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Foodlaw-Reading
Dr David Jukes, The University of
Reading, UK
Providng access to food law since May 1996 |
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Last updated:
20 September, 2021
Improvement Agents: Flavourings
Providing access to EU and UK legislation
On this page:
- Summary - Overview of the development of the controls
- EU Legislation - Listing of EU Regulations covering the topic
- UK Legislation - Listing of UK Regulations covering the topic
- Guidance- Links to recommended supporting documents
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Summary
Although functionally flavourings can be considered as a category of food additive, from a legislative perspective it has been easier to deal with them separately. This recognises that the quantities used for flavouring are significantly less than for most additives (and hence the toxicity issues are different) and that the number of chemicals used as flavourings is much larger than the combined number for all other additives.
The original EU framework legislation on flavourings was agreed in 1988 with the adoption of Directive 88/388. The term 'flavouring' was defined as:
. . . 'flavouring' means flavouring substances, flavouring preparations, process flavourings, smoke flavourings or mixtures thereof.
Each of the 4 elements of this definition were also given definitions and the Directive authorised the adoption of more detailed controls on each of them. In addition, the Directives set maximum limits for certain substances used as flavourings which were known to present a risk to consumers. As a first step, the Directive was supported by Decision 88/389 which provided for the creation of an inventory of source materials and substances. Directive 88/388 was subsequently enhanced by Directive 91/71.
Work on adopting the additional controls proceeded slowly with only 2 categories being subject to specific measures:
- For 'Flavouring substances' a procedure for the creation of a register was established by Regulation 2232/96 and subsequently a register was published (Decision 1999/217). In 2000, a programme for the evaluation of the substances on the register was adopted (Regulation 1565/2000).
- For 'Smoke flavourings', Regulation 2065/2003 established general criteria and a procedure for the creation of an approved list. A subsequent Regulation (Regulation 627/2006) provided approved analytical techniques.
The current legislation on 'food flavourings' is however part of the legislative framework created for 'Improvement Agents' by EU legislation adopted in 2008. Other elements are 'food additives' and 'food enzymes' as indicated in this figure: [for information on 'Food Additives', see the separate page: Food Additives]
For the purposes of the legislation, 'flavourings' are now defined in Regulation 1334/2008 as follows:
. . . ‘flavourings’ shall mean products:
. . . (i) not intended to be consumed as such, which are added to food in order to impart or modify odour and/or taste;
. . . (ii) made or consisting of the following categories: flavouring substances, flavouring preparations, thermal process flavourings, smoke flavourings, flavour precursors or other flavourings or mixtures thereof.
Note that this refers to other sub-categories each of which is defined in the Regulation.
When adopted, Regulation 1334/2008 created an updated framework for the legislation on flavourings. The Regulation contained an Annex headed 'Annex I: Community list of flavourings and source materials approved for use in and on foods' but, on adoption, Annex I was empty. The first step was to transfer the list of approved flavouring substances from the earlier legislation (updated as appropriate). This happened in 2012 with the adoption of Regulation 872/2012 which created Part A of Annex I. The listing in Part A has subsequently been amended to take into account technical and scientific advances. With the exception of one item in Part E (see Regulation 2018/1246), Parts B-F relating to other flavouring elements have not had any substances included although transistional arrangements were established allowing the continued use of any such substances until 22 April 2018 - see Regulation 873/2012 as amended by Regulation 2018/1259.
Labelling of Flavourings
The main rules on the labelling of flavourings used in other foods are provided by Regulation 1169/2011 on the Provision of Food Information to Consumers - see in particular Annex VII, Part D. This does however refer to the definitions provided by Regulation 1334/2008. It also states that the use of the term 'natural' in describing flavourings should be based on Article 16 of Regulation 1334/2008.
For the Commission's page on Flavourings, see: Flavourings. The Commission also provides a 'Food Flavourings Database' which is an online version of Annex I.
