With the aim to improve the enforcement of the regulatory framework and finally to protect the consumer, the Food for Specific Groups regulation (EU) No 609/2013 abolished the previous PARNUT concept in 2016. Later, the Commission Delegated Regulation (EU) 2016/128 was published with updates for the specific requirements for the labelling and composition of Food for Special Medical Purposes (FSMP) including a list of substances allowed for this product category. Basically, the definition of FSMP has not changed significantly, with some exceptions such as the fact that the use of nutrition and health claims in FSMPs is explicitly not allowed. Also new: Article 3 of the FSG Regulation empowers the EU Commission – in case of uncertainty – whether a product falls under the FSMP regulation or not. The Commission may address scientific questions regarding the classification of FSMPs to EFSA. EFSA, in turn, published a technical and scientific guidance document guiding applicants when providing relevant information to help EFSA in the scientific assessment of FSMPs. What is important, the Commission’s power under Article 3 is not intended to replace the presently applicable regime. This means that, in the future, national authorities will also have the general responsibility of enforcing the FSG regulation and verifying whether a product placed on the market as FSMP really falls within the scope of the applicable legislation. With the publication of the EU “Commission Notice on the Classification of FSMP” at the end of last year, the Commission provided another piece to the puzzle of how to implement the FSG regulation, this time intended to support food business operators in providing the relevant data to prove the compliance with the provisions applicable to FSMPs.
As the regulation is not definitive in all points and leaves some room for interpretation, it may be possible that some Member States’ competent authorities will continue to have divergent approaches to the classification of the same product as FSMP.
As the EU Court of Justice is the final authority when interpreting EU law and making binding decisions, it remains to be seen what the practical implementation of the FSG/FSMP regulation will actually look like.