BETA

5 Amendments of Andreas SCHWAB related to 2008/0002(COD)

Amendment 30 #
Proposal for a regulation – amending act
Recital 3
(3) Community rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients and by Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97. For the sake of clarity, Regulation (EC) No 258/97 should be repealed and replaced by this Regulation. The present Regulation should include measures currently governed by Regulation (EC) No 1852/200and Regulation (EC) No 1852/2001 should be repealed. Regulation (EC) No 258/97 should be replaced by this Regulation. Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council1 should be replaced by revised guidance tailored to novel foods. However, applicants should continue to be able to avail themselves of Commission Recommendation 97/618/EC until it is replaced by revised guidance. __________ 1 OJ L 253, 16.9.1997, p. 1.
2008/08/20
Committee: IMCO
Amendment 36 #
Proposal for a regulation – amending act
Recital 22
(22) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods harmonises the provisions in the Member States which relate to nutrition and health claims. Therefore, claims regarding novel foods should only be made in accordance with that Regulation. Where an applicant intents that a novel food should carry a health claim to be authorised in accordance with Article 17 or 18 of Regulation (EC) No 1924/2006, and both the application for authorisation as a novel food and the application for authorisation of the health claim include an application to protect proprietary data, the data protection periods, should the applicant so request, should start together and run concurrently.
2008/08/20
Committee: IMCO
Amendment 55 #
Proposal for a regulation – amending act
Article 9
TWithout prejudice to Article 9(1)(a) of Regulation (EC) No. XXX/XXXX [common procedure], and before this Regulation becomes applicable pursuant to Article 20, the Commission shallould, 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 and notifications under this Regulation. Applicants should continue to be able to avail themselves of Commission Recommendation 97/618/EC until it is replaced by revised technical guidance drawn up in accordance with this Article.
2008/08/20
Committee: IMCO
Amendment 58 #
Proposal for a regulation – amending act
Article 12 a (new)
Article 12a Harmonised data protection Notwithstanding authorisation of a novel food pursuant to Articles 7 and 14 of Regulation (EC) No ... [common procedure] or to authorisation of a health claim pursuant to Articles 17, 18 and 25 of Regulation (EC) No 1924/2006, the data concerning the authorisation and/or publication of the authorisation in the Official Journal shall be identical and the data protection periods shall run concurrently where it is intended to obtain authorisation for a novel food and for a health claim relating to that food, and where data protection pursuant to the provisions of both Regulations is warranted and requested by the applicant.
2008/08/20
Committee: IMCO
Amendment 61 #
Proposal for a regulation – amending act
Article 18 – paragraph 1
1. Any request for placing a novel food on the market submitted to a Member State under Article 4 of Regulation (EC) No 258/97 and for which a final decision has not been taken before the date ofon which the initial assessment report under Article 6(3) of Regulation (EC) No 258/97 has not been forwarded to the Commission before this Regulation becomes applicable shall be considered as an application ofunder this Regulation shall be considered as an application under this Regulation. . Other requests submitted under Articles 3(4), 4 and 5 of Regulation (EC) No 258/97 before this Regulation becomes applicable shall be considered in accordance with the provisions of Regulation (EC) No 258/97.
2008/08/20
Committee: IMCO