Local view for "http://purl.org/linkedpolitics/eu/plenary/2001-02-13-Speech-2-294"
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". – Mr President, I am pleased to be here tonight for your consideration of this proposal for a directive on food supplements. This proposal aims to harmonise very divergent national rules by ensuring that consumers will be able to choose from safe products bearing adequate and appropriate labelling. I would like to thank Mrs Müller for her considerable efforts to prepare this report and for her overall support for the proposal. I know that she has had a very difficult task. This is evident from the number of amendments that were tabled in the Environment Committee and the number of additional amendments tabled for Parliament.
Amendment No 7 concerns the definition of dose form. This is a highly technical matter. I understand that concern is expressed from many sources to have a workable definition that depicts current practices. This is also our aim. I can accept Amendment No 7 in principle but with drafting changes necessary to achieve the stated aim of flexibility.
Amendment No 8 would add a new paragraph to Article 3 with the same text as that proposed for addition to Recital 6. As for Amendment No 1, we have no problem with the principle but the inclusion of the same text in that article is not necessary. Therefore I would not accept Amendment No 8.
Amendment No 51 has partially similar aims to Amendment No 8 and goes further to set rules concerning the principle of free circulation of products. I hope you agree that this cannot be done in a few lines in this specific directive and I cannot accept Amendment No 51.
Amendment No 9 refers to Article 4 and the purity criteria of substances listed in Annex II. I can understand the wish to be more concrete here. In fact, since the tabling of this proposal, appropriate wording regarding purity criteria has been agreed and included in Community legislation, namely the directive on nutritional substances that may be used in the manufacture of foods for particular nutritional uses. This text refers to Community purity criteria that are already adopted for some of the substances in Annex II and to purity criteria recommended by international organisations. For the sake of coherence, the same text should be included in this proposed directive. I can accept the spirit of Amendment No 9 but with drafting that is in line with already agreed Community texts.
Amendment No 3 on Recital 9 is one of a series of amendments concerning procedures and the working rules for managing the directive. Regarding the revision of the lists of the annexes, the Commission may respond to a request by a Member State, a stakeholder including a manufacturer, or take the initiative to set in motion the procedures for adding to the annexes, or it may reject the request of the manufacturer. Amendment No 3 is not acceptable because it constitutes a restriction on the Commission's right of initiative.
Amendment No 10 reduces the procedure of modifying the annexes, which includes both scientific assessment and the subsequent adoption of a Commission directive, into a procedure of evaluation of the safety of substances. It also aims at specifying in this directive working rules for the Scientific Committee for Food. This is not a subject for legislation. Therefore, Amendment No 10 is not acceptable and for the same reason I cannot accept Amendment No 25 which also lays down working procedures for the Scientific Committee for Food. Amendment No 11 poses the same problems that I mentioned regarding Amendment No 6. It also poses problems from the procedural point of view.
The Commission must preserve its right of initiative as to when to present proposals. Therefore, I cannot accept Amendment No 11. For the same institutional reasons I cannot accept Amendments Nos 35 and 47 despite the fact that they include references to ingredients with nutritional or physiological functions.
Amendment No 13, the last on procedures, proposes that the comitology procedure referred to in Article 5(3) shall be subject to the principle of transparency. Of course, I would not deny this but I have a problem dealing with this issue in a specific vertical directive on food supplements. The principle of transparency is a general one to be applied to procedures dealing with products across the board. You are currently considering our proposal for a Food Act which includes provisions on transparency applicable to all foodstuffs. Therefore, I cannot accept Amendment No 13.
Amendment No 12 to Article 5(1) makes a valid point that requirements of children and adults be taken into account when setting maximum levels for vitamins and minerals. The principles can be extended to take into account, and I quote, "sensitivities of different consumer groups" and not only children and adults. Further, the point may be inserted in a more appropriate place in the article than the one suggested, therefore I can accept Amendment No 12 in principle, subject to drafting changes.
I now move to a number of amendments that concern the labelling provisions of the proposal. Amendment No 14 refers to the name of the product. In terms of labelling there is very little significant difference between the name of the product and the labelling. The name of the product must be set in EU legislation otherwise Member States can do that at the national level. This would create confusion for consumers. For this reason, I cannot accept Amendment No 14, however I take note of your request that the name of the product should include the words "food supplement".
