Step 3: Introductions that are categorised as reported

3.1: Introductions of 10 kg or less in an AICIS registration year (1 September to 31 August)

Q1. Is the total introduction volume of the chemical 10 kg or less per year? 

This is the combined volume of the chemical that you will introduce in an AICIS registration year in all your products that contain the chemical.

If yes, go to Q2. If no, go to 3.2: low-risk flavour or fragrance blend introductions, or skip to Step 4.

Q2. Is your chemical in this table below?

If no, go to Q3.

If yes, the chemical is not eligible for the reported category - introductions of 10 kg or less. The reason is because the chemical was either removed from the AICIS Inventory, or its certificate was cancelled because risks to human health or the environment could not be managed. Go to 3.2: low-risk flavour or fragrance blend introductions or skip to Step 4.

Q3. Will your chemical have an end use in cosmetics?

Note: if your chemical will be an ingredient in cosmetic products, then answer yes.

If yes, go to Q4. If no, skip to Q5.

Q4. Is your chemical prohibited or restricted in the EU or USA for use as a cosmetic or in a cosmetic?

Chemicals that are prohibited or restricted in the European Union (EU) or the United States of America (USA):

• Annex II of Regulation 1223/2009/EC on Cosmetic Products (prohibited substances)   
• Annex III of Regulation 1223/2009/EC on Cosmetic Products (restricted substances) 
• US Federal Food, Drug & Cosmetic Act (prohibited and restricted ingredients in cosmetics)

If no, go to Q5. If yes, go to 3.2: low-risk flavour or fragrance blend introductions or skip to Step 4.

Q5. As far as you know, is the chemical classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) as having:

• carcinogenicity?
• germ cell mutagenicity?
• reproductive toxicity?

Note: You could check the SDS, product information sheets, or find out from your supplier.

If no to all, go to Q6. If yes to one or more, go to 3.2: low-risk flavour or fragrance blend introductions or skip to Step 4.

Q6. As far as you know, will the chemical be introduced as a solid or in a dispersion?

Note: You could find out about the appearance from the SDS, technical data sheet or your supplier. For example, if the SDS indicates that the chemical being introduced is a liquid, answer 'no'.

If yes or unsure, go to Q7. If no, skip to Q8.

Q7. As far as you know, does the chemical consist of particles, in an unbound state or as an aggregate or agglomerate, any of which have at least one external dimension in the nanoscale (1-100 nm)?

Note: You could check if there are any claims related to the presence of particles at the nanoscale in technical data sheets and commercial labels for the product containing the chemical.

If no, go to Q8. If yes, go to 3.2: low-risk flavour or fragrance blend introductions or skip to Step 4.

Q8. Does statement A) or B) apply about your chemical?

A) As far as you know, the chemical does not contain fluorine. You could check the chemical name or INCI name to see if it indicates that the chemical contains fluorine (F), or you could check with your supplier.

B) The chemical is an inorganic salt.

If A) or B) or both apply, go to Q9. If neither apply, go to 3.2: low-risk flavour or fragrance blend introductions or skip to Step 4.

Q9. As far as you know, is your chemical persistent, bioaccumulative and toxic (PBT)?

Note: You could check the SDS or find out from your supplier. Further information on the meaning of PBT is in the Industrial Chemicals Categorisation Guidelines.

If yes, go to 3.2: low-risk flavour or fragrance blend introductions or skip to Step 4.

3.2 Low-risk flavour or fragrance blend introductions

Flavour blends are mixtures of chemicals that are formulated to impart a taste. Fragrance blends are mixtures of chemicals that are formulated to impart a scent or cover a malodour. Your introduction is categorised as reported if it meets these requirements:

• your chemical is part of a flavour or a fragrance blend and the blend is introduced either on its own, or with other chemicals
• the concentration of your chemical when it is introduced is 1% or less
• the concentration of your chemical in end-use products is 1% or less
• your chemical must not have an end use in a personal vaporiser, such as e-cigarettes
• your chemical does not have any of the hazard characteristics in the highest human health hazard band (hazard band C)
• your chemical does not have any of the hazard characteristics in the highest environment hazard band (hazard band D)
• your chemical must either be on the IFRA Transparency List at the time that your pre-introduction report is submitted, or certain information about its introduction must be given to us before you introduce the chemical, including:
  • the proper name of your chemical and its CAS number (if assigned)
  • information on known hazard characteristics
  • the maximum concentration of the chemical in the blend at introduction and end use
  • the name you use to refer to the blend

Learn more about categorisation of flavour or fragrance blend introductions

3.3 Chemicals that are used only for research and development

Your introduction is categorised as reported if all of the following apply:

• you only use your chemical for research and development, or make it available to another person who only uses it in research and development
• you don’t make your chemical available to the public in any form (whether on its own, in combination with other industrial chemicals or as part of an article)
• you use control measures to eliminate or minimise any risks to the environment and any risks to the people involved in using the chemical for research and development

and point 1 or 2 or 3 applies:

1. you will introduce more than 250 kg of your chemical in a registration year, use of your chemical will be subject to your (the introducer’s) control and you can demonstrate that your chemical is not introduced as a solid or in a dispersion. To prove that your chemical is not introduced as a solid or in a dispersion, you might have an SDS or product information sheet that indicates the appearance (for example, in liquid form).
    
2. you will introduce more than 250 kg of your chemical in a registration year, use of your chemical will be subject to your (the introducer’s) control and you can demonstrate that your chemical does not consist of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the particle size range of 1 to 100 nm. To prove that your chemical does not consist of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the particle size range of 1 to 100 nm, you might have a study report about the particle size distribution of your chemical.
    
3. you will introduce more than 10 kg, but not more than 100 kg of your chemical in a registration year.

Read our extra guidance on categorisation of chemicals introduced for research and development

Step 3 outcome

My introduction meets the criteria on this page

This means that your introduction is in the 'reported' category. Skip to 'Your obligations after categorisation' to learn about your reporting and record-keeping obligations. Alternatively, you can continue through steps 4, 5 and 6 to see if your introduction can be in the exempted category or can be categorised as another type of reported introduction.

My introduction does not meet the criteria on this page

Continue with this guide to work out if your introduction is in the exempted, reported or assessed category. Go to Step 4: Work out your introduction's risk to human health.