Meeting the challenge of EU registration

Transcription

1 N 5/212 Meeting the challenge of EU registration S

2 EDITORIAL Dear Reader, The legal requirements for the production of farm animals are constantly growing. New EU regulations and directives are aimed at the protection and the health of our farm animals (e.g. minimum standards for protection of livestock), but also for humans and the environment. An important step is the ban of antimicrobial growth promoters, embedded in Directive 1831/23, and in force in the EU since 26. The step is affirmed by similar bans being passed outside the EU, as in Korea, or by the partial ban of antibiotics in poultry production in North America. To ensure the economic of sustainability farm animal production without antibiotic growth promoters, phytogenic feed additives provide a viable alternative. Standardised mixtures from herbs, spices and extracts are well known to have positive effects on animal performance and health. However, until recently there were no phytogenic products listed as zootechnical feed additives in the EU register. Instead, these phytogenic feed additives are listed in the flavouring category, which does not reflect the real potential of these products. The effects of these natural growth promoters reach far beyond the flavouring of the feed. Now this gap has been closed, and Delacon, as a pioneer and market leader, has set another milestone: With the world s first EU registration of an entirely plant-derived feed additive, tested and approved as safe and effective is available to our customers. It conforms to the current requirements for an efficient growth promoter and sustains economic efficiency. This dossier offers background information regarding the legal requirements for feed additives and the evaluation process on the EU level. Further, it offers an insight into the wealth of data upon which EU registration is based. It is quite apparent that the success story of registered phytogenic feed additives will continue. Delacon has already submitted Biostrong 51 for registration. We will keep you informed in due course of further successful registrations. And now enjoy reading Dossier 5. Registering a feed additive in the European Union according to Regulation (EC) 1831/23 Sonja Marschallinger, Delacon Biotechnik Ges.m.b.H., Austria, Regulatory Affairs The publication of regulation (EC) 1831/23 contained many new developments for the feed industry. This regulation stated that antibiotics, other than coccidiostats and histomonostats, might be marketed and used as feed additives only until December 31, 25. The motive for the ban of antibiotics from feed was the fear of overuse and therefore of the development of antimicrobial resistance and of transference of antibiotic resistance genes from animal to human microbiota. Also outside the European Union antibiotics are more and more banned from the feed industry (e.g. Korea). Dr. Karola Wendler Head of Research & Development DELACON

3 Not only the ban of antibiotics was new but also that for all feed additives (for farm animals) used in the European Union a safety evaluation needs to be carried out. Additionally, the additives should be assigned to different categories: technological: substance added to feed for technological purpose, e.g. emulsifiers, anticaking agents sensory: substance which improves/changes organoleptic properties of the feed or visual characteristics of the food derived from the animals, e.g. colourants or flavourings nutritional, e.g. vitamins, trace elements zootechnical: additives which influence favourably the performance of animals in good health or the environment, e.g. digestibility enhancers coccidiostats and histomonostats Until 8th of November 21, for all feed additives which have been already placed on the European market (previously authorised under Directive 7/524/EEC) a dossier had to be submitted to the European Commission for reauthorisation. In the dossier, efficacy and safety need to be proven. Furthermore, a suitable method of analysis has to be provided. In this re-authorisation process, for more than 1 individual additives a dossier was submitted. This means that these additives are allowed to be used in feed after November 21. Allowed substances are listed in the Community register of feed additives under Annex I. Under Annex II those substances are mentioned for which no dossier has been submitted. Currently, the Commission is preparing a law to remove the Annex II substances from the market. For authorisation of a new additive in the European Union also a dossier has to be submitted. The guidelines for such an authorisation dossier are stated in regulation (EC) 429/28. There the structure and the content are defined. Regulation (EC) 429/28 As mentioned above, many different parameters need to be proven to submit a dossier for authorisation as a feed additive. The exact requirements are stated in the regulation (EC) 429/29. Additionally, EFSA has published guidance documents which help to identify which studies are needed. A dossier is splitted up into 5 sections: Section I Here all information from the dossier is summarised. The Public summary will be available for everybody. Section II This section is the so called Identity section. Here the composition of the additive, the method of analysis, stability data, homogeneity, and so on are discussed. The method of analysis needs to be either an official method (like Pharmacopoeia Europea) or a validated and verified in-house method. For a mixture of additives an active substance needs to be identified for analysing purposes. Stability needs to be shown under two different storage conditions for the product, in premix and in feedingstuff. S2

