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1.4.2019 MUTUAL RECOGNITION: Legislation published

Further to our discussion and the European Commission presentation in FSE Forum last week ( which we will circulate separately) , please  note that the new Regulation on Mutual Recognition of goods lawfully marketed in another Member State has been published on Friday last week in the Official Journal of the EU: více

14.3.2019 MUTUAL RECOGNITION: Update

This is to inform you that both the EP and the Council have now adopted the revised Mutual Recognition Regulation (see attached).This is a big step forward in strengthening the principle of mutual recognition, also for food supplements. Food Supplements Europe has provided essential input in these discussions and we can be glad with the outcome.

The Regulation replaces the previous Regulation 764/2008, which, as you know, was not really applied by some Member States. 

The revision includes two major improvements:

- Companies may show by means of a self-declaration that their product is lawfully marketed in a Member State. This shall be sufficient and Member States are not entitled to require further information. Member States may of course verify the veracity of the declaration, but products may be marketed already during this process.

- There is a new problem-solving procedure. If a Member State still refuses the marketing of a product, the company can turn to the SOLVIT center to try and solve the issue. If this does not succeed, the SOLVIT center may ask a formal opinion from the Commission on whether the measure imposed by the Member State is justified, necessary and proportionate. This opinion must be delivered within 45 days. This is seen as a quick non-juridical way to help solve mutual recognition issues, especially for SMEs.

Given the importance of the SOLVIT centres in this new procedure, we have invited the Commission unit responsible for SOLVIT to our next Forum meeting.

The new Regulation will apply 1 year after its publication.


14.3.2019 Issue Essential on Pyrrolizidine Alkaloids

It is our pleasure to share with you the latest Issue Essentials, that covers Pyrrolizidine Alkaloids, herewith attached.  
We know that some of these topics are complicated to follow and also to explain internally within your organisation.  We therefore hope that the attached document is very helpful in setting out simply the issue, the timelines, steps taken and the ongoing challenges. 

We trust this is useful.


4.3.2019 MICROPLASTIC in Food Supplements: Update

Following the input to our request for information, we have initiated activities to be up to speed with these developments.

We have engaged in an cross-industry platform, led by CEFIC to be in direct contact with ECHA. The platform has requested and obtained a webinar from ECHA that took place today. A list of collected questions, including ours has been shared and ECHA today provided more clarification on the scope and further planning 

ECHA confirmed that the food additives identified are covered, provided that also the other criteria are met (e.g. dimensions). However, it was clear that this was not really considered in detail yet and these applications will be assessed more closely based on the outcome of the public consultation. EHCA specified however that more information on digestion of these substances will be required to show that they are degraded and do not end up in the environment via faeces. 

The planning is as follows:

- This week (6/3): discussion and conformity check in the RAC (Committee for Risk Assessment).
- Next week (13/3): discussion and conformity check in the SEAC (Committee for Socio-Economic Analysis).
- If both are OK, the consultation will be started on 20/3.
- There is no fixed deadline for comments. Rather, ECHA will indicate when specific issues will be discussed in the committees and invite comments at an early stage. 
- On 3/4 there will be a special webinar relating to the consultation. 

ECHA would finalise its work for the Commission by March 2020.

We continue to follow this and any input that you can provide in view of the public consultation would be very welcome. We also liaise with other associations on this issue.


28.2.2019 PYRROLIZIDINE ALKALOIDS: Update on EC discussions - For input

This is to update you on the discussions that have taken place in the Commission working group on contaminants relating to pyrrolizidine alkaloids (PA).

Although the discussions have not been finalised, we can see a clear direction in the approach of the Commission, after consideration of all the comments received from the stakeholders.

For pollen-based food supplements, pollen and pollen products, there seems to be willingness to increase the limit to 500 ppb, on the basis of new data.

For food supplements however, the Commission and Member States continue to pursue the establishment of a maximum level of 400 ppb, despite our comments.

There seems to be willingness however, to review the category of the products covered. Today the category is described as: “Food supplements containing herbal ingredients excluding oils”. In the same way as oils are excluded, there is a possibility to exclude some other plant parts that are known not to contain PA (e.g. fruits) or to confine the category to leafy parts. No proposal has been voiced and any input from your side is very welcome.

There will be a further discussion on a concrete proposal during the next meeting of the working group (no date scheduled yet). The aim remains to vote on the proposal before the summer break. Given that the EP needs to be consulted, it will fall upon the new Commission to sign and publish the text by the end of this year. It is likely that a transition period will be included, but there is no indication yet for how long.

