Placing on the market
In accordance with Part C of the Directive, the decision-making procedure for placing GMOs on the market is more elaborate and the final decision is made at the EU level rather than by an individual Member State. Part C does not apply to GMOs as or in products that are authorised by EU legislation which provides for a specific environmental risk assessment carried out in accordance with the principles set out in Annex II and which contains requirements at least equivalent to those laid down in the Directive. (Art 12.) As is further discussed presently, this means that GMOs for use as food or feed are authorised in accordance with the procedure set out in Regulation 1829/2003 on genetically modified food and feed.
Before a GMO or a combination of GMOs as or in products is placed on the market, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. A copy of the notification shall be forwarded to the Commission, which in turn forwards it to the competent authorities of the other Member States.
The notification must normally contain, inter alia, the information required in Annexes III and IV; the environmental risk assessment; the conditions for the placing on the market of the product, including specific conditions of use and handling; a plan for monitoring in accordance with Annex VII; a proposal for labelling complying with the requirements laid down in Annex IV; and a proposal for packaging in accordance with Annex IV.
The competent authority shall prepare an assessment report and send it to the notifier. If the report indicates that the GMO(s) in question should be placed on the market the authority must send the report and any information on which it is based to the Commission, which forwards it to the other Member States. If, on the other hand, the competent authority decides that the GMO(s) should not be placed on the market, the notification shall be rejected. (Arts 13—15.)
When a report is forwarded, the competent authorities and the Commission have sixty days to ask for further information, make comments, or present reasoned objections to the placing on the market of the GMO(s) in question. If no reasoned objection is presented, the competent authority which prepared the report shall give consent for placing on the market for a maximum period of ten years subject to renewal.
In cases where an objection is raised and maintained by a competent authority or the Commission, a decision shall be adopted within 120 days in accordance with the examination procedure set out in Regulation (EU) No 182/2011.[1] [2] [3] The relevant Scientific Committee also must be consulted on the objection.15 When, as tends to be the case with the authorisation of GMOs, the Member State committee acting under the examination procedure is unable to reach a decision, the final decision is made by the Commission in the form of an implementing decision.!6
Where a favourable decision is taken, the competent authority which prepared the report shall give consent to the placing on the market. The notifier may proceed with the placing on the market only after having received the written consent and in conformity with any conditions required in that consent. (Arts 15, 18, 19, and 28.)
For all GMOs that receive consent for placing on the market or whose placing on the market is rejected, the assessment reports and the opinion(s) of the scientific committees consulted must be made available to the public (Art 24).
On labelling requirements see Regulation (EC) No 1830/2003 concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs.
GMOs that have received consent are subject to free circulation, that is, the Member States may not prohibit, restrict, or impede the placing on the market of GMOs, as or in products, which comply with the requirements of the Directive. However, the Directive includes a safeguard clause according to which a Member State may provisionally restrict or prohibit the use and/or sale of a GMO that has received consent on its territory. To do so the Member State must, as a result of new or additional information, have detailed grounds for considering that the GMO as or in a product constitutes a risk to human health or the environment. The Commission and the other Member States shall be informed immediately and a decision on the measure is to be taken in accordance with the examination procedure within sixty days. (Arts 22 and 23.)
- [1] Regulation (EU) No 182/2011 of the European Parliament and of the Council laying down therules and general principles concerning mechanisms for control by Member States of the Commission’sexercise of implementing powers [2011] OJ L 55/13 has replaced Decision 1999/468/EC to whichreference is made in Art 30(2) of the Directive.
- [2] This specific committee is called the Standing Committee on Plants, Animals, Food and Feed,Section Genetically Modified Food and Feed and Environmental Risk.
- [3] See, eg, Commission Implementing Decision (EU) 2015/694 concerning the placing on themarket, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, ofa carnation (Dianthus caryophyllus L., line 26407) genetically modified for flower colour [2015] OJL 112/52.
