Assessment of businesses that manufacture food

The food legislation requires food businesses to:

• ensure food for sale is both safe and suitable for human consumption (Food Act)
• ensure that the design and construction of food premises are 'appropriate for the activities for which the premises are used' (Standard 3.2.3 clause 3(a) of the Australia New Zealand Food Standards Code (the Code) (external site))
• take all practicable measures to process only safe and suitable food (Standard 3.2.2 clause 7 of the Code)
• ensure that food handlers and persons supervising food handling operations have skills and knowledge in food safety and food hygiene matters commensurate with their work activities (Standard 3.2.2 clause 3(1) of the Code).

Accordingly there are a number of factors that authorised officers should consider when assessing a proposal for a new food manufacturing business, including:

• type of foods to be manufactured
• risk posed by the manufacture of these foods
• design and construction of the premises to be used
• food handling skills and knowledge.

Risk assessment of food manufacturing activities

It is important to emphasise that enforcement agencies must consider the risk posed by the food manufacturing activities of any proposed food business, as this will reflect the requirements for the food premises design and construction and level of skills and knowledge. The information below is intended as a guide for authorised officers to differentiate high risk from medium and low risk activities. It is still necessary for an authorised officer to assess compliance with the outcomes based requirements of the Code from evidence obtained from the food business.

High risk activities

High risk activities include the production of:

• dairy products such as cheese, yoghurt, ice cream, custard
• protein based food including fish, meat, chicken, seafood (this includes processed meats such as smallgoods and dried meats such as beef jerky)
• food that requires temperature control including cakes with high moisture content or with cheese icing, sorbet, sushi, sandwiches, pastries, mustard, pesto, soups, savoury meals and desserts)
• food products where ingredients are not heat treated or where the product pH is greater than 4.6 which would require refrigeration once they are opened (cakes with some sauces, marinades, syrups, and salad dressings)
• food recipes that require the use of food additives
• fermented food (including kombucha tea).

Medium risk activities

Medium risk activities include the production of:

• home-made chocolates
• seeds and spice mixes
• dehydrated chillies
• fruit leather / dry fruit slices
• cooking oil including olive oil
• infused oils where fresh herbs, spices or vegetables are used as part of the finished product.

Low risk activities

Low risk activities includes the production of:

• jams, marmalades
• flour based products such as biscuits, shortbread, scones, buns, muffins and cakes which do not contain potentially hazardous foods such as cream
• nougats, fudges, meringues, Turkish delights
• repackaging spices and spice mixes including dry curry powders if ingredients are purchased from an approved food business
• pickled onions
• herb vinegars with a pH of less than 4.5
• chutneys, relishes and sauces that are heat treated by boiling or cooking
• food activities such as cake decorating, repacking of bulk packaged low risk confectionery products.

Note: Low risk activities may become high risk if food recipes require food additives to be used.

Determining the suitability of proposed premises

Standard 3.2.3 of the Code requires that food premises:

• be appropriate for the purposes for which they are used
• provide adequate space for food production and equipment
• facilitate cleaning, sanitising and maintenance
• prevent access by and harbourage of pests
• keep out dust, dirt, fumes, smoke and other contaminants.

The level of risk of the food businesses’ activities should be considered in the design and construction of a food premises, i.e. be ‘appropriate’ for the purposes of Standard 3.2.3 of the Code. Authorised officers should refer to the Food Standards Australia New Zealand (FSANZ) Safe Food Australia Guideline (external site) when assessing the appropriateness of the design and construction of a food premises.

The Code contains a number of exemptions from certain structural requirements at the discretion of the appropriate enforcement agency; specifically Standard 3.2.2 clause 17 and Standard 3.2.3 clauses 4, 10 and 14.  As outlined in the Department of Health factsheet ‘Food Prepared in Residential Premises’, the Department of Health believes that it is only appropriate to grant these exemptions to food businesses that are engaged in ‘low risk’ activities.   

Standards Australia has published “AS 4674-2004 Design, Construction and Fit-out of Food Premises”. This Standard provides guidance on design, construction and fit-out criteria for new food premises and for the renovation or alteration of existing food premises.

Assessing skills and knowledge

Clause 3 of Standard 3.2.2 of the Code requires food businesses to ensure that food handlers and people who supervise food handling operations have skills and knowledge in food safety and food hygiene matters to ensure that the food is safe.

Skills and knowledge in food safety and food hygiene must be commensurate with work activities; therefore the level of skills and knowledge required will depend on the activities of the food business. High risk activities will require greater skills and knowledge of food safety risks and how to control them compared to low risk.

Further guidance on food handling skills and knowledge can be found in the FSANZ Safe Food Australia Guideline (external site) and the FSANZ food handling skills and knowledge fact sheet available on the FSANZ website (external site).

Skills and knowledge can be assessed by an authorised officer through assessment of information provided about the food safety risks and how they will be controlled to ensure the safety of the food. This can be done by asking questions; by assessing relevant documentation (such as recipes, procedures and food safety programs); and/or by observing food handling practices.

What information should an authorised officer request from a food business to ascertain compliance with the Code?

As a part of any food business registration assessment process, authorised officers should request the following information from food businesses intending to manufacture food:

• premises design and fit-out specifications
• detailed recipes (including quantities of ingredients used)
• detailed manufacturing process explanations with temperature and time used for each cooking step
• information on:
• food storage
• cleaning procedures
• product shelf life determination (recommended to be done by a NATA accredited laboratory)
• product labelling
• food recall procedure.

The food business should also be able to demonstrate that the food produced will be safe and suitable for human consumption, which can be demonstrated through regular microbiological testing. The types of tests and acceptable microbiological limits that should be carried out are listed under Standard 1.6.1 and Schedule 27 of the Code.  Guidance on microbiological limits for food can be found on the FSANZ website (external site).

Please note authorised officers are not required to ‘approve’ foods; however, consideration of the above information is necessary to determine the risk posed by the food business and, the level of skills and knowledge needed by the food business in order to achieve compliance with the requirements of the Code.

What if the food business is required to have a documented food safety management system?

If the proposed food business is subject to a regulatory requirement that requires the implementation and management of a documented food safety management system such as a food safety program, an authorised officer should verify that the system meets the legislative requirements prior to registering the food business.

More information

The Environmental Health Directorate can provide assistance to enforcement agencies with risk assessing different types of foods/food businesses. For more information phone (08) 9222 2000 or email: foodsafety@health.wa.gov.au