The most sensitive issue, judging from the amendments tabled, seems to be the range of ingredients that may be present in food supplements. Recital 6 of the Commission's proposal recognises that various nutrients, including vitamins and minerals and other substances such as fibre, plant and herbal extracts, may be ingredients of food supplements. It lays down specific provisions only on vitamins and minerals which are nutrients as a first stage, because that is how far scientific knowledge allows us to go today.
The text proposed by Amendments Nos 15 and 28 does not express a different principle than that in the text of the proposal. They are drafting amendments and I am not convinced that they achieve greater clarity on this point and therefore I would not accept Amendments Nos 15 and 28.
I consider that a statement to the effect that food supplements should not be used as a substitute for a diversified diet is important for consumers both for information and education. Therefore I cannot accept Amendment No 16 that proposes the deletion of this provision. I can accept Amendment No 17 that proposes to include on the label a statement to the effect that food supplements should be stored out of the reach of children. Such a statement would provide additional safeguards to avoid accidental ingestion of these products.
Amendment No 18, although well intended I am sure, raises a number of complicated issues. Any food supplement intended for infants under the age of one year would, be to my mind, a product for particular nutritional uses and would be excluded from the scope of this directive as mentioned in Article 1. The case of supplements for pregnant women could give rise to a similar debate. Amendment No 18 would be potentially contradictory to Article 1 and I cannot accept it.
I can accept Amendment No 19. I can also accept Amendment No 20 in principle but with drafting changes that would be in line with the justification for this amendment provided in your report. Amendment No 21 proposes the addition of two sentences to Article 9. The principle expressed in the first sentence that excess doses should be avoided is already covered in Article 6. The second sentence deals with the issue of tolerance limits for declared quantities of certain nutrients that have stability problems. This is a highly technical issue that needs to be considered by appropriate experts and, if necessary, dealt with through technical implementing measures. Therefore I cannot accept Amendment No 21.
Amendment No 22 proposes to adopt the principles of good manufacturing practices by legally binding measures. This is not the practice in the area of foodstuffs and would set a precedent. We have horizontal rules on hygiene and control that apply to all foods and will apply to food supplements also. We have purity criteria for many of the substances that are listed in Annex II and intend to adopt criteria for the rest. These binding horizontal rules seem to us to be enough. Therefore, I cannot accept Amendment No 22. Of course, nothing stops the relevant industry voluntarily adopting specific GMPs for a specific product. This happens often in the food area.
Amendment No 23 would make it obligatory for Member States to require manufacturers to notify authorities of food supplements when marketed. The Commission proposal allows Member States to waive such requirement if they can monitor these products otherwise on their territory.
Member States are opposed to such imposition because they feel this is an issue of subsidiarity and wish to have a free hand in how they monitor these products. I cannot accept Amendment No 23.
Amendment No 24 also relates to procedures and aims to impose strict time limits for Commission decisions. Such decisions may depend on advice delivered by the Scientific Committee for Food, positions of Member States and other factors beyond the control of the Commission. For this reason I cannot accept Amendment No 24.
Amendments Nos 26 and 27 add to Annexes I and II more minerals, vitamins, preparations and mineral salts. I must be clear on this issue: I cannot accept any additions there in the absence of a positive safety evaluation by the Scientific Committee for Food. I cannot accept Amendments Nos 26 and 27.
On the other hand, Amendments Nos 30, 31, 32, 36, 38, 39, 42, 48 and 49 aim to establish a list of vitamin preparations which should be given priority for safety evaluation and eventual incorporation in the list of substances that may be used in the manufacture of food supplements. I can agree that the principle be expressed in a new recital as proposed in Amendments Nos 30, 38 and 42.
The intention is to lay down specific rules for other nutrients and other ingredients at a later stage as scientific knowledge improves. It is understood that, until the adoption of specific harmonised Community provisions and without prejudice to the provisions of the Treaty, national provisions on these other nutrients and ingredients may be applicable. I agree with the last sentence of the justification for Amendment No 1. The specific rules on vitamins and minerals laid down in the future directive should be applicable to food supplements containing vitamins, minerals and other ingredients. Otherwise it would be very easy for an unscrupulous manufacturer to avoid applying these rules by adding just a small quantity of another ingredient to a product.
