EUR-Lex Access to European Union law

Back to EUR-Lex homepage

This document is an excerpt from the EUR-Lex website

Document Ares(2020)7546840

Revision of the Regulation EC 1831/2003 on additives for use in animal nutrition

COMBINED EVALUATION ROADMAP/INCEPTION IMPACT ASSESSMENT

This combined evaluation roadmap/Inception Impact Assessment aims to inform citizens and stakeholders about the Commission's work in order to allow them to provide feedback on the intended initiative and to participate effectively in future consultation activities. Citizens and stakeholders are, in particular, invited to provide views on the Commission's understanding of the current situation, problem and possible solutions and to make available any relevant information that they may have, including on possible impacts of the different options.

Title of the initiative

Revision of the Feed Additives Regulation (EC) No 1831/2003

Lead DG – responsible unit – AP Number

DG SANTE, Unit E5

Likely Type of initiative

Legislative proposal

Indicative Planning

Q4 2021

Additional Information

https://ec.europa.eu/food/safety/animal-feed/feed-additives_en

This combined roadmap/Inception Impact Assessment is provided for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described by this document, including its timing, are subject to change.

A. CONTEXT, EVALUATION, PROBLEM DEFINITION AND SUBSIDIARITY CHECK

Context

Feed additives are products such as vitamins, anti-oxidants, microorganisms, amino acids, enzymes, used in animal nutrition to keep animals in good health, to improve their productivity and welfare and to reduce environmental impacts of animal farming. Feed additives can exert positive effects on animal welfare, for instance, by reducing the stress of farming animals transitioning to a different production stage (lactating pigs to fattening pigs) and on the animals’ health and well-being by stabilising their intestinal flora and reducing the need for medicinal treatments such as with antimicrobials. This in turn helps reducing the use of antimicrobials thus decreasing antimicrobial resistance and manure contamination.

Before they can be placed on the EU market, feed additives must undergo a safety and efficacy assessment by the European Food Safety Authority (EFSA), through a centralised procedure aiming to protect animals, humans and the environment from potential harmful effects and to ensure that EU farmers and animal keepers can avail of safe, nutritious and high quality feed products. These are the core objectives of the Feed Additives Regulation and remain valid and relevant.

The Farm to Fork Strategy outlines the EU goals as: “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”. The Strategy also highlights the necessity to reduce the use of antimicrobials, to improve animal welfare and to mitigate the effects of climate change and environmental degradation while ensuring an EU wide transition to sustainable food systems.

The aim is to modernise the legislation without compromising health and food safety and improve its effectiveness and efficiency. The rules need to be adapted to the goals of sustainable farming and to raise awareness of the positive effects for the environment and animal welfare. Feed additives can make a contribution to the Strategy’s sustainable goals. They can for instance contribute to the reduction of the animals’ methane and ammonia emissions by modifying the physico-chemical characteristics of manure 1 , or reduce phosphorous excretion and thus the risk of this substance leaching in excess into soil 2 and of waters’ eutrophication 3 ). Feed production is an important contributor to the environmental footprint of animal products, one of the most important factors contributing to increase the environmental footprint in feed is the dependency on imports (feed materials such as maize or soya). Some feed additives can improve the absorption and assimilation of nutrients contained in feed, thus reducing the quantities of feed required to cover the animals’ nutritional needs.

The present initiative aims to amend the existing legislation so that it can better support the ongoing transition towards more sustainable livestock farming, and is complementary to the Farm to Fork agenda (on Animal welfare – evaluation of EU rules (fitness check) and the EU farm policy (evaluation of its impact on habitats, landscapes and biodiversity; impact on sustainable management of the soil; evaluation of its impact on water). The initiative is proposed for inclusion in the 2021 Commission Work Programme in annex II (REFIT) under a European Green Deal.

Evaluation

The initial objectives of the Feed Additives Regulation were to: address the rise of antimicrobial resistance; simplify the rules governing the authorisation of feed additives; better protect humans, animals and the environment from unsafe feed additives; foster innovation in livestock farming, by uptake of scientific and technological progress, and protect consumers’ interests.

