Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity.
(2)
Differences between national laws relating to foodstuffs for particular nutritional uses impede their free movement, may create unequal conditions of competition, and thus have a direct impact on the functioning of the internal market.
(3)
The approximation of national laws presupposes the drawing-up of a common definition, the determination of measures enabling the consumer to be protected against fraud concerning the nature of these products and the adoption of rules to be complied with in labelling the products in question.
(4)
The products covered by this Directive are foodstuffs the composition and preparation of which must be specially designed to meet the particular nutritional requirements of the persons for whom they are mainly intended. It may be necessary, therefore, to provide for derogations from the general or specific provisions applicable to foodstuffs in order to achieve the specific nutritional objective.
(5)
Although foodstuffs intended for particular nutritional uses which are the subject of specific provisions can be efficiently monitored on the basis of the general rules for monitoring all types of foodstuffs, this is not always the case for those foodstuffs in respect of which no such specific provisions exist.
(6)
For the latter the usual means available to the monitoring bodies might not, in certain cases, enable them to check whether a foodstuff actually has the particular nutritional properties attributed to it. It is necessary, therefore, to provide that, where necessary, the person responsible for placing that foodstuff on the market should assist the monitoring body in carrying out its activities.
(7)
Specific provisions applicable to certain groups of foodstuffs should be laid down by means of specific Directives.
(8)
A procedure should be laid down which allows the foodstuffs resulting from technological innovations to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the specific Directive concerned. However, on the grounds of consumer health protection, marketing authorisation may be granted only after consultation of the European Food Safety Authority.
(9)
Since it is not clear whether an adequate basis exists for specific provisions to be adopted for the group of foods intended for persons suffering from carbohydrate metabolism disorders (diabetes), the Commission should be allowed to adopt or propose the relevant provisions at a later stage, after consultation of the European Food Safety Authority.
(10)
It is still possible to harmonise, at Community level, rules applicable to other groups of foodstuffs for particular nutritional uses, in the interests of consumer protection and the free movement of such foodstuffs.
(11)
The drawing-up of specific Directives implementing the basic principles of Community rules and amendments thereto are implementing measures of a technical nature. Their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.
(12)
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).
(13)
In particular, the Commission should be empowered to adopt certain specific Directives, a list of substances with specific nutritional purposes and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them, and, where appropriate, the conditions under which they should be used, provisions rendering it possible to indicate on foodstuffs for normal consumption that they are suitable for a particular nutritional use, special provisions for foods for persons suffering from carbohydrate metabolism disorders (diabetes), rules for the use of terms concerning the reduction or absence of sodium or salt content or the absence of gluten, which may be used to describe the products, as well as conditions under which reference may be made in labelling, presentation and advertising to a diet or to a category of persons. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(14)
When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption and amendment of a list of substances with specific nutritional purposes and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them and, where appropriate, the conditions under which they should be used, as well as for adoption of amendments to this Directive or to specific Directives when it is established that a foodstuff intended for a particular nutritional use endangers human health although it complies with the relevant specific Directive.
(15)
The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.
(16)
This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex II, Part B,
