14 Proposed Amendments for EU Vitamin Directive

EUROPEAN PARLIAMENT

1999

2004

Committee on the Environment, Public Health and Consumer Policy

{31-01-2002}31 January 2002 PE 312.624/14

AMENDMENTS 14

Draft recommendation for second reading (PE 312.624)

Emilia Franziska Müller

ADOPTION OF A DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO FOOD SUPPLEMENTS

Council common position (12394/2001 – C5-0640/2001 – 2000/0080(COD))

Council common position

Amendments by Parliament

Amendment by Hans Blokland, Alexander de Roo, Jonas Sjöstedt, John Bowis, Per-Arne Arvidsson, Jules Maaten, Chris Davies, Avril Doyle and Patricia McKenna

Amendment 1

Legislative resolution, paragraph 1

Approves the common position;

Rejects the common position;

Justification

With regard to the different cultures in the Member States, there is no need for legislation in this area. Having no legislation has not proved to have any negative effects either. Above all, this Common Position will not solve the "problems", instead it will more or less create new ones.

Or. {EN}en

Amendment by Chris Davies, John Bowis and Hans Blokland

Amendment 2

Recital 14

(14) When maximum levels are set, therefore, account should be taken of the upper safe levels of the vitamins and minerals, as established by scientific risk assessment based on generally acceptable scientific data and of intakes of those nutrients from the normal diet. Due account should also be taken of reference intake amounts when setting maximum levels.

Justification

The reference to nutritional need could lead to unacceptable and unnecessary limits on the potency of a wide range of supplements. There is no reason to set maximum levels that are lower than is required to ensure that upper safe levels are not exceeded.

Or. {EN}en

Amendment by Frédérique Ries

Amendment 3

Article 3

Les Etats membres veillent à ce que les compléments alimentaires ne puissent être commercialisés dans la Communauté que s’ils sont conformes aux règles énoncées dans la présente directive.	Les Etats membres veillent à ce que les compléments alimentaires ne puissent être commercialisés dans la Communauté que s’ils sont conformes aux règles énoncées dans la présente directive.
	Les compléments alimentaires qui contiennent des substances autres que celles couvertes par la présente directive et ne font pas l’objet d’une réglementation communautaire spécifique sont soumis aux dispositions nationales.

Justification

Cet amendement reprend en partie l’amendement 8 adopté en première lecture et tient compte du considérant 8 de la position commune.

Il paraît essentiel de clarifier la base juridique des nutriments, autres que les vitamines ou minéraux, ou d’autres produits, qui n’entrent pas dans le domaine d’application de la présente directive et ne font pas l’objet d’une réglementation communautaire spécifique. Ces produits, actuellement soumis à la législation nationale, doivent le rester, dès lors qu’ils ont satisfait aux dispositions en matière de notification pour être commercialisés sans danger depuis des années.

Or. fr

Amendment by Chris Davies

Amendment 4

Article 4, paragraph 5

5. Modifications to the lists referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13 (2)

5. A specific procedure for the evaluation of the safety of substances referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13 (2). This procedure shall be subject to the principle of transparency and give the parties concerned the opportunity to provide further data prior to the adoption of the Scientific Committee for Food opinion.

Justification

Reintroduces amendment 10 tabled at 1^st reading. The amendment seeks to improve procedures for updating the Positive List in order to encourage product development and to promote consumer choice.

Or. {EN}en

Amendment by Heidi Anneli Hautala, Alexander de Roo and Patricia McKenna

Amendment 5

Article 4, paragraph 6

6. By way of derogation from paragraph 1 and until ( the end of the seventh year as from the date of entry into force in this directive), Member states may allow in their territory the use of vitamins and minerals not listed in Annex 1, or in forms not listed in Annex II, provided that :

6. By way of derogation from paragraph 1, Member states may allow in their territory the use of vitamins and minerals not listed in Annex 1, or in forms not listed in Annex II, provided that :

(a) the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive,

(a) the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive,

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than (18 months after the date of entry into force of this Directive).

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than (36 months after the date of entry into force of this Directive).

Justification
It is necessary to introduce a little flexibility into this legislation and thus to allow free access to these substances, without health hazard, for the European consumers.

Or. {EN}en

Amendment by Ria G.H.C. Oomen-Ruijten and Giuseppe Nisticò

Amendment 6

Article 4, paragraph 6 (b)

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 30 months after the date of entry into force of this Directive.

