- Latest available (Revised)
- Original (As adopted by EU)
Commission Delegated Regulation (EU) 2016/128Show full title
Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (Text with EEA relevance)
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Revised version PDFs
- Revised 14/05/20200.29 MB
This is a Regulation originating from the EU
This is a legislation item that originated from the EU
After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.
The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.
Changes over time for: Division PART A
Changes to legislation:
There are outstanding changes not yet made to Commission Delegated Regulation (EU) 2016/128. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to the whole legislation item and associated provisions
- Art. 8(7) inserted by S.I. 2019/651, reg. 72(5)(c) (as substituted) by S.I. 2020/1476 reg. 6(7)(b)
- Art. 9(1) words substituted in earlier amending provision S.I. 2019/651, reg. 72(6) by S.I. 2020/1476 reg. 6(7)(c)(i)
- Art. 9(2)(d) and word omitted in earlier amending provision S.I. 2019/651, reg. 72(6) by S.I. 2020/1476 reg. 6(7)(c)(ii)
PART AU.K. Food for special medical purposes developed to satisfy the nutritional requirements of infants
1.Products referred to in Article 2(1)(a) developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 1.U.K.
2.Products referred to in Article 2(1)(b) developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.U.K.
3.Maximum levels of vitamins and mineral substances present in products referred to in Article 2(1)(c) developed to satisfy the nutritional requirements of infants shall not exceed those specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.U.K.
4.Where this is not contrary to the requirements dictated by the intended use, food for special medical purposes developed to satisfy the nutritional requirements of infants shall comply with the provisions relating to other nutrients applicable to infant formula and follow-on formula, as the case may be, laid down in Commission Delegated Regulation (EU) 2016/127(1).U.K.
Table 1
Values for vitamins and minerals in food for special medical purposes developed to satisfy the nutritional requirements of infants
| a Preformed vitamin A; RE = all trans retinol equivalent. | ||||
| b Preformed niacin. | ||||
| c Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0,6 μg folic acid from food for special medical purposes. | ||||
| d Based on vitamin E activity of RRR-α-tocopherol. | ||||
| e The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. | ||||
| f Total phosphorus. | ||||
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamins | ||||
| Vitamin A (μg-RE)a | 16,7 | 43 | 70 | 180 |
| Vitamin D (μg) | 0,48 | 0,72 | 2 | 3 |
| Vitamin K (μg) | 0,24 | 6 | 1 | 25 |
| Vitamin C (mg) | 0,96 | 7,2 | 4 | 30 |
| Thiamin (μg) | 9,6 | 72 | 40 | 300 |
| Riboflavin (μg) | 14,3 | 107 | 60 | 450 |
| Vitamin B6 (μg) | 4,8 | 72 | 20 | 300 |
| Niacin (mg)b | 0,1 | 0,72 | 0,4 | 3 |
| Folate (μg-DFE)c | 3,6 | 11,4 | 15 | 47,6 |
| Vitamin B12 (μg) | 0,02 | 0,12 | 0,1 | 0,5 |
| Panthotenic Acid (mg) | 0,1 | 0,48 | 0,4 | 2 |
| Biotin (μg) | 0,24 | 4,8 | 1 | 20 |
| Vitamin E (mg α-tocopherol)d | 0,14 | 1,2 | 0,6 | 5 |
| Minerals | ||||
| Sodium (mg) | 6 | 14,3 | 25 | 60 |
| Chloride (mg) | 14,3 | 38,2 | 60 | 160 |
| Potassium (mg) | 19,1 | 38,2 | 80 | 160 |
| Calcium (mg)e | 12 | 60 | 50 | 250 |
| Phosphorus (mg)f | 6 | 24 | 25 | 100 |
| Magnesium (mg) | 1,2 | 3,6 | 5 | 15 |
| Iron (mg) | 0,07 | 0,6 | 0,3 | 2,5 |
| Zinc (mg) | 0,12 | 0,6 | 0,5 | 2,4 |
| Copper (μg) | 14,3 | 29 | 60 | 120 |
| Iodine (μg) | 3,6 | 8,4 | 15 | 35 |
| Selenium (μg) | 0,72 | 2 | 3 | 8,6 |
| Manganese (μg) | 0,24 | 24 | 1 | 100 |
| Chromium (μg) | — | 2,4 | — | 10 |
| Molybdenum (μg) | — | 3,3 | — | 14 |
| Fluoride (μg) | — | 47,8 | — | 200 |
(1)
Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (see page 1 of this Official Journal).
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Annex
PrintThis Part only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.