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Annatto (E160b) Validation

The way food additive Annatto is labelled on food products is changing. Here’s how and why Erudus will be adding a new Validation rule to accommodate the change….

What is Annatto?

Annatto is a natural food colouring isolated from the seeds of the annatto tree(Bixa orellana). Annatto is the name of the crude extract, whereas bixin is the fat-soluble colour and norbixin the water-soluble colour.

Why is a review of it needed in Erudus?

E160b becomes irrelevant for products added (manufactured) after 2 January 2021, due to Regulation 2020/771.

E160b is to change, and should be displayed instead as Annatto bixin (E 160b(i)) or Annatto norbixin (E 160b(ii)).

From Regulation:

It is appropriate to amend the Annexes to Regulation (EC) No 1333/2008. First, since Annatto bixin (E 160b(i)) and Annatto norbixin (E 160b(ii)) have different toxicological properties and, therefore, different ADIs, the food additive ‘Annatto, Bixin, Norbixin (E 160b)’ should be deleted from the Union list of authorised food additives in Part B of Annex II to that Regulation and two separate food additives, namely Annatto bixin (E 160b(i)) and Annatto norbixin (E 160b(ii)) should be listed. As a consequence, the authorised uses and conditions of use for the food additive ‘Annatto, Bixin, Norbixin (E 160b)’ should be deleted from the list of authorised conditions of use in food in Part E of Annex II to Regulation (EC) No 1333/2008, and any references to it contained in the Annexes to the Regulation should be replaced by references to the two new food additives. As regards these two new additives, their authorised uses and use levels should be laid down. On the basis of the Authority’s assessments referred to above, the uses as requested by the applicant on its last revision of the application should be authorised but only at the levels used in the third, and most conservative, use and use levels scenario thereof.

What are the changes in ingredients we will see?

The changes we’ll see are:

  • E160b becomes E160b(i) or E160b(ii)
  • annatto becomes:
  • annatto bixin
  • annatto, bixin
  • annatto norbixin
  • annatto, norbixin

When will this happen?

The changes apply to ‘new products’ added to Erudus from 2 January 2021, but below may also apply.

After the 2 January 2021 Labels and products showing E160b are ok until stock is exhausted but new products and newly produced products should show the new names.

You can find additional information from the FSA here and from the Official Journal of the European Union here.

What are Erudus doing to accommodate this change?

We’ll be introducing the following validation from 2021:

  • E160b to be flagged as entry should be E160b(i) or E160b(ii).
  • A system alert targeted to products containing E160b will be sent out as a notification to relevant users in December 2020, with a follow-up notification in the schedule for mid-to-late January. The natural update of old specifications will also ensure changes are made.