4 Section III This section is about safety. Safety needs to be shown for the target animal species, for the consumer, for the user and worker and also for the environment. It depends on the legal status of the substances which studies needs to be carried out, e.g. for a substance which is allowed to be used in food, less safety/toxicity studies are necessary. Section IV In this section it needs to be shown that the product has the claimed effect on the animal/feed. Therefore at least three studies at two different locations with a significant result are necessary. Another possibility is to do a meta-analysis of at least 4 trials. Section V Here it needs to be explained how the post market monitoring plan looks like. Table 1: Qualified majority vote. Member State N votes Member State N votes DE 29 BG 1 UK 29 AT 1 FR 29 SK 7 IT 29 DK 7 ES 27 FI 7 PL 27 IE 7 RO 14 LT 7 NL 13 LV 4 GR 12 SI 4 CZ 12 EE 4 BE 12 CY 4 HU 12 LU 4 PT 12 MT 3 SE 1 EU Authorization process At least six weeks before the applicant wants to submit the dossier, three samples of the feed additive and three reference samples (active substance) need to be sent to the Community Reference Laboratory for feed additives (EURL- FA). In a next step, the applicant sends the application to the European Commission. The Commission forwards it immediately to the European Food Safety Authority (EFSA). Within 15 days of receipt, EFSA then sends an acknowledge of receipt of the application to the applicant. Also EFSA publishes the public summary on their website. At the same time as the applicant sends the application to the Commission, he needs to send the dossier to EFSA. There they first to a validity check, if all mentioned documents are included in the dossier. EFSA then has six months time to give an opinion ( scientific opinion ) on the additive. If for the assessment supplementary information is required ( clock stop ), the time limit is extended. Additionally, the EURL-FA has three months time to evaluate the method of analysis and forward their opinion to the EFSA. The full scientific opinion is then immediately forwarded by EFSA to the Commission, to the Member States and to the applicant. For a positive majority vote the following three criteria need to be fulfilled: 74 % votes in favor (= 255/345), AND 5 % of Member states in favor, AND 62 % of population in favor The Commission then informs the applicant about the decision and the regulation will be published (takes two to three months). The feed additive is entered in the Community register of feed additives and the authorization is valid for ten years. The Commission now has three months time (may be extended in complex cases) to prepare a draft regulation to grant or deny the authorization. In this process the Commission is assisted by the Standing Committee on the Food Chain and Animal Health. It consists of the 27 member states. They give their opinion to the Commission by a qualified majority vote (QMV). The number of votes for each member state are shown in Table 1. DELACON

5 Biostrong 51 The efficient and safe phytogenic feed additive for poultry Leopold Jungbauer, Delacon Biotechnik Ges.m.b.H., Austria, R&D Species Manager Poultry Biostrong 51 is a phytogenic (plant derived) feed additive which improves nutrient digestibility and performance and thus profitability in poultry production. Additionally, Biostrong 51 reduces ammonia in poultry barns and helps to meet the requirements for poultry welfare (Delacon Dossier 4.). Biostrong 51 is a combination of high quality and well selected essential oils which are partially micro-encapsulated and dried crushed herbs and spices. The formulation of all ingredients is designed to meet poultry needs, as requirements are varying between species. Nutrient digestibility Improved nutrient digestibility is one of the key benefits of Biostrong 51. By improving nutrient digestibility, feed efficiency is improved and thus reduces feed costs in broiler production. For the registration as a digestibility enhancer a meta-analysis of 5 digestibility trials was conducted. This meta-analysis shows that Biostrong 51 significantly improves nutrient digestibility in broilers. On the long road of the registration process as a performance enhancer as well as a digestibility enhancer Delacon had to prove efficacy (performance and nutrient digestibility) and safety of Biostrong 51. Figure 2: Effects of Biostrong 51 on nutrient digestibility in broilers Improved Efficacy For the registration as a performance enhancer it is necessary to run at least three scientific trials at minimum two different locations. For broilers a minimum duration of 35 day and a significant improvement in at least one performance parameter is required. Delacon carried out four scientific performance trials to prove the efficiency of Biostrong 51. The meta-analysis of these trials has confirmed that feeding Biostrong 51 significantly improves feed conversion ratio in broilers (p<.5) Figure 1: Effects of Biostrong 51 on performance in broilers 1-42 d feed / gain (g / g) a b DWI g/d p=.315 DFI g/d p=.288 Biostrong 51 FCR g/d p=.8 Coefficient of digestion (%) Biostrong b a 81.5a b a 38.4b 49.a 39.8b 2 Crude protein p=<.1 Crude fat p=<.1 Phosphorus p=.2 Calcium p=<.1 Safety All active compounds used in Biostrong 51 already have a legal status as feed additive in the EU, have an established history of use in the food chain and are widely used in food in the EU with no maximum limits. Therefore, no safety studies for consumer or users are required by the EFSA. Nevertheless, the safety of the use of Biostrong 51 for broilers had to be proven. For that reason a tolerance study was carried out. This study has shown that even a 1 fold dosage of Biostrong 51 (15 g/t) has no negative effect on performance nor enhances mortality. Additionally, an analysis of the leading substances of Biostrong 51 in breast meat was conducted, which showed no residues. Summary The phytogenic feed additive Biostrong 51 significantly improves nutrient digestibility and performance. Furthermore, the use of Biostrong 51 is safe for target animals as well as for workers handling the product. S 4

