Legislation for foods for special medical purposes (FSMP) amended to also cover infant products


The European Commission Delegated Regulation (EU) 2016/128 concerning certain requirements for FSMPs became applicable on 22 February 2019. As of 22 February this year, the Regulation has also applied to FSMPs developed to satisfy the nutritional requirements of infants.

Since February 2019, the Finnish Food Authority has required notification of all FSMPs placed on the Finnish market. This notification procedure now also applies to FSMPs intended for infants and is therefore now applicable to all infant FSMPs placed on the market in Finland. Furthermore, from 2021, the Finnish Food Authority will require notification of infant formulas based on protein hydrolysates and follow-on formulas containing substances other than those listed in Annex II of 2016/127.

The Food & Nutrition Team at Medfiles has an extensive and strong experience in regulatory checks, guidance and package labels of FSMPs as well as in notifications to and correspondence with the applicable authorities. We are very happy to assist you in all FSMP-related questions!

If you want to learn more about our services, please contact:

Mari Lyyra
Regulatory Affairs Manager, Food & Nutrition

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