Biotechnology
Biotechnology is technology based on biology. It has a broad scope and covers a diverse collection of technologies. Generally we can say that these technologies use the attributes, or involve the manipulation, of organisms or tissues, or cellular, sub-cellular, or bio-molecular components. They can be used to advance knowledge, create goods, products, services, or therapies.
Biotechnology is recognised as having the potential to offer benefits in human and veterinary medicine, agricultural practice, food quality and nutrition, manufacturing and environmental protection. Because it might involve releasing the products of biotechnology to the environment it is regulated by law.
An example of biotechnology regulation is the set of regulatory controls which cover the deliberate release of genetically modified organisms (GMOs).
Regulation of GMOs
The principal EU legislation governing the deliberate release of GMOs to the environment is Directive 2001/18/EC - the "Deliberate Release Directive". This came into force on 17 April 2001 and was required to be implemented in each EU member state by 17 October 2002.
All GMOs or products consisting of or containing GMOs are subject to the step-by-step authorisation procedures of the Directive, except products that fall under other European legislation that provides for specific authorisation. An example of those would be GM food products covered by Regulation 97/258/EEC (as amended) on Novel Foods and Novel Food Ingredients.
The precautionary principle
The so-called ‘precautionary principle’ is central to the Deliberate Release Directive:
- Releases without approval are generally prohibited
- First-time consents for releases of GMOs and renewals of authorisations are generally limited to 10 years.
Traceability regime
The Deliberate Release Directive also introduced the concept of a traceability regime, designed specifically for GMOs. The regime requires member states to ensure that GMOs can be traced at all stages when placing them on the market. It is implemented by way of regulations on the traceability and labelling of GMOs and food and feed products produced from GMOs, and approvals procedures and labelling requirements for GM food and feed.
Liability for damage
Damage caused by releases of GMOs may give rise to liability including under the common law torts of negligence or nuisance.
Depending on the type of damage it may also constitute ‘environmental damage’ for the purposes of the EU Environmental Liability Directive.