EU Regulations – Introduction

Introduction

The foundation for the regulatory framework for biosafety in the EU was established in 1990 with the adoption of two Directives, one pertaining to the release of genetically modified organisms (hereafter “GMOs”) and one pertaining to the contained use of
genetically modified micro-organisms. In 1997, these Directives were complemented by the Novel Food Regulation. In the years that followed, this regulatory framework was adjusted and expanded upon.

The objectives of the current regulatory framework for biosafety are:

  • Protect human and animal health and the environment by introducing a safety assessment of the highest possible standards at EU level before any GMO is placed on the market.
  • Put in place harmonised procedures for risk assessment and authorisation of GMOs that are efficient, time-limited and transparent.
  • Ensure clear labelling of GMOs placed on the market to enable consumers as well as professionals to make an informed choice.
  • Ensure the traceability of GMOs placed on the market.

The current EU regulatory framework for biosafety consists of:

 

Secondary law, e.g.:

  • Directive 2009/41/EC on contained use of GM micro-organisms.
  • Directive 2001/18/EC on the deliberate release of GMOs.
  • Directive 2015/412 – the possibility of ‘Opt out’ of cultivation
  • Regulation 1829/2003 on GM food and feed
  • Regulation 1830/2003 on traceability and labelling.
  • Regulation 1946/2003 on transboundary movements of GMOs
  • Regulation (EU) 2019/1381 on transparency in risk assessment

Implementing rules and decisions, e.g:

  • `Commission Directive 2018/350 amending Directive 2001/18/EC, concerning the environmental risk assessment (ERA) of GMOs.
  • Commission Implementing Decision 2018/1790 on guidance notes on the environmental risk assessment of GMOs
  • Commission Implementing Regulation 503/2013 on applications for authorisation of GM food conform Regulation 1829/200
  • Decision 2009/770/EC establishing standard reporting formats for presenting monitoring results


Guidelines, e.g.:

  • Commission guidelines: e.g.
    • Recommendation 2004/787/EC on technical guidance for sampling and detection of GMOs 23,
    • Recommendation 2010/01/EC on guidelines for the development of national coexistence measures
  • EFSA guidance: e.g.:
    • Administrative guidance, e.g.: submission of applications
    • Scientific Guidance, e.g: allergenicity assessment