Categorisation of chemicals with an end use in articles with food contact

Who should read this? 

Importers and manufacturers (introducers) of industrial chemicals (and products that are designed to release industrial chemicals) that have an end use in articles with food contact. This guidance will help you work out whether your introduction will be an exempted, reported or assessed introduction. You must read this in conjunction with our categorisation guide.  

What is an end use in an article with food contact? 

Note: This page only applies if you’re introducing chemicals that are used to manufacture articles that come into contact with food. If you’re importing finished articles with food contact, you need to read our guidance covering articles.

An industrial chemical has an end use in an article with food contact where the chemical becomes part of an article that will come into contact with food, other than:

• where the end use of the chemical is at the non-food contact surface of a glass or metal article, or
• if the food that the article will come into contact with is rainwater - where the contact with the rainwater is transient.

Note: 'Food' is defined in the Food Standards Australia New Zealand Act 1991.

Your chemical does have an end use in an article with food contact, if for example, following its introduction it becomes part of: 

• food wrapping
• food containers
• coatings on the inside of food cans
• coatings on the inside of water storage tanks

Your chemical doesn’t have an end use in an article with food contact, if for example, following its introduction it becomes part of:

• cardboard packaging that doesn’t directly contact food (the food is contained in plastic within the cardboard packaging)
• coatings on gutters (contact with rainwater is transient)

Introductions of an industrial chemical for an end use in an article with food contact are referred to as a ‘specified class of introduction’.

We have an increased level of concern for introductions of chemicals for an end use in an article with food contact because there is a potential for adverse effects if chemicals that have migrated from the article into food are ingested and absorbed into the body. The additional or different requirements arising from these concerns are outlined below.

Is this introduction listed, exempted, reported or assessed?

There are different criteria for each category and you must work out which one applies to your introduction by going through our categorisation guide, starting at 'Step 0: introductions that are in the listed category'. If your introduction does not meet the criteria for the exempted or reported category, it will be an assessed introduction.

You can find additional or different requirements you need to be aware of when working out your introduction category at:

• Step 4.4: Work out your human health hazard characteristics

Information you need to demonstrate that your chemical does not have human health hazard characteristics

If the human health exposure band for your introduction is 4, you’ll need additional or different information to show your chemical doesn’t have the following human health hazard characteristics:

• specific target organ toxicity after repeated exposure - human health hazard band B

The information you need for all other human health hazard characteristics (and introductions in other human health exposure bands) is the same as other chemical introductions.

Specific target organ toxicity after repeated exposure - human health hazard band B

If the human health categorisation volume for your introduction is greater than 100 kg, and your introduction is to be categorised as exempted or reported, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need the information that is required in Part 6.16.2 of the Categorisation Guidelines.

For example, you could show that your chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives. The human health exposure expected from the industrial use of your chemical must be no higher than the human health exposure expected from food use.

Additional record keeping obligations for exempted or reported introductions

If your introduction is of a chemical for an end use in an article with food contact, and:

• you worked out your introduction category as exempted or reported by following steps 4-6 of our categorisation guide steps, and
• your introduction is not internationally-assessed for human health, then, you must keep the following records:

Record of the chemical being approved for food contact use in another country (if applicable)

If you know that your chemical has been approved for end use in an article with food contact in another country by an agency or authority of that country, then you must keep the records that demonstrate that your chemical has been approved.

Record of the potential for your chemical to migrate to food

You need quantitative information on the extent of your chemical’s transfer from the article to food, unless any of the following apply to your chemical:

1. it has an estimated dietary exposure value less than the threshold of toxicological concern (TTC) for your chemical based on its structural class categorisation according to Cramer, or 
2. its end use, concentration at the end use, and dietary concentration associated with the end use, as applicable, are consistent with one or more of the following:
   1. the listing of the industrial chemical under Annexes I or II to Regulation (EC) No 10/2011 or Annex I to Regulation (EC) No 1935/2004 and any applicable restrictions, or 
   2. an adopted opinion on the industrial chemical by the European Food Safety Authority that is in favour of authorising the evaluated substance, or 
   3. use of the industrial chemical authorised under the United States Food and Drug Administration (US FDA) regulations, 21 FR.170-199, or
3. it is a permitted flavouring substance as defined by Standard 1.1.2 of the Food Standards Australia New Zealand Act 1991, with the dietary concentration associated with the end use of your chemical in an article with food contact less than that associated with end use as a flavouring substance, or
4. the extent of its migration was below the level of detection in a migration study conducted under conditions that simulated:
   1. the food types that will be contacted at end use, and
   2. the food contact conditions that are relevant for the end use, or
5. the No Observed Adverse Effect Level (NOAEL) in an in vivo study on your chemical or from suitable read-across information conducted:
   • for an acceptable test guideline for subacute oral toxicity - in vivo of greater than or equal to 1000 mg/kg bw/day
   • for an acceptable test guideline for subchronic oral toxicity greater - in vivo of greater than or equal to 300 mg/kg bw/day

For record keeping requirements that apply to your chemical introduction see our guidance on reporting and record keeping obligations.