Biotechnology refers to all technologies and their applications that use

  • living organisms (plants, animals, bacteria, yeasts)
  • their derivatives (cells, enzymes, organelles)
  • biological systems

in order to create or modify products and processes for specific uses, useful to meet the needs of the company (solve problems and get useful products).

Biotechnology represents theintersection of natural sciences (biological and physical)withengineering,to date the most complete definition is the one that is reported art. 2 of the Convention on Biological Diversity (CBD), opened at the signing on 5 June 1992 and came into force on 29 December 1993.

scientific research and privacy protection

The two macrocategories in which biotechnology is classified on the basis of their historicality are:


Traditional biotechnology

Used for millennia they consist of Agriculture, Zootecnia, Domestication, Alcoholic and Lactic Fermentation, Yeast (used for the production of wine, beer, bread, cheese, spirits etc.), Food storage and so on.


Innovative biotechnology

Over the past two centuries, the levels of knowledge accumulated over 7,000 years have been vastly exceeded, using molecular biology and genetic engineering techniques in order to obtain manipulable organisms for obtaining specific product.

The list of innovative biotechnology is very broad, including molecular breeding, evolution, Gene Shuffling, Protein Engineering, Bioinformatics, CRISPR/Cas9 and more.

From an application point of view, there is a global tending to divide biotechnology into four categories, although there are many intersections and overlaps.


GREEN Biotechnology

Agri-food biotechnology application to the agri-food segment, i.e. agriculture and food.

In agriculture and horticulture, in livestock, new techniques of genomic sequencing and smart breeding, transgenic and cysogenicplants, genetically modified foods,are the key science and innovation can address the challenges of food safety and environmental sustainability.

ROSSE Biotechnology


i.e. medical-pharmaceutical biotechnology, including all health-related applications,(Healthcare)

as much to aid the medical and health profession as well as to the pharmasector.

From diagnostics to gene therapy,from regenerative medicine (stem cells, tissue engineering and biomaterials)to molecular farming

for the creation of plant biopharmaceuticals , to include veterinary sciences, the applications of red biotechnology are aimed at improving the quality of life and reducing suffering.

WHITE Biotechnology

Industrial biotechnology,used for the process and manufacture of chemicals, materials and energy.

Enzymes and microorganisms are used to make useful products in a variety of economic sectors: from chemist to pharmaceutical, from paper to textiles, from food to energy(bioenergy), passing through polymers.

Microorganisms are used as bioreactors.

GREY Biotechnology

Environmental biotechnology,in particular technologies to remove pollutants, from industrial effluents to wastewater, from
contaminated soils
towater for food use, the techniques used are the bioremediation, biodegradation and bioophylact.

In the diagnostic field, biosensors are used to detect and monitor contaminants and molecular probes to monitor microorganisms.

In particular, bioremediation (bioremediation) technologies exploit the degradation of contaminants and the acceleration of natural environmental detoxification by certain microorganisms.

Biogeochemical control techniques biostimulate pollutants and environmental matrices to be rehabilitated.

In the light of this brief take on the whole, it can certainly be argued that, taken together, biotechnology is strategic for sustainable development and underpins the bioeconomy.

At the end of the taxonomic roundup, it should be noted that – for decades now – in daily life we hear -often incorrectly – about genetically modifiedmicroorganisms,better known as MOGM.

These are organisms whose genetic material has been altered to obtain results that would otherwise not be possible naturally.

MOGMs are not only found in the agri-foodsector, but are also used in industrial processes,as well as having great use in medicine and drug administration.

In thefood industry they are used both to strengthen crops (e.g. increasing resistance to pesticides) and to change the quality of food.

Italy has adopted a number of EU directives since the 1990s(directives 90/219 and 90/220 on the use andissuance of MOGM),which regulated the release into the environment of these bodies and their Use.

The first of the two has been amended by Directive 98/81, which has been adopted in our country by the D.Lgs. N. 206/2001.

The reasons behind this review are to be found in the desire to harmonize the subject with the new directives, to classify MOGm on the basis of the risks they pose to humans, to impose reporting obligations on the basis of these risks, improve transparency, etc…

The agri-food sector has also been affected for some years by the development of
which converges with biotechnology in a series of intersections that are difficult to separate. A nanometer is a billionth of a meter.

