New restrictions on the use of certain flavouring substances
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EU proposes to limit the use of flavouring substances 2-phenyl-2-butenal, 5-methyl-2-phenyl-2-hexenal, and 4-methyl-2-phenyl-2-pentenal – WTO SPS consultation
Draft Regulation amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the introduction of restrictions on the use of certain flavouring substances
The European Commission has informed the World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee of its intention to introduce limits on use of the flavouring substances 2-phenyl-2-butenal, 5-methyl-2-phenyl-2-hexenal, and 4-methyl-2-phenyl-2-pentenal (G/SPS/N/EU/681). This is because EFSA is carrying out further evaluations on the safety of these substances for human consumption.
What is changing?
Regulation (EC) 1334/2008 (Annex I) lists flavouring substances that are authorised for use in foods in the European Union and, where necessary, restrictions on their use. There are currently no restrictions of use for the following three substances:
- 2-phenyl-2-butenal (FL-No. 05.062)
- 5-methyl-2-phenyl-2-hexenal (FL-No. 05.099)
- 4-methyl-2-phenyl-2-pentenal (FL-No. 05.100).
The Commission proposes to introduce restrictions – the quantities of the flavourings that may be used in each category of foods – as set out in the proposed Annex to the Regulation. The limits proposed are based on current use of the flavourings in food manufacturing.
EFSA’s (2022) evaluation was inconclusive regarding a possible link between these substances and aneugenicity. (Aneugenicity is a substance’s ability to cause cells to have an abnormal number of chromosomes.) Some interested companies have agreed to give EFSA additional data to enable further studies. While awaiting further evaluation, the Commission wants to ensure use of the substances is not increased.
The new restrictions are expected to apply from Q1 of 2024.
What are the major implications for exporting countries?
As the proposed restrictions reflect current use of the flavourings, this Regulation should not affect existing trade.
Exporters of foods containing the flavourings 2-phenyl-2-butenal, 5-methyl-2-phenyl-2-hexenal, and 4-methyl-2-phenyl-2-pentenal should review current use to ensure quantities do not exceed the levels proposed by this Regulation.
Regulation 1334/2008 prohibits the addition of certain natural undesirable substances to food. It also lays down maximum levels for certain substances that are naturally present in flavourings, and in food ingredients with flavouring properties, but which may raise concern for human health. The Regulation defines different types of flavourings, and lists the substances for which evaluation and approval is required.
The Union list of flavouring substances approved for use in and on foods (Regulation 872/2012) was adopted in 2012. The substances 2-phenyl-2-butenal, 5-methyl-2-phenyl-2-hexenal, and 4-methyl-2-phenyl-2-pentenal were included in the Union list of flavouring substances on the condition that safety data addressing EFSA’s concerns was submitted.
When EFSA evaluates flavouring substances, it allocates them a unique identification number called an FL-number. FL comes from “FLAVIS”, the EU’s flavouring information system. The FL-number is not used for labelling purposes (European Commission 2012).
EFSA (2022) Scientific opinion on Flavouring group evaluation 216 revision 2 (FGE.216Rev2): consideration of the genotoxicity potential of α,β‐unsaturated 2‐phenyl‐2‐alkenals from subgroup 3.3 of FGE.19. EFSA Journal, 20(8): 7420.
European Commission (2012) FAQ – Food – EU adopts list of approved flavouring substances
Regulation (EC) 1334/2008
Commission Implementing Regulation (EU) 872/2012
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