Activities of Kartika Tamara LIOTARD related to 2008/0002(COD)
Plenary speeches (4)
Novel foods (debate)
Novel foods (debate)
Novel foods (debate)
Novel foods (debate)
Reports (2)
REPORT Report on the proposal for a regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure] PDF (592 KB) DOC (883 KB)
REPORT Recommendation for second reading on the Council position at first reading for adopting a regulation of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 PDF (437 KB) DOC (713 KB)
Amendments (30)
Amendment 54 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Whereas the European Group on Ethics in Science and New Technologies stated in its Opinion (no. 23) on ethical aspects of animal cloning for food supply of 16 January 2008 that it ‘does not see convincing arguments to justify the production of food from clones and their offspring’. Whereas the Scientific Committee of the European Food Safety Authority concluded in its Opinion1 of 15 July 2008 that ‘the health and welfare of a significant proportion of clones … have been found to be adversely affected, often severely and with a fatal outcome’’. 1 The EFSA Journal (2008) 767, 1-49
Amendment 80 #
Proposal for a regulation
Article 2 – paragraph 2 – point b a (new)
Article 2 – paragraph 2 – point b a (new)
(ba) foods derived from cloned animals and their descendants. Before the date of entry into force of this Regulation referred to in Article 20, the Commission shall present a legislative proposal to prohibit the placing on the market in the Community of foods derived from cloned animals and their descendants. The proposal shall be forwarded to the European Parliament and the Council.
Amendment 82 #
Proposal for a regulation
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
3a. Where a food is altered by a new production procedure, including but not limited to nanotechnology and nanoscience, concerning which there are at present gaps in the knowledge needed to carry out a risk assessment, the food in question may only be placed on the market after it has been judged safe by means of a valid risk assessment.
Amendment 83 #
Proposal for a regulation
Article 2 – paragraph 3 b (new)
Article 2 – paragraph 3 b (new)
3b. Where a food can have an effect on the human body comparable to that of a medicine, the European Medicines Agency (EMEA) must decide whether it is a medicine and is thus covered by Regulation (EC) No 2309/93, as amended by Regulation (EC) No 762/2004.
Amendment 85 #
Proposal for a regulation
Article 3 – paragraph 2 - point (a) (i) – introduction
Article 3 – paragraph 2 - point (a) (i) – introduction
(i) food that has not been used for human consumption to a significant degree within the Community before 15 May 1997;, including food which has been approved under the ‘fast track’ procedure of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients.
Amendment 94 #
Proposal for a regulation
Article 3 – paragraph 2 - point (c a) (new)
Article 3 – paragraph 2 - point (c a) (new)
(ca) ‘produced with the aid of nanotechnology’ means a product which contains, consists of or is produced with the aid of synthetic substances no larger than 100 nm in length, breadth or height or, where larger than 100 nm, is generally scientifically accepted as a product of nanotechnology.
Amendment 120 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The entry of a novel food in the Community list shall include a specification of the food, and, where appropriate, specify the conditions of use, additional specific labelling requirements to inform the final consumer and/or a post- market monitoring requirement.
Amendment 127 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. By way of derogation from the third paragraph of Article 7 of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, other than traditional food from third countries, shall be decided in accordance with the regulatory procedure referred to in Article 14(2) in cases where newly developed scientific evidence and proprietary data are protected in accordance with Article 12. In the cases referred to in the first subparagraph the entry of a novel food in the Community list shall indicate, in addition to the information referred to in paragraph 2: (a) the date of entry of the novel food in the Community list; (b) the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 12; (c) the name and address of the applicant.
