The use of unauthorised feed additives in animal feeding
trials
The Department of Agriculture, Food and the Marine (DAFM) sometimes receives requests for
agreement to use unauthorised feed additives in animal feeding trials. These trails for the most part
are performed in order to generate data to support an application for authorisation of a new feed
additive. Such requests are made under the procedure set out in Article 3.2 of Regulation 1831/2003
‘For experiments for scientific purposes, Member States may authorise the use, as additives, of
substances which are not authorised at Community level, with the exception of antibiotics, provided
that the experiments are carried out in accordance with the principles and conditions laid down in
[Regulation 429/2008] or the guidelines set out in Article 7(4) of this Regulation and provided that
there is adequate official supervision. The animals concerned may be used for food production only
if the authorities establish that this will have no adverse effect on animal health, human health or
the environment.’ Such feeding trials can only be performed only where the conditions of Regulation
1831/2003 are met. This document is intended to guide and inform potential applicants, to facilitate
a quick response to requests, and to help maintain consumer, animal and environmental safety.
Important Information: This Department requests a copy of confirmation from the Irish Health
Products Regulatory Authority (HPRA; https://www.hpra.ie/homepage/veterinary/scientific-animalprotection) indicating if your proposed feeding trial does/does not require authorisation in line with
SI 543 of 2012.
Procedure for applications under Article 3.2 Regulation 1831/2003
1. The applicant must provide the HPRA response indicating if you have any requirements in
line with SI 543 of 2012.
2. The applicant must provide DAFMs Animal Feed Division with a formal request for
agreement to undertake the trial (Annex I), together with a copy of a full and complete trial
protocol (Annex II). Where the produce from the trial animals is intended for food use, an
assessment of the risk to the consumer, the environment, and to the animals themselves will
be required from the applicant (Annex III).
3. All information will be treated as commercial-in-confidence, unless a significant safety issues
arises.
4. We will assess the information provided, and give our comments to the applicant as soon as
possible. This will normally be within one week. Our initial advice might include a request
to modify the protocol by providing more information.
5. Our agreement would be notified to the applicant via return of a modified copy of the form.
This would indicate any particular additional conditions that would apply to the trial (e.g.
animal produce not for food use), and would provide contact details for the local authority
that covers the trial establishment, if applicable.
6. The experimental feed additive, and any premixtures and/or feed containing them should be
labelled in order to ensure that they are not used outside the trial. The applicant or
researcher should keep records of the fate of any unconsumed materials.
7. DAFM must be informed immediately of any adverse reactions encountered during the trial.
In addition, we would ask for a brief report from the applicant on completion of the trial.
This would set out a summary of the results of the trial, and any problems encountered.
Once again, this will be treated in confidence.
For further information please contact:
Mary Canty, BAgrSc, PhD, MSc,
Agricultural Inspector,
Feedingstuffs, Fertiliser, Grain and Poultry Division,
Department of Agriculture, Food and the Marine,
Administration Building,
Backweston Campus,
Youngs Cross,
Celbridge,
Co. Kildare.
Email: mary.canty@agriculture.gov.ie
Phone: +353 (0)1 5058772
Annex I: Feeding trials with unauthorised feed additives (except coccidiostats and
histomonostats)
Applicant: Please complete and email the following information to mary.canty@agriculture.gov.ie
1. part A of this form;
2. Annex II The experimental protocol; and
3. Annex III Risk assessment to cover consumer health, animal health and the environment – if
produce from the trial animals is to enter the food chain.
Part A. Applicant - please provide information relating to the following aspects of your trial
Unique identifier for the trial (e.g.
‘DAFM AFT 001)
Place(s) where the trial is to be performed
(including eircode); intended start date and
duration; full contact details for person
responsible for performing the trial
Sponsoring company; full contact details for
person responsible
Name and description of test additive (e.g.
‘HEnZime’, a xylanase from E. lefant CBF 600)

Who will manufacture the test additive?

How will it be incorporated into feed?

How will test additive/feed containing the
test additive be stored to prevent usage
outside of the trial?
Objective of the trial
Species or category of trial animal
Will the produce from trial animals (meat, milk,
eggs etc) be used as food? If ‘yes’, please
specify
Part B. For DAFM use only
Date received
Date receipt acknowledged to applicant
Comments on protocol
Risk assessment? (where appropriate)
HPRA Response included?
DAFM agreement for trial?
Date when applicant informed of DAFM
agreement
Specific conditions or requirements for the trial
in question
Any adverse effects notified to DAFM
Date post-trial report received
Annex II: Experimental Protocols for Animal Feeding Trials
The protocol should address the following:
Trial

A unique trial identifier

Whether the trial meets the requirements of Regulation 429/2008 (‘guidelines Regulation’)

Objective

Duration and critical dates
Contact details

Full contacts details for the sponsoring company, trial site, trial director/site manager,
veterinary consultant, feed supplier and analytical laboratory.
Animals

Origin, species, category age, gender, breeds.

Animal management, housing, grouping, separation, stocking density, environmental
conditions.

Fate of the animals at the end of the trial.

Approximate number of animals involved in the trial.
Feeds

Any pre-trial feed, or treatments.

Test additive, contraindications, current EU or other authorisations.

Feed ingredients, origin, mixing, composition, form, labelling of test additives and
premixtures and feed containing it to prevent them being used for other purposes.

Analytical details.
Procedure

Control and treatment groups.

Numbers of animals per group, selection/replacement/withdrawal parameters.

Parameters to be measured.

Data collection, recording, statistical treatment.

Veterinary/welfare inspection, health records, treatments, medication.

Procedure for deviations from protocol, unusual incidents.

Disposal and recording of unused feed.

Compliance with HPRA requirements
DAFM FFGPD RT001
Annex III: Risk assessments for animal feeding trials with unauthorised
additives (except coccidiostats and histomonostats)
Introduction
European Council and Parliament Regulation 1831/2003 Article 3.2 allows Member States to
authorise the use of feed additives that are not unauthorised at European Union (EU) level in animal
feeding trials for scientific purposes. However, it is a requirement that any such trial must be carried
out in accordance with Regulation 429/2009 (‘as regards the preparation and the presentation of
applications’). Regulation 1831/2003 permits the use of produce from animals used in the trial to
enter the food chain provided that this would have no adverse effect on consumers, animal health
or the environment.
Risk assessment
In order to help the DAFM to establish that the entry of the trial animals into the food chain would
have no adverse effects, we ask that the sponsoring company provides a risk assessment to cover
consumer health, animal health and the environment. Given the wide variation in test substances
and the trials themselves, it is difficult to advise on what would be required for each case. Clearly,
the requirements for a totally novel xenobiotic chemical would be higher than for micro-organism
product with EFSA Qualified Presumption of Safety (QPS) status. Annexes II and III of Regulation
429/2009 can be used as a guide as to what information might be included. Please indicate if the
HPRA have highlighted any concerns in this area.
DAFM FFGPD RT001