Justification

There is a great number of substances on the European market which are not listed in the Annexes of the directive. The preparation and the composition of the dossiers will require a considerable amount of time and financial effort for those enterprises that want to add the substances on the Annexes. The number of small and medium enterprises is very large. The suggested 18 months after the introduction of the Directive is clearly too short to gather the great amount of information that will be required. These requirements are laid down in the "Guidance on submission for the safety evaluation of sources of nutrients or of other ingredients proposed for the use in the manufacture of foods" which has been adopted by the Scientific Committee for Food in July 2001 as a basis for the requirements for the preparation of a dossier.

Or. {EN}en

Amendment by Dorette Corbey

Amendment 7

Article 4, paragraph 6 (b)

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 18 months after the date of entry into force of this Directive.

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 24 months after the date of entry into force of this Directive.

Justification

Producers, especially SME´s, need sufficient time to compile and submit a dossier.

Or. {EN}en

Amendment by Chris Davies and Dirk Sterckx

Amendment 8

Article 4, paragraph 6 (b)

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than ...............*

(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements within 18 months after having received a dossier supporting use of the substance in question submitted to the Commission by a Member State. Such a dossier should be submitted to the Commission by the Member State not later than ................*

*18 months after the date of entry into force of this Directive

*18 months after the date of entry into force of this Directive

Justification

The Scientific Committee should also be obliged to deliver their opinion on a dossier received by a Member State within a reasonable period. The Member State and company concerned should not have to to wait indefinitely for an opinion on the dossier submitted to the Scientific Committee.

Or. {EN}en

Amendment by Chris Davies

Amendment 9

Article 4, paragraph 6 (b)

(b) The Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than…. 18 months after the date of entry into force of this Directive

(b) The Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than…. 72 months after the date of entry into force of this Directive.

Justification

The procedure will be costly and time-consuming for manufacturers, some of whom will find they will have to register several substances at once. An extension of the period for submitting dossiers does not jeopardize the functioning of the Directive since the Scientific Committee has up to seven years to review the dossiers.

Or. {EN}en

Amendment by Caroline F. Jackson, John Bowis, Alexander de Roo, Jules Maaten and Phillip Whitehead

Amendment 10

Article 4, paragraph 6 (b)

(b) The scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than…. 18 months after the date of entry into force of this Directive

(b) The Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than…. 36 months after the date of entry into force of this Directive.

Justification

This extension takes account of the needs of small manufacturers who may find it prohibitively expensive to carry out safety testing over a short period on a large number of products. Without this adjustment, the generosity of the seven year grace period is more apparent than real

Or. {EN}en

Amendment by Chris Davies, John Bowis and Hans Blokland

Amendment 11

Article 5, paragraph 2

2. When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population

Deleted

Justification

The reference to nutritional need could lead to unacceptable and unnecessary limits on the potency of a wide range of supplements. There is no reason to set maximum levels that are lower than is required to ensure that upper safe levels are not exceeded.

Or. {EN}en

Amendment by Avril Doyle, John Bowis, Hans Blokland and Jules Maaten

Amendment 12

Article 5, paragraph 2

2. When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population.

2. When the maximum levels referred to in paragraph 1 are set,due account should also be taken of reference intakes of vitamins and minerals for the population, where these are close to upper safe levels.

Justification

This reinserts an amendment adopted at 1^st reading. The maximum levels for food supplements should be based on the upper safe levels established by science. Population reference intakes (PRI) relate to the absolute minimum intake of nutrient necessary to avoid a deficiency in that nutrient, bearing no relationship whatsoever to the issue of safety; the original aim of the directive.

Or. {EN}en

Amendment by Chris Davies, John Bowis and Hans Blokland

Amendment 13

Article 5, paragraph 4

4. The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted in accordance with the procedure referred to in Article 13 (2).

4. The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted in accordance with the procedure referred to in Article 13 (2). This procedure shall be subject to the principle of transparency.

Justification

Self-explanatory, reintroduces amendment 13 from first reading.

Or. {EN}en

Amendment by Ria G.H.C. Oomen-Ruijten and Giuseppe Nisticò

Amendment 14

Article 9, paragraph 2 a (new)

In order to ensure quality and safety, food supplements have to be produced according to Good Manufacturing Practice to be decided upon in accordance with the procedure referred to in Article 13 (2).

Justification

Reintroduces amendment 22 from first reading.

Or. {EN}en

6. By way of derogation from paragraph 1 and *until ( the end of the seventh year as from the date of entry into force in this directive),* Member states may allow in their territory the use of vitamins and minerals not listed in Annex 1, or in forms not listed in Annex II, provided that :	6. By way of derogation from paragraph 1, Member states may allow in their territory the use of vitamins and minerals not listed in Annex 1, or in forms not listed in Annex II, provided that :
(a) the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive,	(a) the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive,
(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than (18 months after the date of entry into force of this Directive).	(b) the Scientific Committee for Food has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than (36 months after the date of entry into force of this Directive).