FSA Consultation, 15 December 2003

PARNUTS - Food for Particular Nutritional Uses (PARNUTS) Regulations 2004

Draft Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004. Responses are requested by: 5 February 2004

Consultation details

These Regulations implement two new Commission Directives amending Directive 2001/15/EC on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (PARNUTS foods).

Directive 2001/15/EC includes an Annex which contains a 'positive list' of substances (sources of vitamins; minerals; amino acids; carnitine & taurine; nucleotides; and choline & inositol) that may be added for specific nutritional purposes in certain foods for particular nutritional uses.

Infant formulae, follow-on formulae, processed cereal-based foods and baby foods for infants and young children are outside the scope of Directive 2001/15/EC and its amending Directives. Article 3 of 2001/15/EC requires that Member States prohibit trade in non-compliant products with effect from 1 April 2004.

The purpose of these new Directives is to allow the continued use, beyond 1 April 2004, of two groups of substances which are not currently included in the positive list in 2001/15/EC. These two groups comprise substances

• which at the time of adoption of 2001/15/EC were already being used in marketed PARNUTS foods but which had not been evaluated by the Scientific Committee on Food and whose evaluation by the EFSA is currently underway
• which have now been evaluated by the SCF or EFSA and have received a positive scientific opinion.

Consultation documents

The draft Commission Directives; draft implementing Regulations; and the partial regulatory impact assessment (RIA) are available from the FSA web site (at time of writing, go to: http://www.food.gov.uk/foodindustry/Consultations/consulteng/parnutsengland2004)

The new Directives require implementing legislation to be in force by 31 March 2004 (see Article 2 of each of the draft Directives). The Directives have not yet been finalised and may not be adopted and published in the Official Journal until next year.

Therefore, in order to consult as soon as possible the FSA have drafted the Regulations on the basis of the draft texts of the Directives (SANCO/5143/2003rev.1 and SANCO/5144/2003rev.1) that were discussed at a meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH) on Monday 8 December.

These texts are not yet finally agreed by Member States and will be discussed again at an SCFCAH meeting on Friday 12 December. If they are amended as a result of that meeting the FSA will send out the new texts along with a new draft of the Regulations if necessary.

Three of the substances (calcium sulphate, N-acetyl-L-methionine and N-acetyl-L-cysteine) in the Annex to SANCO/5144/2003rev.1 may be moved to the Annex of SANCO/5143/2003rev.1 if EFSA adopts favourable opinons on them prior to formal adoption of the Directives by the Commission. This is the reason why those substances are in square brackets in the new Schedule 3 which is inserted by Schedule 2 to the draft Regulations.