Ares(2017)4196253

EVALUATION ROADMAP
title of the evaluation/fc	Evaluation of the feed additives Regulation
lead dg – responsible unit	SANTE –E5	date of this roadmap	2017
type of evaluation	Evaluation EX-POST MIXED	planned start date planned completion date	09 / 2017 09 / 2018
		Planning calendar	http://ec.europa.eu/
This indicative roadmap is provided for information purposes only and is subject to change.

A. Purpose
(A.1) Purpose
The purpose of this exercise is to evaluate how the feed additives legislation (Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition) 1 has performed in delivering its objectives and to what extent it is still relevant. The overall effectiveness, efficiency, relevance, coherence, and EU added value of this regulation will be evaluated in order to be able to identify possible regulatory burdens, overlaps, inconsistencies, obsolete measures and gaps in the legislative framework. The evaluation should help the Commission to have a better understanding of where, and why, the current EU legislation has worked well or not so well, identifying factors which have helped or hampered achievement of the objectives. It will also analyse whether the legislation is still adapted to the needs of society and in line with other Commission priorities such as fostering jobs and growth.
(A.2) Justification
The Feed Additives Regulation has not undergone an evaluation since its entry into force in October 2003. In the light of the 13 years since its entry into force and the finalisation of several hundred authorisations of feed additives and considering the context of the Commission's better regulation policy, an evaluation of the Regulation appears timely and appropriate. Amongst others, the evaluation will look at difficulties which have been identified during its implementation, from experience gained from discussions with the Member States, meetings with the applicants, consultants and from EFSA output. Some such difficulties concern – for example - the operation of certain elements of the authorisation process and exceedingly complex procedures, which impact competent authorities of the Member States, businesses and the Commission.