An evaluation of the Feed Additives Regulation 4 is ongoing covering all EU Member States during the period from the entry into force of the Regulation in 2004 until now. The evaluation examines the performance and impacts of the Regulation as a whole, including an assessment of the following aspects: definitions of the Regulation; relevance and legal clarity of its provisions; criteria and procedures to authorise feed additives and amend existing authorisations; adaptation to technical and scientific progress; confidentiality and data protection procedures; and costs and benefits, including assessment of the administrative burden and labelling of feed additives.

The evaluation is being conducted according to the Better Regulation guidelines and covers effectiveness, efficiency, relevance including the fight against antimicrobial resistance, the animal welfare goals and sustainable livestock production and environmental protection. The evaluation examines the coherence of the Feed Additives Regulation internally and in relation to other legislation on feed/food, food chemicals, pesticides, biocides, veterinary medicinal products as well as its EU added value. All implementing acts related to feed additives authorisations, to guidelines for applicants or to technical or administrative aspects are also part of the evaluation. 

Problems the initiative aims to tackle

The preliminary results of the evaluation suggest that, though the Regulation has worked well in general, there are potential areas for improvement, in particular:

Current needs of sustainable animal farming are not sufficiently addressed: The development of innovative feed additives and additives intended to improve sustainability of farming is not sufficiently promoted. Efficacy criteria to demonstrate the positive effects of feed additives focus only on improving animal performance (e.g. increase egg or meat production) and not on their positive impacts on animal well-being (e.g. stress reduction) and the environment (e.g. reduction of nitrogen excretion on the soil). There are no criteria in the different categories to assess other sustainability effects of feed additives such as better use of resources. This, in combination with lengthy and costly authorisation procedures, discourages the development of sustainable and innovative feed additives and deprives feed manufacturers and farmers of valuable tools to develop a more sustainable animal husbandry. Another problem identified is that the higher costs for feed additives authorisation/production in the EU have contributed to move the production capacity of industries to third countries with less focus on emissions (carbon leakage) and lower environmental standards. This reduces the sustainability in feed production and in consequence also in the animal farming sector.

Limited availability of certain feed additives due to the lack of flexibility in the Regulation to promote technical and scientific innovation:

·Additives are allocated in different categories according to the actions they perform (e.g. nutritional, sensory, or technological). The authorisation process is not flexible enough to adapt to new technical and scientific developments and to ensure that criteria for authorisation match with the desired actions related to the efficacy of feed additives. The process for creating a new category of additives should be streamlined to reduce the time necessary for placing on the market innovative and sustainable feed additives. 

·The procedure for authorising innovative additives entails an assessment of efficacy that is very demanding in studies (in a range of 1-6 efficacy studies) and costly (32% of the total authorisation costs).

·The guidance requirements to demonstrate efficacy in new additives sometimes are unclear for certain aspects and do not always allow the preparation of solid dossiers (this issue has been recently addressed by the latest modification of the General Food Law (GFL), which provides for pre-advice meetings with the applicants). 

·Operators may not make claims in the labelling beyond the effects assessed by EFSA. Feed business operators perceive this as a barrier against raising awareness on the latest scientific innovation. The absence of data sharing between applicants, due to unclear rules, increases the number of tests on vertebrates.

·Some enterprises also perceive negatively the granting of non-holder authorisations (authorisations that allow any person to place the feed additive on the market if the additive complies with the specifications of the authorisation). This puts the entire financial burden of the authorisation on the applicants, while other operators can place the same additives on the market without costs (once the additive is authorised). This issue has discouraged some applicants from investing in non-holder authorisation additives and has reduced the availability of essential additives on the market (e.g. vitamins).

·Applicants and compound feed manufacturers also consider that the 10 years duration of authorisations is too short.

A lengthy authorisation process: the period for granting an authorisation is rather long (average 2.5 years per application) and some shortcomings have been identified: too many tests are required on target animals with high costs for the applicant that are not always justified on safety grounds; testing alternatives have not been sufficiently explored; extrapolation from major to minor species could be improved; efficacy tests could be skipped for certain additives already authorised in food; and missing or incomplete information in the dossiers, due to a lack of understanding of the guidance. This triggers the stop of the clock by EFSA in order to request complementary information, which also lengthens the authorisation time. These problems affect directly the Commission, EFSA and applicants, and indirectly farmers and manufacturers of feed additives/compound feed. Last but not least, the high costs of authorisation reduce the capacity of enterprises, in particular SMEs to develop innovative additives.

