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20.10.2020 FOOD SUPPLEMENTS for Infants and Young Children: Intensive discussions at EU level

This is to inform you about ongoing discussions relating the category of food supplements intended for infants and young children.

Discussions in the EC Expert Groups on Novel Foods, Food Additives and Food supplements show a trend in favour of restricting the use of food supplements in this age group (0-3 years of age) and possibly older children.

Novel Foods:
It is observed that novel foods are increasingly being requested for use in food supplements intended for infants and young children. This is a trend that the Novel Food experts in the Member States are very critical about. In fact there seems to be a majority of Member States that refuses to accept such products even despite a positive EFSA opinion not highlighting safety concerns.
This is currently mostly addressed by the applicant withdrawing this food category to avoid that the whole application will be rejected. 
At the meeting of the EC Expert Group (8 September), it was reported that the Expert Group holds the opinion that food supplements for infants are not acceptable if there is no nutritional need in this age group. It was recalled that under the Food for Special Groups legislation, not only the safety but also the suitability must be assessed.
Given that novel foods are generally authorised for all age groups, including infants and young children, the Commission is discussing a more systematic approach to these products.
A discussion is again tabled for the next meeting of the Expert Group on 28 October (see agenda attached).

Food Additives:
As you know, the discussion about the acceptance of food additives in this category of products is long standing and the Commission is now progressing with only three additives in one product type (Vit A-K droplets):
E 306 tocopherol-rich extract
E 307 alpha-tocopherol
E 330 citric acid
According to what is reported following the meeting of the EC Expert Group on 16 September, several Member States would want EFSA to assess the safety first and no opening is made for any other additives in any other food supplements type, despite our call. It is clear that such products are also regulated as medicinal products in certain Member States.

Food Supplements:
This was also discussed during the last meeting of the EC Expert Group on Food Supplements (28 September). One Member State argued that there is no need for such products, while the Commission indicated that in certain cases such products could be useful and that there is no legal basis for not accepting such products. Safety should be the basis, not need. The Commission did also indicate that there is no legal basis to consider ’suitability’ next to safety for such products.

This discussion is likely to continue in the various EC Expert Groups, with different outcomes depending on the experts that participate.
There is indeed no legal basis to consider the criterion of ’nutritional need’ for food supplements for infants, but the call for a change of the legislation to this effect is getting stronger.
The maximum levels discussion and EFSA’s work relating to the update of the UL will be an additional factor that can influence this discussion.

We will keep you further updated.

16.10.2020 ARTICLE 8: Minutes of the EC Expert Group of 28 September: Garcinia cambogia accepted for the Article 8 Procedure

Apart from HAD, Monocolin K and Green tea catechins, the meeting also discussed the other substances currently considered for inclusion under the Article 8 procedure. These include: více

16.10.2020 GREEN TEA CATECHINS: Minutes of the EC Expert Group of 28 September

During the EC working group meeting on food supplements of 28 September 2020, an exchange of views took place on the impending restriction of green tea catechins in food supplements. více

16.10.2020 MONACOLIN K: Minutes of the EC Expert Group of 28 September

At the EC Working Group meeting of 28 September the proposal to restrict monacolin K in food supplements was discussed by the Member States. více

16.10.2020 HAD: Report of the Meeting of the EC Working Group of 28 September and SCOPAF of 5 October

Please find herewith the minutes by the Dutch authorities of the Commission Working Group on Food Supplements or 28 September and the Standing Committee meeting of 5 October. více

7.9.2020 HYDROXY ANTHRACENES: FSE paper on technical threshold and analytical methods for HAD

Please find attached a document that was developed in support of the work the Commission has now launched to establish a technical threshold for the presence of HAD in products from which HAD are removed. více

26.8.2020 ARTICLE 8 - GREEN TEA CATECHINS: EC Proposal

We want to inform you that the European Commission is now proceeding with the measures to restrict the use of green tea catechins under the Article 8 procedure, following the EFSA opinions on both substances. více

26.8.2020 ARTICLE 8 - MONACOLIN K: EC proposal

We want to inform you that the European Commission is now proceeding with the measures to restrict the use of monacolin K under the Article 8 procedure, following the EFSA opinions on both substances.  více


This is to inform you about the actions that are currently being undertaken from our side on the issue of HAD.

As you are aware, on 22 April we submitted extensive comments in the feedback public consultation.

Given the outcome of the discussions in the Standing Committee, we wrote to the Director-General of DG Heath and Food Safety on 19 June, with arguments to strongly request that Aloe extracts are placed in Part C and not in Part A, to allow companies to provide data to show the safety of their products and given that Member States have less restrictive measures in place today. 
We also raised a number of elements that we had covered in our comments to the public consultation, e.g. relating to the threshold and analytical methods.

The Commission replied on 16 July, basically reiterating their position that the EFSA position was very clear and that therefore the measure to put Aloe extracts in Part A is fully justified. 

The reasoning provided is that Aloe extracts were considered by EFSA, without scientific uncertainty, as genotoxic and/or carcinogenic and cannot therefore be placed under Union scrutiny, as this would not be in line with the scientific assessment made by EFSA and the objective to provide high level of consumer protection. Furthermore, restricting the use of those substances would suggest that their use is safe under certain conditions and taking certain precautions. However, the safety of Aloe extracts cannot be established from the conclusions of the scientific opinion, considering in particular that EFSA has not been able to provide advice on a daily intake of HADs that does not give rise to concerns for human health. In other words, allowing the use of Aloe extracts in food, subject to certain warning statements or to an upper daily intake level, would not protect adequately consumers’ health.

