This book assesses the EU legal framework applicable to dairy products obtained through
precision fermentation. It maps the authorisation and labelling requirements for these products
to be placed on the EU market. It compares these provisions to those governing the food markets
in the USA and Singapore which are considered to be more innovation-friendly. At the time of
writing the precision-fermented dairy sector is still in the developmental phase with only a
few precision-fermented dairy alternatives available on the market none of which are present
in the EU. Regulatory uncertainty has been cited as significant obstacle for food business
operators seeking to introduce alternative protein products in the EU. The book confirms these
reports as the current EU regulatory framework presents several legal uncertainties that are
challenging for food business operators to overcome. Broadly speaking there are two
authorisation frameworks applicable to dairy products obtained through precision fermentation
in the EU. The choice between these frameworks depends on the presence of genetically modified
organisms (GMOs) or residues thereof in the final product. If such GMOs or residues are present
the pre-market authorisation procedure is governed by the Genetically Modified Food and Feed
Regulation (GMFR). If the final product does not contain any GMOs or residues it falls under
the scope of the Novel Food Regulation (NFR) and the pre-market authorisation procedure is
governed accordingly. Both of these authorisation pathways entail high regulatory requirements
which can pose challenges for the development of the precision fermentation sector. Despite the
difficulty in accurately classifying products it is crucial for food business operators to
comprehend the applicable legal framework early in the product development process given that
the authorisation paths differ in their standards. In addition to pre-market authorisation
requirements companies must address labelling issues. Food labelling shall provide a basis for
consumers to make informed choices in relation to the foods they consume. The primary objective
of EU food labelling law is to prevent consumer deception making it crucial for dairy
products and their animal-free alternatives to adhere to a stringent naming law as stipulated
in the Common Market Organisation and specific accompanying legislation. Moreover it is
imperative to consider regulations regarding the use of health and nutrition claims as well as
labels such as vegan or organic etc. Furthermore the labelling of novel foods and genetically
modified foods may necessitate mandatory information specified in the authorisation process.
The book serves as a comprehensive guideline for food business operators involved in the
production of precision-fermented dairy alternatives aiding them in navigating the intricate
European regulatory landscape.
