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AgVetLink June 2003

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Generally Regarded as Safe (GRAS) registers

Why do we have GRAS registers?

The ACVM Group uses GRAS registers to prevent unnecessary reassessment of substances that are considered to be of low or no regulatory interest under the ACVM Act and Regulations when they are included in a trade name product used to manage plants or animals. This means that the focus of the ACVM Group regulatory assessments can be on substances where there is insufficient knowledge and experience for them to be considered safe or where known risks occur.

Further, trade name products whose formulations consist solely of GRAS substances are usually exempted from the requirement to be registered under the ACVM Act (refer schedule 1 [10] of the ACVM Regulations 2001).

The Operational Policy explaining the GRAS process was developed in March 2003 and is available on the website ( http://www.nzfsa.govt.nz/acvm/publications/policies-procedures/gras-policy.pdf). The policy covers a number of the issues debated and agreed at that time such as the fact that GRAS listings will not be initiated by the ACVM Group unless there is a compelling public good reason.

Applying to have a substance GRAS registered

A GRAS application consists of a completed application form and nine copies of the supporting rationale. The rationale must consist of a case supporting the fact that the proposed GRAS substance is well known, is in common use and has a history of safety in the context of its use.

This can be done by reference to the GRAS register of another appropriate regulatory authority such as the US Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), or the European authorities. In this case, nine copies of the referenced entry should be submitted.

No charge is made for the GRAS application process; therefore only complete applications not requiring any significant resource input from the ACVM Group should be submitted.

Processing of applications depends upon the workloads of the staff involved and, as a result, it is not possible to give a definite timeframe for the application process. However, all applications are dealt with as quickly as possible. Applications are considered by a group of (industry) technical experts and are advised for public comment.

GRAS registers and ACVM Regulations

Currently there are three GRAS registers maintained by the ACVM Group. The GRAS Substances for Oral Nutritional Compounds and the GRAS Substances for Plant Compounds registers are found in Schedule 7 of the Agricultural Compounds and Veterinary Medicines Regulations 2001. The Veterinary Medicines Other than Oral Nutritional Compounds GRAS register is not included in the Regulations – these substances are dealt with administratively by the ACVM Group.

The purpose of these registers is to confirm to both regulators and applicants that a substance can be included in a particular trade name product and does not require repeated, in-depth assessment.

The process of modifying the GRAS registers, either adding/deleting a substance or modifying an existing entry, requires consultation with experts and the public. Those lists currently found in Regulations can be formally altered only by amendments.This process can be interrupted by other Government priorities.

Therefore, once a decision has been made to approve a substance for inclusion in Schedule 7 of the Regulations, the ACVM Group has decided to treat this substance as GRAS even though it may be some time before the Regulations are updated to include the substance.

For this reason the ACVM Group has created administrative versions of each GRAS register. These versions include all substances that are currently in Schedule 7 of the Regulations and substances that will be added to the Regulations when they are next updated. The lists are available on the website (www.nzfsa.govt.nz/acvm/registers-lists/gras/), and all substances listed here may be used as GRAS substances in the formulation of products.

Limitations applied to GRAS substances

Substances included in the registers must be used in accordance with any stated limitation and the conditions applicable to GRAS substances. Where a product contains only GRAS substances it may still require assessment depending on the characteristics of the product.

A substance declared as GRAS by the ACVM Group is considered GRAS only for the purposes of the risks stated in section 4 of the ACVM Act 1997. These substances still may pose risks that are managed under other New Zealand legislation.

Public consultation

There is currently a ‘Proposed Changes to GRAS Registers’ discussion document on the ACVM website ( http://www.nzfsa.govt.nz/acvm/publications/discussion/gras-register/gras.pdf ). You are invited to take this opportunity to comment on the appropriateness of the proposed substances. All comments should be submitted to the ACVM Group by 23 June 2003.

For further information on GRAS registers, please see the ACVM website or contact the Assessor (Technical Standards – Toxicology).