Brussels, 23 January 2018
GENETICALLY MODIFIED FOOD AND FEED
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that, unless a ratified withdrawal agreement1 establishes another date, all Union primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) (‘the withdrawal date’)2. The United Kingdom will then become a ‘third country’.
In this regard, business operators involved in the activities falling under the scope of Regulation (EC) No 1829/2003 on genetically modified food and feed and Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment are reminded that preparing for the withdrawal is therefore not just a matter for European and national authorities, but also for private parties.
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, authorisation holders and applicants are reminded of certain legal repercussions, which need to be considered when the United Kingdom becomes a third country.
Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of genetically modified food and feed and the deliberate release of genetically modified organisms into the environment no longer apply in the United Kingdom. This has, in particular, the following consequences in the different areas of genetically modified food and feed and the deliberate release of genetically modified organisms:
– under Regulation (EC) No 1829/2003, authorisation holders or their representatives must be established in the European Union (or in one of the contracting states of the European Economic Area);
1 Negotiations are ongoing with the United Kingdom with a view to reaching a withdrawal agreement.
2 Furthermore, in accordance with Article 50(3) of the Treaty on European Union, the European Council, in agreement with the United Kingdom, may unanimously decide that the Treaties cease to apply at a later date.
– applications for the placing on the market of genetically-modified organisms under Directive 2001/18/EC must designate a person responsible for the placing on the market which must be established in the European Union (or in one of the contracting states of the European Economic Area).
Business operators should consider that applications and notifications pursuant to Regulation (EC) No 1829/2003 and Directive 2001/18/EC can only be submitted to the competent authorities of EU Member States (or of contracting states of the European Economic Area). In particular, business operators should carefully take into account the expected timelines before the submission of any new application in which the United Kingdom would be acting as rapporteur Member State under Directive 2001/18/EC.
The website of the Commission on food safety provides general information concerning genetically modified food and feed and the deliberate release of genetically modified organisms into the environment. If necessary, Questions & Answers (Q&A) in relation to Regulation (EC) No 1829/2003 and Directive 2001/18/EC will be made available.
European Commission Directorate-General for Health and Food Safety.
This article contains European Union public sector information which is reproduced pursuant to Commission Decision of 12 December 2011 on the reuse of Commission documents (2011/833/EU)