BETA

Activities of Heidi HAUTALA related to 2018/0088(COD)

Legal basis opinions (0)

Amendments (54)

Proposal for a regulation
Recital 23 a (new)

(23a) The Aarhus Convention establishes a number of rights of the public with regard to the environment. The Convention provides for the right of everyone to receive environmental information that is held by public authorities, the right to participate in environmental decision-making, and the right to review procedures to challenge public decisions that have been made without respecting the two aforementioned rights or environmental law in general.

2018/09/07
Committee: JURI

(27) To determine what level of proactive disclosure strikes the appropriate balance, the ~~relevant rights of the public to~~need to ensure 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.

2018/09/07
Committee: JURI

Proposal for a regulation
Recital 27 a (new)

(27a) The provisions on active dissemination laid down in this Regulation are not intended to limit in any manner the scope of the rights given by Regulation 1049/2001 and 1367/2006.

2018/09/07
Committee: JURI

Proposal for a regulation
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.

2018/09/07
Committee: JURI

Proposal for a regulation
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 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. _________________ 35Regulation (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).deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 178/2002
Article 32a

At the request of a potential applicant for a food law authorisation, the staff of the Authority ~~shall~~may, in written form, advise 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~~staff of the Authority providing the advice referred to in paragraph 1 shall not be involved in any scientific work, including within the meaning of Article 28 (5f), that is directly or indirectly relevant to the application that is the subject of the advice. The advice provided by the staff of the Authority shall be documented and be published on the Authority’s website immediately after it has been provided. It 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. The advice provided shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels. Within [36 months after the entry into force of this regulation], the Commission shall assess the impact of this article on the functioning of the Authority. Particular attention shall be paid to the additional workload and mobilisation of staff, and whether it has led to any shift in the allocation of the Autority’s resources, at the expense of activities of public interest.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 178/2002
Article 32e

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 Commission shall adopt a delegated act in accordance with Article 32f to determine the modalities of this fund.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)

Regulation (EC) No 178/2002
Article 32f (new)

(4a) The following Article 32f is inserted: Article 32f 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 32e shall be conferred on the Commission for a period five years from... [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 32e may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 32e shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a

Regulation (EC) No 178/2002
Article 38 – paragraph 1 – introductory part

The Authority shall ~~carry out its activities with a high level of transparency~~ensure a high level of transparency, in line with the Aarhus Convention and Regulation 1367/2006, providing for an active and systematic dissemination to the public of environmental information. It shall in particular make public without delay:

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b

Regulation (EC) No 178/2002
Article 38

~~(a) to any intellectual property right which may exist over documents or their content; and,~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b

Regulation (EC) No 178/2002
Article 38

(b) any provisions set out in Union food law ~~protect~~giving the ~~investment made by innovators in gathering the information and data supporting relevant applications for authorisations~~temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant (‘data exclusivity rules’).

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b

Regulation (EC) No 178/2002
Article 38

The disclosure to the public of the information mentioned in paragraph (1)(c) 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 for commercial purposes and its use by third parties shall not engage the responsibility of the European Union.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point c a (new)

Regulation (EC) No 178/2002
Article 38 – paragraph 3a

(ca) the following paragraph 3a is inserted: 3a. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information justification and to Regulation 1049/2001 and Regulation 1367/2006.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 2

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 concerned~~and provided that the request for confidential treatment demonstrates, with adequate and verifiable justification, that disclosure would significantly, specifically and actually, harm the commercial interest of the applicant:

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a

(a) ~~Where urgent action is essential~~If circumstances so require in order to protect public health, animal health or the environment, ~~such as in emergency situations,~~ the Authority ~~may~~shall disclose the information referred to paragraphs 2 and 3; and,

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point ba

(ba) Where an overriding public interest in disclosure exists.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) No 178/2002
Article 39 – paragraph 4a

4a. This provision is without prejudice to Directive 2003/4 and Regulations 1049/2001 and 1367/2006.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 7

Regulation (EC) No 178/2002
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 without the information the applicant ~~deem~~requests confidential treatment for in accordance with paragraphs 2 and 3 of Article 39. This information shall be garbled by black bars. The confidential version shall contain all information submitted, including information the applicant ~~deem~~considers confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the ~~ground~~verifiable justifications on the basis of which confidentiality is requested for each of the different pieces of information.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 9 – introductory part

(9) in Article 41, ~~the following sentence is add~~paragraph 1 is replaced atby the ~~end of paragraph 1~~following::

