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Classification of Substances as Generally Recognised as Safe (GRAS)

ACVM Operational Policy No 158

August 2008

Important Disclaimer

Every effort has been made to ensure the information in this report is accurate.

NZFSA does not accept any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be present, however it may have occurred.

Website

This document may be altered at any time. It was current as at the date in the footer of each page. It is recommended that anyone intending to use this document should contact the ACVM Group of NZFSA or check its website (http://www.nzfsa.govt.nz/acvm/) to confirm that it is the current version.

1 Introduction

1.1 Statutory basis for approving a substance as GRAS

Substances are determined as generally recognised as safe (GRAS) by NZFSA under section 8B of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997. This section allows NZFSA to consider compounds and products containing compounds that are listed in the online GRAS register exempt from the requirement of registration under sections 21 and 27 of the ACVM Act 1997 when they are used in a manner listed under Schedule 4 or Schedule 4a of the ACVM Regulations.

1.2 Scope

This policy, which provides a basis for carrying out assessment of a feed additive for its addition to the GRAS register, addresses:

• applications and supporting data

• receiving and considering submissions

• internal consultation and discussion

• approving or declining applications.

1.3 References

Agricultural Compounds and Veterinary Medicines Act 1997

Agricultural Compounds and Veterinary Medicines Regulations 2001

2 Purpose of Policy

This policy provides guidance to the ACVM Group when carrying out classification of a substance as GRAS to ensure that:

• assessment of supporting data is consistent against requirements

• the public has an opportunity to address new risks

• submissions and internal concerns are duly taken into account.

3 Policy

3.1 GRAS applications and supporting data

A GRAS application will be accepted only if it proposes addition of a feed additive that is identifiable by a single chemical name, taxonomic name or chemical abstract services number. Applications will not be accepted for trade name or mixture name substances.

A substance will be considered for addition to the GRAS register only when a fully completed and signed GRAS application form is submitted. Application forms and supporting data will be considered through submission in hard copy or in electronic form.

No fee will be charged for applications to include a substance on the GRAS register.

Substances are considered on a case by case basis, but not in regard to their inclusion in a particular trade name product.

The applicant must provide a satisfactory case showing that a substance proposed to be GRAS is well-known and has a history of safety in the context of use. This may include a reference to another regulatory authority’s GRAS register if that reference is relevant to what is being proposed.

The substance must be safe across a wide range of trade name products before it could be considered as GRAS. The classification of some substances may be qualified where required. Those qualifications will be stated on the GRAS register with the associated substance.

A substance is considered safe only when it is manufactured according to good manufacturing practices and used according to good feeding practices or applied/administered according to good agricultural or good clinical practices. This means that a substance can be considered safe only when it is manufactured and used in accordance with common practice.

Existing entries on registers can be reassessed in light of new information that shows that a substance should no longer be considered safe, or that its conditions should be altered.

3.2 Receiving and considering submissions

All GRAS applications will be publicly notified via the NZFSA website. Public submissions will be accepted on any notified application for a period of 15 working days after notification.

The public notification will include information on:

• how to make a submission

• what must be and what can be included in a submission, and

• when submissions must be received.

Submissions will be considered when received through hard copy or electronic form.

Receipt of a submission will be acknowledged, in writing, in the most appropriate manner (ie letter, email etc).

It is not the role of the ACVM Group to, on behalf of the applicant, investigate or resolve issues raised in submissions. The Group must not act as an advocate for the application in question. The Group must maintain a neutral position in regard to the application. However, issues raised by submitters may prompt the Group to investigate on its own behalf matters that are pertinent to the appraisal of the application.

All submissions will be provided to the peer reviewer in advance of final consideration of an application for approval.

3.3 Internal consultation and discussion

Prior to any approval of an application, the case to register the substance as GRAS will be peer reviewed by a second party within NZFSA.

If significant issues are raised over the course of appraisal and consultation of a GRAS application, the appraiser may convene an internal meeting with relevant parties to discuss the implications or concerns with approving the application.

3.4 Approving or declining an application

Where an application has been appraised, undergone public notification and been peer reviewed, it may be approved or declined.

An application that is declined may be held on file pending the submission of additional supporting data dependant on its perceived deficiencies.

When an application is approved, the substance will be considered as GRAS from the day of approval. A notification indicating that the substance has been added to the current GRAS register will be made through the New Zealand Gazette.