I. The current EU legal framework for feed additives

The placing on the EU market, labelling and use of feed additives is regulated by Regulation (EC) 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionFootnote ² (hereinafter, Feed Additives Regulation). According to Article 2(2)(a) of the Feed Additives Regulation, feed additives are “substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform one or more of the following functions: 1) favourably affect the characteristics of feed; 2) favourably affect the characteristics of animal products; 3) favourably affect the colour of ornamental fish and birds, 4) satisfy the nutritional needs of animals; 5) favourably affect the environmental consequences of animal production; 6) favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedstuffs; or 7) have a coccidiostatic or histomonostaric effect”.

The Feed Additives Regulation subordinates the placing on the EU market of feed additives to a centralised authorisation process dealt with by the Commission. For an authorisation to be granted, Article 5 of the Feed Additives Regulation requires that the manufacturer provide sufficient information to demonstrate that the feed additive intended to be placed on the EU market is effective and safe for animal health, human health and the environment, and that its presentation would not mislead users.

In accordance with the current rules, feed additives may be classified into the following categories: (1) technological additives (eg preservatives, antioxidants or silage additives); (2) sensory additives (eg flavourings or colourants); (3) nutritional additives (eg trace elements or vitamins); (4) zootechnical additives (eg digestibility enhancers or gut flora stabilisers); and (5) coccidiostats and histomonostats. According to the Feed Additives Regulation, an application requesting the authorisation for placing a feed additive on the EU market must be submitted to the Commission. The Commission forwards the request to the European Food Safety Authority (hereinafter, EFSA) with a formal request of providing an opinion on the safety and efficacy of the feed additive based on the information provided by the applicant. Within three months from the receipt of the EFSA opinion, the Commission presents a draft Regulation to the EU’s Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) to grant or deny authorisation. Article 9 of the Feed Additives Regulation establishes that authorisations for feed additives belonging to the categories of zootechnical additives, coccidiostats, histomonostats and feed additives consisting of, containing or produced from genetically modified organisms (GMOs) must include the name of the holder of the authorisation.

II. Possible areas of improvement

In the framework of the European Green Deal, the EU’s Farm-to-Fork StrategyFootnote ³ establishes the following important objective: “to reduce the environmental and climate footprint of the EU food system and strengthen its resilience, ensure food security in the face of climate change and biodiversity loss and lead a global transition towards competitive sustainability from farm to fork”. In that respect, feed additives can play a role in reducing antimicrobial resistance, improving animal welfare and mitigating the effects of climate change and environmental degradation.

The Commission intends to modernise the EU rules applying to feed additives and to adapt them to the goals of sustainable farming. There is unanimous agreement that a modern legal framework aimed at fostering innovation may support sustainability in several areas, such as in the reduction of greenhouse gas emissions resulting from farm operations and in reducing the loss of soil nutrients due to excessive rain and irrigation. Moreover, feed additives can play a role in limiting the eutrophication of water sources originating from the excessive presence of minerals and nutrients released into the soil as a consequence of farming practices.Footnote ⁴

The evaluation, published on 14 December 2020, although admitting that the core objectives of the Feed Additives Regulation remain valid and relevant, identifies several areas of possible improvement that might be addressed in order to increase the performance of the future feed additives authorisation process. The main problems identified relate to the insufficient support of innovation and the burdensome and lengthy authorisation process. The lengthy and costly authorisation procedure discourages the development of sustainable and innovative feed additives, such as those focused on animal well-being. This lack of innovation deprives farmers of important tools for the development of sustainable livestock production. Furthermore, the lack of flexibility in the authorisation process results in the limited availability of certain products that have been developed by the industry but experience difficult authorisation paths. At present, the Feed Additives Regulation categorises feed additives into five different categories according to their effects on animals and animal products. The process of creating new categories to respond to technological and scientific advancements is considered burdensome. A practical example is related to probiotics, which are innovative components considered useful in animal farming, for instance, as alternatives for increasing hygiene practices and limiting the use of antimicrobials. For those intended uses, the industry is currently exploring ways to place those products on the EU market in the category of zootechnical additives.

Additional shortcomings have been identified in the analysis of the criteria required to demonstrate the efficacy of new feed additives. Those criteria are considered too vague by the industry in certain aspects, and this complicates the preparation of the authorisation dossiers. This issue has partially been addressed by Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) 178/2003, (EC) 1831/2003, (EC) 2065/2003, (EC) 1935/2004, (EC) 1331/2008, (EC) 1107/2009, (EU) 2015/2283 and Directive 2001/18/ECFootnote ⁵ (hereinafter, Transparency Regulation). Article 1 of the Transparency Regulation, which will apply from 27 March 2021, establishes a procedure defined as “pre-submission advice”, where the EFSA’s staff, “at the request of a potential applicant or notifier, provide advice on the rules applicable to, and the content required for the application or notification, prior to its submission”.Footnote ⁶

According to the evaluation carried out by the Commission, an additional burden to innovation is created by the granting of generic authorisations (ie non-holder authorisations that allow any operator to place on the EU market a feed additive if it complies with the specifications of the authorisation). This mechanism puts the entire financial onus on the applicants, while other operators may manufacture and place the same substance on the market once the feed additive has been granted authorisation. The legal status of feed additives not being linked to an authorisation holder might be modified by granting several years of exclusive rights, similar to the EU’s approach to novel foods laid down in Article 26 of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001,Footnote ⁷ which establishes that, in case of inclusion in the application of newly developed scientific evidence or data, such information may not be used by other applicants for a period of five years.

III. The Commission’s consultation and feedback received

The Commission’s evaluation has been submitted to a public consultation, which closed on 25 January 2021.Footnote ⁸ The feedback provided by stakeholders appears to agree with the Commission on the enormous potential that a modernised legal framework in the sector of feed additives may trigger in reducing the environmental impact of the farming sector. According to the feedback provided by major manufacturers, there appears to be agreement that, in order to foster innovation and greater sustainability of the food chain, the new legal framework should tackle the lack of flexibility, namely by streamlining the mechanism of authorisation, by introducing new categories of feed additives and by providing more protection to proprietary data.

However, some stakeholders are advocating for a greater degree of ambition in the reduction of animal testing as part of the efficacy and toxicological studies required by the authorisation procedure. A transition from in vivo to in vitro methodologies has been suggested as an option for reducing unnecessary animal testing. Additional comments underlined that action should be taken to avoid shortages of feed additives for end users on the EU market. According to the industry, the dependence on the import of specific feed additives should be limited. With respect to the import of feed additives, some interested parties raised the issue that the EU should take into account the environmental standards of production in those third countries to which the manufacture is outsourced.

IV. Way forward

The proposal from the Commission for a draft revised regulation on feed additives is expected to be published during the fourth quarter of 2021.Footnote ⁹ After that, the draft will be evaluated at the inter-institutional level in the framework of the EU legislative process, and modifications are still expected to be taken on board at that time. Manufacturers of feed additives aiming at enhancing their position in the EU market are advised to closely monitor this legislative process and any proposed changes in order to adapt their application procedures, as well as their production and supply chains.