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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:
9 July, 2024
Fortified Foods
Providing access to the EU and UK legislation
On this page:
- Summary - Brief details of the chronology of developments linked to this topic
- EU Legislation - Listing of Regulations covering the topic
- UK Legislation - Listing of Regulations covering the topic
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Summary
The topic of Food Supplements is related to this topic but is covered on a separate page. For details, see: Food supplements.
The approach to food fortification and the imposition of legal controls by Member States has historically followed quite different routes. These have varied from strict controls placing significant limits on its use by some Member States to
an approach where controls were limited or absent allowing manufacturers much greater freedom but subject to over-riding controls requiring the production of safe products.
These differences made devising a common approach difficult but, for the purposes of helping free movement of goods, it made the need more important. Ultimately limited agreement was reached and Regulation 1925/2006 was adopted. This provides a list of of subatances (Annexes I and II) which are be permitted
for use
as vitamins and minerals. Although a procedure was included for providing maximum levels for the addition of vitamins and minerals to foods was included (Article 6 and 14(2)), no levels have so far been adopted. Until any Union-wide rules are adopted, Member States have been allowed to maintain their existing limits.
The controls also cover the addition of 'other substances'. These are defined in Article
2 as 'substances other than a vitamin or a mineral that has a nutritional or physiological effect.' A procedure is provided (Article 8) for the assessment of these other substances when their use 'would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.' The Regulation provides (in Annex III) a place for the listing of these substances (whether prohibited, restricted, or under scrutiny).Two substance have been considered for approval under these rules but, due to safety concerns, their use for fortification has been prohibited.
For the Commission's page on this topic, see: Addition of vitamins and minerals. The Commission maintains a register giving details of both the substances approved by the Regulation and the different national provisions imposing national limits (see link below).
EU Law
Framework Regulation:
- Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L404, 30.12.2006, page 26) as amended by:
- Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L39, 13.2.2008, page 11)
- Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements (OJ L314, 1.12.2009, page 36)
- Commission Regulation (EU) No 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be added to foods Text with EEA relevance (OJ L296, 15.11.2011, page 29)
- 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 .... (OJ L304, 22.11.2011, page 18)
- Commission Regulation (EU) No 119/2014 of 7 February 2014 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods (OJ L39, 8.2.2014, page 44)
- Commission Regulation (EU) 2015/403 of 11 March 2015 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Ephedra species and Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) (OJ L67, 12.3.2015, page 4)
- Commission Regulation (EU) 2017/1203 of 5 July 2017 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards organic silicon (monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) added to foods and used in the manufacture of food supplements (OJ L173, 6.7.2017, page 9)
- Commission Regulation (EU) 2019/649 of 24 April 2019 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards trans fat, other than trans fat naturally occurring in fat of animal origin (OJ L110, 25.4.2019, page 17)
- Commission Regulation (EU) 2019/650 of 24 April 2019 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) (OJ L110, 25.4.2019, page 21)
- Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (OJ L96, 19.3.2021, page 6)
- Commission Regulation (EU) 2022/2340 of 30 November 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards green tea extracts containing (-)-epigallocatechin-3-gallate (OJ L 310, 1.12.2022, page 7)
- Commission Regulation (EU) 2023/1065 of 1 June 2023 amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards nicotinamide riboside chloride added to foods (OJ L 143, 2.6.2013. page 6)
- Commission Regulation (EU) 2024/1821 of 25 June 2024 amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards iron milk caseinate added to foods and used in the manufacture of food supplements (OJ L, 2024/1821, 27.6.2024)
Supporting Measures:
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Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (OJ L102, 12.4.2012, page 2) as amended by:
- Commission Implementing Regulation (EU) 2021/842 of 26 May 2021 amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny (OJ L186, 27.5.2021, page 16)
- Commission Implementing Regulation (EU) 2023/612 of 17 March 2023 amending Implementing Regulation (EU) No 307/2012 as regards certain procedures for the Union assessment of the safety of a substance or group of substances under scrutiny (OJ L 80, 20.3.2023, page 89)
- Commission Implementing Regulation (EU) No 489/2012 of 8 June 2012 establishing implementing rules for the application of Article 16 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (OJ L150, 9.6.2012, page 71)
Guidance:
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.
Guidance (from Department of Health and Social Care):
EU Legislation amended for application in the UK: with links to legislation.gov.uk
- Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food as amended by:
- Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 651) as amended by:
Enforcement
Requirements for implementation and enforcement are provided separately for the four parts of the United Kingdom.
- England
- Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 (SI 2007, No. 1631) [Revised] as amended by:
- Food Supplements (England) and Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2009 (SI 2009, No. 3251)
- Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2010 (SI 2010, No. 1886)
- Food Information Regulations 2014 (SI 2014, No. 1855)
- Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 651) as amended by:
- Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2020 (SI 2020, No. 256)
- Wales
- Scotland
- Addition of Vitamins, Minerals and Other Substances (Scotland) Regulations 2007 (SSI 2007, No. 325)
as amended by:
- Food Supplements, Vitamins, Minerals and Other Substances (Scotland) Regulations 2009 (SSI 2009, No. 438)
- Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2010
(SSI 2010, No. 308)
- Food Information (Scotland) Regulations 2014
(SSI 2014, No. 312)
- Foods for Specific Groups (Medical Foods for Infants) and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020
(SSI 2020, No. 7)
- Food Information and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020
(SSI 2020, No. 156)
- Northern Ireland
- - Addition of Vitamins, Minerals and Other Substances Regulations (Northern Ireland) 2007
(SRNI 2007, No. 301)
- Food Supplements and the Addition of Vitamins, Minerals and Other Substances (Amendment) Regulations (Northern Ireland) 2009 (SRNI 2009, No. 407)
- Addition of Vitamins, Minerals and Other Substances (Amendment) Regulations (Northern Ireland) 2010
(SRNI 2010, No. 292)
- Food Information Regulations (Northern Ireland) 2014
(SRNI 2014, No. 223)
- Food (Miscellaneous Amendments and Revocations) Regulations (Northern Ireland) 2019
(SRNI 2019, No. 5)
- Nutrition (Amendment) (Northern Ireland) (EU Exit) Regulations 2019 (SI 2019, No. 650) [revoked by SI 2020, No. 1476]
- Addition of Vitamins, Minerals and Other Substances (Amendment) Regulations (Northern Ireland) 2020
(SRNI 2020, No. 310)
This page was first provided on 8 January 2021
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