weeks and no later than four weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
Amendment 409 #
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
Amendment 416 #
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 423 #
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
For the purpose of ensuring an efficient access to documents that it possesses, the Authority shall answer requests to access information. Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply.; Upon request, information found confidential under the proactive disclosure procedures set out in Article 38 and 39 shall be disclosed , if the conditions for disclosure are met under Regulation (EC) No 1367/2006 and Regulation 1949/2001. __________________ 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 444 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Directive 2001/18/EC
Article 25 – paragraph 2
Article 25 – paragraph 2
Amendment 456 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2
Article 30 – paragraph 2
Amendment 468 #
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 489 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation No 1935/2004
Article 20 – paragraph 2 – point a
Article 20 – paragraph 2 – point a
Amendment 491 #
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Article 6 – paragraph 1 – point 3
Regulation No 1935/2004
Article 20 – paragraph 2 – point b
Article 20 – paragraph 2 – point b
Amendment 511 #
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, except for information that is considered toxicologically, ecotoxicologically or environmentally relevant, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by adequate and verifiable justification.
Amendment 518 #
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