(This note is not part of the Regulations)
1
These Regulations implement in England Commission Directive 2001/15/EC on substances that may be added for specific nutritional purposes in foods for particular nutritional uses.
2
These Regulations concern food for most particular nutritional uses (definition of “designated PNU food” in regulation 2(1) which excludes infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children) where there has been added to that food for a specific nutritional purpose a substance falling within one of the following categories: vitamins; minerals; amino acids; carnitine and taurine; nucleotides; choline and inositol. The Regulations prohibit the sale of such food unless the substance is listed under the relevant category in Schedule 1 or, in the case of foods for special medical purposes, is listed under the relevant category in either Schedule 1 or 2. Relevant purity criteria must be met for the substance. (Regulation 3(1) to (3)).
3
The Regulations also impose general restrictions on the sale of designated PNU foods in the manufacture of which any substances have been used for specific nutritional purposes (regulation 3(4)); and require the manufacturer or importer to supply the Food Standards Agency with information on request to verify that those restrictions are met (regulation 4). The Regulations prohibit the sale by the manufacturer or importer of certain designated PNU foods to which L-tryptophan has been added for a specific nutritional purpose, unless prior notification has been given to the Food Standards Agency before the first marketing of food of that particular type (regulation 5).
4
The Regulations make provision as to responsibilities for enforcement (regulation 6); create offences and penalties (regulation 7) and apply certain provisions of the Food Safety Act 1990 (regulation 9). The Regulations provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (OJ No. L186, 30.6.89, p.23) on the official control of foodstuffs (regulation 8).
5
The Regulations also disapply the prohibitions in the Tryptophan in Food Regulations 1990 (in their application to England) in so far as they conflict with Directive 2001/15/EC, Article 5 of Commission Directive 91/321/EEC (OJ No. L175, 4.7.91, p.35) on infant formulae and follow-on formulae and Article 5 of Commission Directive 96/5/EC (OJ No. L49, 28.2.96, p.17) on processed cereal-based foods and baby foods for infants and young children (regulation 10).
6
A regulatory impact assessment has been prepared and placed in the Library of each House of Parliament together with a Transposition Note setting out how the main elements of Directive 2001/15/EC are transposed in these Regulations. Copies may be obtained from the Food Labelling and Standards Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.