B. Content and subject of the evaluation
(B.1) Subject area
Feed additives are products used in animal nutrition to improve the quality of feed and the quality of food of animal origin, or to improve the animals’ performance and health. Feed additives may not be put on the market unless authorisation has been given following a scientific evaluation demonstrating that the additive has no harmful effects on human and animal health and on the environment (safety), and unless it is established that they have specific effects determined by the legislator (efficacy). It is for the applicant requesting an authorisation to demonstrate by scientific studies both the safety and the efficacy of the product. The feed additives Regulation is part of a wider legal framework governing food and feed safety such as the General Food Law 2 and legislation on feed hygiene, marketing of feed, residues in feed 3 and legislation on genetically modified food and feed 4 . The feed additives Regulation was adopted in 2003 as part of the actions contained in the White Paper on Food Safety, which aimed to ensure the highest standards of food safety in the EU. With a view to bringing coherence to the EU legislation in a "farm to table" approach, the White Paper announced new rules on additives in feedingstuffs, aimed at clarifying and simplifying pre-existing legislation 5 . The Directive's provisions had proved to be rather complex (lengthy authorisation procedure, different types of authorisation - provisional, 10-year validity, with no time limit, linked to the applicant company or not - and subject to uneven implementation as in certain cases Member States could derogate from the common provisions; different interpretations across Member States and sub-optimal enforcement of certain decisions adopted at EU level were a direct consequence of that complexity. Furthermore, antibiotics were still authorised as feed additives under the Directive. Regulation 1831/2003 aimed at simplifying significantly the rules on feed additives, in particular as regards the authorisation process. Authorisations are for specific animal species and with maximum dosage allowance and, for new feed additives, are limited to a ten-year period. Applicants have to demonstrate the absence of any risk for human health, animal health and the environment (safety criteria) and the additive's positive effect for the animal (efficacy criteria). The European Food Safety Authority (EFSA) is assessing the application with respect to set criteria and issues its opinion. Within three months of receipt of a favourable EFSA opinion, the Commission proposes a draft Commission Regulation authorising the additive for a ten year period. All authorisations are renewable for ten year periods upon application at least one year before the expiry date. Authorisations in certain categories are linked to an authorisation holder who is responsible for the placing on the market and the implementation of the post monitoring plan. The Regulation also phased out in 2006 antibiotics authorised as feed additives and used as growth promoters. The feed additives Regulation was adopted at a time when the focus was oriented towards increase of animal production and performance of production. The current needs of the society have evolved and the focus changed towards sustainable production. In addition problems such as antimicrobial resistance become more prominent to which novel solutions need to be found which may not necessarily fit within the current quite prescriptive system of feed additive authorisation. In 2003 the feed additives Regulation introduced rules for feed business operators for placing feed additives on the market. The Commission should establish implementing rules for the preparation and presentation of applications for authorisation of feed additives, through comitology and after consultation with EFSA. These implementing rules established in Regulation (EC) No 429/2008, cover general provisions including definitions, general principles; a general description of the studies to be provided with an applications for authorisation of feed additives, and specific requirements for specific situations and categories of feed additives. These rules are currently being amended. Since the entry into force of the Regulation in 2004 until now, hundreds of feed additives have reached the 10 years authorisation limit and were submitted for re-authorisation. We have gained experience through this re-authorisation process and have identified several problems that could be looked into during the evaluation.
(B.2) Original objectives of the intervention
The general objectives of the Regulation, which reflect the principles of the General Food Law, are: 1. High level of protection of human health 2. High level of protection of animal health and welfare 3. High level of protection of the environment 4. Ensure the effective functioning of the internal market
(B.3) How the objectives were to be achieved
The details on how the objectives were to be attained are described in this section: 1. To ensure a high level of protection of human health: A. Protection of citizens' health by: -banning the use of antibiotics as feed additives, thus contributing to fight against antimicrobial resistance; -linking certain types of feed additives to an authorisation holder to increase control and traceability; -by ensuring adequate supervision and monitoring of feed additives and traceability through a system of authorisation holders; -by ensuring enforcement and control at Member State level. B. Protection of consumers' health and interests in relation to feed additives: -by setting safety and efficacy criteria for feed additives to ensure the consumers are not mislead with regard to the quality of the food. C. Protection of workers and users health: -by ensuring adequate labelling of feed additives and safe handling of feed containing feed additives through the establishment of a safety assessment for each feed additive authorised. 2. To ensure a high level of animal health and welfare: -by ensuring that only safe and efficacious feed additives are placed on the market; -by meeting the nutritional and physiological needs of the animals; -by ensuring that feed is safe and attractive to animals; -by improving digestion; -by re-authorising feed additives every 10 years. 3. Protection of the environment: -by assessing potential harmful effects of feed additives on the environment; -applicants have to prove the lack of toxicity of the feed additives on the environment; -by authorising feed additives which lower the impact of animal production on the environment. 4. Ensuring the effective functioning of the internal market: A. Increase of productivity: -by using the appropriate categories of feed additives which increase animal production, stimulate or improve digestion, etc.; -by meeting the physiological needs of the animals; -by reducing the costs of production; -by setting common rules for pets and thus developing a growing market; -by establishing the public and free EU Register of Feed Additives; -by establishing EU guidelines to help applicants build the scientific dossier. B. Ensure good functioning of the internal market for feed additives producers: -by harmonising the authorisation procedure; -by ensuring predictability of authorisations and of categories and functional groups to which the feed additive belong; -by ensuring timely authorisations; -by setting labelling rules which apply throughout the EU

