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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

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

24.10.2018 OFFICIAL CONTROLS: Outcome of the meeting of the Advisory Group of 10 October

Last week the European Commission organised a meeting of the Advisory Group on the Food Chain to present and discuss the implementing measures that are currently undertaken in the context of the Official Controls Regulation 2017/625.

This work involves official from various DG’s in DG Santé (Mainly G3, but also D2, E2, E4, F6, G1, G2, G4, G5 are involved). Implementing measures for 85 topics are foreseen, about 50 of which are now being elaborated. Some are advanced already, while others are only at the drafting stage. The general target date for finalisation is 14/12/2019.

The meeting specifically addressed animals and goods subject to official controls at border control posts (BCP – replacing the current Border Inspection Posts (BIP) and Designated Points of Entry (DPE’s)). Some of these measures are relevant to certain food supplements that are imported into the EU. Although not specifically covered today, this may also affect imports from UK once the BREXIT is finalised.

As you know, the OCR aims to implement a more modern system for border controls, with new terminology, a CHED (Common Health Entry Document) and integration of the various systems for reporting non-conformities (e.g. the rapid alert system for feed and food (RASFF), TRACES, Europhyt) in the IMSOC system.

The system foreseen systematic checks for high risk goods and at a risk-based frequency for low risk goods.

Below are some elements that may be of relevance for food supplements

1.           Article 47(2)a: establishment of the lists of animals and goods with CN codes, subject to systematic BCP controls.

These lists identify the animals and goods that needs systematic checks and will be based on existing listing. Plants and plant products will be included in a separate list (under the Plant Health Law). Empty gelatin capsules are no longer listed for systematic checks at BCPs.

2. Article 47(3): establishment of lists of composite products, hay and straw, subject to systematic BCP inspections.

There is no definition of composite products. The descriptions of products build on EU hygiene legislation. It is foreseen that the future system is risk-based. The current approach to exempt products to be accompanied by certificates based on a certain % of risk material (e.g. 50% for ingredients from animal origin), is not risk-based and will be replaced by a new system based on shelf-stability. The lowest risk category are shelf stable products, which will not require any document any longer or a statement from the food business operator. This will be developed in the course of 2019/2020. The current lists with exceptions will apply until 21/04/2021. This is the date the Animal Health Law becomes applicable. By that date the new conditions will apply. This is likely to result in a significant change for certain food supplements that now are subject to a health certificate despite being fit for human consumption over a prolonged period of shelf life. 

3. Article 48: Animals and goods exempted from official controls at BCPs

This implementing measure is in the drafting stage. It covers 8 categories of products.
For goods sent as trade samples or display items for exhibitions are currently exempted from BCP controls, provided they are authorised by Member States and destroyed after the exhibition. The proposal does not foresee exemptions any longer for goods of animal origin. Feed or food of non-animal origin can be imported under temporary increase of controls and provided the goods are destroyed or re-dispatched after exhibition.
For the other categories (not of relevance for food supplements) the current rules are envisaged to be kept.

4. Article 54.3: Frequencies of physical and identity checks at BCPs

The EC presented informally their ideas on this topic.
The general principles is that the frequency of documentary checks is 100%. Identity and physical checks should be carried out at a risk-based frequency. This should need to take into account data collected via the IMSOC system and the results of EC controls in third countries. The IMSOC system will recommend the frequency and random selection of consignments for checks to ensure that the risk of control is always a reality.
It is proposed to set frequency for animals and plant and plant products at 100% s today, with possibility for reduced frequency as provided in current legislation.
The MS will have to follow the frequency indicated. The individual selection of the consignments will be under MS discretion, based on their experience and data.
Depending on the profile of the goods there will be a basic frequency for inspection, that can be increased based on experience and data. The basic frequency will however never be reduced based on good track record of operators.


5. A number of other implementing measures, which are more operational for control authorities and not relevant for food supplements are also underway:

-             Article 49.5: Training of BCP staff
              This draft is quite advanced and will be published in the feedback mechanism soon. více

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.

více

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

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