Law No. LP199/2025 “On the use of genetically modified microorganisms in isolation conditions and for the amendment of certain normative acts”.

The purpose of this Law is to establish a regulatory framework necessary for carrying out activities for the use in contained conditions of genetically modified microorganisms, in compliance with the precautionary principle, in order to protect human health and the environment. In accordance with the precautionary principle, in order to avoid adverse effects on human health and the environment, the use in isolated conditions of genetically modified microorganisms is prohibited without the authorization issued by the Environmental Agency. The user shall provide a risk assessment for the contained use of genetically modified microorganisms with regard to risks to human health and the environment, using at least the assessment elements set out in Annex 3, supplemented by the provisions of Annex 4. The user shall apply the appropriate containment and other protective measures, as set out in Annex 5, corresponding to the class of use under contained conditions, so that the degree of exposure to any genetically modified micro-organism in the workplace, as well as in the environment, is kept to the lowest possible level, in order to ensure an adequate level of biosecurity. The authorization for the contained use of genetically modified microorganisms shall be issued in electronic form and, at the request of the holder, on paper and shall include: (a) general information: name of the legal entity, legal address, registration number state identification, contact details; (b) the characteristics of the genetically modified microorganism to be used under containment conditions; (c) description of the genetic modification taking place, with strict indications regarding intermediate genetically modified microorganisms obtained until their final form; (d) isolation conditions, biosecurity measures that apply to protect human health and the environment, with strict reference to waste management, emergency plans in case of accident, remediation and national implications; (e) the risk category for which the authorization was issued; (f) the risk category for which the authorization was issued; and (g) the risk category for which the authorization was issued. The validity of the authorization for the contained use of genetically modified microorganisms is 10 years for type A use and unlimited for type B use. Labelling by the user of containers containing microorganisms genetically modified is mandatory. Law No. LP160/2011 “On regulation of entrepreneurial activities by permits” shall be amended to add the following wording: “If new information, unknown at the date of issuing the authorization, appears regarding the risk of using genetically modified organisms that may affect human health or the environment, the Environmental Agency shall temporarily restrict or prohibit its use, and/or sale of the respective genetically modified organism, as a product itself or component of another product”.