Date: 2022-06-30Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2022/1038 of 29 June 2022 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polyvinylpyrrolidone (E1201) in food for special medical purposes, in tablet and coated tablet forms (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This regulation amends Annex II to Regulation (EC) No 1333/2008, authorizing the use of polyvinylpyrrolidone (E 1201) as a food additive in food for special medical purposes in tablet and coated tablet forms. The authorization follows an application and a safety re-evaluation by the European Food Safety Authority (EFSA). This regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment of Annex II to Regulation (EC) No 1333/2008:**
* Authorizes the use of polyvinylpyrrolidone (E 1201) in food for special medical purposes, specifically in tablet and coated tablet forms.
* E 1201 will be used as a tablet binder to ensure ingredient cohesion and slow disintegration.
* The use of E 1201 is permitted "quantum satis" (as much as is needed).
* **Scope and Limitations:**
* The authorization applies to category 13.2 "Dietary foods for special medical purposes" excluding products from food category 13.1.5.
* The use of E 1201 does not automatically classify a product as a food for special medical purposes under Regulation (EU) No 609/2013.
* **Entry into Force:**
* The regulation entered into force on the twentieth day after its publication in the Official Journal of the European Union.
Impact Analysis:
Food Manufacturers producing food for special medical purposes in tablet and coated tablet forms:
* Impact: Can now use polyvinylpyrrolidone (E 1201) as a food additive in their products, within the specified conditions.
* Action Required: Ensure compliance with the regulation, including using E 1201 only in tablet and coated tablet forms for food for special medical purposes and adhering to the "quantum satis" principle.
Member States:
* Impact: Must apply the regulation and ensure its enforcement within their jurisdiction.
* Action Required: Monitor and control the use of polyvinylpyrrolidone (E 1201) in food for special medical purposes to ensure compliance with the regulation.
European Food Safety Authority (EFSA):
* Impact: EFSA's scientific opinion supported the authorization.
* Action Required: No specific action required, but may be involved in future reviews or assessments related to the use of polyvinylpyrrolidone (E 1201).
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Parliament: One of the legislative branches of the European Union.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EC No 1333/2008: A regulation of the European Parliament and of the Council on food additives.
Regulation EC No 1331/2008: A regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
polyvinylpyrrolidone E1201: A food additive authorized for use in tabletop sweeteners and food supplements.
European Food Safety Authority: The Authority reevaluated the safety of polyvinylpyr rolidone E1201 as a food additive
Brussels: The de facto capital city of the European Union, where the regulation was adopted.
L 173/56 EN Official Journal of the European Union 30.6.2022
COMMISSION REGULATION (EU) 2022/1038
of 29 June 2022
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council
as regards the use of polyvinylpyrrolidone (E1201) in food for special medical purposes, in tablet and
coated tablet forms
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008on
food additives(1), and in particular Article 10(3) thereof,
Having regard to 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(2), and in
particular Article 7(5) thereof,
Whereas:
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and
their conditions of use.
(2) That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC)
No 1331/2008, either on the initiative of the Commission or following an application.
(3) In accordance with Annex II to Regulation (EC) No 1333/2008, polyvinylpyrrolidone (E1201) is authorised for use
as a food additive in table-top sweeteners in tablets and in food supplements supplied in a solid form, excluding
food supplements for infants and young children.
(4) On 29 October 2018, an application was submitted for authorisation of the use of polyvinylpyrrolidone (E1201) as
a food additive in food for special medical purposes, in tablet and coated tablet forms, as a tablet binder. The
application was made available to the Member States pursuant to Article 4(1), second subparagraph, of Regulation
(EC) No 1331/2008.
(5) Polyvinylpyrrolidone (E 1201) was evaluated by the Scientific Committee for Food in 1990(3). In its 1 July 2020
scientific opinion(4), the European Food Safety Authority (‘the Authority’) re-evaluated the safety of polyvinylpyr
rolidone (E1201) as a food additive and considered the extension of its use in food for special medical purposes in
tablet and coated tablet forms. In that opinion, the Authority concluded that such an extension of use, at the
proposed maximum permitted level and recommended consumption level, is not expected to be of a safety concern.
(6) There is a technological need for the addition of polyvinylpyrrolidone (E1201) during the production of the tablets
for special medical purposes to strongly bind the ingredients, ensure their cohesion and slow down their
disintegration. It is therefore appropriate to authorise the use of this additive as a stabiliser of food for special
medical purposes in tablet and coated tablet forms.
(1) OJ L 354, 31.12.2008, p. 16.
(2) OJ L 354, 31.12.2008, p. 1.
(3) Report of the Scientific Committee for Food, twenty-sixth series. Report EUR 13 913.
(4) EFSA Journal 2020;18(8):6215.30.6.2022 EN Official Journal of the European Union L 173/57
(7) The authorisation of the use of polyvinylpyrrolidone (E1201) as a food additive in category 13.2 ‘Dietary foods for
special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)’ of Part E
of Annex II to Regulation (EC) No 1333/2008 does not entail the classification of a product processed with that food
additive as a food for special medical purposes under Regulation (EU) No 609/2013 of the European Parliament and
of the Council(5).
(8) Regulation (EC) No 1333/2008 should therefore be amended accordingly.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 13.2 ‘Dietary foods for special medical purposes
defined in Directive 1999/21/EC (excluding products from food category 13.1.5)’, the following entry is added:
‘E 1201 Polyvinylpyrroli- quantum satis only in tablet and
done coated tablet forms’
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 June 2022.
For the Commission
The President
Ursula VON DER LEYEN
(5) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC,
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).