Implementing regulation 2013/503 - Applications for authorisation of genetically modified food and feed in accordance with Regulation 1829/2003 - Main contents
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Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 Text with EEA relevance| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2013/503 |
| CELEX number i | 32013R0503 |
| Document | 03-04-2013 |
|---|---|
| Publication in Official Journal | 08-06-2013; OJ L 157, 8.6.2013,Special edition in Croatian: Chapter 03 Volume 072 |
| Effect | 28-06-2013; Entry into force Date pub. +20 See Art 13 |
| End of validity | 31-12-9999 |
8.6.2013 |
EN |
Official Journal of the European Union |
L 157/1 |
COMMISSION IMPLEMENTING REGULATION (EU) No 503/2013
of 3 April 2013
on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 5(7), 11(5), 17(7) and 23(5) thereof,
After consulting the European Food Safety Authority,
Whereas:
(1) |
Regulation (EC) No 1829/2003 lays down Union procedures for the authorisation and supervision of genetically modified food and feed, including rules for the labelling of such food and feed. That Regulation provides for a scientific evaluation to be carried out on the risks that the genetically modified food or feed may present for human and animal health and, as the case may be, for the environment. It also provides that a genetically modified food or feed must not mislead the consumer or the user and must not differ from the food or feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for humans or animals. |
(2) |
Regulation (EC) No 1829/2003 provides, in particular, that applications for authorisation are to adequately and sufficiently demonstrate that the genetically modified food and feed satisfy the requirements laid down in that Regulation, in respect of their proposed uses. |
(3) |
In the interest of consistency of Union legislation, certain definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2) should also apply to this Regulation. |
(4) |
Commission Regulation (EC) No 641/2004 (3) on detailed rules for the implementation of Regulation (EC) No 1829/2003 provides for certain detailed rules concerning applications for authorisation submitted in accordance with Regulation (EC) No 1829/2003. To facilitate the preparation of applications and ensure that they contain all the information needed for their assessment, it is necessary to provide for more comprehensive and systematic rules concerning applications for authorisation, which should also be specific to each type of genetically modified organisms (GMO), namely plants, animals and micro-organisms. |
(5) |
The rules laid down in this Regulation should only cover applications concerning genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food or feed produced from such plants. Genetically modified plants, for which sufficient experience is available to date, constitute the vast majority of current applications. |
(6) |
The rules laid down in this Regulation should specify the general requirements for the presentation and preparation of applications, namely requirements to provide general and scientific information, including methods for detection, and identification, as well as reference material so as to ensure that applications comply with the conditions laid down in Articles 5, 17 and 30 of Regulation (EC) No 1829/2003. |
(7) |
The applicant should also take into consideration the scientific information to be provided in the application as regards the environmental risk assessment of GMOs or food and feed containing or consisting of GMOs, as set out... |
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