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10.8.2017 Commission Decision: Cranberry not to be considered as Medical Device

This is to inform you that today the decision of the Commission was published, specifying that products containing proanthocyanidins (PAC) present in cranberry (Vaccinium macrocarpon) and presented to prevent or treat cystitis, cannot be registered as medical device any longer. This follows an opinion of the European Medicines Agency on 22 July 2016 to the effect that the principal intended action of this group of products is achieved probably by pharmacological means as metabolites of PAC and other constituents of cranberry exhibit most probably a pharmacological activity and that a mechanical mode of action of PAC is highly unlikely.

As you know, after the claims legislation came into force, a number of claims for these products have been introduced but received negative EFSA opinions. Certain companies subsequently registered their products successfully as medical devices. This possibility is now blocked and products presented for the treatment or prevention of cystitis will need to be registered as medicinal product. Cranberry food supplements can obviously remain on the market, but unfortunately so far, no health claim has been approved or been put on hold.

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17.7.2017 Italy's formal adoption of the Belfrit list notified to the Commission

This is to update you that the draft Italian plant decree recently notified to the European Commission and Member States via TRIS has now been officially translated in EN (please see attached). více

10.7.2017 Italy's formal adoption of the Belfrit list notified to the Commission

This is to inform you that Italy has notified its new plants decree to the European Commission. This is the last step in the formal adoption of the BELFRIT list by Italy.

As you know, in 2014, Italy modified its plants decree by including the BELFRIT list plants next to the Italian list in two annexes:

Annex 1 including 1212 plants
Annex 1.bis (BELFRIT) includes 1037 plants of which 122 new for Italy

Today’s notification is the merging of both list, after a period in which companies could provide data and an assessment of the plants for which data have been submitted.

The draft decree is only available in Italian for the time being. An English translation is expected soon.

You can find the information at: http://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search.detail&year=2017&num=276

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30.5.2017 VMS: Swedish assessment for maximum levels of vitamins and minerals

This is to inform you that the Swedish National Food Agency (NFA) has been commissioned by the government to investigate and, if necessary, introduce national legislation on maximum levels for vitamins and minerals in food supplements.  více

19.5.2017 ITALY: Updated guidelines for food supplements

This is to inform you that the Italian Ministry of Health has recently revised two food supplement guidelines, namely: více

18.5.2017 OTHER SUBSTANCES': Your comments welcome on Belgian draft Decree

This is to inform you that the Belgian authorities have just notified to the European Commission and Member States via TRIS a draft Ministerial decree amending the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations (notification number 2017/182/B). více

27.4.2017 IMPORT REQUIREMENTS: model health certificates for composite products

This is to inform you that the Commission has published a new Implementing Regulation (EU) 2017/731 amending model veterinary certificates for imports of certain products. The Implementing Regulation is attached to our email. více

13.4.2017 Pesticides/ Amendments of MRLs

Please note that the European Commission has recently published a series amendments regarding the maximum levels of pesticides in foods: EU Regulation 2017/ 626, 627 and 627.  více

13.4.2017 OFFICIAL CONTROLS: New Regulation published on 7 April 2017

This is to inform you that as anticipated, Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation), has today been published in the official journal of the EU. více

16.3.2017 OFFICIAL CONTROLS: New Regulation adopted on 15 March, publication expected soon

We would like to inform you that the European Parliament and the Member States in the Council have yesterday adopted the new Official Controls Regulation.  více

15.3.2017 Revision of the Free Movement of Goods Regulation

This is to inform you that this week the European Commission published a road map relating to the evaluation of the functioning of Regulation (EC) 2679/98 on the functioning of the internal market in relation to the free movement of goods among Member states. This rather old Regulation provides for general principles Member States must obey in the context of Mutual Recognition. We wonder if Member States today remember that this Regulation actually still exists. více

27.2.2017 FSE draft comments on the Belgian food supplements law (TRIS notification number 2016/615/B)

Please find herewith the final comments that we have submitted in relation to this notification.We can inform you that the stand still period for this law has been extended until 29/05/2017. více

27.2.2017 Caffeine/ Italy is moving ahead

Last July, the Parliament decided to oppose two of the four claims that the Commission wanted to authorise. The claims remain still on hold until a decision to reflect the vires of the Parliament is taken.  více

13.2.2017 Belgium publishes it new plants decree based on the BELFRIT list

We would like to inform you that the new Belgian Royal Decree amending the Decree of 29 August 1997 on the production and marketing of foods composed of plants or containing plant preparations has today been published in the Belgian Official Journal (please see attached).

The Decree amends the Annex to the previous legislation, namely:

List 1: Negative list of plants that may not be used in or as food, including food supplements [derogation possibility exists based on a case-by-case assessment by the Plant Commission].
List 2: Edible mushrooms
List 3: Positive list of plants for use in food supplements to be notified [with for certain plants conditions of use including maximum levels or warning statements].

Article 2 provides a 2 year transition period for the placing on the market of products in compliance with previous rules that do not however meet the requirements of this Decree, which immediately applies.

In terms of the content, as expected list 3 now includes a number of additional plants, counting 1026 botanical species (as compared to 685 previously).

These 343 additional plants include entries from the list of the Belfrit project, which as you know was developed with France and Italy with a view of harmonising legislations.

A small number of these, such as Griffonia simplicifolia did nonetheless not get included into the new list, presumably due to the restrictive view of the Belgian authorities with regards to potential therapeutic effects of this species.

However, in general the new list is a very positive step as it now includes a number of botanicals that where traditionally used in food supplements for instance in Italy, and will therefore facilitate the free movement of goods into Belgium for these products. Just a few examples include Ambrette (Abelmoschus moschatus), Indigo (Indigofera tinctoria) and Corn (Yucca filamentosa & schidigera).

