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Scottish Statutory Instrument 2000 No. 83
The Genetically Modified and Novel Foods (Labelling)
(Scotland) Regulations 2000
© Crown Copyright 2000
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SCOTTISH STATUTORY INSTRUMENTS
2000 No. 83
FOOD
The Genetically Modified and Novel Foods (Labelling) (Scotland)
Regulations 2000
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Made |
17th March 2000 |
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Laid before the Scottish Parliament |
17th March 2000 |
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Coming into force |
10th April 2000 |
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The Scottish Ministers in exercise of the powers conferred on them by
sections 6(4), 16(1)(e) and (f), 17, 18(1), 26(1) and (3) and 48(1) of
the Food Safety Act 1990[1]
and of all other powers enabling them in that behalf, hereby make the following
Regulations, after consultation in accordance with section 48(4) of that
Act with such organisations as appear to them to be representative of interests
likely to be substantially affected by the Regulations:
Citation, commencement and extent
1. - (1) These Regulations may be cited as the Genetically
Modified and Novel Foods (Labelling) (Scotland) Regulations 2000 and shall
come into force on 10th April 2000.
(2) These Regulations extend to Scotland only.
Interpretation
2. - (1) In these Regulations-
"the Act" means the Food Safety Act 1990;
"biscuits" include wafers, rusks, oatcakes and matzos;
"confectionery product" means any item of chocolate confectionery
or sugar confectionery;
"Directive 79/112" means Council Directive 79/112/EEC[2]
on the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs, as amended by Council directive
86/197/EEC[3]
and Council Directive 89/395/EEC[4];
"edible ice" includes ice-cream, water ice and fruit ice, whether
alone or in combination, and any similar food;
"fancy confectionery product" means any confectionery product in
the form of a figure, animal, cigarette or egg or in any other fancy form;
"flour confectionery" means any cooked food which is ready for consumption
without further preparation (other than reheating), of which a characterising
ingredient is ground cereal, including shortbread, sponges, crumpets, muffins,
macaroons, ratafias, pastry and pastry cases, and also includes meringues,
petits fours and uncooked pastry and pastry cases, but does not include
bread, pizzas, biscuits, crispbread, extruded flat bread or any food containing
a filling which has as an ingredient any cheese, meat, offal, fish, shellfish,
vegetable protein material or microbial protein material;
"the GMO particulars" means the additional specific labelling particulars
required by Article 2(3) of Regulation 1139/98 and Articles 2 and 4 of
Regulation 50/2000;
"novel food", "novel food ingredient" and "places on the market"
have the same meaning in these Regulations as they have in Regulation 258/97;
"prepacked for direct sale" means-
(a) in relation to a food other than flour confectionery, bread
and edible ices, prepacked by a retailer for sale by him on the premises
where the food is packed or from a vehicle or stall used by him; and
(b) in relation to flour confectionery, bread and edible ices, prepacked
by a retailer for sale as in sub-paragraph (a) of this definition, or prepacked
by the producer of the food for sale by him either on the premises where
the food is produced or on other premises from which he conducts business
under the same name as the business conducted on the premises where the
food is produced,
and in this definition "premises" includes any ship or aircraft;
"preparation", in relation to food, includes manufacture and any
form of processing or treatment, and "prepared" is construed accordingly;
"Regulation 258/97" means Regulation (EC) No. 258/97 of the European
Parliament and of the Council[5]
concerning novel foods and novel food ingredients;
"Regulation 1139/98" means Council Regulation (EC) No. 1139/98[6]
(as corrected[7])
concerning the compulsory indication, on the labelling of certain foodstuffs
produced from genetically modified organisms, of particulars other than
those provided for in Directive 79/112/EEC, as amended by Commission Regulation
(EC) No. 49/2000[8];
"Regulation 50/2000" means Commission Regulation (EC) No. 50/2000[9]
(as corrected[10])
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;
"sell" includes offer or expose for sale and have in possession
for sale, and "sale" shall be construed accordingly.
(2) Other expressions used both in these Regulations
and in Regulation 1139/98 or Regulation 50/2000 have the same meaning in
these Regulations as they have in Regulation.
(3) Food shall be regarded as prepacked for the
purposes of these Regulations if-
(4) Any reference in these Regulations to a numbered
regulation is, unless the context otherwise requires, to be construed as
a reference to the regulation so numbered in these Regulations.
Food to which Regulation 1139/98 or Regulation 50/2000 applies
Exemptions
3. - (1) Subject to paragraph (2), these Regulations do not
apply in respect of any food brought into Scotland-
(a) from a member State (other than the United Kingdom); or
(b) from another part of the United Kingdom,
in which it was lawfully sold, having been produced in a member State,
or in which it was in free circulation and lawfully sold, if the requirements
of Regulation 1139/98 or Regulation 50/2000 (as applicable), as read in
each case with Directive 79/112, are met in respect of that food.
(2) Nothing in paragraph (1) prevents the enforcement
of regulation 7(c).
(3) For the purposes of paragraph (1), "free circulation"
has the same meaning as in Article 23(2) of the Treaty establishing the
European Community.
