Simplification of rules on feed additive authorisations
- Biotechnologies
Summary
The European Commission proposes to simplify the authorisation process for feed additives to improve its efficiency, and the competitiveness of the European Union (EU) feed sector. It also proposes to introduce digital labelling options for certain non‑safety‑related information.
Under the proposal, feed additive authorisations will remain valid for an unlimited period of time instead of the current rules that require renewal every 10 years. The European Commission will retain the right to cancel authorisations if safety or effectiveness problems arise. Only authorisations for feed additives in the category of coccidiostats and histomonostats will remain limited to 10 years. Most existing authorisations will become unlimited automatically. Pending applications will be assessed under the old rules, but granted unlimited approval if successful. The proposal also seeks to simplify the process of modifying authorisations.
It is also proposed to expand the use of digital labelling, permitting some non-safety labelling information to be provided digitally, while all essential safety and use information must remain on the physical label.
European Commission proposes to simplify feed additive authorisation process, and introduces digital labelling options
Proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) No 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Update
The European Commission proposes to simplify the authorisation process for feed additives to improve its efficiency, and the competitiveness of the European Union (EU) feed sector. It also proposes to introduce digital labelling options for certain non‑safety‑related information.
Under the proposal, feed additive authorisations will remain valid for an unlimited period of time instead of the current rules that require renewal every 10 years. The European Commission will retain the right to cancel authorisations if safety or effectiveness problems arise. Only authorisations for feed additives in the category of coccidiostats and histomonostats will remain limited to 10 years. Most existing authorisations will become unlimited automatically. Pending applications will be assessed under the old rules, but granted unlimited approval if successful. The proposal also seeks to simplify the process of modifying authorisations.
It is also proposed to expand the use of digital labelling, permitting some non-safety labelling information to be provided digitally, while all essential safety and use information must remain on the physical label.
Impacted Products
Food residues and waste; prepared fodder
What is changing?
The European Commission proposes the following major changes to Regulation 1831/2003 on feed additive authorisations.
Duration of authorisations
Feed additive authorisations are currently valid for 10 years and must then be renewed (Art. 9(8)). The proposal is for feed additives to be authorised for an unlimited period of time. The European Union (EU) would still be able to revoke authorisations at any time if concerns arise about safety or efficacy (current Art.13). As an exception, authorisations of feed additives in the category of coccidiostats and histomonostats would still be limited to 10 years due to the high risk profile (antimicrobial nature) of these additives.
Extension of existing authorisations
Feed additives that have already been authorised before these revised rules apply will be considered authorised for an unlimited period of time, except for:
- feed additives in the category of coccidiostats and histomonostats
- urgent authorisations granted to ensure the protection of animal welfare (Art. 15)
- authorisations for which no renewal has been submitted
- authorisations which have been withdrawn
- authorisations for which an application have been submitted, but no decision taken.
Applications already submitted
Where an application has been submitted and no decision taken, these will continue to be reviewed under the previous rules. However, if the authorisation is successfully renewed, authorisation will be granted for an unlimited period of time.
Modification of authorisations
The Commission proposes to allow changes to the name of the authorisation holder that can be made public through the Community Register of Feed Additives without having to adopt a new Regulation (Art. 13). There will also be a new opportunity for interested parties to submit an application for modification of an authorisation (e.g. expanding the specifications or conditions included in the authorisations) for additives for which is there is no specific authorisation holder (certain categories of technological, sensory, or nutritional additives).
Labelling responsibilities (Art. 16)
The Commission proposes to allow digital labelling for certain non-safety-related information (Art. 16), for example the name/address of the person responsible for labelling, manufacturer’s approval number, batch reference number, and date of manufacture. Safety-critical and essential-use information must remain on the physical label. Basic conditions for digital labelling are proposed.
The proposal also clarifies responsibility for labelling: the feed business operator established within the EU that first places the feed additives on the EU market, or the operator under whose name the feed additives are placed on the market, must comply with the labelling rules.
Why?
A review of existing feed additive rules (European Commission 2024) identified administrative burdens for the feed sector and for EU (national) authorities when processing applications for feed additive authorisations. The current 10-year renewal application was widely considered too costly to justify investment; in practice there are currently very few withdrawals or refusals of authorisation for food safety reasons. Labelling requirements were also considered to be outdated given the growing availability of digital tools. The Commission’s proposals aim to address these weaknesses to improve the efficiency and competitiveness of the EU feed sector.
Timeline
This proposal will be discussed by the Council of the EU (Member States) and the European Parliament, a process that can take up to 2 years. So its application is possible in the second half of 2027.
Background
The current proposal reflects the views of Member States and stakeholders across a number of areas of food law regarding simplifying food and feed safety rules.
The EU Vision for Agriculture and Food 2025–2029 sets out a number of priorities, which include ensuring the competitiveness and resilience of the EU agri-food sector. The EU is aiming to simplify legislation by removing unnecessary regulatory obstacles. It does not intend to change rules in a way that will reduce the current level of consumer protection provided by these rules.
Resources
European Commission (2024) Commission Staff Working Document: Evaluation of Regulation (EC) No 1831/2003 on additives for use in animal nutrition
Regulation (EC) No 1831/2003 on additives for use in animal nutrition
Sources
Proposal for a Regulation amending Regulations 999/2001, 1829/2003, 1831/2003, 852/2004, 853/2004, 396/2005, 1099/2009, 1107/2009, 528/2012, 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.
European Commission proposes to simplify feed additive authorisation process, and introduces digital labelling options
Proposal for a Regulation amending Regulations 999/2001, 1829/2003, 1831/2003, 852/2004, 853/2004, 396/2005, 1099/2009, 1107/2009, 528/2012, 2017/625 as regards the simplification and strengthening of food and feed safety requirements
What is changing and why?
In response to criticisms made by stakeholders about the efficiency of the current authorisations procedure, the European Commission proposes the following simplifications to Regulation 1831/2003 on feed additive authorisations.
Duration of authorisations
Feed additives would no longer need renewal every 10 years and would be authorised for an unlimited time. However, the European Union (EU) can still cancel an authorisation if there are safety or effectiveness problems. Coccidiostats and histomonostats will still be limited to 10 years because they are high risk.
Extension of existing authorisations
Most feed additives that are already authorised will automatically become authorised for an unlimited time. This does not apply to coccidiostats and histomonostats, urgent animal welfare authorisations, or cases where renewal has not been requested or is not yet decided.
Applications already submitted
Applications that have been submitted but are not yet decided at the time the new rules apply will be assessed under current rules. If they are approved, the authorisation will then be unlimited.
Modification of authorisations
The Commission proposes to allow changes to an authorisation holder’s name without issuing a new Regulation. It also intends to make it easier to modify authorisations that do not have a specific authorisation holder.
Labelling responsibilities
Some non-safety information may be provided digitally instead of on the physical label. All important safety and use information must still appear on the product label.
Timeline
This proposal will be discussed by the Council of the EU (Member States) and the European Parliament, a process that can take up to 2 years. So its application is possible in the second half of 2027.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.