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10.10.2018 GFLR: update and urgent action required

Following our discussions last week with the Council, Commission and Parliament, the status of the GFLR is as follows: 

-             All parties are still convinced to get an agreement under this term
-             Our main request on the timing of disclosure of the application is only taken up by the ENVI rapporteur, but not by the Council and remains non-negotiable for the Commission. In the EP therefore a comprise solution should be found between EPP and S&D.
-             In the Council, there may be a possibility for some changes still on the sectorial law that we can exploit and that might be acceptable for the Commission. This would include a request for additional elements to be kept confidential, as is already the case in the other sectorial legislation.

The next meeting of the Council this week on 12 October is critical. We therefore again seek your help to reach out to your national delegation participating to the discussions in the Council to ask for support for the below. Given the technicality it would be best if this would be under the form of a meeting.

It is our view that the point on confidentiality rules for both novel food, but also food improvement agents has neither adequately been addressed in the Commission proposal nor has it been appropriately been discussed at Council level. Few countries are vocal to address these rules for novel food and food improvement agents. However it is absolutely crucial that Member States understand that novel food and food improvement agents are less protected than pesticides and GMOs in the proposal and that the single reference to article 39 general food law is not sufficient to protect our products. 

We would therefore ask you to share with your national representatives attending the Council working group meeting on 12th October the amendments, which we share with FoodDrinkEurope hereby attached. 

We also would like to inform you that Food Supplements Europe met the Commission on 4th October to discuss confidentiality rules, together with a number of other affected sectors. This was to discuss in detail the content of the letter we sent in July (Attached for your convenience). We will circulate the feedback from this meeting separately.

We would be glad to hear any feedback of your activities in this regard. This is the last chance we have to make improvements in the text. více

4.10.2018 TRANS FATTY ACIDS: EC proposal for a limit - Your urgent input required

You may be aware that the Commission is proposing to limit the level of trans fats acids (TFA) in foods. The proposal is attached.

You can see that the Commission uses Article 8 of Regulation 1925/2006 to put these substances in annex III, which is interesting.

It is proposed that the content of trans fat, other than trans fat naturally occurring in animal fat, in food which is intended for the final consumer, shall not exceed 2 grams per 100 grams of fat.

The provisions would apply immediately, with a transition period for products not in compliance until 1 April 2021.

We have been made aware that this limit may pose a problem for certain food supplements.

Would you be able to check and come back urgently if this limit would not be feasible in your products? Please provide any input that you may have by 1 November.


4.10.2018 3-MCPD in fish oils: EC consultation on proposed limits - Your input requested

Here is another consultation by the European Commission. This one covers proposed levels for 3-MCPD and Glycidyl fatty acid esters in foodstuffs. více

4.10.2018 GFLR: Update on EP discussions - 1 October 2018

Attached is a report on the discussions that took place in the EP yesterday evening on the GFLR proposal, based on the 359 amendments submitted and in view of the discussions with the Shadow rapporteurs that takes place today. více

1.10.2018 ITALY: Publication of Decree on Plants

We are happy to inform you that, following its successful notification through TRIS last year ( positive opinion from the EC received in June), the Italian Decree on the use of plant substances and preparations in food supplements has been published last week in the Italian Gazzetta Ufficiale (available only in Italian):  více

18.9.2018 GLUCOSAMINE: Change in the legal status in the UK

Attached the UK CRN statement that was not attached to the below mail. více

17.9.2018 NATIONAL UPDATES: Italy - New Notification System for FS

This is to follow up on our mail below informing you that the Italian Ministry of Health had introduced a new web-based electronic notification system for food supplements and other foods that require to be notified in Italy, which has become applicable as of 2 July 2018. více

17.9.2018 CONTAMINANTS: Update one Pyrrolizidine alkaloids, 3-MCPD and Perchlorate

UPDATE 18.9.2018 více

12.9.2018 OTHER SUBSTANCES : NORWAY notifies Draft Regulations

Based on the comments received and our own analysis, please find attached the comments we intend to submit in relation to this legislation. více

10.9.2018 GLUCOSAMINE: Change in the legal status in the UK

We have been informed by CRN-UK of a change in the legal classification of food supplements containing glucosamine in the UK, that we would want to inform you of. více

10.9.2018 HAD: EFSA publishes a statement on genotoxicity assessment of chemical mixtures for public consultation - Comments to be submitted

Based on the input received, please find attached the comments that we propose to submit in this consultation (that runs until 9 September).  více

10.9.2018 HAD: Update and call for action

This is to inform you on the progress by the Commission on the article 8 measures relating to hydroxyanthracene derivatives (HAD).

