April 6, 2020

The Regulation (EU) 2020/354 revises and updates the list of intended uses of feed intended for particular nutritional purposes

On 4 March 2020, the Commission published the Regulation (EU) 2020/354 (“Reg. (EU) 2020/354”) establishing a list of intended uses of feed intended for particular nutritional purposes, repealing Directive 2008/38/EC (“Dir. 2008/38/EC”). The Regulation revises and updates both Part A and Part B of Annex I of the Dir. 2008/38/EC which established general conditions for the abovementioned feed and listed the intended uses respectively. It shall apply from 25 December 2020 and, once applicable, it will replace the relevant Italian legislation on the matter.

Generally speaking, the placing on the market and the use of feed is governed by Regulation (EC) 767/2009. Concerning the feed intended for particular nutritional purposes, Article 9 of that Regulation states that it may only be marketed if its intended use is included in a list of uses established in accordance with Article 10 of the said Regulation. Such list together with the general conditions have been set out in Dir. 2008/38/EC implemented by the Italian Government through the Decree of 1 August 2008 of the Minister for Labour, Health and Social Policies.

To the present day, these provisions have proven to be too vague and outdated, especially given the scientific and technological developments, thus the Commission felt the urge to reassess them. This review process has led to the adoption of the Reg. (EU) 2020/354 which notably aims to provide more accurate and up-to-date information on the essential nutritional characteristics and the labelling declarations. Indeed, the list in Part B of Annex I contained poor and overly general descriptions, in particular in the column “Essential nutritional characteristics”, which made very difficult for the control authorities to verify the compliance with the requirements.

Without prejudice to the new framework now described, the Reg. (EU) 2020/354 provides for transitional measures in order to avoid unnecessary disruption of commercial practices and to not create unnecessary administrative burden on the operators. Specifically, the feed intended for particular nutritional purposes may continue to be placed on the market if it complies with the provisions of Dir. 2008/38/EC, provided that an application for an intended use included therein has been submitted to the Commission in accordance with Article 10 of Regulation (EC) 767/2009 before 25 March 2021; in this case, the feed can be marketed until the Commission decides on the respective application. Furthermore, the feed may continue to be placed on the market and used until the existing stocks are exhausted if it has been labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020.

As last remarks, the choice to repeal the Dir. 2008/38/EC by means of a regulation – source of law ensuring a higher degree of harmonisation – shows a willingness to provide greater clarity and rationalisation to the matter. Moreover, Reg. (EU) 2020/354 has been marked as EEA relevant by the EU, therefore it is currently under scrutiny for incorporation into the EEA Agreement.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
March 21, 2022
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
Search by...
Search
Follow us on
Follow us on