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 9

Regulation (EC) No 178/2002
Article 41 – paragraph 1

~~Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367~~1. The Authority shall ensure wide access upon demand to the documents which it possesses. Regulation 1049/20061 of the European Parliament and of the Council39 shall also apply.; _________________ 39Regulation (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) and 1367/2006 of the European Parliament and of the Council shall apply.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 11

Regulation (EC) No 178/2002
Article 61

2. Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the ~~Commission shall assess the Authority’s~~Authority jointly with the Commission shall commission an independent external evaluation of its achievements and performance in relation to its objectives, mandates, tasks, procedures and location~~, in accordance with Commission guidelines. The evaluation sha~~s. The evaluation shall be based on the terms of reference issued by the Management Board in agreement with the Commission, and will a~~ddr~~ssess the ~~possible need to modify the mandate of the Authority, and th~~working practices and the impact of the Authority. The evaluation shall take fin~~ancial implications of any such modification.~~ to account the views of all stakeholders, at both Community and national level.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 11

Regulation (EC) No 178/2002
Article 61

3. Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 11

Regulation (EC) No 178/2002
Article 61

4. The ~~Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings. The findings of the evaluation shall~~evaluations and recommendations referred to in paragraphs 1 and 2 shall be forwarded to the Council and the European Parliament, and be made public.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)

Directive 2001/18/EC
Article 24

(2a) In Article24, the following paragraph (3a) is inserted:“3a. The obligation to proactively disseminate informationset out in paragraph 1 of this Article, including Article 25 below, andArticles 38 and 39 of Regulation 178/2002, is without prejudice to the right ofany natural or legal person to access document upon request as set byRegulation 1049/2001 and Regulation 1367/2006.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 2 – paragraph 1 – point 3

Directive 2001/18/EC
article 25 – paragraph 2

2. In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, which shall apply mutatis mutandis, confidential treatment may be accepted with respect to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concernedno 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.:

2018/09/07
Committee: JURI

Proposal for a regulation
Article 2 – paragraph 1 – point 3

Directive 2001/18/EC
Article 25 – paragraph 2

~~(a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and,~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 2 – paragraph 1 – point 3

Directive 2001/18/EC
Article 25 – paragraph 2

~~(b) breeding patterns and strategies.;~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 3 – paragraph 1 – point 9

Regulation (EC) No 1829/2003
Article 29

1a. The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 30 below, and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 3 – paragraph 1 – point 10 Regulation (EC) No 1829/2003

2. In ~~addition to Article 39(2) and pursuant~~formation relating to the following shall not be considered confidential: (a) name and composition of the GMO, food or feed referred to in Articles 3~~9(3) of Regulation (EC) No 178/2002,~~(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 Aauthori~~ty may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, up~~sation-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 eve~~rifiable justification, to significantly harm the interests concerned:~~nt 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.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 3 – paragraph 1 – point 10

Regulation (EC) No 1829/2003
Article 30

~~(a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and,~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 3 – paragraph 1 – point 10

Regulation (EC) No 1829/2003
Article 30

~~(b) breeding patterns and strategies.~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)

Regulation (EC) No 1831/2003
Article 17

(1a) In Article17, the following paragraph (2a) is inserted:“2a. The obligation to proactively disseminate information set out in this Article and Articles 38 and 39 of Regulation178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation1367/2006.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 4 – paragraph 1 – point 2

Regulation (EC) No 1831/2003
Article 18

3. ~~In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provid~~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 con~~fidential treatment to the following informati~~ human and animal health and on the environment; (d) the conclusions of the study results on effects of the feed additive on, the ~~disclosure of which may be deemed, upon verifiable justification, to significantly harm the inte~~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 ~~concerned:~~ of the monitoring.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 4 – paragraph 1 – point 2

Regulation (EC) No 1831/2003
Article 18

~~(a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and,~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 4 – paragraph 1 – point 2

Regulation (EC) No 1831/2003
Article 18

(b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment..deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 4 – paragraph 1 – point 2

Regulation (EC) No 1831/2003
Article 18

3a. 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.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 4 – paragraph 1 – point 2

Regulation (EC) No 1831/2003
Article 18

3b. 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.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 5 – paragraph 1 – point 2 a (new)

Regulation (EC) No 2065/2003
Article 14

(2a) In Article14, the following paragraph (1a) is inserted: “1a. The obligation to proactively disseminate information set out in paragraph 1 of this Article and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 5 – paragraph 1 – point 3