Unnecessary administrative burden: the authorisation of some additives is linked to an authorisation holder who has the exclusive right to place the additive on the market. Those rights are often transferred to other companies during business mergers or acquisitions. A Commission Regulation must be adopted every time a change of an authorisation holder occurs. The administrative burden is disproportionate for a change that could be solved by a simplified administrative procedure.

Reduction of the capacity of Member States to control imports in an efficient manner leading to unfair competition between EU operators and non-EU operators: feed additives do not have an identification code and are often imported as chemical substances intended for different purposes. The lack of a precise identification at declaration time does not allow quantifying/identifying accurately the amount of feed additives/premixtures in international trade.

Dependency on imports from third countries for some additives (e.g. vitamins): due to the costs of production/authorisation), production sites were moved outside the EU to third countries with less focus on emissions (carbon leakage) and lower environmental standards.

Restrictions on the circulation of feed additives only intended for export. This concerns feed additives and premixtures for which an authorisation in the EU has not been requested/granted but which are manufactured within the EU. These feed additives can only be exported if they are considered safe and under the condition that the importing country expressly agrees to the export (Article 12 of the GFL). This issue should be addressed to fulfil the GFL safety requirements while avoiding unnecessary restrictions to the circulation of those feed additives/premixtures within the EU or at MS level for commercial purposes. Labelling rules for these products are also necessary. 

Insufficient legal clarity and consistency for a few aspects of the Regulation: some definitions or provisions of the Regulation need to be revised to provide greater clarity. For example, whether the use of certain additives in drinking water can be justified since, for certain functional groups, this use is currently not allowed. This needs to be better clarified in view of a possible extension of the use of feed additives in drinking water to other functional groups of additives. The use of certain feed additives in drinking water could have positive effects on animal welfare, as this administration route is more efficient. The delineation between the uses of drinking water as an administration route vs. the exertion of an action of the substances added on the drinking water itself can be better defined. This is important to reduce inconsistencies in relation to the use of biocidal products in drinking water for animals under the Biocidal Products Regulation. In addition, some technical aspects in the practical implementation of the use of additives in drinking water (e.g. simultaneous use in water and feed) can be further detailed. A definition of preparations would facilitate their proper classification and improve their control by the competent authorities. The environmental assessment for farmed non-food producing animals needs to be better clarified in the Regulation.

The establishment of tolerances for feed additives in premixtures will allow aligning with the existing tolerances of feed additives incorporated in compound feed. The labelling rules for worker safety provisions in premixtures are complex as the CLP legislation and feed additives legislation apply simultaneously. This triggers some contradictory directions that may reduce the effectiveness of the messages conveyed through the labelling. This complexity can be minimised by the sole implementation of the CLP legislation in premixtures exclusively for worker safety provisions. For other labelling matters such as labelling provisions on the environment, CLP and feed additives Regulations will continue to apply simultaneously in premixtures. Such clarification will facilitate smooth circulation of feed additives within the EU, better implementation of worker/user safety provisions and will ensure a level playing field. The Register of Feed Additives can be adapted to provide more information to operators in a user-friendly manner.

The information required in accordance with the labelling provisions of the Feed Additives Regulation is too extensive to be included in a physical label attached to the product and creates undue burden for manufacturers. Operators need to have to reprint new labels each time a change occurs. This restriction reduces the use of digital tools, it is disproportionate, not justified for safety reasons and it is not aligned with the requirements in the Feed Marketing Regulation, which makes a distinction between a feed ‘label’ (the document attached to each pack) from ‘labelling’ (general documentation using any medium). The most relevant information will be kept in the physical label and the rest transmitted through other means. This limitation has an impact on manufacturers of feed additives/premixtures and compound feed. The initiative will contribute to a greater use of information and communication technologies amongst operators when passing the information on additives/premixtures.

As the evaluation is ongoing, these preliminary findings will be further examined and additional weaknesses may be identified as the work progresses. The root causes and drivers for the problems identified will be analysed in more detail and complemented, as necessary. Based on this analysis the problem definition will be refined and the possible policy options further developed.

