DSM Nutritional Products Europe Ltd would like to highlight additional points for the Evaluation, based on its long user experience of the Regulation (developing new feed additives (FA) & placing & maintaining them on the market in both, holder specific & non-holder specific categories and in almost all Member States (MS)). The objectives of the Regulation are many and to ensure they are met requires work from all stakeholders. Certainly, the Regulation has improved access to the Common Marketplace and to an extent the predictability for feed business operators. It has also ensured increased safety for consumers/animals/environment.
However, most issues in terms of reaching its objectives are caused by the seemingly inconspicuous yet important details of its application in practice; therefore, crucial fine-tuning is needed to achieve its full relevance & coherence. The legislation that will emerge as a result of this Evaluation will have to be relevant for the future and address its potential challenges. To secure these objectives, as well as the position of the EU as a globally recognised player, DSM considers it crucial that the Regulation is thoroughly adjusted as part of this Evaluation.
Safety: Safety is the most important assessment criteria of FA; during the past 10 yrs however, there was a noticeable shift from the safety to the efficacy aspect. DSM considers that even if efficacy is not addressed as part of the authorisation, it will not negatively affect safety for the consumer/animal/environment. Efficacy could be evaluated by the market. To ensure that users of FA are not mislead when uncoupling efficacy from the safety and quality assessment the EU has already provided Dir 2006/140.
Innovation: Current experience shows that companies are hindered from developing innovative products due to the long time between development and obtaining market authorisation. Additionally there is not enough protection of IP for the innovating company: there should be holder-specific-authorisations for innovative products in all categories. As a result producers of innovative products are increasingly incentivised to manufacture and market outside the EU. This in turn may have a disadvantageous effect on the EU feed & farming sector in the medium run by reducing the choice of new products to be used and consequently negatively affecting the EU competitive position.
Renewals: From a scientific point of view DSM is questioning the time period of 10-yrs for renewals of authorisations. This fixed time frame holds insufficient significance on the safety of a product while adding a significant burden on the applicant: if new data is generated/obtained on safety it could be expected that the EU would take appropriate steps regardless. This seems even more justified when looking at the example of food additives, for which the regulation was established after the Regulation and where there was no need identified to establish a fixed renewal time aiding safety.
Scope:a) A market imbalance, leading to instances of unfair market practices, was unintentionally created by the legislator through the differentiation of FA and feed materials. Both might provide similar functionality while their definitions do not indicate exact boundaries of classification. High uncertainty on the market (mainly in 2012)was created when some FA changed regulatory status to feed material and therefore, more importantly, safety requirements.
b)To serve market demand the use within animal species/categories could be broadened e.g extrapolate automatically the possibility of use from major to minor species.
c)Enforcement by MS: There can be significantly different views on how to interpret the Regulation; this may distort consistency of official controls in a harmonised market and even influence markets on a global scale.
Other comments B3,1A: Since traceability is already covered in the GFL and Feed Hygiene Regulation DSM sees no need to address this topic.
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