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3.7.2019 PYRROLIZIDINE ALKALOIDS: Update and further actions

This is to update you on the status and our actions relating to the Pyrrolizidine Alkaloids proposal of the Commission.

As expected and despite our contacts with certain Member Status, the Standing Committee did not raise questions on 27 June. The Commission is therefore proceeding and will have a final discussion in the working group meeting on 6 September, to finalise the remaining technical issues.

The proposal will also be shared with us mid July to selected stakeholders for comments. It will not go in the feedback mechanism for a general public consultation. After the working group meeting it will be notified to WTO. 

The Commission is not clear yet when the proposal will go into inter-service consultation. This can be within the next 2 weeks also at a later stage.

We are now focusing our work in collaborating with EUROPAM to convince DG AGRI two voice comments into the proposal during the inter service consultation.  více

18.6.2019 GENERAL FOOD LAW : Council adopts final text

The Council has formally approved the compromise text on the Proposal for Regulation on the Transparency and Sustainability of the EU risk assessment in the food chain on June 13, 2019. This closes the adoption process of this text, which now has to be published in the Official Journal (expected on September 6, 2019). více

14.6.2019 CONTAMINANTS: PYRROLIZIDINE ALKALOIDS - Outcome of the meeting of the EC working group

As announced, last Friday we were invited to the working group on agricultural contaminants to present our arguments in favour of an approach that sets maximum levels for PA on the basis of the recommended daily amount.
We had asked for that meeting and went together with AESGP and EUROPAM.

The feedback from the Commission on the meeting shows unfortuntely that the Member States did not move from their usual approach, despite the good arguments we presented. There was little discussion and also quite a few Member States were not even present.

The proposal (the value of 400 µg did not change neither) will now be presented to the Standing Committee and them follow the usual process of inter service consultation and formal adoption. There may also still be a consultation.

There is still a possibility to change the approach, if we can convince a few important Member States. Attached is the presentation we used. We are very happy to help you in your contacts with national authorities where-ever necessary. Any feedback you could collect from their side on the meeting and the approach would be great.

I propose that we have a call to see how we can further coordinate. Would Thursday or Friday afternoon work for you? více

28.5.2019 CONTAMINANTS: PYRROLIZIDINE ALKALOIDS - Outcome of the MS working group meeting

Last Friday the EC Working Group on Agricultural Contaminants discussed Pyrrolizidine Alkaloids and in particular our position.

We are pleased to inform you that there was agreement to increase the LoQ for analysis from 5 to 10 µg/kg and that there was only limited objection to a transition period for the measure.

The Member States however have not yet accepted our approach for 1 µg/kg yet. The approach was presented by the Commission, but is quite different from what is applied today, with some Member States firmly objecting and no further support from others. We have secured however a slot during the next meeting of the Working group, on 7 June to come and present our proposal directly to the Member States.

We will now coordinate with the other associations how to present our position.

We will keep you further updated.

více

14.5.2019 PYRROLIZIDINE ALKALOIDS: Outcome of a meeting with the Commission

Yesterday Food Supplements Europe met with the European Commission to discuss our approach.
We are glad to inform you that the Commission is willing to discuss and support our approach at the next meeting of the Member States, taking place on 24 May.

1. Declaration per recommended daily amount:

- The approach was welcomed and generally supported. The Commission asked us to provide an overview of what this would mean in terns of actual content in the final product and also to provide us with examples on how the daily amount is mentioned on the label (so Member States are clear and would not differ in how they will calculate the levels).

2. Benchmark level:

- This may be difficult for the Member States to accept, but in any case a transition period will be set. 
- The Commission noted that, since the approach is based on the BMDL10, Member States could in principle consider products exceeding the levels as dangerous and take action under the General Food Law Regulation. Also for products that are specifically intended for children, they could consider exposure based on the lower body weight.

3. LoQ set at 10 mcg/kg

- There is still feedback fro the European Reference Laboratory that is expected. The LoQ will be discussed in the light of these findings.

Our agreed position therefore remains unchanged (except that we will remove ‘pollen and pollen products’, as these are not food supplements). 
This approach is supported also by AESGP and EUROPAM and we will go to the Commission together.

It is the intention of the Commission to finalise this work before the summer break. There will be a consultation on the final proposal.

Give that the Commission asked us asked to provide an overview of actual contents in final products and examples on how the daily amount is mentioned on labels, we would appreciate if you could send us labels of products from your country (products will remain anonymised). Attached is an overview, based on products that were purchased in Brussels, and we hope that with the information received, we will be able to complete this overview and provide examples to the Commission by mid next week. více

7.5.2019 TRANS FATS: clarification on Outcome of Standing Committee of April 8, 2019

Further to our e-mail below, this is to clarify the question on trans fats. The EC indicated to us that France had requested clarification as to whether conjugated fatty acids (e.g. conjugated linoleic acid) were also covered by the limit.  více

30.4.2019 PYRROLIZIDINE ALKAOIDS: Invitation to the conference call

Many thanks for the input and participation to the conference call this afternoon. Below is a short summary of the conclusions:

Question 1:
The meeting agreed that the secretariat could explore with the Commission if a maximum level expressed per daily recommended amount would be acceptable as approach to set maximum levels for PA for food supplements. A direct comparison with medicinal products should not be made but the level of 1 mcg/day would be acceptable, as it would enable more flexibility for many, but not all products than the proposed 400 mcg/kg.
If the Commission would indicate that this approach would not be acceptable for food and would stick to the per weight expression, FSE would advocate 1000 mcg/kg as maximum limit and this as a guidance level for a period of three years.

Question 2:
The meeting agreed that setting a limit for the finished product provides the most flexible approach for manufacturers in particular for products containing small amounts of botanical extracts and that setting the limit of 1000 mcg/kg for the raw materials would considerably limit this. It was remarked that the burden of analysis would be on the finished product manufacturers but also that suppliers will be sufficiently bound by specifications to take their responsibility. Food Supplements Europe would therefore not ask for a limit to be set for the raw material.

FSE will proceed to discuss this outcome with AESGP to try and arrive at a common approach.

Participants:
Robert Nielsen (Danish association)
Sharon Porter (Pfizer)
Kamal Morsali (Herbalife)
Antje Preussker (BLL)
Simone Mueler (P&G)
Marinella Trovato (ASSOERBE/SISTE)
Chi Hee Kim, Kamal Morsali, Alessandro Tschirkov (Herbalife)
Wei Qian (Amway)

We will keep you further updated,

více

30.4.2019 ISSUE ESSENTIALS on SOLVIT

It is our pleasure to share with you the latest Issue Essentials, that covers the EU SOLVIT system. 
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 system, the timelines, and steps to be taken. více

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.

více

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.

více

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.

více

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.

Next:

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.

více

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.

více

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.

více

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