WRITTEN QUESTION P-1528/96 by Hiltrud Breyer (V) to the Commission (6 June 1996)

Subject: Authorization of the use of single-cell oils (LCPs) in baby food

1. a) Does the Commission agree that organisms which have never before been used in human nutrition and are now being added to it should be regarded as novel foods?

b) Should single-cell oils, which have never before occurred in human nutrition and are now being added as a new kind of foodstuff to baby food manufactured by the Nutricia company, not therefore be classified as a novel food?

c) Is the Commission aware in this context that the Scientific Committee for Food (SCF) stated in its report of 27 October 1989 and 30 March 1990 that novel food ingredients should not be used in the manufacture of baby food?

2. a) What conclusion does the Commission draw from the scientific fact that the source of single-cell oils is 'cryptohecodinium', which is one of the well-known 'dinoflagellate' toxin producers?

b) Why did the Commission nonetheless authorize the marketing application?

3. Does the Commission have the results of quality standard tests documenting and verifying any impurities caused by the manufacturing process, microbiological impurities and the dioxin content? How do these parameters compare with those of conventional ovolipids?

4. Can the Commission cite scientific sources and study findings that verify the acceptance, tolerance, development parameters and absorption of single-cell oils?

5. How does the Commission view the fact that single-cell oils are extracted with hexane and that, if these oils are not adequately purified, undesirable hexane residues may be left in them, the hexane possibly containing polycyclic aromatics, which are classified as carcinogenic? Is this not a further risk inherent in the production process that ought to have been considered during the authorization procedure?

6. Is it true that the marketing of single-cell oils has not been authorized in any other country and that even the FDA rejected the marketing application received from the company located in the USA?

7. Is it true that in a series of tests in Dutch hospitals and maternity wards preparations containing single-cell oils were fed to babies without their parents being informed or asked for their permission?

8. What scientific evidence persuaded the Commission to authorize the marketing of single-cell oils, now distributed in Belgium as 'Premilon' and 'Nenatal', despite the health risks for newborn children referred to above?

Answer given by Mr Bangemann on behalf of the Commission (27 June 1996)

1.a) The Commission considers that the use in food of organisms which have never before been used in human nutrition would fall within the scope of its proposal for a regulation on novel foods and novel food ingredients ((COM(92) 295 final; amended proposals, COM(93) 631 final and COM(96) 229 final. )). However the Commission would point out that single cell oils are not in themselves organisms, although they may be extracted from such organisms.

1.b) A decision on whether a particular product constitutes a novel food has to be taken on a case by case basis, having regard to the scientific evidence.

1.c) The Commission is aware that in its report of 27 October 1989 and 30 March 1990, the Scientific committee for food did indeed state that novel food ingredients should not be used in the manufacture of baby foods. However, the Committee added that 'this view may change if more extensive nutritional and toxicological evidence concerning their value and safety becomes available'. The Commission therefore considers that the acceptability of novel food ingredients for use in infant formulae and foods for young children has to be judged on a case by case basis having regard to the available scientific information.

2.-8. Contrary to the statement contained in point 2b of the Honourable Members's question, the Commission has not authorized the marketing of the products cited. Until the Commission's proposal for Communuty measures on novel foods and novel food ingredients is adopted by the Council and Parliament and enters into force, novel foods remain subject to the national provisions in force in the Member States. However, any such national provisions must of course comply with other Community legislation.

The Commission understands that the two products have been authorized in the Netherlands in accordance with its national procedures governing novel foods. The Belgian authorities have accepted that these products may be placed on their market in accordance with the general Community rules on the free movement of goods.

The Commission does not have access to the full scientific and technical dossier concerning these products. Therefore, it cannot comment on the various scientific issues raised by the Honourable Member or on the manner in which any tests and trials were conducted during the development of the product. Likewise, the Commission has no information on the status of any applications to market these products in other Member States or in third countries.