The proposal to ban aloe and put the other plants in the scrutiny list is being finalised by the Commission by written procedure. There will be no further discussion in the working group since the text has been modified taking into account the comments by the MS. The text will therefore now go into inter-service consultation and then the feed back mechanism will follow. This means that the only way to have the text still modified is via the other DGs during the inter-service consultation or via the MS. This also means that the text cannot be adopted in October, but only possibly November/December.

Although we have not seen the text, the EC reassured us that products from which HAD have been removed are not covered. Any information you would be able to get from your authorities on the text of the proposal would be great.
We would like to share the proposal from the HAD task force of the following wording that we would like to have included in the proposal to ensure that this is the case:

“Whereas food supplements derived from the non-decolorized whole leaf or the latex of aloe spp., used for laxative or non-laxative purposes should be placed in part A of the Annex III;
Whereas preparations produced from aloe leaf gel and decolourised whole leaf aloe are not covered by this Regulation and should not be included in Annex III.”

We would like the support of our members to have this proposed by their national authorities. Please let us know if you can help in this respect.

Please keep us informed of any further developments.


3.9.2018 LATVIA: notification of a new law regulating the use of plants and other substances in food

his is to inform you that Latvia notified in the TRIS system (2018/421/LV) a new Regulation relating to plants, parts of plants and other substances prohibited or restricted for use in foods.

The draft, in English, is attached for your convenience.

The end of standstill period for comments is 28 November 2018.

This new Regulation seeks to introduce:
- Annex 1: a list of 62 plants and parts of plants which may not be used in foods. (Most of these plants are well known for their toxicity).
- Annex 2: a list of 16 plants and parts of plants whose use in foods is restricted. 13 species are to be used only in food supplements. This Regulation does not seem to restrict the use of other (i.e. non listed) botanicals.
- Annex 3: a list of 16 other substances with a nutritional value or physiological effect for use in food supplements. Also in this case non listed substances are not restricted. The content should be such that it does not exceed the quantity necessary to achieve the desired nutritional value or physiological effect or reach the intake considered to be therapeutic.
- Annex 4: a template of the application for the registration of a food product containing restricted use plants or parts of plants (not applicable to food supplements).
The date of proposed entry into force of the Regulation would be 1 January 2020, with only a 20 day transition period for products containing the toxic plants as listed in Annex 1 and a one year transition for products containing plants or plant parts listed in Annex 2.

Let us know if you see any issues that should be addressed by 30 September, so we can prepare comments to the EC as appropriate.


3.9.2018 GFLR: Update on GFLR in European Parliament (ENVI discussion has just started at this moment)

Please find herewith an update of the status of the revision of the General Food Law Regulation at the level of the European Parliament. více

24.8.2018 MUTUAL RECOGNITION REVISION: Update on activities in the EP and Council

This is to update you on the status of the Mutual Recognition revision. The Commission’s proposal, issued on 19 December 2017 is currently being discussed in the EP and Council under the ordinary legislative procedure.
In the EP, The IMCO committee has now all the amendments that will be discussed in the coming months. The Council also achieved an agreement under the Bulgarian presidency.

Attached is an analysis of the main outcomes of these amendments and changes.

In both cases there is broad agreement with the EC proposal. The changes proposed by the Council are more fundamental than those by the EP. Given that EP and Council focussed on different aspects, further negotiations will be required.

We are pleased to see that most of our concerns and suggestions have been taken on board, thanks to our contacts with the EC and the institutions. We would also like to thank our members for their efforts.

Our main concern was the removal of the mutual recognition procedure before the problem-solving system is initiated. This has been taken on board by the Council, but is however still open for improvements during the negotiations with the EP.

We will continue to keep up our contacts and alliances with other groups to maximise our input and keep you informed of the further timings and developments.

The next discussion in IMCO is foreseen in the session of Monday 3 September 2018, 15.00 – 18.30.

