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23.3.2020 IMPORTS: Exceptional measures for import controls


6.3.2020 HYDROXY ANTHRACENES: IMPORTANT - Analysis and request for input

We have now analysed the proposed COMMISSION REGULATION (EU) …/… 
of XXX amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives, that was published yesterday evening.
Please find below our findings together with actions we expect from our members to be able to effectively provide arguments in this consultation.

1. As we indicated, the proposal confirms what we already knew and does not contain new elements. The proposal bans all Aloe preparations without threshold for residual HAD content (Part A) and puts the other plants under scrutiny (Part C, allowing companies to provide data within the following 18 months). 

2. We would draw attention to the completely misleading title of the feedback entry: Initiative prohibiting and permitting under scrutiny certain hydroxyanthracene derivatives in food supplements.

This proposal contains measures relating to the use of these botanicals and the HAD they contain, irrespective of where these botanicals are use. It therefore covers not only food supplements, but also regular foods and alcoholic beverages. It is therefore recommended to liaise with national associations covering these food categories. Food Supplements Europe will liaise with these organisations at the EU level and try to achieve a common view on the principles of this proposed measure.

3. Whereas 2 specifies that plants containing HAD are widely used in food supplements and herbal medicinal products for their laxative effect. It does not mention that HAD are also present in preparations of these plants not used for their laxative purpose. It would be great to be able to have examples of other purposes than the laxative effect for which preparations of in particular Aloe are used for in food and food supplements.

4. Whereas 7 gives an overview of the main conclusions of the EFSA opinion, but fails to mention that the opinion was only based on limited data and that uncertainty remains. It specifies that whole leaf Aloe extract has been shown to be carcinogenic. One crucial element of our comments will be the argument that this is based on data obtained from specific whole leaf extracts that are not necessarily representative of what is being used as food ingredients. We would therefore ask for data relating to other Aloe extracts that can demonstrate that not all extracts are carcinogenic. If your members have undertaken such studies or if such studies are underway, please let us know,

5. Whereas 9 and Article 1 justify why Aloe preparations containing HAD should be included in Part A and thus be banned immediately. As we extensively have argued before, this covers all Aloe preparations, also those in which residual amounts of HAD remains (based on Aloe gel or decolorized aloe). It is imperative that a threshold is included to exclude these preparations, that are widely used in food and food supplements. Based on the outcome of our recent consultation, there is support from the Membership that FSE proposes a threshold of 0.5 ppm (expressed as Aloin on the final product). The fact that all aloe preparations are covered is new to many Member State authorities, since no draft was available before. We would urge our members now to contact their relevant food authorities to show that all aloe preparations are covered by this measure, also those that only contain HAD as unavoidable impurities and defend and exclusion based on our propose threshold.

6. Article 1 clearly specifies the substances that are covered by the ban (PartA):
‘aloe-emodin and all extracts in which this substance is present’;
‘emodin and all extracts in which this substance is present’;
‘extracts from the leaf of Aloe species containing hydroxyanthracene derivatives’;
‘danthron and all extracts in which this substance is present’.

What is not clear, as expressed also in Recital 10, is if emodin, aloe-emodin and danthron are also present in the plants included in Part C. If so, this would lead to legal uncertainty as to whether these preparations are banned or under scrutiny. Any data on the presence of emodin, aloe-emodin and danthron in these plants is therefore essential to address this issue. Please let us know if you have such data from your membership.

7. Article 1 also specifies what plants and their preparations are covered by part C (under scrutiny):
‘extracts from the root, rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives’;
‘extracts from the leaf, fruit of Cassia senna L. containing hydroxyanthracene derivatives’;
‘extracts from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives’.
It is imperative that extracts from the leaf of Aloe spp containing hydroxyanthracene derivatives are also included in part C, as the uncertainty also applies to such preparations and companies should have the possibility to provide data showing safety of these preparations. 
As we have communicated to the Commission before, this should at least be the case for Aloe extracts providing a daily intake of HAD up to 10 mg. 
This is of equal importance as the threshold for excluding preparations with residual HAD content from the proposal and we would therefore ask our members to also raise this with national authorities to gain support that not all aloe preparations are immediately banned.

8. Finally, as you can seem, there is no transition measure foreseen. In order to be able to provide input into this, we would appreciate if you could inform us of the typical shelf life of products containing the plants under consideration.

Next steps:

We would ask our members to provide us with all relevant information and data by 19 March to enable us to consolidate the input in detailed comments to be submitted. We have a meeting planned with Commissioner Kyriakides’ Cabinet on 20 March, during which we can raise our concerns already. více

25.2.2020 HYDROXYANTHRACENES (HAD): proposed threshold

We would like to thank those of you who have provided us with data in this call. více

4.2.2020 BOTANICALS: Germany publishes the 2nd edition of its botanicals list for public consultation - Your inout requested

This is to inform you that the German BVL (Federal Office of Consumer Protection and Food Safety) has published a draft of the 2nd edition of the list of substances (Stofflisten) This publication comes with three revised Excel Annexes (2 updated lists of plants (A-K and L-Z) and 1 list of mushrooms. The new list has been elaborated with support from the Austrian and Swiss authorities and is attached for your convenience. více

20.12.2019 PYRROLIZIDINE ALKALOIDS: Update and agenda of the next EC working group meeting

This is to inform you of the outcome of the last meeting of the working group on contaminants that took place on 29 November 2019, as reported by the Dutch authorities (See attached). více

