The EU market for food and food products is now the most valuable in the world. As a result, European legislation affecting the food chain has global implications, since operators wishing to supply this market must comply with all relevant laws. The total ban on antibiotic growth promoters (AGPs), effective since January 2006, is just one element in a wave of EU legislation ultimately affecting food animal production around the world..jpg)
The new feed additive regulation (EU FAR), published in 2003, will have further profound effects on this sector, requiring producers to pay close attention to the quality and legal status of feed additives used. Sel-Plex®, a yeast providing organic selenium, is one of the first feed additives to be approved under EU FAR. The dossier submitted illustrates that meeting current EU standards requires considerable expertise and resources, as well as a high-quality data package (Figure 1).
Increased control of feed additives
The EU FAR began to bite with an initial requirement to notify all feed additives currently in use. Notifications were checked for legality by the EU authorities prior to producing a new positive list, the Community Register of Feed Additives (CFAR). Products such as amino acids and silage agents were classified as feed additives for the first time and all vitamins, provitamins, and flavours/aromas required individual specification. Over 11,000 notifications were received, resulting in a CFAR of approximately 300 pages.
The EU FAR began to bite with an initial requirement to notify all feed additives currently in use. Notifications were checked for legality by the EU authorities prior to producing a new positive list, the Community Register of Feed Additives (CFAR). Products such as amino acids and silage agents were classified as feed additives for the first time and all vitamins, provitamins, and flavours/aromas required individual specification. Over 11,000 notifications were received, resulting in a CFAR of approximately 300 pages.
Table 1 shows the basic structure of the CFAR. The EU plans to review this list. In order to maintain a legal status for most products, feed additive manufacturers will have to submit dossiers to current regulatory standards by November 2010. Many additives have never been formally evaluated and most manufacturers lack the skills and experience to produce the required data and documentation.
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These changes in EU feed additive legislation are taking place in a new legislative environment where all operators in the food chain are held responsible for any food- or feed-related health or contamination problems and must finance product recalls if necessary.
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Table 2 illustrates that the EU food chain is effectively and efficiently policed by RASFF (Rapid Alert System for Food and Feed), which detects illegal and unsafe products destined for the European market, resulting in withdrawal or prohibition. The expense of product recalls can cripple a business. Operators in food, feed and animal production have become extremely sensitive to the legal status of all products used.
“Grey-Zone” Additives
In parallel with the EU reduction in antibiotic usage and the completion of the AGP ban in 2006, there is a substantial “Grey-Zone”, largely composed of natural or nature-identical additives marketed as alternatives to AGPs. Additives include herbs, spices, essential oils, nutraceuticals and phytogenics. Many of these achieved a positive listing on CFAR as flavours, aromas or appetents (flavours). In fact around 60% of CFAR additives are categorised as flavours, although, in the majority of cases, this classification is a temporary regulatory strategy to maintain an EU legal status, thus permitting continued sales and market access. By the November 2010 dossier submission deadline it is expected that many so-called ‘flavours’ will attempt reclassification by submitting zootechnical dossiers supporting improved animal performance.
In parallel with the EU reduction in antibiotic usage and the completion of the AGP ban in 2006, there is a substantial “Grey-Zone”, largely composed of natural or nature-identical additives marketed as alternatives to AGPs. Additives include herbs, spices, essential oils, nutraceuticals and phytogenics. Many of these achieved a positive listing on CFAR as flavours, aromas or appetents (flavours). In fact around 60% of CFAR additives are categorised as flavours, although, in the majority of cases, this classification is a temporary regulatory strategy to maintain an EU legal status, thus permitting continued sales and market access. By the November 2010 dossier submission deadline it is expected that many so-called ‘flavours’ will attempt reclassification by submitting zootechnical dossiers supporting improved animal performance.
