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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

26.7.2019 OTHER SUBSTANCES : NORWAY adopts Regulation following notification

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24.7.2019 OFFICIAL CONTROLS : EC Consultation on List of products subject to Border Controls

As part of the implementation of the new official Control Regulation (EU) 2017/625, the Commission is consulting stakeholders on the proposed implementing regulation laying down rules as regards the lists of animals, products of animal origin, germinal products, animal by-products and derived products and hay and straw subject to official controls at border control posts (BCPs) and amending Decision 2007/275/EC (see draft regulation and draft annex attached) .  více

24.7.2019 Netherlands notifies an amendment to their Herbal Preparation Decree

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24.7.2019 MAXIMUM LEVELS : Poland Sets MLs for certain Vitamin and Minerals

We would like to inform you that the Polish Chief Sanitary Inspectorate has recently published maximum amounts for several vitamins and minerals in food supplements for adults. více

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

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