Glossary

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Biodiversity or biological diversity: "The variability among living organisms of all kinds, including, among others, the land, the sea and those of other aquatic ecosystems and the ecological complexes of which they are part. This includes diversity within species, between species and diversity of ecosystems "(article 2, Convention on Biological Diversity).

Biosafety: the set of measures, policies and procedures to minimise potential risks to the environment and human and animal health arising from modern biotechnology.

Biotechnology: Science which uses technological applications on living organisms to develop or to produce products of industrial or scientific interest. An important branch of biotechnology uses the recombinant DNA technology to produce in the laboratory variation in genome of cells or organisms by modification, insertion or deletion of one or more genes in order to obtain an organism with desired characteristics.

Capacity Building: strengthening biosafety capacity through scientific and technical training and the transfer of technology, know-how and financial resources, especially in developing countries and countries with economies in transition (article 22, Cartagena Protocol).

Clearing House Mechanism: a mechanism provided for in the Convention on Biological Diversity to promote, facilitate scientific and technical cooperation, sharing and exchange of information on the topics of the Convention and its Protocols.

Comitology: see committee procedure.

Committee procedure: a set of procedures, including meetings of representative committees, by which EU countries can express their views on European Commission implementing acts.

Contained use: means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment (article 3, Cartagena Protocol).

Convention on Biological Diversity (CBD): convention signed in Rio de Janeiro on 5 June 1992, aims to protect biological diversity, the sustainable use of its components and the fair and equitable sharing of its benefits, at a global level, by promoting cooperation between countries.

Decree Law: a provisional measure, having the force of law, adopted by the Government in extraordinary cases of necessity and urgency and issued by the President of the Italian Republic.

Decision: binding act for the Member States of the European Union and directly applicable.

Deliberate release: any intentional introduction into the environment of a GMO or combination of GMOs for which no specific containment measures are used to limit their contact with the general population and the environment and to ensure a high level of security for them " (article. 2, Directive 2001/18/EC).

Directive: act which obliges the Member States of the European Union to achieve certain objectives, leaving them the choice of the means to achieve them. It may be addressed to one Member State, several or all Member States. In order to ensure that the principles set out in the directive are applied in practice to citizens, the national legislator must adopt one or more acts implementing the directive in the national law of the Member State, i.e. adapting national legislation in order to achieve the objectives set out in the Directive. The time-limit by which the Directive must be implemented in national law is indicated in the Directive; as regards the manner of implementation, the Member States have a margin of discretion to ensure that national specificity is respected. On the other hand, the deadline for transposition of the directive is mandatory

DNA (deoxyribonucleic acid): organic molecule containing the hereditarily transmitted genetic information. The DNA is made up of two chains of deoxyribonucleotides, joined by hydrogen bonds between complementary base pairs (adenine with thymine, cytosine with guanine) and coiled around in opposite directions (antiparallel) each other to form a double helix.

Environmental risk assessment: the evaluation, carried out in accordance with Annex II of directive 2001/18/EC, of the risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of a GMO may pose (article 2(8) of Directive 2001/18/EC).

Gene: it is a fundamental, physical and functional unit, of the inheritance that transmits information from one generation to the next. A gene have a defined and fixes position (locus) in a particular chromosome. From a biochemical point of view, a gene is a polynucleotide sequence of DNA that transcribes an messenger RNA coding for a specific protein. A gene consists of a coding region and a regulative transcription region. Often, with the exception of prokaryotes, genes are structurally discontinuous, i.e. they contain an alternation of coding sequences (exons), which are found in the mature transcript, and non-coding sequences (introns) that are removed from the RNA after the transcription. The exhibition of the characters encoded by the information contained in the genetic material (genotype) represents the phenotype.

Genetically modified microorganism (GMMO): a microorganism whose genetic material has been modified with nucleic acid recombination techniques, with techniques of direct introduction of genetic material or with cell fusion or hybridization techniques, however in a different way from the recombination or crossing processes occurring in nature (article 2, legislative decree 12 april 2001, no. 206).

Genetically modified organism (GMO): an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (article 2, directive 2001/18/EC).

Living modified organism (LMO): “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology” (article 3, Cartagena Protocol).

Microorganism: any cellular or non-cellular microbiological entity capable of replicating or transferring genetic material, including viruses, viroids, animal cells, and cultured plant cells.

National Competent Authority (NCA): each Contracting Party to the Cartagena Protocol designates the Competent National Authority that is responsible for performing the administrative functions of the Protocol and is authorised to act on behalf of the State in the exercise of those functions (article 19, Cartagena Protocol).

Notification: about GMOs, it is the submission of the information required by directive 2001/18/EC and by the local regulations to the competent authorities of a Member States, in order to obtain the authorization for the deliberate release of GMOs into the environment.

Notifier: the person submitting the notification (article 3, legislative decree 8 july 2003, no. 224).

Placing on the market: the making available to third parties, whether in return for payment or free of charge (article 2(4), Directive 2001/18/EC).

Placing on the market: the holding of food or feed for the purpose of sale, including offering for sale, or other forms of transfer, whether free of charge or not, to third parties, and the sale, distribution and other forms of transfer themselves (article 4(14), Regulation (EC) No 1830/2003).

Placing on the trade: the making available to third parties, whether in return for payment or free of charge (article 3(1)(d), Legislative Decree 8 July 2003, no. 224)

Recommendation: it is a non-binding act, it allow European institutions to disclose their positions and suggest action without imposing legal obligations on recipients.

Regulation: it is a binding act, it is mandatory in all its elements and directly applicable in the legal systems of the Member States of the European Union.

Risk: a function of the probability and severity of an adverse effect on human, animal or plant health, animal welfare or the environment resulting from the presence of a hazard (article 3(24), regulation (EU) 625/2017).

Species: taxonomic category that includes individuals belonging to one or more populations able to cross each other giving birth to fertile offspring.

Transgene: gene synthesized in laboratory or from another organism that is artificially inserted into a host organism that is sexually incompatible with the donor organism.

Transgenic: organism whose genome has been modified by the introduction of foreign one or more genes or nucleotide sequences with the technique of recombinant DNA, and that can transmit this modification to his descendants.

Use in a contained environment: the release of GMOs other than micro-organisms for exclusive use in activities in which strict and specific containment measures are implemented to limit the contact of these organisms with the population and the environment and to ensure a high level of safety for them (article 3(1)(d)(2), legislative decree 8 July 2003, no. 224).

Unique identifier: a simple numeric or alphanumeric code to identify a GMO, on the basis of the authorised transformation event through which it was developed, and to allow the retrieval of specific data relevant to that GMO (article 3(1)(4), Regulation (EC) no. 1830/2003).