Amendment 131 #
Council position – amending act
Recital 34
Recital 34
Amendment 132 #
Council position – amending act
Recital 35
Recital 35
Amendment 133 #
Council position – amending act
Recital 36
Recital 36
(36) In addition, tThe Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the Union before 15 May 1997. It is of particular importance that the Commission consult experts in the preparatory phase in accordance with the commitment of the Commission undertaken in the Communication of 9 December 2009 on the implement, in respect of the determination of whether a type of food falls within the scope of this Regulation, the adjustment and adaptation of the definition of "engineered nanomaterial" to technical and scientific progress and in line with definitions subsequently agreed at international level, rules on how to proceed in cases in which the Commission has no information about use of a food for human consumption before 15 May 1997, as well as in respect of rules for the application of Article 290 of4(1) and the Treupdatye onf the Functioning of the European UnionUnion list. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Amendment 134 #
Council position – amending act
Article 2 – paragraph 2 b (new)
Article 2 – paragraph 2 b (new)
(2b) Where necessary and taking into account the scope defined in this Article, the Commission may determine, by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23, whether a type of food falls within the scope of this Regulation. Where a novel food is capable of having an effect on the human body comparable to that of a medicinal product, the Commission may seek an opinion of the European Medicines Agency (EMEA) on whether it falls under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency1, and therefore not under this Regulation. 1 OJ L 136, 30.4.2004, p. 1.
Amendment 135 #
Council position – amending act
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Commission may adopt further criteria to clarify the definitions in sub- points (i) to (iv) of point (a), and inIn view of the various definitions of nanomaterials published by different bodies at international level and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt points (c), (d) and (e) of paragraph 2 of this Article in accordance with the regulatory procedure referred to in Article 19(2)to technical and scientific progress, and in line with definitions subsequently agreed at international level, by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
Amendment 136 #
Council position – amending act
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Where necessary,In order to ensure the completent authority may consult other competent authorities and the Commission concerning the extent to which a food was useess of information regarding the classification of novel foods, the Commission shall, not later than...*, adopt rules on how to proceed in cases in which the Commission has no information about the use of a food for human consumption within the Union before 15 May 1997. Replies to any such consultation shall also be transmitted to the Commission. The Commission shall summarise the replies received and communica by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23. * Six months after the result of the consultation to all competent authoritiesdate of entry into force of this regulation.
Amendment 137 #
Council position – amending act
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The Commission may adopt implementing measures for paragraph 3 of this Article in accordance with the regulatory procedure referred to in Article 19(2)detailed rules on the application of paragraph 1, in particular as regards the type of information to be collected from Member States and/or from food business operators, by means of delegated acts in accordance with Article 21 and subject to conditions of Articles 22 and 23.
Amendment 139 #
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1
Article 8 – paragraph 1 – subparagraph 1
1. A food business operator intending to place a traditional food from a third country on the market in the Community shall notify it to the Commission,submit a detailed application to the Commission. The detailed application shall meet the requirements contained in the guidelines drawn up by the Commission after consulting EFSA, and shall indicatinge the name of the food, its composition and country of origin.
Amendment 141 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The Commission shall forward the notifapplication including the demonstration of history of safe food use referred to in paragraph 1 without delay to the Member States and the Authority.
Amendment 142 #
Council position – amending act
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The Union list shall be updated in accordance with the procedure laid down in Regulation (EC) No 1331/2008 andCommission shall update the Union list, inter alia in cases of data protection referred to in Article 16, in accordance with the procedure laid down in Regulation (EC) No 1331/2008. By way of derogation from paragraphs 4 to 6 of Article 7 of Regulation (EC) No 1331/2008, wthere applicable, in accordance with Article 16 of this Regulation. Regulation updating the Union list shall be adopted by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23. The Commission shall publish the Union list on a dedicated page of its website.
Amendment 143 #
Council position – amending act
Article 9 – paragraph 2 g (new)
Article 9 – paragraph 2 g (new)
2g. Before the expiry of the period referred to in Article 16(1), the Union list shall be updated in accordance with paragraph 1 of this Article so that, provided that the authorised food still meets the conditions laid down in this Regulation, the specific indications referred to in point (g) of paragraph 2 of this Article, are no longer included.
Amendment 144 #
Council position – amending act
Article 9 – paragraph 2 h (new)
Article 9 – paragraph 2 h (new)
2h. For the purposes of updating the Union list through entry of a novel food, where the novel food does not consist of or contain food subject to data protection according to Article 16 and: (a) the novel food is equivalent to existing foods, in composition, metabolism and level of undesirable substances, or (b) the novel food consists of or contains food previously approved for food use in the Union, and the new intended use can be expected not to significantly increase the intake of consumers, including consumers in vulnerable groups, then the notification procedure referred to in Article 11 of this Regulation shall apply mutatis mutandis, by way of derogation from paragraph 1 of this Article.