Basis for EU intervention (legal basis and subsidiarity check )

The legal basis for this action are Article 43 and Article 168(4) (b) of the TFEU. According to the TFEU, a high level of protection of human health shall be ensured. This action is justified primarily to protect human health but also animal health and the environment, and to contribute to the well-functioning of the Single Market.

The high level of protection of human health, animal health and the environment can be better achieved through EU action. Feed additives are part of an integrated EU approach covering the whole food chain. The centralised science-based approach and systematic implementation of risk analysis at EU level provide for a high standard of safety proven already by the high level of compliance of samples and analyses (median: 96-98%, for both) in the official controls carried out during the period 2004-2017. Similarly, there is an added value in having harmonised labelling rules, which ensures a high and uniform level of protection of the interests of the different stakeholders along the food chain and the smooth circulation of feed additives within EU.

A non-EU intervention will reduce the capacity of innovation in feed additives, with negative impact on the sustainability of the livestock farming as well as the environment, and will also undermine the level playing field for European operators.

B. OBJECTIVES AND POLICY OPTIONS

In line with the European Green Deal, and the Farm to Fork Strategy, this initiative aims to facilitate the marketing of sustainable and innovative feed additives and a more sustainable livestock production, avoid carbon leakage through imports while keeping a high level of protection of animal, human health and the environment. It aims to streamline the corresponding authorisation process, including its information requirements and evaluation criteria, by updating the current EU rules. In doing so, it will improve the environmental and climate performance of the livestock sector (as set out in the Farm to Fork strategy) and it will encourage a better functioning of the Single Market. Other objectives are the reduction of unnecessary burden, the improvement of information along the food chain and the prevention of shortage of certain feed additives.

-The impact assessment will analyse against the baseline, the policy options described below, which may be complemented or fine-tuned on the basis of the findings of the ongoing evaluation.

Baseline

The baseline for the assessment of the different options will be the current legislative framework.

Different actions are described below with the range of policy options envisaged for each of them:

Sustainable farming and scientific innovation. The envisaged options range from maintaining the current approach, where additives will continue to be framed within a well-established predetermined and detailed system of categories and functional groups but permitting categories/functional groups with benefits for the environment, animal welfare or sustainability (eliminating the obligation to demonstrate a zootechnical effect), to a more flexible approach eliminating the classification of additives in categories and functional groups, so applicants may ask for any intended use compatible with the definition of additives, including uses to protect the environment, animal welfare and sustainability. This second option would incite operators towards more innovation and flexibility in developing new actions to satisfy newly needs in animal nutrition but would represent a substantial change in the current system.

Extension of the authorisation period. A possible extension of the authorisation’s duration will keep a high level of protection of human health, animal health and the environment. The options will range from an extension based on the risk profile of the additive (additives with low risk will benefit from such extension) to an extension “rewarding” the positive effects on sustainability of the additive.

Additives not linked to an authorisation holder. The legal status of authorisations for additives not linked to an authorisation holder will be modified by granting exclusive rights to the applicant for the placing on the market of additives for a defined period. The options will range from granting several years of exclusivity (e.g. 3-5 years), and after that, the authorisation will become generic (similar to the Novel Food Regulation approach) to promoting a cost sharing system (e.g. by consortia) that will allow applicants to share the costs of the application/s. The possibility to have exclusive rights for a defined number of years (e.g. 3-5 years) for the consortium members will be also considered.

Claims. The options will range from a claim system based primarily on the responsibility of the operator to a more regulated claim approach supported by implementing rules adopted by the Commission. In the first option operators will have the possibility to substantiate claims they intend to make and Member States will be responsible for verifying the use of such claims (approach followed in the Feed Marketing Regulation),

Circulation of feed additives only intended for export. Additives/premixtures not authorised in the EU, which do not pose a safety risk, will be allowed to circulate. The options range from the possibility to circulate within the exporting Member State (e.g. manufacturing and export happens in the same Member State) to the possibility to circulate at EU level.