6 FRESTA F: the first performance enhancing phytogenic product registered as a zootechnical feed additive Karola R. Wendler is the Head of Research and Development at Delacon Biotechnik. Delacon pioneered phytogenic feed additives and is the largest producer and distributor of phytogenic feed additives in the world. Phytogenic feed additives are plant-derived, natural, botanical compounds, comprised of herbs, spices and extracts. They are increasingly used in animal nutrition because they have beneficial biological effects, improve performance and are effective supports for livestock production. All phytogenic and non-phytogenic feed additives sold in the EU are regulated by EC directive 1831/23; concerning the registration and application of feed additives. The regulation demands evaluation of additives for safety and efficacy before entry into the European feed additive register. Until this EU announcement all plant derived products currently available in the EU were registered solely as sensory additives. This allowed manufactures to only make claims based on feed palatability and intake. Animal health and performance claims were forbidden in the absence of documented proofs, and registration as a zootechnical additive. Feed additives are divided into groups, by function and effect: - Technological: substance added to feed for technological purpose, e.g. emulsifiers, anticaking agents - Sensory: substance which improves/changes organoleptic properties of the feed or visual characteristics of the food derived from the animals, e.g. colorants or flavourings - Nutritional: e.g. vitamins, trace elements - Zootechnical: additives which favourably influence the performance of animals in good health or the environment, e.g. digestibility enhancers - Coccidiostats and Histomonostats nutrient utilization and better growth. Extensive research and trials went into developing the product some years ago. The wide application of Fresta F in the field, long with significant and rigorous analysis identified further beneficial health effects, that make the product an excellent tool for modern pig production. Fresta F fed piglets gained significantly more weight during the prestarter (+1.6 %) and starter period (+4.9 %), compared with the control groups (Figure 1). This was reflected in significantly higher body weights after the prestarter period (9.8 kg vs. 1.1 kg) and at the end of the experiment (23.3 vs kg). Supplementation with Fresta F also increased feed intake during prestarter and starter period (Figure 2). Fresta F fed piglets had improved feed conversion ratios, compared with control animals during the prestarter phase (improvement of %), indicating improved nutrient utilization. Safety in the target animals was proven with a safety margin of five. This means that 5 times the maximum recom- Figure 1: Weight gain (kg/d) in weaned piglets P Treat =.4 P Treat*Time =.56 The classification of feed additives into these groups is clearly connected to the beneficial claims that can be made by the authorization holder The efficacy of Fresta F, applied at the minimum recommended dosage of 25 mg/kg feed, was evaluated in a total of five feeding trials with weaned piglets. The products mode of action enhances digestive processes, leading to improved days 42 7 days Fresta F DELACON

7 Delacon PNRC (Performing Nature Research Centre) mended dosage (2, mg/kg feed), is safe for performance and blood characteristics in weaned piglets. Consumer safety was confirmed by blood and meat analyses in piglets fed 1 fold the maximum recommended dosage (4, mg/kg feed). Given the huge amount and diversity of active plant substances, it is necessary to continue research into their effects on livestock and to discover new synergies that will allow the development of products to solve new issues in animal production. The results clearly demonstrate that dietary supplementation with Fresta F is safe for animals and consumers and improves zootechnical performance in weaned piglets. To meet the high standards of its research and development programme, Delacon built its own research facility, the Performing Nature Research Centre. The highlight of the facilities is the emission chamber section, which allows measurement of aerial emission from livestock in 12 individual chambers suitable for poultry, pigs and small ruminants. As a result of the recent exacting safety, quality and efficacy evaluation by the European Food Safety Authority, the European Union Reference Laboratory, the EU Commission and 27 EU Member States, Fresta F was approved February 16th as a performance enhancing zootechnical feed additive. Fresta F is the now the first and only phytogenic (plant derived, natural, botanical) product in the world approved by the European Union as a zootechnical additive. Delacon s Biostrong 51 has also been submitted for evaluation as a performance enhancing zootechnical additive in broilers, and a decision is pending. Figure 2: Feed intake (kg/d) in weaned piglets.8 Delacon continues to do its part to make farming profitable, sustainable and safe, in a natural way. But there are challenges for the sector: changing regulations, new technologies, evolving animal diseases, complex consumer expectations and the constant concern with the bottom line economics of farming in the 21st century. Delacon is preparing to meet these future challenges. Figure 3: Feed efficiency in weaned piglets Feed conversion ratio (kg/kg) PTreat =.651 PTreat*Time =.55 PTreat =.234 PTreat*Time days 42 7 days Fresta F days 42 7 days Fresta F S 6

8 Delacon pioneered phytogenic feed additives and leads the global market. Our formula for success is research, innovation, strong management and paying attention to our customers. We are the largest producer and distributor of phytogenic feed additives in the world. With over 25 years of phytogenic research and product development experience we are the global leaders in phytogenic innovation, knowledge and applications. Working with nature to discover new combinations of phytogenic substances, our mission is to improve animal nutritional efficiency, health and food safety while minimizing environmental impact. Consistent, high quality and secure products and delivery technologies are key to our success and we take it seriously. We have the most advanced expertise in: - Feed additive formulations that improve animal production - Micro-encapsulation technology - Quality Management & Standard Product Consistency - Ammonia Reduction All references on request. Imprint: Delacon Biotechnik GmbH, Weissenwolffstr. 14, 4221 Steyregg, Austria, Tel , Fax , office@delacon.com FRESTA F Safe Effective Proven First and only EU approved phytogenic zootechnical additive