Generally Recognised as Safe (GRAS) substances

After consultation with interested parties MAF has established lists of substances that it considers as generally recognised as safe (GRAS). The purpose of the lists is to identify substances that have a long and well-known history of common and safe use, so that information does not have to be repeatedly provided by applicants for registration of products containing those substances. There are three lists:

1. GRAS substances as feed additives in oral nutritional compounds;
2. GRAS substances in veterinary medicines other than oral nutritional compounds; and
3. GRAS substances in plant compounds. Each list will be prefaced with general conditions that must always be met in order to consider a substance as safe.

For example, a feed additive can be considered safe only if it is incorporated into an oral nutritional compound in accordance with good manufacturing practices and good feeding practice. This includes the following restrictions:

• the quantity of the substance added to the oral nutritional compound does not exceed the amount reasonably required to accomplish its intended physical, nutritional or other technical effect; and
• the quantity of the substance that becomes a component of the oral nutritional compound as a result of its use in manufacturing, processing, or packaging, and which is not intended to accomplish any physical or other technical effect, shall be reduced to the extent reasonably possible; and
• the substance is of appropriate grade for inclusion in an oral nutritional compound, and is prepared and handled as a food ingredient.

As stated above, substances must be well-known and in common use. When appropriately incorporated into products, the substances must not exceed any of the hazards thresholds proposed by the Ministry for the Environment under the HSNO Act. There must be no concern in regard to residues in food, and they must not pose any threat to the welfare of animals treated or exposed.

In its public discussion document on the GRAS concept MAF suggested some possible substances. Now that the lists have been established, each substance will have to go through the approval process. Therefore, at this point there are no substances on any of the lists. It must be noted that the lists will be made up of substances not products (coincidentally, a substance may be marketed as a product).

Anyone may propose to MAF to have a substance or list of substances approved as GRAS. Since the establishment of the lists of substances is of general benefit with no special rights granted to the person who proposes a substance, there will be no specific charge for processing a proposal. However, MAF will not consider any proposal that does not have sufficient evidence provided by the proposer that each substance can be listed with confidence. The proposer must provide either:

• specific references that the substance has already been listed as generally recognised as safe by another MAF recognised competent authority; or
• evidence that the substance has a common and well-known history of safe use.

At this stage MAF recognises GRAS listing in European Community Directives or in the United States Code of Federal Regulations as adequate evidence of safety.

While MAF will make the decision, all proposals will be sent to a network of specialists who can advise whether a particular substance should or should not be listed as GRAS, and whether or not any special qualifier(s) must be placed on its listing. MAF has identified individuals and organisations that can provide it with the necessary advice. However, MAF will consult with anyone who wishes to participate in the expert consultative process if they can verify their competency to provide relevant advice.

After consultation with experts, MAF will advise the public what substances it intends to put on or remove from the lists prior to taking that action, and to consider any submissions received.

Requests to participate in the expert consultative process should be sent to:

Chris Boland
Special Advisor (Technical Policy)
ACVM Group
PO Box 2526, WELLINGTON
Email: bolandc@maf.govt.nz

Proposals for substances to be listed as GRAS should be sent to:

Erin Daldry
Technical Advisor
ACVM Group
PO Box 2526, WELLINGTON
Email: daldrye@maf.govt.nz