Independently from the options chosen on the above, the following actions will also be considered:

Sustainable farming, scientific innovation and authorisation process: new guidance to improve the extrapolation from food to feed will be introduced; the extrapolation from major to minor species and new testing strategies (to reduce animal testing) will be explored to improve the authorisation process and to reduce uncertainties in the assessment of innovative additives. The obligation of sharing data to prevent the duplication of tests on vertebrates will be established and implementing rules will be set out to facilitate the implementation of this obligation.

Unnecessary burden: The labelling will keep the essential information on the physical label and the rest of the information will be available by other means (e.g. electronic means), similar to the approach in the Feed Marketing Regulation; The change of the authorisation holder will not require the adoption of an implementing Regulation; this will be made by a simple administrative procedure.

Legal clarity and consistency: A definition of preparations will facilitate their proper classification and improve their control by the competent authorities. The delineation between the use of drinking water as an administration route for certain additives vs. the exertion of an action of the substances added on the drinking water itself will be clarified, in order to avoid inconsistencies in relation to the use of  biocidal products in drinking water under the Biocidal Products Regulation. Worker safety requirements of the Feed Additives Regulation will not apply to premixtures, so only the CLP Regulation (containing classification and labelling provisions for hazardous substances and mixtures to be applied in conjunction with worker protection legislation) will remain applicable reducing the inconsistencies and contradictory directions of the simultaneous implementation of the two Regulations. Tolerances for additives incorporated in premixtures will be established by implementing rules. The Register of Feed Additives will be adapted to be more informative and user friendly.

Use of feed additives in drinking water: consideration of the extension of the use of additives in drinking water to other functional groups and clarification of its use by implementing rules/ Codes of Good Practice (soft law).

Identification of feed additives/premixtures in international trade: a precise identification at declaration time will be established to identify feed additives and premixtures, improve the control by the MSs and quantify the magnitude of international trade.

Feed additives only intended for export: specific labelling provisions to identify those products will be set up.

Environmental assessment of feed additives for farmed non-food producing animals: clarify better in the Regulation that those animals are covered by the environmental assessment.

Carbon leakage: all the actions mentioned above intended to improve the authorisation process, reduce the costs of applications (by reducing tests), reduce undue burden for applicants and promote innovation will contribute to reduce carbon leakage through imports.

C. PRELIMINARY ASSESSMENT OF EXPECTED IMPACTS

Likely economic impacts

The above-mentioned elements are expected to have a positive macro-economic impact for feed additives producers such as an increase of growth, investment in new additives, innovation, research and exports of new and innovative feed additives. Farmers and feed compounders can also benefit from more efficient, innovative and sustainable feed additives that would positively influence their income. Feed additives may contribute to increase production efficiency while keeping a more sustainable livestock production in line with the Farm to Fork Strategy.

The micro economic impact on SMEs related to the possible modification of the non-holder authorisations should be fully assessed to prevent any significant negative effect on SMEs.

More flexibility in the definition and functions of feed additives and the adaptation/simplification of efficacy requirements could boost the innovation potential including that of European SMEs.

The possible establishment of claims may demand additional resources for the EU national authorities in enforcing this requirement.

The modernisation of the Register of feed additives will entail costs for the Commission to design and implement an appropriate IT tool but it will contribute to increase transparency for operators and citizens. This will not have a significant economic impact compared with the benefits expected.

Likely social and health impact

The activation of the feed additives sector by enhancing innovation and improving the authorisation process may stimulate the production of feed additives that may lead to positive effects on employment (i.e. increase of the number of jobs). The increased use of sustainable additives will contribute to meet consumers’ expectations for sustainably sourced food.

The initiative may have positive impacts on animal health (see context in Background section).

The extension of the authorisation period for feed additives will not undermine the current level of safety.

Likely environmental/animal welfare impacts

The initiative will contribute to mitigate climate change by reducing greenhouse emissions produced by farm animals. Other expected impacts are: fostering the efficient use of resources, best management and reduction of waste (manure), reduction of pollution in land soils and water and avoid carbon leakage (imports). The possibility to use associated claims related to the environmental effects of some additives may raise awareness, amongst feed manufacturers and farmers/breeders about the beneficial effects of some additives/technologies on the environment and on their contribution to reduce the environmental impact of livestock production.