Please let us know any information that you have that can enable a further limitation of the scope of the category by end of next week (8 March). více

19.2.2019 BOTANICALS + TRANSFATS : Official minutes from the EC and Members Working Group of December 7, 2018

Further to our update below reporting on the Dutch authorities minutes from the EC and Member States working Group of December 7, please note that the official minutes from the EC have been published.  více

19.2.2019 GFLR: Agreement reached between EP and Council - Text available

Please find attached the final text agreed during the trilogue meeting of 11 February. As already confirmed by our contacts, we can see that we have been very successful in keeping the additional elements that are eligible for confidential treatment in the text.

This includes:

- Recital 28: the inclusion of the sentence: “These items should amongst others comprise the manufacturing and production process, including the method and innovative aspects thereof, as well as technical and industrial specifications, such as impurities, inherent to that process except for information which is relevant to the assessment of the safety.”

- Article 39.2(1): “the manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of the safety;”

- Articles 7 and 9: in article 12 of the Additives legislation and article 23 of the novel foods Regulation: “ In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree: 
a) where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the novel food subject to the authorisation, and detailed information on the nature and composition of the specific substances in which the applicant intends to use this novel food, except for information which is relevant to the assessment of the safety;
b) where applicable, detailed information on the variability and stability of individual production batches, except for information which is relevant to the assessment of the safety. “

- Article 39b.2 now contains a strengthened appeal process by which the applicant can challenge a decision of EFSA to disclose certain information it has requested confidentiality for.

We trust that these elements will at least offset the negative effects of early disclosure of the content of an application for authorisation (i.e. at the moment the application is considered valid or admissible).

- Also of importance is that advice on study designs is now included in the pre-submission advice. Although it is not as part of the individual meetings, EFSA has the obligation to “publish general guidance on its web-site regarding applicable rules and required content of applications and notifications, including general guidance on the design of required studies where appropriate”.

We trust this will enable a more informative discussion during such meetings.

- Finally, the possibilities to justify the absence of certain studies from the register of notified studies (Article 32b) have been widened. All studies carried out in support of an application need to be notified and an application or notification shall not be considered valid or admissible, where it is supported by studies that have not been previously notified or where previously notofoied studies are not included, unless the applicant or notifier provides a valid justification for the non-notification of such studies. In addition, the application or notification may be re-submitted, provided that the applicant or notifier notifies the studies that have not been previously notified or includes the notified studies that were not included. In that case there will be a delay of 6 months before the validation process starts.

The text is now scheduled to be adopted by the EP on 20 February, after which the final adoption by the Council will follow. více

19.2.2019 Imports Border Control : EC Consultation on Draft Regulation re Common Health Entry Document (CHED)

The EC has launched a 4 weeks consultation of stakeholders regarding its proposed Regulation on Common Health Entry Document for imports of animals and goods (See attached). více

12.2.2019 GFLR: Agreement reached between EP and Council

This is to inform you that yesterday, during the last scheduled trilogue meeting, the Council and Parliament reached a provisional agreement on the revision of the General Food Law Regulation.

Thanks to our efforts, together with FoodDrinkEurope, in the European Parliament and Council, we succeeded in improving significantly the protection of confidential data as opposed to what the Commission had proposed.

Although the agreed draft is still being finalised today and is not available, we have understood that:

- The concept of ‘innovative ideas’ is included as a concept that can be subject to confidentiality.
- Further elements are added to the list of items that can be considered confidential in sectorial legislation (e.g. novel foods, additives).
- The data will only be disclosed once the application is validated and confidential data will not be disclosed.
- There is an appeal process (confirmatory request) include by which an applicant can launch an appeal if he disagrees with EFSA's assessment of confidentiality.

The above has been confirmed by our contacts, but the final text will need to be awaited for final confirmation and an analysis of how these elements will be worded.


If this agreement is confirmed by EU ambassadors in the Committee of Permanent Representatives (Coreper), the regulation will then be submitted for approval by the European Parliament and then back to the Council for final adoption.

The new rules will enter into force on the twentieth day after their publication on the Official Journal of the European Union but will mostly apply 18 months after that date.

Attached is the press release by the Council.


12.2.2019 3-MCPD in fish oils: Update

This is to update you on the status of the setting of a maximum level for 3-MCPD and glyceryl esters in fish oil, after the consultation end of last year.

