Smoke flavourings: no reauthorisation of 10 primary products

Draft Commission Implementing Regulation (EU) amending Implementing Regulation (EU) No 1321/2013 as regards the deletion of entries SF-001 to SF-010 from the Union list of authorised smoke flavouring primary products

Draft Annex

Update

The European Commission has informed the World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee that it does not intend to renew its authorisation of 10 smoke flavouring primary products due to safety concerns (G/SPS/N/EU/760).

What is changing?

Regulation 1321/2013 (Annex) lists smoke flavouring primary products that are authorised to be used in foods in the European Union.

In 2014, the European Commission authorised 10 smoke flavouring primary products for use in the EU until 1 January 2024. The Commission has refused to reauthorise these products. All 10 products (SF-001 to SF-010) will therefore be deleted from the EU list.

The EU foresees a transition period to allow producers of products that use these smoke flavourings to adjust their production processes or recipes (see Timeline).

Why?

No application was made for the renewal of products SF-007 and SF-010.

Following a series of scientific opinions by the European Food Safety Authority (EFSA 2023a–h), which identified potential safety concerns for genotoxicity, the Commission refused to renew its authorisation of the remaining eight smoke flavouring primary products (SF-001 to SF-006, SF008, and SF-009).

Timeline

Foods containing smoke flavouring primary products SF-001 to SF-006, SF-008, or SF-009 may continue to be put on the EU market in accordance with current rules until:

• 1 July 2029 for cheese and cheese products (food category 1.7), meat (8), processed fish and fishery products (9.2), fish roe (9.3) (foods for which smoke flavourings replace traditional smoking processes)
• 1 July 2026 for all other food categories.

For further information on these food categories, see Regulation 1333/2008, Annex II.

Mixtures of these smoke flavouring primary products with other food ingredients may also be placed on the market for use in the food categories listed above (with the same timelines).

SF-007 and SF-010 can no longer be used.

What are the major implications for exporting countries?

Smoke flavourings are used extensively in a wide range of food products. For exporters of foods that make use of smoke flavouring primary products, adjusting production processes may take time and require significant investment. The EU therefore foresees a transition period during which these smoke flavouring primary products can still be used (see Timeline).

Recommended Actions

Exporters of foods currently containing smoke flavouring primary products must urgently review their use of these products and aim to find alternatives within the transition period foreseen by the EU.

Background

Smoke flavourings are used as an alternative to the flavouring effects of traditional smoking, giving foods a particular taste rather than preserving them (which is the traditional aim of smoking). They are complex mixtures of chemical substances which are specifically regulated in the EU under Regulation 2065/2003.

In addition to offering an alternative to the traditional smoking process for foods such as meat, fish, and cheese, smoke flavourings are added to other food such as soups, sauces, drinks, crisps, edible ices, and confectionery (EFSA 2023i).

Only approved primary products authorised under Regulation 1321/2013 may be used to produce smoke flavourings. The genotoxic substances in smoke flavourings that have been identified by EFSA are also expected to be produced during traditional smoking (BfR 2024).

Resources

Sources

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Regulation

Draft Regulation as regards the deletion of entries SF-001 to SF-010 from the Union list of authorised smoke flavouring primary products

Draft Annex

What is changing and why?

The EU will not reauthorise 10 smoke flavouring primary products, either because no reauthorisation was requested, or because of potential safety concerns due to genotoxicity. These products will be removed from the EU list of authorised smoke flavouring primary products. However, they may still be used in food products for a certain period of time so that suppliers can adjust their production processes.

Actions

Exporters of foods currently containing smoke flavouring primary products must urgently review their use of these products and aim to find alternatives within the transition period provided by the EU.

Timeline

Foods containing smoke flavouring primary products SF-001 to SF-006, SF-008, or SF-009 may continue to be put on the EU market in accordance with current rules until:

• 1 July 2029 for cheese and cheese products (food category 1.7), meat (8), processed fish and fishery products (9.2), fish roe (9.3) (foods for which smoke flavourings replace traditional smoking processes)
• 1 July 2026 for all other food categories.

For further information on these food categories, see Regulation 1333/2008, Annex II.

Mixtures of these smoke flavouring primary products with other food ingredients may also be placed on the market for use in the food categories listed above (with the same timelines).

SF-007 and SF-010 can no longer be used

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