Notification Detail

Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012

Notification Number: 2017/276/I (Italy)
Date received: 28/06/2017
End of Standstill: 29/09/2017 ( 29/12/2017)

Issue of comments by: Denmark
Issue of detailed opinion by: Spain
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Message 002

Communication from the Commission - TRIS/(2017) 01619
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2017/0276/I

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201701619.EN)

1. Structured Information Line
MSG 002 IND 2017 0276 I EN 28-06-2017 I NOTIF


2. Member State
I


3. Department Responsible
MINISTERO DELLO SVILUPPO ECONOMICO
Direzione generale per il mercato, la concorrenza, il consumatore, la vigilanza e la normativa tecnica
Divisione XIII - Normativa tecnica
00187 Roma - Via Sallustiana, 53
tel. +39 06 4705.5430 - .5340 - e-mail: ucn98.34.italia@mise.gov.it


3. Originating Department
MINISTERO DELLA SALUTE
Direzione generale per l'igiene e la sicurezza degli alimenti e la nutrizione
UFFICIO 4
Roma


4. Notification Number
2017/0276/I - C80A


5. Title
Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012


6. Products Concerned
Vegetable substances and preparations allowed for use in food supplements


7. Notification Under Another Act
- Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
- Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs


8. Main Content
The draft decree now notified under Directive (EU) 2015/1535, Article 12 of Regulation (EC) No 1925/2006 and Article 45 of Regulation (EU) No 1169/2011 replaces the decree of 9 July 2012, notified under No 2011/0152/I. The technical regulation consists of six articles and two annexes. The following are laid down in the draft’s enacting terms:
- the scope and purpose of the decree laying down the list of vegetable substances and preparations allowed for use in food supplements and indicating the requirements to be met to make sure that they are safe;
- reference to Annex 1 - List of vegetable substances and preparations allowed for use in food supplements, and Annex 2 - Documentation to be prepared and procedures to be followed for the use of vegetable substances and preparations in supplements;
- the notification procedure provided for in Article 10 of Legislative Decree No 169 of 21 May 2004 implementing Directive 2002/46/EC relating to food supplements shall remain in force;
- the procedures and conditions for application of the principle of mutual recognition;
- transitional and final provisions;
- the procedure for updating Annexes 1 and 2.
Annexes 1 and 2 include the list and specific indications referred to in Articles 1 and 2.


9. Brief Statement of Grounds
Under the cooperation project between Belgium, France and Italy known as ‘BELFRIT’, a list of plants eligible for use in food supplements was drawn up and submitted to the Commission and the other Member States in November 2013 during a special meeting at the head office of the Belgian competent authority.
In addition to the desire to raise the level of consumer protection by unifying the experience acquired and facilitate trade among the three Member States, the common aim of the BELFRIT project was to bring to the EU's attention the need to harmonise the issue at hand, demonstrating the feasibility of its implementation.
In order to facilitate the application of the principle of mutual recognition, the Ministerial Decree of 9 July 2012 laid down a streamlined procedure for amending Annex 1, which has allowed, by way of the Decree of the Director-General of 27 March 2014 supplementing Annex 1, for the drafting of the BELFRIT list, calling it ‘Annex 1bis’.
To give maximum visibility to the project and the results achieved, the BELFRIT list, understood as a tool open to further additions, was promptly adopted in Italy, even though several plants of the national list for aspects mainly related to their correct botanical identification were still not included in the list.
To proceed at national level with the evaluation of plants not yet included in the BELFRIT list, in order to adopt a single list, by the aforementioned Managerial Decree of 27 March 2014, a procedure was also introduced to gather data and useful items from the operators concerned.
After a prolonged evaluation by the Ministerial Commission’s botanical experts on ‘Dietetics and nutrition’, said Commission approved a single list of plants.
Compared to what has already been set out in Annex 1 to the Ministerial Decree of 9 July 2012, the new list of plants (see ‘Reference(s) to basic text(s)’) shall be accompanied by further additional label warnings similar to those already used in Belgium and France.
In conclusion, the new decree substantially reproduces the current situation vis-à-vis the range of plants that can be used in Italy in supplements, with the addition, in the cases mentioned, of new provisions to facilitate their proper use.




10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Decree of 9 July 2012: Notification No 2011/0152/I - final text;
Decree of the Director-General of 27 March 2014: attached;
Explanatory report - list of plants for which additional label warnings similar to those already used in Belgium and France are required: attached.


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft is neither a sanitary nor phytosanitary measure.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

Stakeholders Contributions

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Due to the end of standstill we are currently not accepting any further contributions for this notification via the website.


pl
  Polska Rada Leku Roślinnego on 29-09-2017
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 Sznowni Pańswto,

Polska Rada Leku Roślinnego przesyła w załączeniu uwagi do włoskiego Rozporządzenia w sprawie przepisów dotyczących stosowania substancji i przetworów roślinnych w suplementach diety zastępujące rozporządzenie Ministra Zdrowia z dnia 9 lipca 2012 r.

Notifikacja nr 2017/276/I.

Będziemy bardzo wdzięczni za przesłanie informacji o dalszych pracach nad tym rozporządzeniem.

Z poważaniem
Sekretariat Polskiej Rady Ziołowych Produktów Leczniczych.


en
  Food Supplements Europe on 28-09-2017
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 Please find attached our comments on this draft law.


en
  BPI e.V. on 13-09-2017
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Dear Madame or Sir,

 please find attached the BPI´s comments and concerns with regard to the Italian decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012, notification procedure: 2017/0276/I.

 

In case you should have any questions or need further information please do refer to my colleague:

Dr. Nicole Armbrüster

narmbruester@bpi.de

+49 30 279 09 117

 

Kind regards,

Kevin Rieger