This is great progress in the area of botanicals.

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9.2.2017 Contaminants/ MCPD-esters and glycidyl esters & Pyrrolizidine alkaloids - No decision taken

We have been informed this morning by the Commission that no decision has been taken to move ahead with the setting of maximum limits for  MCPD-esters and glycidyl esters in supplements :  The Commission and Member States both agreed with our statement that it would be premature - based on the two studies received (also attached)  - to set a limit for fish oil supplements.  We understood that data submitted by FSE has been useful for the discussion.  více

31.1.2017 Norway microorganism assessments for addition to fod supplements

This is to inform you that Norway has also recently made an assessment of microorganisms used as other substances in food supplements.

The publications include a guidance document for risk assessments of microorganisms used as “other substances” in food supplements (and other food):
http://www.english.vkm.no/dav/3d8ea0c2fb.pdf

A list of microorganisms taken into consideration is available at:
http://www.english.vkm.no/dav/d8b154fb7e.pdf

General principles for the risk assessments were literature search, hazard identification and characterisation, exposure, risk characterisation and time limitations in the conclusions. It did not take into account any claimed beneficial effects, but rather considered only possible adverse effects for the general population including vulnerable groups such as, infants and babies, pregnant and breast feeding women or those suffering from certain illnesses.

VKM referred to the EFSA QPS, and accepted the safety status as given by EFSA (list from 2015) including possible qualification criteria, provided that literature did not identify new information pertinent to safety. 

Furthermore, in the assessment VKM did not refer to any specific product or dose, but rather assessed exposure from food in general.

The terms of reference can be found at: 
http://www.english.vkm.no/dav/dfb8dde253.pdf

VKM published detailed opinions on the following strains:

Lactobacillus acidophilus: http://www.english.vkm.no/dav/84ed9e2ca9.pdf 
Lactobacillus rhamnosus: http://www.english.vkm.no/dav/09812f88bf.pdf 
Lactobacillus plantarum: http://www.english.vkm.no/dav/15129849db.pdf
Lactobacillus paracasei: http://www.english.vkm.no/dav/fa8b5bbc20.pdf 
Lactobacillus salivarius: http://www.english.vkm.no/dav/8cf84ca4c6.pdf 
Lactobacillus delbrueckii: http://www.english.vkm.no/dav/be2921b9b7.pdf 
Lactobacillus helveticus Rosell-52 ND: http://www.english.vkm.no/dav/d6c5f4a13c.pdf 
Lactobacillus casei W56: http://www.english.vkm.no/dav/c816488360.pdf 
Bacillus coagulans: http://www.english.vkm.no/dav/f4581d3fb4.pdf 
Streptococcus thermophilus: http://www.english.vkm.no/dav/fad6cc856d.pdf 
Lactococcus lactis W58: http://www.english.vkm.no/dav/48c33e06b1.pdf
Bifidobacterium spp: http://www.english.vkm.no/dav/f8faa2549b.pdf

The outcome was overall positive, with VKM concluding it ‘unlikely that microorganisms in supplements have negative health effects for healthy population with mature intestinal flora’ but noted that ‘no data on long-term adverse effects on infants and young children were identified’. 

Furthermore, VKM found ‘the evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut flora and the immune system of the growing child’ but it ‘is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term adverse effects on that development of the gut flora and the immune system of the growing child’.

As you may recall, these risk assessments, together with those on ‘other substances in food supplements and energy drinks’ should serve as a background for development of the Norwegian legislation on ‘other substances’.

We will therefore monitor developments to keep you informed.

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25.1.2017 Contaminants/ MCPD-esters and glycidyl esters & Pyrrolizidine alkaloids

Thanks to those members who have provided input. Food Supplements Europe have been in touch on this issue with GOED, the Global Organization for EPA and DHA Omega-3 for the expertise on this specific issue. You will find attached their report, shared with the Commission,  providing a comprehensive review of the  limits  of MCPD-esters and glycidyl esters in fish oil products and an analysing of the two studies circulated  for comments.  více

25.1.2017 Norway publishes the last batch of opinions relating to 'other substances'

This is to inform you that Norway has released the last batch of opinions on the safety of the following ‘other substances’:

Glycine
Creatine
Collagen
L-tyrosine
L-lysine
L-serine
L-proline
L-methionine
L-citrulline

As you may recall, these opinions are from the Norwegian Scientific Committee for Food Safety (VKM) at the request of the Norwegian Food Safety Authority, following assessment of the health risk of 38 so-called ‘other substances’ in food supplements and energy drinks. Full information, inclusing all the opinions is available here:
http://www.english.vkm.no/eway/default.aspx?pid=278&trg=Content_6444&Main_6359=6582:0:31,2568&Content_6444=6393:2169160::0:6596:1:::0:0

Overall the conclusions are positive with no safety concerns identified at the doses currently present on the market except for the daily intake of:  
Creatine at doses = or > 5 g / day in adults > 3 g / day in children 
L-tyrosine = or > 1250 mg / day in all groups
Methionine: VKM maintains the guidance level from 2013 at 210 mg / day

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16.1.2017 Poland notifies a change in its food supplements law: setting of minimum amounts for vitamins and minerals

This is to inform you that the Polish authorities have notified to the European Commission a change in their food supplements law: http://ec.europa.eu/growth/tools-databases/tris/nview.cfm?p=2017_8_EN_EN více

9.1.2017 Contaminants/ Strict limits of 3 -MCPD-esters and glycidyl esters in supplements containing fish oil - Input needed by 24 January

Please find below a request from the European Commission.The Commission is considering setting strict maximum levels for 3-MCPD esters and glycidyl esters in food supplements containing fish oil (fish body oil or fish liver oil).  více

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