This proposal for a Directive covers two topics, the placing on the market of genetically modified micro-organisms (GMMs) and the processing of organs. This notification concerns only the part on GMMs (Article 1 of the proposed Directive), which is the relevant part under the SPS Agreement.
Amendment (as regards GMMs) to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
Directive 2001/18/EC regulates the deliberate release into the environment of genetically modified organisms (GMOs) for any other purposes than placing on the market within the European Union (Part B of the Directive) and the placing on the market of genetically modified organisms as or in products within the European Union (Part C). This Directive does not apply to the market authorisation of food and feed containing, consisting of or produced from GMOs.
The proposed amendments introduce specific provisions in Part C of the Directive applicable to the placing on the market of GMMs as or in products (other than food and feed) with the aim of tailoring the requirements of the regulatory framework to GMMs while maintaining a high safety level for human health and the environment.
The provisions proposed relate to the risk assessment, to the validity of the consent granted for the placing on the market, and to detection methods applicable to all GMMs. Inrelation to a tailored risk assessment, provision is made for the information requirements in Annex III of Directive 2001/18/EC to be amended by the European Commission by way of delegated act in order to adapt them to the specificities of GMMs, respecting the general principles for the environmental risk assessment of Annex II of Directive 2001/18/EC. The validity of consent granted by the competent authorities would last for an unlimited period of time for GMMs. The modalities to comply with detection method requirements in cases where it is not feasible to provide a method that detects,
identifies and quantifies are also adapted in the proposal.
Further, the proposal would also introduce specific provisions for low-risk GMMs, including scientific criteria to establish this status, a streamlined authorisation procedure and adaptation of the requirement for post-market environmental monitoring.