(4) No prepacked food, which is either contained
in an indelibly marked glass bottle intended for re-use and having no label,
ring or collar, or the largest surface of whose packaging has an area of
less than ten square centimetres, need be marked or labelled with the GMO
particulars.
Marking or labelling: general requirement
4. When any food other than food to which regulation 5 applies is
sold, the particulars with which it is required to be marked or labelled
by Regulation 1139/98 or Regulation 50/2000 must appear-
(a) on the packaging;
(b) on a label attached to the packaging; or
(c) on a label which is clearly visible through the packaging,
provided that where the sale is otherwise than to the final consumer,
such particulars may, alternatively, appear only on the commercial documents
relating to the food where it can be guaranteed that such documents, containing
all such particulars, either accompany the food to which they relate or
were sent before, or at the same time as, delivery of the food.
Marking or labelling: special rules
5. - (1) This regulation applies to-
(a) food which is not prepacked;
(b) food which is prepacked for direct sale; and
(c) any individually wrapped fancy confectionery product which is
not enclosed in any further packaging and which is intended for sale as
a single item.
(2) Subject to paragraph (3), when any food to which
this regulation applies is sold to the final consumer, the particulars
with which it is required to be marked or labelled by Regulation 1139/98
or Regulation 50/2000 must appear-
(a) on a label attached to the food; or
(b) on a menu, notice, ticket or label which is readily discernible
by an intending purchaser at the place where he chooses that food.
(3) In any case where food-
use of alternative labelling in place of the GMO particulars is not
alone be treated as a contravention of those labelling requirements and
for this purpose alternative labelling is used where, instead of the particulars
referred to in Article 2(3) of Regulation 1139/98 or in Articles 2 and
4 of Regulation 50/2000 appearing in the manner specified in paragraph
(2)(a) or (b) above, alternative particulars are displayed in accordance
with paragraph (4) below.
(4) Alternative particulars are displayed in accordance
with this paragraph in relation to any food referred to in paragraph (3)
if there appears on a menu, notice, ticket or label which is readily discernible
by an intending purchaser and which is located at the place at the premises
where he chooses that food-
(a) in the case of food to which the labelling requirements of Regulation
1139/98 apply, indications to the effect that some of the food sold at
those premises contains ingredients produced from genetically modified
soya beans or maize, or both, as the case may be, and that further information
is available from the staff; and
(b) in the case of food to which the labelling requirements of Regulation
50/2000 apply, indications to the effect that some of the food sold at
those premises contains additives or flavourings, or both, as the case
may be, produced from a genetically modified organism, and that further
information is available from the staff.
(5) In this regulation, "premises" includes any ship
or aircraft and "appropriate premises" means premises where-
(6) When any food to which this regulation applies
is sold otherwise than to the final consumer, the particulars with which
it is required to be marked or labelled by Regulation 1139/98 or Regulation
50/2000 must appear-
(a) on a label attached to the food; or
(b) on a ticket or notice which is readily discernible by the intending
purchaser at the place where he chooses the food; or
(c) in commercial documents relating to the food where it can be
guaranteed that such documents either accompany the food to which they
relate or were sent before, or at the same time as, delivery of the food.
Manner of marking or labelling
6. - (1) The particulars with which a food is required to
be marked or labelled by Regulation 1139/98 or by Regulation 50/2000, or
which appear on a menu, notice, ticket or label pursuant to these Regulations,
shall be easy to understand, clearly legible and indelible and, when a
food is sold to the final consumer, the said particulars must be marked
in a conspicuous place in such a way as to be easily visible.
(2) Such particulars must not in any way be hidden,
obscured or interrupted by any other written or pictorial matter.
(3) Paragraph (1) above is not to be taken to
preclude the giving of such particulars at mass caterers, in respect of
foods the variety and type of which are changed regularly, by means of
temporary media (including the use of chalk on a blackboard).
General
Offences and penalties
7. If any person-
(a) sells any food to which the labelling requirements of Regulation
1139/98 or of Regulation 50/2000 apply which is not marked or labelled
with the GMO particulars, except in the case of any food to which regulation
5(3) applies and in respect of which alternative particulars are displayed
in accordance with regulation 5(4);
(b) sells any food which is not marked or labelled in accordance
with regulation 4, 5 or 6; or
(c) places on the market any novel food or novel food ingredient
in respect of which the additional requirements relating to consumer information
set out in Article 8(1) of Regulation 258/97 have not been met,
he is guilty of an offence and liable on summary conviction to a fine
not exceeding level 5 on the standard scale.
Enforcement
8. Each food authority shall enforce and execute these Regulations
in its area and be the competent authority in its area for the purposes
of the second paragraph of Article 2(2)(b) of Regulation 1139/98.