If you have a particular interest in certain aspects of this work, do not hesitate to let us know.

Attached we have also included the original proposal, the EP amendments and Council agreement for your easy reference. více

31.7.2018 CONTAMINANTS: Update on WG Contaminants July 13, 2018

This is to inform you about the outcome of the meeting of the Commission working group on agricultural contaminants of July 13, 2018 as reported by the Dutch national authorities (not an official EC report), which confirms Patrick’s recent update on contaminants (mail of July 11 below). For your convenience, we attach the Dutch authorities report available only in Dutch.  více

30.7.2018 FOOD LAW - Revision of GFLR: EP draft report published

Mrs Sommers’ draft report  on the EC proposal for a Regulation of the European Parliament and Council on the transparency and sustainability of the EU risk assessment in the food chainis now available at: více

19.7.2018 Italy - New Notification System for FS; Croatia - New Rules on edible Fats & Oils; Belgium : Recommended Methods of Analysis for Plants

This is an update on a number of recent national developments regarding food supplements:  více

11.7.2018 CONTAMINANTS: update on EU discussions and agenda of next meeting

Please find below an update on the various dossiers on contaminants that are currently being discussed at Commission level, based on feedback from the Commission and certain Member States.

-           Ochratoxin A: As you know, Food Supplements Europe submitted its comments into the public consultation in May and argued that there is no justification to set a maximum level for botanicals. The Commission discussed the outcome of this consultation with the Member States at its last meeting in June. Based on comments by the Member States, the Commission will ask EFSA for a new exposure estimate and on this basis to identify the food categories that would need to be considered.

-           Erucic acid: Also in May, Food Supplements Europe submitted its comments in the Commission consultation on this topic, indicating that the proposed limit (20 g/kg) is not feasible for borage oil. As a result, the Commission will exempt this oil, as well as camelina oil and mustard oil. Specific limits will also be proposed for infant formula (4 g/kg) and mustard (35 g/kg) (all values calculated on the total level of fatty acids)

-           Pyrrolizidine alkaloids (PA): The last meeting focused on methods of detection and the problem of the low levels of quantification. EURL (EU Reference Laboratories) will carry out a proficiency test this year. Based on the comments provided by Food Supplements Europe and Tea and Herbal Infusions Europe, several Member States also asked the Commission to investigate what reduction of levels is achievable by Good Agricultural and Collection Practices (GACP) and to promote such principles. For PA containing plants, the maximum value of 4 µg/kg (as for novel foods) is being discussed. However, this is much lower than what current occurrence data show. The occurrence of PA in spices and kitchen herbs is also being taken up in the discussions.

-           Citrinin in red yeast rice: The current maximum. level of 2000 μg/kg is proposed to be lowered to 100 μg/kg for food supplements. This is not expected to be problematic by the Commission as data communicated to the Commission by Member States show much lower levels (<10 µg/kg).

-           Perchlorate: Discussions on maximum levels continue.

-           3-MCPD(esters): Discussions on a possible level of 2500 μg/kg for all oils continue A lower level (1250 μg/kg) may be appropriate for certain oils, while for others a higher level could be adopted (3000 μg/kg). There is still a possibility that these levels will also apply to fish oil, despite the data from GOED, submitted by Food Supplements Europe.

The next meeting of the agricultural contaminants working group is on 13 July. The agenda is attached, as well as the reports of the last meeting by the UK and NL authorities. více

11.7.2018 CoQ10: Belgian scientific opinion does not support increase to 300 mg/d ion food supplements

We would like to inform you that the Belgian Superior Health Council (SHC) has published an opinion relating to a permissible maximum level of ubiquinone (CoQ10)  in food supplements (Opinion n° 9483 and 9487, available in French and Dutch):

For ubiquinone in food supplements, legal minimum (4 mg/day) and maximum (200 mg/day) levels are already applicable for food supplements. A higher level (300 mg/day) was requested by the Belgian food supplements sector. 

The SHC concluded that they do not see a reason to increase the level, as there are no scientific data showing a benefit or need to complement the diet with ubiquinone in healthy individuals, nor a preventive or curative role in certain pathologies (No health claim is authorised).

It remains to be seen what action the Belgian authorities will take, given that the opinion also does not highlight any safety concern of an intake level of 300 mg/day.



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