The attitude of the European Union, towards those who call themselves nanoproducts, was not to introduce new regulations, but to apply existing ones.

In the food and cosmetics sector they are not considered different from equivalent substances, without any provision concerning safety: there has not yet been such a ruling, no pronunciation byEFSA , theEuropean Food Safety Agency.

The only regulation that dictates specific rules on the subject is the N. 1333/08, which regulates food additives.


A separate nod, in the treatment of biotechnology and in their regulation, deserves what between the emerging and convergent technologies NBIC , probably represents the par-life fringe technology,

the The most daring border science between Life Sciences: synthetic biology,also called Synbiosynthetic biology.

Biological phenomena are traditionally only explained in retrospect: thanks to the engineering study of biological systems and their modular decomposition, the biological sciences are beginning to enjoy typical properties of the “hard sciences” “, primarily that of predictiveness.

The new discipline of synthetic biology is part of this epochal turning point and is characterized by the research and creation of new biological properties of the living, properties that have never appeared on the planet until so far, useful to solve situations that have never arisen.

Synthesis Biology is therefore concerned with the artificial creation of new forms of life, which like machines can be built to perform determined tasks.

It is therefore defined as a “
problem solving enterprise
” aimed at the production of biological organisms for the example of:

  • Revealing and treating pathologies(cell regeneration)
  • Produce new materials(biodegradable plastics, food fuels)and nano-scale bio-electronic circuitries
  • Controlling the behavior of cell membranes(artificial biosensors,bioremediation from xenobiontes)

As with
synthetic biology employs both the top-down engineering approach (starting with existing organisms to obtain the desired operational modules) and bottom-up.

The latter is the approach that enhances the idea of modularity of living systems: new biological properties are created, assembling biological modules characterized by specific properties (as with Lego).

These forms are available for “ordering” from a “common parts catalogue”, such as on the Massachussets Institute Of Technology Common Parts Register.

The creation of synthetic life forms involves a number of ethical, legal and environmental risks, against which there is an intense debate between ethicists, lawyers and scientists.

For a wide-ranging study of ethical aspects, please refer to the Ethics of Synthetic Biology report, Opinion No. 25

, (Brussels 17.11.2009) prepared by the European Group on Ethics in Science and New Technologies.

In December 2010, the US Presidential Commission for the Study of Bioethics published a report on synthetic biology and emerging technologies.

Before moving on, however, a premise on the different US-EUROPA approach to

regulation of science by law.

Because of nature”Science Based”

American legal system, in which science is assumed as a neutral and prevailing value,based on legal law and binding precedent,the focus is always on the individual case in practice: does not adhere to abstract preventive assessments of harm and risk, preferring to severely punish former posts.

Otherwise, the European ordinances of Civil Law (policy-oriented) are centred on the legal norm and therefore on abstract and general regulation. With no effective procedural remedies such as those in the US, a kind of “pre-emptive consent” on the regulation of science by lawis needed.

Science in Europe recognises insurmountable limits and – especially in practical applications – the final word is the right,or rather to say to politics; This is why, under the precautionary principle, the gaps in science are filled with precautionary protection measures for citizens.

Returning to the report of the American Commission on Synthetic Biology,in accordance with the tradition of US law policy, the same is characterized by the usual cautious approach, geared towards the preservation of the freedom of conduct of the scientific research and the exclusion of the creation of ad hoc rules on the subject.

In conclusion of this comprehensive look at biotechnology,it seems appropriate to point out that the relationship between science and law is complex, iridescent and susceptible to very rapid transformations, but necessarily transdisciplinary.

While science must be regulated, the law must listen properly to science, without unreasonably harnessing research: we need a science willing to be wisely disciplined and a cleverly informed policy.

The biotechnology revolution in particular poses ever-new questions with which the lawyer and the economist have to confront: from the definition of embryo and its patentability to the property of fabrics, biological samples genetic information,access and limits of genetic genetic diagnosis cognitive enhancement,from genetic manipulation of plant species to impacts on human health andlegalissues are many and complex.

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