Activities of Franz OBERMAYR related to 2013/0435(COD)
Plenary speeches (1)
Novel foods (A8-0046/2014 - James Nicholson) DE
Amendments (24)
Amendment 16 #
Proposal for a regulation
Recital 2
Recital 2
(2) AIn the pursuit of Union food policies priority should be given to transparency and to compliance with the precautionary principle, with a view to guaranteeing a high level of protection of human health and of consumers’ interests and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 24 #
Proposal for a regulation
Recital 11
Recital 11
(11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in at least two third countryies has been demonstrated. Those foods should have been consumed in at least two third countryies for at least 25 years as a part of the customary diet within a large part of the population of the country. The history of safe food use should not include non-food uses or uses not related to normal diets.
Amendment 29 #
Proposal for a regulation
Recital 12
Recital 12
Amendment 30 #
Proposal for a regulation
Recital 16
Recital 16
(16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States. Food business operators should consult Member States if they are unsure of the status of the food they intend to place on the market. When there is no information or insufficient information available on human consumption before 15 May 1997, a simple and transparent procedure, involving the Commission, the Member States and food business operators, should be established for collecting such information. Implementing powers should be conferred on the Commission to specify the procedural steps of such consultation process. These provisions notwithstanding, existing national arrangements governing the steps in the process may remain in force in the Member States if they are not fundamentally at odds with the requirements laid down by the Commission.
Amendment 33 #
Proposal for a regulation
Recital 19
Recital 19
(19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed by the EFSA or a Member State. The need to consider scientific evidence notwithstanding, the Commission should be required to initiate an ordinary legislative procedure for the authorisation of a traditional food from a third country if objections are raised by at least one-fifth of the Member States. As the updating of the Union list implies the application of criteria laid down in this Regulation, implementing powers should be conferred on the Commission in that respect.
Amendment 50 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘traditional food from a third country’ means novel food, other than the novel food as referred to in point (a)(i) to (iii), which is derived from primary production, with a history of safe food use in at least two third countryies;
Amendment 58 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
The Commission may, by means of implementing acts, specify the procedural steps of the consultation process provided for in paragraph 2. This provision notwithstanding, existing national arrangements governing the consultation process may remain in force in the Member States if they are not fundamentally at odds with the requirements laid down by the Commission.
Amendment 63 #
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) it does not, in the light of the Union’s precautionary principle and on the basis of thesufficient scientific evidence availablefrom independent sources, pose a safety risk to human health;
Amendment 69 #
Proposal for a regulation
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) adding, removing or changing the conditions, specifications, mandatory labelling requirements or restrictions associated with the inclusion of a novel food on the Union list.
Amendment 72 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d
Article 9 – paragraph 1 – subparagraph 2 – point d
(d) where applicable, a proposal for the conditions of use and a proposal for specific labelling requirements which do not mislead the consumer.
Amendment 74 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
(2) The Commission mayshall request EFSA to render its opinion if the update is liable to have an effect on human healthasked to do so by a Member State or if the update could give rise to a breach of the conditions laid down in Article 6.
Amendment 78 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b
Article 10 – paragraph 1 – subparagraph 2 – point b
(b) whether the composition of the novel food and the conditions of its use are consistent with the Union’s precautionary principle and thus do not pose a safety risk to human health in the Union.
Amendment 81 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – point a
Article 11 – paragraph 1 – subparagraph 1 – point a
(a) the conditions provided for in Article 6 where applicable;
Amendment 84 #
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
(d) documented data demonstrating the history of safe food use in at least two third countryies;
Amendment 88 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
(2) Within foursix months from the date on which the valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or EFSA may submit to the Commission reasoned safety objections, based on scientific evidence, to the placing on the market within the Union of the traditional food concerned. The need to consider scientific evidence notwithstanding, the Commission shall be required to initiate an ordinary legislative procedure for the authorisation of a traditional food from a third country if objections are raised by at least one-fifth of the Member States.
Amendment 90 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
(1) EFSA shall adopt its opinion within sixnine months from the date of receipt of a valid application.
Amendment 91 #
Proposal for a regulation
Article 16 – paragraph 2 – point b
Article 16 – paragraph 2 – point b
(b) whether the composition of the novel food and the conditions of its use, are consistent with the Union’s precautionary principle and thus do not pose a safety risk to human health in the Union.
Amendment 92 #
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 1
Article 16 – paragraph 4 – subparagraph 1
In duly justified cases, where EFSA requests additional information from the applicant, the period of sixnine months provided for in paragraph 1 may be extended.
Amendment 93 #
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 3
Article 16 – paragraph 4 – subparagraph 3
Where the Commission does not object within eight working days of being informed by EFSA, the period of sixnine months provided for in paragraph 1 shall be automatically extended by that additional period. The Commission shall inform the Member States of that extension.
Amendment 95 #
Proposal for a regulation
Article 16 – paragraph 6 – subparagraph 2
Article 16 – paragraph 6 – subparagraph 2
In such cases, EFSA shall give its opinion within the period of sixnine months provided for in paragraph 1.
Amendment 96 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 – point a
Article 17 – paragraph 1 – subparagraph 1 – point a
(a) the conditions provided for in Article 6 where applicable;
Amendment 101 #
Proposal for a regulation
Article 23 – title
Article 23 – title
Post-market monitoring and changes to labelling requirements
Amendment 102 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
(1) The Commission may, for food safety reasons and with a view to guaranteeing transparency as regards the use of the novel food, on the basis of a properly substantiated request from a Member State or taking into account the opinion of EFSA, impose a requirement for post- market monitoring of a novel food or additional labelling requirements to ensure that the use of the authorised novel food is within safe limits and that transparency for consumers is guaranteed.
Amendment 104 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
(1) On request by the applicant, supported by appropriate and verifiable information included in the application provided for in Article 9(1), newly developed scientific evidence or scientific data from independent sources supporting the application may not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation and the inclusion of the novel food in the Union list without the agreement of the prior applicant.