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-animal-

protection) 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.iePhone: +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 trialSponsoring 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