12.12.2019 CONTAMINANTS (3- MCPDs ...): Methods of Analysis

On December 9th, 2019, the Commission Implementing Regulation 2019/2093 amending Regulation (EC) No 333/2007 as regards the analysis of 3-monochloropropane-1,2-diol (3-MCPD) fatty acid esters, glycidyl fatty acid esters, perchlorate and acrylamide has been published in the Official Journal. více

6.12.2019 OFFICIAL CONTROLS : Gelatine & Collagen - List of third countries authorised for imports

An amendment to Regulation (EU) 2019/626 regarding the lists of third countries and regions thereof that are relevant for gelatine and collagen imports  has been published on the Official Journal of the EU. více


Last Friday PA was on the agenda of the Commission Working Group meeting but there was little discussion, nor progress. The levels are not bound to change and the transition period seems to be agreed at 2 years. The Commission is still waiting for more advise on analytical methods. The interservice consultation still has to start, but it is still the aim to have the text adopted at the February Standing Committee meeting, which means that it can be published after EP scrutiny and WTO notification by July 2020.

We are still working with EUROPAM via DG AGRO to achieve a higher maximum levels and longer transition period. více

18.11.2019 CONTAMINANTS : Publication of Regulations on maximum levels of erucic acid in vegetable oils & citrinin in food supplements

As expected, the Regulation regarding maximum levels of citrinin in food supplements from red rice yeast and the Regulation on maximum levels for erucic acid in vegetable oils and fats have now been published in the Official Journal  of the EU:  více

12.11.2019 MONAKOLIN K: Update on national measures

We have been informed that actions have been initiated in some Member States to request the withdrawal from the market of food supplements containing RYR monacolin K above 3 mg per daily recommended amount. This obviously follows the draft proposal by the Commission that was discussed during the meeting of the Member States experts on 14 October and in which these products are proposed to be banned (put in Part A). více

12.11.2019 PYRROLIZIDINE ALKALOIDS (PA): Meeting with DG AGRI - Call for Action

This is to inform you that on 23 October, Food Supplements Europe together with EUROPAM had a meeting with the Head of Unit in DG AGRI, responsible for food safety. The meeting was well prepared and very constructive and we trust that DG AGRI will provide input when the proposed lease will enter the Commission Inter-service Consultation.

Attached is the follow-up letter that was sent to DG AGRI, following the meeting.

Success will depend on two activities at national level:

- We will obviously need to convince the Member States. We would therefore ask our members to see if a similar initiative with farmers/growers can be initiated at national level to communicate the same messages.

- It is important to show we are active in preparing. This means that awareness to the issues of PA must be raised with companies. Our call for data and lack of responses make it painfully clear that companies and extract suppliers are not yet preparing for this measure, despite this being known for almost 2 years already. Worse, many have no idea about the level of PA in their products. We can only assume that this also means that no measures are put in place to reduce the risk of PA contamination. In particular the presence on the market of products containing high levels of PA (by the use of PA producing botanicals) is of serious concern for consumer health.

Food Supplements Europe will update its quality guide with explicit recommendations relating to PA and take further steps to raise awareness in its membership. We will do so in close collaboration with the growers of botanicals. We would ask our members to do the same. If required, we can organise a webinar for your membership to explain the issue and to raise awareness for action. Do not hesitate to call upon the Secretariat if you would need any support. více

18.10.2019 ARTICLE 8: Outcome of Working Group on food supplements meeting of October 14, 2019

This is to provide you with the information we have received regarding the outcome of yesterday’s Commission and Member States working group on food supplements.  více

10.10.2019 ARTICLE 8: Comments on betaine, D-ribose and Trans-resveratrol

As we informed you, the meeting of the Member States Working Group on food supplements is scheduled to discuss a number of article 8 issues during their meeting on 14 October.

Three new candidates include Betaine, D-Ribose and Trans-resveratrol. The discussion on these substances is fall-out from the discussions on these substances authorised as Novel Food. The reasons for the individual cases are listed below.

The Commission asked our views, if any, before the meeting. Attached are our initial comments that we have communicated. Although this is a first discussion on these substances, it would be great if members could also convey these messages to the national authority experts participating to the meeting.

For your ease, a background document for internal use is also attached, explaining the issue on these three compounds.


4.10.2019 ARTICLE 8 Substances & Dribose/betaine/transresveratrol : Agenda of Food Supplement Working Group - October 14, 2019

As indicated during our Forum Meeting this week, the EC and Members states Working Group on Food Supplements will take place on October 14, 2019. The agenda is attached for your information.  více

4.10.2019 HAD: Draft document on the importances of Aloe in the EU

Please find attached for your information and use the final document that has been shared with the Commission. více

4.10.2019 Official Controls: Outcome of the meeting with EC

Today, the FSE secretariat met with the EC officials in charge of the Official Control Regulation (Mr Gumbel, deputy head of Unit G3 and Mr Debaere, policy officer).  více

6.9.2019 GFLR: New Regulation published

This is to inform you that today, the amendment to the General Food Law Regulation has been published in the OJ as Regulation 2019/1381. It shall apply from 27 March 2021.See: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2019:231:FULL&from=EN více

30.8.2019 OFFICIAL CONTROLS : Draft Proposals for consultation


21.8.2019 CONTAMINANTS : update on adoption of proposals on citrinin in FS and erucic acid in vegetable oils

This is to inform you of that in August, the European Commission (EC) has notified to the WTO, two draft text of relevance to food supplements: the first one concerning the maximum level of erucic acid in certain foodstuffs, the second concerning the level of citrinin in red rice yeast supplements.  více

19.8.2019 SWITZERLAND: Proposed new maximum levels for nutrients in food supplements: FSE proposed comments

Please find attached the final comments that have been submitted from our side by SANI in the consultation on the new maximum levels. více


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