The SWEET project has been set up with an aim to examine the barriers and facilitators to the use of sweeteners and sweetness enhancers (S&SEs), defined as non-nutritive food additives - and the likely risks and benefits of using them to replace sugar in the diet in the context of health, obesity, safety & sustainability. In order to address this broad aim, one of its objectives is to examine S&SE regulation and risk governance and assess its impact on industry’s ability to innovate. The aim of this report is to describe the regulatory framework within the EU that provides the backdrop and legal framework for decisions relevant to the introduction of new S&SEs into the European market. The objectives of this stream of work are to: map the regulatory framework and decision-making process for new S&SEs introduction at both EU and member state level; explore the interaction between the S&SE legislation and innovation in the food supply chain and the role of the regulation as a facilitator or barrier to new S&SEs introduction; investigate existing industry led applications for new S&SEs and establish the types of information submitted to substantiate the applications in terms of potential toxicological, nutritional and allergenic risks.

A mixed-method approach was adopted, including desk research of key legal, policy, implementation and scientific opinion documents; semi-structured interviews with key informants and a case-study of an application for approval of mogroside V (luo han guo, Monk fruit extract) as a new food additive, which was rejected by the European Food Standards Agency (EFSA) in November 2019.

The results show a complex regulatory framework that establishes responsibilities of key institutions, including member states (via the EU Parliament and the Council), the European Food Standards Agency (EFSA) and the European Commission (EC). The legal framework has undergone amendments with a twin purpose to enable harmonisation of regulation in order to ensure more efficient delivery of new products to the market, but also to ensure that consumer safety and health are protected. Since 2008 the regulation has changed in order to streamline the approval process through a dedicated e-submission system, through a central role being granted to the EC for administration of the risk governance process and through a more open communication of the protocols for risk assessment. The interviews indicated that there are a number of barriers to innovation associated with the approval process: a) the strict application of the precautionary principle and the burden of proof requirement facing the industry; b) the lack of transparency about the types of data and evidence that will be necessary and permissible for assessment; c) the uncertainty in timeline linked to the EFSA evaluation of the dossier. In addition, there are a number of barriers associated with the specific provisions within the law (Regulation 1333/2008, including: a) the conditions of use, specifying no sugar or reduction in calories by 30%; b) the precautionary principle with respect to safety; c) the requirement for innovation to benefit the consumer and “other legitimate interests” that may be used even when the application is approved on safety grounds. The interviewees perceived the political and institutional context to introduce additional uncertainty in the decision-making process, through the role of member states as gate-keepers and the key actor to ensuring that a positive scientific opinion is adopted and implemented.