European Manufacturers of Feed Minerals Association
EMFEMA
Inform and support members to conform to legal obligations of high quality standards respecting food and feed safety as well as the environment; contact and cooperate with other professional organizations with similar interests; cooperate with European and national authorities to create and maintain the correct legal environment for the safe and sustainable use of its products; stimulate scientific research and developments in the field; inform end-users, schools, universities and the public of the technical and nutritional value of products for animal feeding.
ID: 322887113869-18
Lobbying Activity
Response to Food and Feed Safety Simplification Omnibus
14 Oct 2025
Comment on the 'Feed Additives' section. While any lightening of the regulatory burden in this area is welcome, we do not think that the measures envisaged and described in the Call for Evidence documents will reduce the burden on the authorisation process for feed additives, to the extent needed for the resilience and autonomy of the EU feed additive business and its users. Amongst the measured flagged in the document, the authorisation renewal cycle is indeed worth a revision (cancelling, lightening drastically and/or balancing operators obligations). The evaluation of the Feed Additives Regulation, which is ongoing for several years, has identified fundamental issues that need to be addressed, and the proposed Omnibus Regulation should not be seen as relieving the need to revise Regulation (EC) No 1831/2003. Regulation 1831/2003 innovated to ensure the proportionality and predictability of regulatory requirements by clearly separating the responsibilities of risk managers and risk assessors. It set out a clear process for addressing this issue, with the EC establishing the evaluation framework (and its limits via a 'guideline regulation') and EFSA detailing the scientific aspects (via its guidance). However, the effective implementation of this model has now faded away, and today, EFSA practically sets market access conditions based on its recognised scientific expertise, but outside of any socio-economic considerations. We believe that the regulation should reinforce the genuine separation of responsibilities approach. This would affect new authorisations/innovation as well as the burden of authorisation renewals that the Omnibus Regulation is targeting. Another important aspect of this Regulation was the non-holder-specific authorisation introduced, which aimed to balance the obligations and responsibilities of operators fairly, including those from third countries, in convergence with the Feed Hygiene Regulation (EC) No 183/2005. However, the practical shift to a 'generic' approach and its impact on the implementation of feed hygiene rules does not achieve this objective anymore and has a negative impact on EU operators. This is another important area to revisit. A third priority area relates to claims. While the functionality of additives is fundamental to their existence, opening up the market for claims in a fair way, as was done for feed materials and compound feed through the Marketing of Feed Regulation (EC) No 767/2009, might appear to be absolutely essential. A significant part of the market access burden has also been generated by the revision of the General Food Law through the 'Transparency Regulation' amendment. While this amendment did not benefit from a full impact assessment at its inception, it is now clear that a large part of it, particularly the pre-notification obligations regarding studies, has created an enormous administrative burden and deterred innovation, particularly among small and medium-sized businesses. We believe a revision of this should be included in the process of reducing the burden. Recognising that such a comprehensive revision might take some time, and that the current omnibus proposal is well-suited to addressing urgent topics, we propose using it to fill the legal void created by the exemption of feed additives and premixtures from the scope of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of hazardous substances and mixtures (This exemption follows a legal analysis by EU Commission services in 2023/24). Filling the gap could be achieved by referencing the relevant sections/articles of the CLP legislation in Regulation (EC) No 1831/2003, allowing for a standardised classification of feed additives and premixtures, and ensuring coherent labelling and SDS transmission along the supply chain. This is important to avoid multiple, potentially incoherent, requirements for products with multiple applications.
Read full responseResponse to European Critical Raw Materials Act
25 Nov 2022
While the EU is on a long-standing path for its raw material policy, including criticality aspect, we highly welcome the increase emphasis put on this matter and the announced intention to increase efforts besides the Raw material strategy that is already in place (COM (2020)474). Both the Covid Crisis and the geopolitical context developments have highlighted that the EU sits in a dangerous dependency on a wide range of raw materials. These developments also point to the fact that the criticality as it has been conceived so far, including in its assessment methodology, might require some further consideration. Although some biotic materials have been marginally considered in the past, the criticality assessments have so far mainly focused on minerals and metallic ones in particular. The criticality being (methodologically) defined as a combination of Supply Risk and Economic Importance, even for the minerals, some of their criticality dimension might not have been fully captured yet for a range of applications that are not immediately obvious and/or are economically smaller than others. In most cases, the individual criticality assessments have not identified/accounted the importance of the feed applications. More input is provided in the attached document.
Read full response16 Aug 2022
Considering the period chosen for the present call, we would like to focus our input on one specific element: the need for an impact assessment. While the target of creating an open and common basis of data for various assessment through some convergence of different notification/authorisation regimes is appreciated, one cannot ignore the diversity and complexity of the legislations and data collection/assessment processes that underline them. Contrarily to the “Better Regulation” statement included in the Call for Evidence document, we anticipate that such data streamlining might have very significant consequences on those generating and processing data under the various assessment regimes, and on the whole authorisation dynamic and resulting innovation. While we support the overall objective of the initiative, we call for it to be carried out under very close impact assessment considerations that should allow to select policy choices and avoid burdensome measures.
Read full responseResponse to Amendment of products and substances allowed in organic production
31 Jul 2019
Annex III updating Annex IV of Reg. 889/2008 lists trace element compounds which may be used as feed additives in organic production. As a consequence of Reg. 1831/2003 all feed additives have passed or are still passing a re-evaluation process which has led to new approvals. In this context some additive names and all ID numbers of the re-approved additives have changed. Annex III updating Annex VI of Reg. 889/2008 should be made consistent with the actual denominations and ID numbers laid down in Reg. 2016/1095 for zinc, Reg. 2017/1490 for manganese, Reg. 2018/1039 for copper and Reg. 2019/49 for selenium. Furthermore those trace element compounds which were withdrawn by Reg. 2017/1145 should be deleted from Annex III, updating Annex VI of Reg. 889/2008. A detailed overview about the necessary changes is given in the attached document.
Moreover the mentioned regulations set the provision, that the additive must be incorporated into compound feed in form of a premixture. This general provision is applicabe also if the additives are used in organic production. However in practise the production of premixtures requires the use of agents (e.g. propylene glycol, polyethylene glycol, etc.) which reduce the dust emission of the product and help to keep the mixture homogeneous. Currently the rules for substances allowed in organic production do not allow the application of such auxiliary substances, which however are essential for product safety and quality. The inclusion rate of such auxiliary substances in a premix usually is low (1-5%) and given the fact, that premixtures are included in small quantities in compound feed only the amount of the auxiliary substances in the animals diet will be neglectable. To safeguard the availability of premixtures which are legally required now a possibility should be created, that such auxiliary substances can be used also in premixture manufacturing for organic production.
Read full responseResponse to Transparency and sustainability of the EU risk assessment model in the food chain
17 Jan 2018
Please find our feedback in the attached document
Read full response