Regulation (EC) No 2065/2003
Article 15 – second paragraph (new)

Without prejudice to Article 39(3) of Regulation (EC) No 178/2002, information relating to the following shall not be considered confidential: (a) the name and address of the applicant and the name of the product; (b) in the case of an opinion in favour of authorising the evaluated product, the particulars mentioned in Article 6(2); (c) information of direct relevance to the assessment of the safety of the product; (d) the analytical method referred to in point 4 of Annex II.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 6 – paragraph 1 – point 2 a (new)

Regulation (EC) No 1935/2004
Article 19 – paragraph 2a (new)

(2a) in Article 19, the following paragraph 2a is inserted: “2a. The obligation to proactively disseminate information set out in paragraph 1 is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 6 – paragraph 1 – point 3

Regulation (EC) No 1935/2004
Article 20

2. In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) of that Regulation, the Authority may also accept to provide confidential treatment to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: formation relating to the following shall not be considered confidential: (a) the name and address of the applicant and the chemical name of the substance; (b) information of direct relevance to the assessment of the safety of the substance; (c) the analytical method or methods.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 6 – paragraph 1 – point 3

Regulation (EC) No 1935/2004
Article 20

(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;deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 6 – paragraph 1 – point 3

Regulation (EC) No 1935/2004
Article 20

~~(b) the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 6 – paragraph 1 – point 3

Regulation (EC) No 1935/2004
Article 20

~~(c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation..~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 7 – paragraph 1 – point 2

Regulation (EC) No 1331/2008
Article 11

The obligation to proactively disseminate information set out in paragraph 1 of this Article, including Article 12 below and Articles 38 and 39 of Regulation 178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation 1367/2006.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 7 – paragraph 1 – point 3

Regulation (EC) No 1331/2008
Article 12

3a. Information relating to the following shall not, in any circumstances, be regarded as confidential: (a) the name and address of the applicant; (b) the name and a clear description of the substance; (c) the justification for the use of the substance in or on specific foodstuffs or food categories; (d) information that is relevant to the assessment of the safety of the substance; (e) where applicable, the analysis method(s).

2018/09/07
Committee: JURI

Proposal for a regulation
Article 7 – paragraph 1 – point 3

Regulation (EC) No 1331/2008
Article 12

3b. The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, 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.

2018/09/07
Committee: JURI

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 following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned: (a) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically a) or environmentally relevant and the related methods of analysis for these impurities; (b) results of production batches of the active substance including impurities; and, (c) information on the complete composition of a plant protection product.;deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 8 – paragraph 1 – point 5

Regulation (EC) No 1107/2009
Article 63

(a) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for these impurities;deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 8 – paragraph 1 – point 5

Regulation (EC) No 1107/2009
Article 63

~~(b) results of production batches of the active substance including impurities; and,~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 8 – paragraph 1 – point 5

Regulation (EC) No 1107/2009
Article 63

~~(c) information on the complete composition of a plant protection product.;~~deleted

2018/09/07
Committee: JURI

Proposal for a regulation
Article 8 – paragraph 1 – point 5 a (new)

Regulation (EC) No 1107/2009
Article 63 – paragraph 3

(5a) in Article 63, paragraph 3 is replaced by the following: 3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and to Regulation 1049/2001 and Regulation 1367/2006.

2018/09/07
Committee: JURI

Proposal for a regulation
Article 9 – paragraph 1 – point 4

Regulation (EU) No 2015/2283
Article 23

4a. Confidentiality shall not apply to the following information: (a) the name and address of the applicant; (b) the name and description of the novel food; (c) the proposed conditions of use of the novel food; (d) a summary of the studies submitted by the applicant; (e) the results of the studies carried out to demonstrate the safety of the food; (f) where appropriate, the analysis method(s); (g) any prohibition or restriction imposed in respect of the food by a third country.”

2018/09/07
Committee: JURI

Proposal for a regulation
Article 9 – paragraph 1 – point 4 a (new)

Regulation (EU) No 2015/2283
Article 25

(4a) In Article25, the following paragraph (1a) is inserted: “1a. The obligation to proactively disseminate information set out in this Regulation and Articles 38 and 39 of Regulation178/2002, is without prejudice to the right of any natural or legal person to access document upon request as set by Regulation 1049/2001 and Regulation1367/2006.”

2018/09/07
Committee: JURI