Health and food safety

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Feed additives legislation

Summary
Evaluation
Commission Proposal
Legal Act
Implementation

Overall state of Play:

Evaluation ongoing to be finalised in 2023

State of play, main conclusions, outlook:

The Commission carried out an evaluation to examine the performance and impacts of Regulation (EC) No 1831/2003 since its entry into force. In particular, it examines if the provisions on the different procedures, on the adaptation to technical or scientific knowledge and on the labelling, have been effective and continue to be fit for purpose. It analyses the implementation costs compared with the benefits achieved, the coherence with other pieces of legislation and the relevance in the context of fight against antimicrobial resistance. In addition, the economic impact and the added value of the EU intervention has been assessed.

Results of the evaluation suggest that though the Regulation has worked well in general, there are potential areas for improvement, including aspects that have a simplification and burden reduction dimension. Building on this, the Commission has started preparatory work in support of a revision proposal of the feed additives legislation. The Commission will decide future action once the impact assessment is finalised.

Estimated savings and benefits

Based on the evaluation findings a number of actions would have a positive impact on reducing administrative burden, such as:

- Better use of information and communication technologies (eg electronic means).

- Possible extension of the authorisation period.

- Streamlining of the regulatory procedures, including a simplified procedure in case of change of the authorisation holder.

- Adaptation of the Register of Feed Additives to be more informative and user friendly.

- Clarification of certain rules and definitions would increase legal certainty.

State of Play:

Evaluation ongoing, to be finalised in 2023

Scope:

Evaluation of the Feed additives Regulation (EC) No 1831/2003.

Evaluation findings:

The results of the evaluation suggest that, though the Regulation has worked well in general, there are potential areas for improvement. Several of these have a simplification and burden reduction dimension, such as for example:

- A lengthy authorisation process: the period for granting an authorisation is rather long (average 2.5 years per application) and some shortcomings have been identified: too many tests are required on target animals with high costs for the applicant that are not always justified on safety grounds; testing alternatives have not been sufficiently explored; extrapolation from major to minor species could be improved; efficacy tests could be skipped for certain additives already authorised in food; and missing or incomplete information in the dossiers, due to a lack of understanding of the guidance. This triggers the stop of the clock by EFSA in order to request complementary information, which also lengthens the authorisation time. These problems affect directly the Commission, EFSA and applicants, and indirectly farmers and manufacturers of feed additives/compound feed. Last but not least, the high costs of authorisation reduce the capacity of enterprises, in particular SMEs to develop innovative additives.

- Unnecessary administrative burden: the authorisation of some additives is linked to an authorisation holder who has the exclusive right to first place the additive on the market. Those rights are often transferred to other companies during business mergers or acquisitions. A Commission Regulation must be adopted every time a change of an authorisation holder occurs. The administrative burden is disproportionate for a change that could be solved by a simplified administrative procedure.

- Insufficient legal clarity and consistency for a few aspects of the Regulation: some definitions or provisions of the Regulation need to be revised to provide greater clarity.