The Commission is working on a draft in which they:
- do not intend to change the levels (they will remain the same as for vegetable fat: 1000 ppb for glyceryl esters and 1200 ppb for 3-MCPD (2500 ppb for mixtures)), despite the fact that exposure to fish oil is far lower than for vegetable oils.
- Make the levels applicable to fish and oils from other marine organisms.
- Introduce a transition period until 30 June 2021.

This draft proposal is now being discussed with the Member States in the Working group.

This draft needs then to go into inter service consultation in the Commission.

There will then be a further public consultation (under the feed back mechanism) probably in April.

After that, there will then be a proposal for adoption by the Standing Committee, but it is unlikely that this will be finalised before June/July.

We continue to work with GOED to provide input in this work.


29.1.2019 Botanicals: Italy - Executive Decree of January 9, 2019 on Plants

This is to inform you that an Executive Decree of January 9, 2019 amending the Italian  ‘Decree on permitted plant substances and preparations used in food supplements of August 10, 2018’ has been published on the website of the Ministry of Health. více

21.1.2019 CONTAMINANTS: CITRININE: Reduced maximum level of citrine proposed for red yeast rice products - For your comments

This is to inform you that the European Commission is discussing a reduction of the level of Citrinine in food supplements based on Red Yeast Rice.

We understand that the level is proposed to be reduced from 2000 to 100 µg/kg. This is based on analyses from a Member State showing that levels in such products are generally very low (except for some outliers that can be rather high).

We understand this is to be brought to the Standing Committee soon and would welcome any comments from your side by 1 February at the latest.

As always, comments that this level is not feasible should be justified with analytical occurrence data.


17.1.2019 ISSUE ESSENTIAL: General Food Law Regulation Revision

Please find attached an Issue Essential covering the revision of the General Food Law Regulation.

As we have informed you, the trilogue meetings are starting this week between the Council and the European Parliament (EP). For the Council, it is the Bulgarian Presidency that takes the lead; For the EP, it is Mrs. Pilar Ayuso (EPP) who succeeds Mrs. Sommer. The ambitious aim is to reach agreement already in the course of February,

Food Supplements Europe is closely working with FoodDrinkEurope to maintain the additional elements that are eligible for confidentiality we succeeded to introduce into the Council text and support a number of amendments that were adopted by the Parliament, including:
- Am 140, ensuring that non-confidential data that is subject of a dispute is published only when the EFSA opinion is published
- Am 26,93 and 96 installing a Board of Appeal to treat disputes over confidentiality
- Am 18 and 57 that include scientific aspects in the EFSA presubmission advice
- Am 65 and 102 covering transition periods
- Am 129 ensuring a means for updating the novel foods Regulation on confidential data

We trust this is useful and will keep you further updated on progress více

17.1.2019 CONTAMINANTS: Consultations on the presence of Ergot and Tropane Alkaloids launched

Together with the consultation on pyrolizidine alkaloids, the Commission is also consulting on proposed maximum levels for ergot and tropane alkaloids. více

21.12.2018 MAXIMUM LEVELS: Updated French Guidance Levels

This is to inform you that un updated version of the French guidance document (dated January 2019) on  indicative maximum limits for vitamins and minerals in food supplementshas been released and is available on their website: více

18.12.2018 GFLR update

This is to inform you that the Council text, elaborated by the Council working group was adopted yesterday by the COREPER and will be tabled for adoption at the Agricultural and Fisheries Council next week. více

11.12.2018 TRANS FATTY ACIDS: Adoption of EC proposal by Standing Committee

On December 7, 2018 the Standing Committee has endorsed the draft Commission Regulation setting up a maximum limit to industrially produced TFA in foods in the framework of Regulation 1925/2006 and its Annex III.  více

11.12.2018 GFLR: Outcome of today's EP vote

This is to inform you that today the EP has agreed to go into inter-institutional negotiations with the Council and Commission, following their vote on the proposed revision of the General Food law Regulation.  více

11.12.2018 ARTICLE 8 SUBSTANCES : Green Tea and Monacolin K - Outcome of MS & EC Working Group of November 21

This is to inform you that the Dutch authorities have just shared their take on the working group meeting on food supplements and fortified foods of November 21, 2018 ( see attached in Dutch), which confirm the feedback we had obtained from the EC. více

3.12.2018 OTHER SUBSTANCES /NATIONAL: Belgian Decree on Other Substances in Food Supplements Published

This is to provide you with  the new Belgian Ministerial Decree (attached) amending the Ministerial Decree of 19 February 2009 on the manufacture and marketing of food supplements containing substances other than nutrients and plants or plant preparations, which was published in the Belgian Official Journal on November 19, 2018, following its adoption on October 26, 2018. více


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