- PDF Version ( 60K) - Print Friendly - Help

Information Requirements for Classification of Substances as Generally Recognised as Safe

1 INTRODUCTION

1.1 Purpose and scope

Many common substances known to present negligible hazards to human or animal health or the environment are used in agricultural compound trade name products both in New Zealand and around the world. The New Zealand Food Safety Authority (NZFSA) considers that repeated assessment of such substances when they are incorporated into new trade name products is not necessary.

The criteria for inclusion on the GRAS register are conservative so that substances are classified as GRAS only where they have a proven history of safety when used appropriately.

The register provides a practical means of ensuring that regulatory interest only focuses on substances that should be of concern either because they do pose hazards or because there is insufficient experience to determine whether or not the substance should be recognised as safe when incorporated into a range of products.

Under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997, the GRAS register for feed additives in oral nutritional compounds will be used to classify the feed additives that may be used in these products while allowing the products to maintain their exemption status. It must be noted that a substance declared by NZFSA to be GRAS cannot necessarily be recognised as safe when used for some purpose other than that specified on the GRAS register. The GRAS declaration only applies to regulation under the ACVM legislation, and the substance could still pose risks that are managed under other New Zealand legislation, such as the Hazardous Substances and New Organisms Act 1996 or the Food Act 1981.

1.2 Definitions and abbreviations

Definitions from the ACVM Act apply.

Feed additive: A non-nutrient substance added to a food of animals to improve the preservation, digestion, colour, palatability, texture, or nutritive value of food.

1.3 References

Agricultural Compounds and Veterinary Medicines Act 1997

Agricultural Compounds and Veterinary Medicines Regulations 2001

Hazardous Substances and New Organisms Act 1996

2 CLASSIFICATION OF SUBSTANCES AS GRAS

2.1 Substances will be considered on a case by case basis but not in regard to their inclusion in a particular trade name product. Where a feed additive is a trade name mixture only, its individual composite ingredients will be considered.

2.2 Applicants must provide a satisfactory case showing that the proposed GRAS substance is well known, in common use and has a history of safety in the context of use. A JECFA (Joint WHO/FAO Expert Committee on Food Additives) determination indicating its safety and common use can also be considered.

2.3 When incorporated into oral nutritional compounds for food-producing animals, the additive must comply with the residue requirements for compounds as stated in the current New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards. For animals not considered to enter the food chain, this requirement is waived.

2.4 When appropriately incorporated into products, the additive must not pose any risk to the welfare of animals treated or exposed. It must not pose a risk to the international trade in New Zealand primary produce, and it must not be a source of unwanted organisms or interfere with official pest control programs.

2.5 An application may include a relevant reference to the GRAS register established by an authority recognised by NZFSA as being competent. At this stage NZFSA recognises the GRAS listings in European Community Directives or in the United States Code of Federal Regulations as falling into this category.

2.6 The classification of some substances may be qualified where those substances are safe under most circumstances but may not be under certain notable and specific exceptions. Those exceptions will be stated on the GRAS register with the associated substance.

2.7 Where a substance is recognised to qualify as GRAS up to a certain final feed concentration but has not been demonstrated as safe or has reported adverse effects at a level exceeding this, a maximum final feed concentration will be incorporated into the GRAS classification.

2.8 Where current research indicates that a substance previously considered suitable for GRAS is now considered to be at risk of breaching sections 2.3 and 2.4 above from its use at required levels will be removed from the GRAS register and have its GRAS classification revoked.

3 GRAS REGISTER

3.1 NZFSA maintains one GRAS register that is designed to contain substances as feed additives in oral nutritional compounds.

This register is maintained upon the NZFSA website as an official extension to Schedule 7 of the ACVM Regulations 2001.

3.2 All GRAS registered substances are required to meet the following generic 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.

3.3 In addition to the criteria listed above, GRAS substances for inclusion in oral nutritional compounds must:

• be used in compliance with Regulation 8 and Schedule 4 of the ACVM Regulations 2001;

• have a known regulatory status, i.e. whether it is regulated in any way (both in New Zealand and overseas); and

• have no anti-nutritional properties.

3.4 Anyone may propose to NZFSA to have a substance or list of substances approved as GRAS. Because 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, NZFSA will not consider any proposal that does not have sufficient evidence provided, so that each substance can be listed with confidence.

3.5 Anyone may propose to NZFSA that a substance be reassessed in light of new information and removed from a GRAS register. A case supporting the proposal must be provided.

3.6 The ACVM Group will monitor any new information that it receives in order to establish if there is a need to amend a GRAS registered substance. For example, a reassessment may be prompted by changes in food standards set by New Zealand’s trading partners or new information that indicates that a GRAS substance can no longer be considered toxicologically acceptable and poses a risk to human health, animal welfare or trade in primary produce.

4 THE ASSESSMENT AND CLASSIFICATION PROCEDURE

4.1 Applications to include or amend a GRAS listing must be lodged on the form 77.1 ACVM 06 (Application for Alteration of Substances Generally Recognised as Safe). Completion of all applicable sections is mandatory for the application to be accepted.

4.2 Required supporting information should be structured and annotated to allow the technical assessor to identify whether the compound is suitable for GRAS list inclusion.

4.3 Applications will be presented for public consultation upon the NZFSA website for a set period of 21 days. Any comments received relating to an application will be collated and considered as part of the technical evaluation.

4.4 Applications will be reviewed by a technical expert on the suitability for inclusion onto the GRAS register. The primary areas of concern during this technical evaluation will be the assessment of the suitability of the compound to meet the following requirements:

• clearly determined chemical identity

• recorded safety in target animal species

• no indication of residues in animal commodities.

Where the technical expert feels the application does not identify the suitability of the substance to meet the above requirements, additional data will be requested.

4.5 NZFSA will make the final decision whether or not the register will be altered.

4.6 Listing a substance as GRAS will not in any way limit the obligations or power to impose regulatory control under existing legislation.

4.7 The GRAS register will be made publicly available, both in hard copy (on request and at a charge from the ACVM Group) and placed on the ACVM Group’s website. NZFSA’s decisions and the registers will be open to public scrutiny and comment.