C. Scope of the evaluation/FC
(C.1) Topics covered
The evaluation will focus on the provisions of Regulation 1831/2003 (and on tertiary legislation adopted by the Commission to implement it) and will aim to ascertain whether the intended objectives of the legislation as outlined above have been achieved. It will evaluate to what extent the legislation create a legal framework that is effective, efficient, relevant, coherent and brings EU added value and will focus in particular on the following aspects put in place: Definitions; EU procedure for the authorisation of feed additives: the conditions for authorisation of feed additives, EFSA evaluation of safety and efficacy of feed additives, EFSA opinion, the categories of feed additives, the procedure to apply for an authorisation, the authorisation by the Commission. The conditions for modification, suspension and revocation of authorisations. Renewal of authorisations, time limited authorisations. The conditions for supervision of feed additives. Labelling rules Rules on confidentiality of data, data protection and data sharing. Rules for administrative review. The evaluation will look at the interactions with other relevant pieces of EU legislation in food and feed area. It will cover the relevance of the legislation in the context of fight against antimicrobial resistance and against objectives such as animal welfare, sustainable livestock production and protection of the environment. The costs linked to the implementation of the Regulation will be analysed and compared with the benefits achieved. The Impact of the legislation on SME's, growth and jobs will be assessed as well as the enforcement of the legislation by the Member States.
(C.3) Other tasks


D. Evidence base
(D.1) Evidence from monitoring
EU Register of feed additives : Register of feed additives authorised for use in the EU under the provisions of Regulation (EC) No 1831/2003 on additives for use in animal nutrition. RASFF (Rapid Alert System for Food and Feed): Notifications of any serious health risks deriving from feed additives (by selecting relevant hazard category) and any measures taken. Health and Food Audit Reports : DG SANTE audits, inspections and related non-audit activities aimed at ensuring that EU legislation on food and feed safety is properly implemented and enforced. EFSA Chemical Contaminants Occurence data : Aggregated statistics on the analysis of data collected from the Member States as regards chemical contaminants found in food or feed due to food production, distribution, packaging or consumption. FEEDAP opinion : EFSA Panel on Additives and Products or Substances used in Animal Feed.
(D.2) Previous evaluations and other reports
Report from the Commission to the Council and the European Parliament on the use of coccidiostats and histomonostats as feed additives . The Regulation has never been evaluated before. However, relevant information can be found in: (1) on-going Fitness check evaluation of the General Food Law : (2) regular EFSA evaluations
(D.3) Evidence from assessing the implementation and application of legislation (complaints, infringement procedures)
Positive as well as negative feedback from the risk assessment and management of hundreds of feed additives have already been collected during the 13 years of implementation of the Regulation. Main problems highlighted are: the criteria to determine the efficacy of the feed additives, the conditions to modify existing authorisations, labelling rules and confidentiality of the authorisation files.
(D.4) Consultation
The consultation of stakeholders will seek their opinion on the main evaluation criteria (relevance, efficiency, effectiveness, coherence and EU added-value). It will also look for identification of any unexpected impacts of the regulation and the general view on the scope and approach set in the regulation. Targeted consultations will be conducted with EFSA, Member State authorities and relevant stakeholders through surveys, interviews and: Bilateral meetings with business associations (e.g FEFAC, FEFANA, FEDIAF). In the Standing Committee for Plants, Animals, Food and Feed to gather the comments of the Member States. Bilateral meeting with EFSA. Key stakeholder groups have been identified as follows: • Member State competent authorities for feed additives including relevant Ministries; • Professionals working in feed additives • Feed additives professional associations; • Manufacturers of feed additives • Manufacturers of food additives Feed producers Livestock sector • Other EU authorities and agencies such as EFSA and the EURL • Consumer organisations and EU citizens. A 12 week Open Public consultation will take place in the fourth quarter of 2017. The Open Public consultation will be carried out in English while replies can be made in any of the 24 official EU languages. The open public consultation can be accessed via the Commission's central public consultation page . A synopsis report in English, summarising the results of all consultation activities will be published on the public consultation page once all consultation activities are closed.
(D.5) Further evidence to be gathered
An external study will be contracted to provide input to the evaluation, including answering to the different evaluation questions based on the information gathered and the results of the different consultations including the public consultation. Where information gaps remain the contractor will be expected to find additional sources of information.


E. Other relevant information/ remarks