The reply ignores the fact that no measures are envisaged for other regulated products containing Aloe and shows the determination of the Commission to drive their proposal through.

Building upon this, we have therefore today written to the Commission to ask what process companies should follow to demonstrate that their products are safe, since the EFSA conclusion was reached on the basis of data obtained from a limited number of specific preparations, that are not representative of all Aloe preparations that are being used in food supplements.

This is based on the fact that settled case law of the Court of Justice of the EU has established that:
-              Articles 32 and 34 of the Treaty (Free movement of goods and restrictions based on grounds of protection of the health and life of humans) also apply to the European Institutions
-              Any prohibition on the marketing of products must be accompanied by a procedure designed to allow products to be excluded from such a prohibition. Such procedure must comply with the general principles of EU law, in particular the principle of sound administration and legal certainty. It must be accessible in the sense that it must be expressly mentioned in a measure of general application which is binding on the authorities concerned. It must be capable of being completed within a reasonable time. An application to have a product excluded from a prohibition may be refused by the competent authorities only on the basis of a full assessment of the risk posed to public health by the product, established on the basis of the most reliable scientific data available and the most recent results of international research. If the procedure results in a refusal, the refusal must be open to challenge before the courts.

It is our view that for substances put in Part C of Annex III to Regulation (EC) No 1925/2006, this procedure is foreseen, as it gives companies the possibility to provide information about their product and includes a risk assessment by EFSA before any risk management measure is taken. It is not clear however, what process could be followed for products that are included by Part A.

These are arguments that can also help those Member States in support of putting Aloe extracts in Part C to maintain and strengthen their request at the next discussion and even persuade hesitating Member States to support. If you need support in communicating this to your authorities, please let us know.

On a separate work flow, we are also working on the issue of thresholds and analytical methods in view of the discussion that has been started by the Commission that we informed you about on 16 July.


23.7.2020 NANO: EFSA public consultation on a new EFSA guidance of relevance for novel foods and nutritional substances

This is to inform you that EFSA has opened a public consultation on a draft EFSA Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles (See attached). více

15.7.2020 ALLERGENS: EC Proposal on cross-contamination of allergens

This is to inform you that the Commission has published a draft amendment to the EU food hygiene legislation (Regulation (EC) No 852/2004), as to the following three aspects:

- Management of cross contact food allergen management
  (based on the recent Codex Alimentarius code of practice on food allergen management for food business operators) více

8.7.2020 HYDROXY ANTHRACENES: Official minutes of the Standing Committee meeting published

Please find herewith the official report of the Standing Committee meeting of 10 June during which the proposal on HAD was discussed (Attached).
See: https://ec.europa.eu/food/sites/food/files/safety/docs/reg-com_gfl_20200610_sum.pdf
The report confirms the feedback that we have already obtained before  více

8.7.2020 MAXIMUM LEVELS: Norway notifies changes to its Food Supplements legislation


2.7.2020 MICROPLASTICS: SEAC opinion published for public consultation

This is to inform you that, as expected the SEAC (Committee for Socio-Economic Analysis) at ECHA has now published its opinion on the restriction of microplastics for a public consultations. více

23.6.2020 PYRROLIZIDINE ALKALOIDS: FSE Guidelines published

This is to inform you that the new FSE Guidelines and recommendations to reduce the presence of Pyrrolizidine alkaloids in food supplements have been published on our website: https://foodsupplementseurope.org/publications-guidelines/ více

12.6.2020 SWITZERLAND: New maximum levels for food supplements adopted

This is to inform you that the Swiss authorities have approved amendments to various food law regulations, including the law setting maximum levels for vitamins and minerals in food supplements and fortified foods. These changes come into force on 1 July 2020.

The main elements of the changes in this law include: více

12.6.2020 HYDROXYANTHRACENES: Outcome of discussion in yesterday's Standings Committee meeting

As we have informed you, yesterday discussion took place on the proposed measure relating to HAD. It appears that the Commission has not at all taken into account the comments received in the food back mechanism and continues to strongly defend its proposal více

12.6.2020 BOTANICALS: LATVIA notifies list of plants that are prohibited for use in food

This is to inform you that Latvia has notified in the TRIS system a new draft Regulation on plants and parts of plants prohibited for use in foods (Notification 2020/322/LV)

See: http://ec.europa.eu/growth/tools-databases/tris/nview.cfm?p=2020_322_EN_EN. The draft text is attached.

We understand that from 1 January 2021 the use for human consumption of the plants listed in the annex will be prohibited. The annex includes 61 plants/species.

This notification is framed in the context of a previous notification (2018/421/LV). This draft legislation also foresaw a list of plants  whose use in foods is restricted and a list of other substances with a nutritional value or physiological effect used in food supplements. These annexes have not yet been notified.

The end of the Standstill Period is 28 August 2020. 

Any comments from your side on this list are welcome by 1 August. více

25.5.2020 PYRROLIZIDINE ALKALOIDS: FSE Guidelines and request for Benchmark approach

It is our pleasure to share with you the draft Guidelines and Recommendations to Reduce the Presence of Pyrrolizidine Alkaloids in Food Supplements that have been developed by the Botanicals Task Force. více

27.4.2020 HYDROXY ANTHRACENES: Outcome of the EC public consultation

Now the consultation on the HAD restriction proposal is closed, we have analysed the comments submitted více


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