Innovation in feed additives
Organic Se from yeast, an innovative concept in nutrition, was not approved as a feed additive in the EU prior to 2006; this was one reason for Alltech to submit the Sel-Plex® dossier. The other reason was the innovative nature of the product, which offers selenium in bioavailable and nature-identical organic forms, resulting in enhanced selenium status and associated performance and health benefits throughout the food chain. The submission of this pioneer dossier was in March 2005, with approval in November 2006, a time scale that indicates the complexity of the evaluation process (Figure 2). Other Se yeast dossiers submitted in 2005 have not yet completed assessment.
Organic Se from yeast, an innovative concept in nutrition, was not approved as a feed additive in the EU prior to 2006; this was one reason for Alltech to submit the Sel-Plex® dossier. The other reason was the innovative nature of the product, which offers selenium in bioavailable and nature-identical organic forms, resulting in enhanced selenium status and associated performance and health benefits throughout the food chain. The submission of this pioneer dossier was in March 2005, with approval in November 2006, a time scale that indicates the complexity of the evaluation process (Figure 2). Other Se yeast dossiers submitted in 2005 have not yet completed assessment.
The cost and resources involved in achieving and maintaining EU approvals is such that only innovative feed additives backed by sound scientific data and supported with adequate resources will succeed.
EU evaluation and authorization
The dossier is first validated by EFSA (European Food Safety Authority) and then evaluated by the EFSA FeedAp Panel (20 independent scientists, often supported by external experts forming dossier- or subject-specific working groups). Experts from the 25 EU Member States conduct a parallel assessment and as a result their questions may be added to those generated within EFSA. Often, substantial additional data is requested during dossier assessment.
The dossier is first validated by EFSA (European Food Safety Authority) and then evaluated by the EFSA FeedAp Panel (20 independent scientists, often supported by external experts forming dossier- or subject-specific working groups). Experts from the 25 EU Member States conduct a parallel assessment and as a result their questions may be added to those generated within EFSA. Often, substantial additional data is requested during dossier assessment.
Meanwhile, three samples of the feed additive are sent to the Community Reference Laboratory (CRL), who audit the methods of analysis proposed in the dossier and maintain reference samples of the additive. Scientific review of a dossier takes a minimum of six months, often longer when questions are asked and more data is required. EFSA then publishes an opinion on the safety, quality and efficacy of the additive, including the CRL report on analytical methods. The EFSA public opinion is subject to stakeholder consultation. Stakeholders include all interested parties, including EU citizens, who may express their own opinions on whether the additive should be approved or not.
Taking into account EFSA’s scientific opinion (risk assessment) and relevant risk-management considerations highlighted by stakeholders, the EU Commission drafts a Regulation to approve or prohibit authorisation of the additive. The draft is subject to Comitology, a debate involving delegates from all EU Member States. Such debate may take two or more meetings of Comitology after which a vote is taken.
Three evaluation pillars
For the draft Regulation to be approved, a qualified majority vote (QMV) is required. This means that at least 50% of Member States and 70% of votes cast must be in favour. Finally, the Regulation approving (or not) the additive is published in the Official Journal of the European Union. An approval under EU FAR is valid for 10 years, after which an updated dossier is required to renew the authorisation. Examples of categories of feed additives under EU FAR are shown in Table 1.
For the draft Regulation to be approved, a qualified majority vote (QMV) is required. This means that at least 50% of Member States and 70% of votes cast must be in favour. Finally, the Regulation approving (or not) the additive is published in the Official Journal of the European Union. An approval under EU FAR is valid for 10 years, after which an updated dossier is required to renew the authorisation. Examples of categories of feed additives under EU FAR are shown in Table 1.
As illustrated in Figure 1, the three pillars of feed additive evaluation by EFSA are Safety, Quality and Efficacy. EFSA and the EU’s objectives are to ensure safety of animals, consumers, workers and the environment, as well as to prevent fraud (e.g. unsubstantiated claims). Due to feed hygiene and traceability obligations, premixes and feed manufacturers require a clear legal status for all additives used in their businesses. Finally the EU evaluation and authorisation process illustrated in Figure 2 meets the needs of all key stakeholders.
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