It should be noted that Annex II includes only vitamin preparations and mineral salts. It does not include other ingredients. It should also be noted that the procedure referred to in Article 13 is not applicable to the evaluation of the substances in question. That procedure concerns the addition of substances to the list and includes as a step their evaluation. Therefore the proposed new recital would have to be drafted accordingly. I can accept Amendments Nos 30, 38 and 42 with the appropriate drafting changes.
However, the corresponding article proposed by Amendments Nos 31, 36 and 48 is not acceptable either from the drafting point of view or from the institutional point of view. So I have to say "no" to Amendments Nos 31, 36 and 48. However, we should discuss this further, afterwards, to find a satisfactory solution for everybody. An article along the lines of this recital, making reference to priority for evaluation of certain substances that are listed in a separate annex could be explored by all institutions involved in the process.
Amendments Nos 32, 39 and 49 cannot be accepted because they are directly linked to Amendments Nos 31, 36 and 48. However this should not be taken as a judgment on the substances contained therein.
I should like to thank Parliament for the support it has given to the Commission in having scientific risk assessment for the basic criterion for setting maximum levels of vitamins and minerals in food supplements. Article 5 is finely balanced to ensure the required high level of protection for the consumer. Amendments Nos 40 and 50 would upset this balance and therefore cannot be accepted.
Finally, I come to Amendment No 43. I do not see what are the testing procedures set out in this directive that other ingredients should comply with. Therefore I cannot accept Amendment No 43.
In conclusion, the Commission can accept Amendments Nos 2, 4, 17, 19, 33 and 44 as such, and Amendments Nos 1, 5, 7, 9 12, 20, 30, 34, 37, 38, 42, 45 and 46 in principle, with drafting changes. The Commission cannot accept Amendments Nos 3, 6, 8, 10, 11, 13, 14, 15, 16, 18, 21, 22, 23, 24, 25, 26, 27, 28, 29, 31, 32, 35, 36, 39, 40, 41, 43, 47, 48, 49, 50 and 51.
I can, therefore, accept Amendment No 1 in principle with necessary drafting changes that will depend on the final wording of Article 2. Amendments Nos 29, 37 and 41 add to the text of Amendment No 1 the principle that specific rules for these other nutrients and ingredients should be prepared when the science enables us to do so. I accept this principle. However, and in terms of drafting, I can accept Amendment No 37 with some drafting changes, but I cannot accept Amendments Nos 29 and 41. Amendment No 5 purports to introduce in the definition in Article 2 what is explained in Recital 6. Food supplements are concentrated sources of nutrients and other substances, or ingredients as they are called in Recital No 6. This would clarify the definition, an essential part of the directive. I can therefore accept No 5 in principle with drafting changes to ensure coherence of the text.
Amendments Nos 33 and 44 have the same purpose as Amendment No 5 and the clarification goes further in stating that these substances have a nutritional function, as have vitamins, minerals and amino acids or a physiological function, as has fibre or some antioxidants extracted from plants. So I can accept Amendments Nos 33 and 44, provided that the status of the substances that would thus come under the scope of the directive is very clear, both in terms of the criteria that would be applicable for drawing up positive lists and their status until these positive lists are adopted.
Amendments Nos 34 and 46 refer also to Article 2 and are acceptable because they follow the same logic as Amendment No 33. However, from the drafting point of view the proposed addition should be separate from the provision of Article 2(b) so I can accept them with that drafting change.
Amendment No 45, an alternate to Amendments Nos 34 and 36, is in line with Amendment No 5 which I could accept. Here again the proposed addition should be separate from the provisions of Article 2(b). I can therefore accept Amendment No 45 with the necessary drafting change.
Amendment No 6 on the same point is an alternate that creates confusion. The justification given in the committee's report would seem to be in line with Recital 6 and with the proposed text of Amendment No 5 by acknowledging that ingredients such as amino acids, fatty acids and herbal extracts are included in food supplements. But the proposed text is in contradiction with them by limiting such ingredients to those having a nutritional function. I cannot see the reason for this limitation and therefore cannot accept Amendment No 6.
I can accept Amendment No 2 to Recital 7 and also Amendment No 4 to Recital 14, which is a technical correction to the text of the proposal."@en1
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