EU Legislation
The process for authorising food additives, food enzymes and food flavourings is provided by a 'common authorisation procedure' regulation :
- Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L354, 31.12.2008, page 1)
Amendments:
- Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L231, 6.9.2019, page 1)
- Commission Implementing Regulation (EU) 2020/1823 of 2 December 2020 amending Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L406, 3.12.2020, page 43)
The specific controls for flavourings are contained in a separate regulation:
- Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L354, 31.12.2008, page 34)
Amendments
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L304, 22.11.2011, page 18) [A change consequential on the repealing of Directive 2000/13]
- Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L267, 2.10.2010, page 1)
- Commission Regulation (EU) No 545/2013 of 14 June 2013 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene (OJ L163, 15.6.2013, page 15)
- Commission Regulation (EU) No 985/2013 of 14 October 2013 amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L273, 15.10.2013, page 18)
- Commission Regulation (EU) No 246/2014 of 13 March 2014 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L74, 14.3.2014, page 58)
- Commission Regulation (EU) No 1098/2014 of 17 October 2014 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L300, 18.10.2104, page 41)
- Commission Regulation (EU) 2015/648 of 24 April 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance of N-Ethyl (2E,6Z)-nonadienamide (OJ L107, 25.4.2015, page 15)
- Commission Regulation (EU) 2015/1102 of 8 July 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L181, 9.7.2015, page 54)
- Commission Regulation (EU) 2015/1760 of 1 October 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance p-mentha-1,8-dien-7-al (OJ L257, 2.10.2015, page 27)
- Commission Regulation (EU) 2016/54 of 19 January 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards inclusion of gamma-glutamyl-valyl-glycine in the Union list of flavouring substances (OJ L13, 20.1.2016, page 40)
- Commission Regulation (EU) 2016/55 of 19 January 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L13, 20.1.2016, page 43)
- Commission Regulation (EU) 2016/178 of 10 February 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L35, 11.2.2016, page 6)
- Commission Regulation (EU) 2016/637 of 22 April 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L108, 23.4.2016, page 24)
- Commission Regulation (EU) 2016/692 of 4 May 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L120, 5.5.2016, page 7)
- Commission Regulation (EU) 2016/1244 of 28 July 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances from a group related with an alpha beta unsaturation structure (OJ L204, 29.7.2016, page 7)
- Commission Regulation (EU) 2017/378 of 3 March 2017 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L58, 4.3.2017, page 14)
- Commission Regulation (EU) 2017/1250 of 11 July 2017 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance 4,5-epoxydec-2(trans)-enal (OJ L179, 12.7.2017, page 3)
- Commission Regulation (EU) 2018/678 of 3 May 2018 amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L114, 4.5.2018, page 13)
- Commission Regulation (EU) 2018/1246 of 18 September 2018 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of pyroligneous distillate in the Union list of flavourings (OJ L235, 19.9.2018, page 3)
- Commission Regulation (EU) 2018/1482 of 4 October 2018 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards caffeine and theobromine (OJ L251, 5.10.2018, page 19)
- Commission Regulation (EU) 2018/1649 of 5 November 2018 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L275, 6.11.2018, page 7)
- Commission Regulation (EU) 2019/36 of 10 January 2019 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the substance N-(2-methylcyclohexyl)-2,3,4,5,6-pentafluorobenzamide (OJ L9, 11.1.2019, page 85)
- Commission Regulation (EU) 2019/799 of 17 May 2019 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal from the Union list of the flavouring substance furan-2(5H)-one (OJ L132, 20.5.2019, page 12)
- Commission Regulation (EU) 2020/1681 of 12 November 2020 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L379, 13.11.2020, page 27)
- Commission Regulation (EU) 2021/1532 of 17 September 2021 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione in the Union list of flavouring substances (OJ L330, 20.9.2021, page 69)
- Commission Regulation (EU) 2021/1916 of 3 November 2021 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3oxopropoxy)-2-methylquinoline-3-carboxylic acid in the Union list of flavourings (OJ L389, 4.11.2021, page 11)
- Commission Regulation (EU) 2021/1917 of 3 November 2021 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)acetamide in the Union list of flavourings (OJ L389, 4.11.2021, page 15)
- Commission Regulation (EU) 2022/1465 of 5 September 2022 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L 231, 6.9.2022, page 24)
- Commission Regulation (EU) 2022/1466 of 5 September 2022 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list (OJ L 231, 6.9.2022, page 32)
- Commission Regulation (EU) 2023/441 of 28 February 2023 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 2-hydroxy-4-methoxybenzaldehyde in the Union list of flavourings (OJ L 64, 1.3.2023, page 9)
A consolidated text is available which incorporates the amendments into the text of the Regulation. See: Regulation 1334/2008 (September 2022)
Smoke Flavourings
Note: The legislation on smoke flavourings is still based upon the controls adopted in 2003. The legislation now includes a list of authorised primary products.
- Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L309, 26.11.2003, page 1)
Amendment:
- Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (OJ L188, 18.7.2009, page 14) [Procedural changes]
- Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (OJ L198, 25.7.2019, page 241) [Provides increased authority to the Commission to adopt delegated legislation]
- Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L231, 6.9.2019, page 1)[These amendments take effect from 27 March 2021]
See also:
- Commission Regulation (EC) No 627/2006 of 21 April 2006 implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products (OJ L109, 22.4.3006, page 3)
- Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings (OJ L333, 12.12.2013, page 54)
Amendment:
- Commission Implementing Regulation (EU) 2023/952 of 12 May 2023 amending Implementing Regulation (EU) No 1321/2013 as regards the name of the holder of the authorisation for the smoke flavouring primary product ‘TradismokeTM A MAX’ (unique code SF-007) (OJ L 128, 15.5.2023, page 79)
A consolidated text of Regulation 2065/2003 is available which incorporates the amendments into the text of the Regulation. See: Regulation 2065/2003 (Note: This text is dated 27 March 2021, the date when Regulation 2019/1381 becomes effective)
UK Legislation
Brexit: Prior to the IP Completion Day (31 December 2020), the legal requirements given in the EU Regulations listed above still applied to the UK. Since IP Completion Day, the EU Regulations above have been incorporated into UK legislation but with amendments to correct deficiencies. Information on this is given below. For more details of the process of incorporating EU legislation into UK law, see the separate page: UK Food Law: EU Legislation as Amended for the UK. Provisions for the enforcement of the controls (originally the EU Regulations but now as amended) have been provided in the UK Regulations listed below. For Northern Ireland, EU rules still apply.
1 January 2021: For interim guidance, see:
EU Legislation amended for application in the UK: with links to legislation.gov.uk
- Regulation (EC) No. 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods - as amended by
- Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 860) as amended by:
- Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (SI 2020, No. 1504)
Enforcement
Requirements for implementation and enforcement are provided separately for the four parts of the United Kingdom.
- England
- Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 (SI 2013, No. 2210) as amended by:
- Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (2019, No. 860) as amended by:
- Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (SI 2020, NO. 1504)
- Wales
- Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 (SI 2013, No. 2591 (W.255)) as amended by:
- Food and Feed Regulated Products (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (SI 2019, No. 425 (W.99))
- Food (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (2019, No. 1046 (W.185))
- Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (SI 20201, No. 581 (W.331))
- Scotland
- Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013 (SSI 2013, No. 266) as amended by:
- Food Composition, Labelling and Standards (EU Exit) (Scotland) (Amendment) Regulations 2019 (SSI 2019, No. 53) as amended by:
- - Food and Feed (EU Exit) (Scotland) (Amendment) Regulations 2020 (SSI 2020, NO. 372)
- Food Information, Labelling and Standards (EU Exit) (Scotland) (Amendment) Regulations 2019 (SSI 2019, No. 285) as amended by:
- - Food and Feed (EU Exit) (Scotland) (Amendment) Regulations 2020 (SSI 2020, NO. 372)
- Northern Ireland
- Food Additives, Flavourings, Enzymes and Extraction Solvents Regulations (Northern Ireland) 2013 (SRNI 20113, No. 220) as originally amended by
- Regulated Products (Amendment) (Northern Ireland) (EU Exit) Regulations (SI 2019, No. 849)[Note: revoked by SI 2020 No. 1504]
Guidance
The following provide useful guidance to the legislation:
This page was first provided on 15 July 2016
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