Likely impacts on fundamental rights

This initiative has limited impact on fundamental rights. The contribution to the ‘fair and just working conditions (article 31 of ’Charter of Fundamental Rights Of The European Union)’ may be positive for workers manufacturing premixtures of feed additives. Preventing duplication of the worker safety provisions will have a positive impact in worker safety as it improves the efficiency of the labelling intended to protect workers.

Likely impacts on simplification and/or administrative burden

Some of the actions with a positive impact on reducing administrative burden have been identified:

- Use of other means (IT tools) for transmission of information will benefit all stakeholders.

- Extension of the authorisation period.

- Streamline the regulatory procedures, including the change of the authorisation holder.

- Clarification of the applicable labelling rules will increase legal certainty.

D. EVIDENCE BASE, DATA COLLECTION AND BETTER REGULATION INSTRUMENTS

Impact assessment

The IA will build on and complement the preliminary results of the evaluation in assessing the socio-economic, environmental and regulatory impacts under each policy option. An external study will support the IA.

During the ongoing evaluation, some issues (the possible modification of non-holder authorisations) demanding deep assessment were identified. For those, possible options should be carefully considered, as they may have impacts on SMEs. The analysis of impacts will involve different stakeholders groups (applicants, producers of feed additives, producers of compound feed, farmers, competent authorities, traders, EU citizens, etc.). The IA will make best use of the Better Regulation Tools.

Evidence base and data collection

The Commission has collected information by an Online Public Consultation (OPC) and a survey targeting 8 non–EU National Competent Authorities (NCAs). The external study supporting the evaluation has been finalised and will be published at the time of the IA report. The information collected, consultations organised and all the evidence were analysed and presented in the conclusions of the study. The contractor carried out an extensive consultation by two specific surveys addressed to stakeholders and to the NCAs of the EU MSs.

Furthermore relevant evidence will be collected from several sources including the following:

-Internal database and publicly available information on feed additives in DG SANTE and EFSA

-Report from the Commission to the Council and the European Parliament on the use of coccidiostats and histomonostats as feed additives. (COM/2008/0233 final)

-Register of feed additives

-Open public consultation

-Audits and fact-finding reports carried out in the feed additives sector by DG SANTE

-Target consultation to 8 NCAs from non EU countries carried out by DG SANTE

-Rapid Alert System on Food and Feed database.

-Joint Research Centre-EU Reference Laboratory on Feed Additives

-European Patent Office and EUROSTAT

-World Trade Organisation

The above list is not exhaustive and additional resources will be sought in the course of the analysis. One of the major limitations is the lack of data of the EU feed additives market (turnover, added value, employment, trade) from official statistical sources (EUROSTAT), as there is no specific industrial or trade classification for this sector. This lack of data will require additional primary and secondary data collection. 

Consultation strategy

The Commission has already consulted stakeholders concerning the evaluation (Public Consultation and two targeted consultations, one to NCAs of MSs and the other to the rest of stakeholders) and will further engage relevant public and targeted consultations. This will include NGOs, professional associations, consumer associations, EU citizens, NCAs and Academia. This consultation aims at collecting evidence about practical experience in the implementation of the FA Regulation, data about costs and information about societal/economic/environmental impact, and potential benefits as well as the possible policy intervention options to be identified.

The consultation process will include:

-12 week Online Public Consultation by January 2021 published on the Commission’s ‘Have your say’ webpage’. The survey and replies will be available in all EU official languages.

-A set of targeted consultations with national competent authorities and stakeholders, including surveys and interviews that will be conducted in the context of an external study performed by a consultant (around June 2021)

-A Seminar/workshop with national authorities and stakeholders is envisaged during the impact assessment.

A synopsis report (a summary of all consultation activities' results) will be published once the consultation activities are closed.

Will an implementation plan be established?

An implementation plan is not envisaged, as there are no deliverables or implementation challenges identified.

(1)      Agriculture is responsible for 10.3% of the EU’s GHG emissions and nearly 70% of those come from the animal sector
(2)      Leaching is the loss of water-soluble plant nutrients from the soil due to rain and irrigation
(3)      Eutrophication means that a body of water (sea, river, lake) becomes overly enriched with minerals and nutrients, which induces excessive growth of algae.
(4)  Roadmap of the feed additives Regulation (https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1483-Evaluation-of-the-feed-additives-Regulation )
Top