Amendment 145 #
Council position – amending act
Article 11 – paragraphs 6 and 7
Article 11 – paragraphs 6 and 7
6. At any stage of the procedure the interested party may withdraw its application. 7. By ..…*In order to ensure smooth functioning of the notification procedure provided for in this Article, the Commission shall, before ...*, adopt detailed rules foron the implementapplication of this Article in accordance with the regulatory procedure referred to in Article 19(2). * OJ: please insert date: 2 years after theby means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23. * Six month after the date of entry into force of this Regulation.
Amendment 145 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Within four months from the date on which the notifapplication provided for in paragraph 2 is forwarded by the Commission, a Member State and the Authority may inform the Commission that they have reasoned safety objections, based on scientific evidence, to the placing on the market of the traditional food concerned. In that case, the food shall not be placed on the market in the Community. The Commission shall notify the food business operator concerned accordingly without delay, and Articles 5 to 7 shall apply. The notifapplication as referred to in paragraph 1 shall then be considered as an application referred to in Article 3(1) of the Regulation XX/XXX [common procedure]. The Commission shall inform the food business operator concerned accordingly unless the operator, within fiveour months from the date of the notification in accordance with paragraph 1Commission’s notification of the non- marketing of the traditional food in the Community, can provide scientific evidence of the safety of the food.
Amendment 147 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. If no reasoned safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Community after five months from the date of the notifapplication in accordance with paragraph 1.
Amendment 148 #
Council position – amending act
Article 21
Article 21
1. The power to adopt the delegated acts referred to in Articles 2(2b), 3(3), 4(3), 4(4), 9(1), 11(6) and 20 shall be conferred on the Commission for a period of five years following the entry into force of this Regulation. The Commission shall make a report in respect of the delegated powers at the latest six months before the end of the five-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 22. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 22 and 23.
Amendment 149 #
Council position – amending act
Article 22
Article 22
1. The delegation of power referred to in Articles 2(2b), 3(3), 4(3), 4(4), 9(1), 11(6) and 20 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission at the latest one monthwithin a reasonable time before the final decision is taken, stindicating the delegated powers which could be subject to revocation and thpossible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Amendment 150 #
Council position – amending act
Article 23
Article 23
1. The European Parliament or the Council may object to thea delegated act within a period of threewo months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, or if, before that date, the European Parliament and the Council have both informed the Commission that they have decided not to raise objections, the delegated act shall enter into force on the date stated therein it shall be published in the Official Journal of the European Union and shall enter into force at the date started therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to thea delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.
Amendment 153 #
Proposal for a regulation
Article 9
Article 9
The Commission shall, where appropriate, in close cooperation with the Authority, make available technical guidance and tools to assist food business operators and especially small and medium-sized enterprises in preparing and submitting applications under this Regulation. The technical guidance and tools shall be published on a publicly accessible and dedicated page of the Commission’s website no later than six months from the date of entry into force of this regulation.
Amendment 167 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. The Commission mayshall impose for food safety reasons and following the opinion of the Authority, a requirement for post- market monitoring. The food business operators placing the food in the Community market shall be responsible for the implementation of the post-marketing requirements specified in the entry of the food concerned in the Community list of novel foods. Monitoring shall comprise food safety aspects, environmental impact, and animal health and welfare. All novel foods shall be subjected to an inspection on these points every five years.
Amendment 175 #
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
1a. The Commission shall determine, after consulting the applicant, which manufacturing data are to be treated confidentially and for how long a period, on the understanding that this period shall not exceed three years.
Amendment 176 #
Proposal for a regulation
Article 12 – paragraph 1 b (new)
Article 12 – paragraph 1 b (new)
1b. After the expiry of the confidentiality period for manufacturing data, these data shall automatically be added to the existing data concerning the novel food on the Community list.