Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulation (EU) 2015/2283 on novel foods - Analysis of the amendments and their impact on regulatory work ***

Heike Trautmann (Abschlußjahr: 2019)

Summary
Language: English
One of the most important principles in the EU is to protect the health and interests of consumers. Consequently, new foods or food ingredients require a comprehensive safety assessment and authorisation before they can be placed on the EU market. On 27 January 1997 the European Parliament and the Council adopted the first Regulation (EC) 258/97 on novel foods and food ingredients for the purpose to eliminate differences between national laws concerning the safety assessment and authorisation of Novel Foods. Due to the increasing globalisation, immigration of diverse ethics groups and new technical ways of food production more and more new foods, food from new sources or new substances as well as food which is or has been traditionally eaten outside of the EU enter the European market over the years. For the sake of harmonisation and filling in of legislative loopholes Regulation (EC) 258/97 were further developed and the Regulation (EU) 2015/2283 on novel foods come into force on 1 January 2018.
The present work describes whether and to what extent the Regulation amendments affect regulatory work and facilitate the procedure of authorisation with regards to full food safety. For this purpose, the changes of the new Regulation (EU) 2015/2283 on novel foods are worked out and compared with the old legislation. Subsequently, advantages and disadvantages are described and analysed with regard to the significance for the research question.
In the course of the thesis it can be shown that the amendments, especially the reorganisation of the authorisation procedure and the notification procedure for traditional foods from third countries, have the potential to facilitate the process of authorising and placing Novel Food on the European market in such a way that it will be simpler, faster and more applicant friendly without neglecting the safety aspects.
Pages: 50