(This note is not part of the Regulations)
These Regulations make continued provision for the enforcement of–
a
Council Regulation (EC) No. 1139/98 concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive ; and
b
the labelling requirements in Article 8(1) of Council Regulation (EC) No. 258/97 concerning novel foods and novel food ingredients (as read with Articles 1 and 2 of that Regulation).
These Regulations also make provisions for the enforcement of–
a
Commission Regulation (EC) No. 49/2000 which amends regulation 1139/98; and
b
Commission Regulation (EC) No. 50/2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms.
The products covered by Regulation 1139/98 are foods and food ingredients which are to be delivered as such to the final consumer, having been produced in whole or in part from genetically modified soya beans or genetically modified maize, as referred to in Article 1 of that Regulation. Regulation 49/2000 extends the scope of Regulation 1139/98 to cover sales to mass caterers and establishes a de minimis threshold of 1% for adventitious contamination of an ingredient with material derived from genetically modified organisms. Regulation 50/2000 also applies in the case of food and food ingredients intended for final consumers and mass caterers. Regulation 1139/98, as amended, and Regulation 50/2000 contain transitional provisions. The labelling requirements in Regulation 258/97 are to ensure the final consumer is informed of any characteristic or food property rendering a novel food or novel food ingredient no longer equivalent to an existing food or food ingredient; of the presence in the novel food or food ingredient of material which is not present in an existing equipment foodstuff and which may have implications for the health of certain sections of the population or give rise to ethical concerns; and of the presence of a genetically modified organism.
Regulation 1139/98, as amended, and Regulation 50/2000 were made pursuant to Article 4(2) of Council Directive on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. Pursuant to Articles 11 and 13 of that Directive, these Regulations contain–
a
an exemption from the need to be labelled with the particulars required by those EC Regulations in the case of small packages and certain indelibly marked glass bottles (regulation 3(4)); and
b
make provision as to the manner of marking or labelling in the case of the particulars required by those Regulations (regulations 4 to 6).
Further to Article 12 of that Directive, these Regulations–
a
allow alternative labelling arrangements instead of the particulars required by those EC Regulations in the case of sales to the final consumer at appropriate premises of food which is prepacked for direct sale or not prepacked (regulation 5); and
b
contain transitional arrangements in respect of sales of such food to the final consumer or to a mass caterer (regulation 13).
These Regulations also–
a
create offences and prescribe a penalty (regulation 7), contain exemptions (regulation 3) and specify enforcement authorities (regulation 8);
b
provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive (O.J. No. L186, 30.6.89, p.23) on the official control of foodstuffs, as read with the ninth recital to that Directive (regulation 9);
c
incorporate specified provisions of the Food Safety Act 1990 (regulation 10); and
d
make consequential amendments (regulations 11 and 12).
A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations would have on business costs, has been prepared and placed in the Scottish Parliament Information Centre and copies may be obtained from the Food Standards Agency, Sixth Floor, St. Magnus House, 25 Guild Street, Aberdeen LB11 6NG.