Defence in relation to exports
9. In any proceedings for an offence under these Regulations, it
is a defence for the person charged to prove-
(a) that the food in respect of which the offence is alleged to
have been committed was intended for export to a country which has legislation
analogous to these Regulations and that it complies with that legislation;
and
(b) in the case of export to a member State of food to which Regulation
1139/98 or Regulation 50/2000 applies, that the legislation complies with
the provisions of Regulation 1139/98 or Regulation 50/2000, as appropriate,
as read with Directive 79/112.
Application of various provisions of the Act
10. - (1) The following provisions of the Act apply for the
purposes of these Regulations and, unless the context otherwise requires,
any reference in those provisions to the Act or Part thereof is to be construed
for the purposes of these Regulations as a reference to these Regulations-
section 2 (extended meaning of "sale" etc);
section 3 (presumption that food is intended for human consumption);
section 20 (offences due to fault of another person);
section 21 (defence of due diligence) as it applies for the purposes
of section 8, 14 or 15;
section 30(8) (which relates to documentary evidence);
section 35(1) to (3) (punishment of offences) in so far as it relates
to offences under section 33(1) and (2) as applied by paragraph (3) below;
section 36 (offences by bodies corporate).
(2) In the application of section 32 of the Act (powers
of entry) for the purposes of these Regulations, the reference in subsection
(1)(a) of that section to "the provisions of this Act" is to be construed
as including a reference to Regulation 258/97, Regulation 1139/98 and Regulation
50/2000.
(3) The following provisions of the Act apply
for the purposes of these Regulations and, unless the context otherwise
requires, any reference in those provisions to the Act is to be construed
for the purposes of these Regulations as including a reference to these
Regulations, Regulation 258/97, Regulation 1139/98 and Regulation 50/2000-
section 33 (obstruction etc. of officers),
section 44 (protection of officers acting in good faith).
Consequential amendments
11. - (1) The Food Labelling Regulations 1996[11]
are amended in accordance with paragraphs (2) to (11).
(2) In regulation 2(1) (interpretation), the definitions
of "the GMO particulars" and "Regulation 1139/98" are deleted.
(3) In regulation 3(1)(iv) (exemptions), for ",
Directive 94/54 and Regulation 1139/98" there is substituted "and Directive
94/54".
(4) In regulation 26 (small packages and certain
indelibly marked bottles)-
(a) paragraph (1)(b) is deleted; and
(b) in paragraph (3A), "and the GMO particulars" are deleted.
(5) In regulation 35 (general requirement as to manner
of marking or labelling), "or by Regulation 1139/98" is deleted.
(6) In regulation 36 (manner of marking or labelling
in the case of food to which regulation 23 or 27 applies)-
(7) In regulation 38(1) (intelligibility of marking
or labelling), "or by Regulation 1139/98" is deleted.
(8) In regulation 44(1) (offences and penalties),
sub-paragraph (f) is deleted.
(9) In regulation 47(b) (defence in relation to
exports), for ",Directive 94/54 and Regulation 1139/98" there is substituted
"and Directive 94/54".
(10) In regulation 48 (application of various
provisions of the Food Safety Act 1990), paragraph (2) is deleted.
(11) In regulation 50 (transitional provision),
paragraphs (5) to (7) are deleted.
12. The Novel Foods and Novel Food Ingredients Regulations 1997[12]
shall be amended, by deleting paragraph 7 in the Schedule (specified Community
provisions).
Transitional provisions
13. - (1) In any proceedings for an offence under-
(a) regulation 7(a); or
(b) regulation 7(b), as read with regulations 5 or 6,
in relation to the particulars with which any relevant food is required
to be marked or labelled by regulation 1139/98, it is a defence to prove
that-
(2) In any proceedings for an offence under-
(a) regulation 7(a); or
(b) regulation 7(b), as read with regulation 5 or 6,
in relation to the particulars with which any relevant food is required
to be marked or labelled by Regulation 50/2000, it is a defence to prove
that the food was sold to the final consumer or to a mass caterer and was
prepared using an ingredient which was on sale before 10th April 2000.
(3) For the purposes of paragraphs (1) and (2)
above, "relevant food" means food which is-
SUSAN C DEACON
A member of the Scottish Executive
St Andrew's House, Edinburgh
17th March 2000
EXPLANATORY NOTE
(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
79/112/EEC; 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 79/112/EEC 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 89/397/EEC (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.
Notes:
[1] 1990 c.16; see section 4(1) for the definition of "the Ministers".
The functions of the Secretary of State were transferred, so far as within
devolved competence, to the Scottish Ministers by virtue of section 53
of the Scotland Act 1998 (c.46). Section 6(4)(a) of the Act was amended
by the Deregulation and Contracting Out Act 1994 (c.40), Schedule 9, paragraph
6.back
[2] O.J. No. L33, 8.2.79, p.1.back
[3] O.J. No. L144, 29.5.86, p.38.back
[4] O.J. No. L186, 30.6.89, p.17.back
[5] O.J. No. L43, 14.2.97, p.1.back
[6] O.J. No. L159, 3.6.98, p.4.back
[7] O.J. No. L190, 4.7.98, p.86.back
[8] O.J. No. L6, 11.1.2000, p.13.back
[9] O.J. No. L6, 11.1.2000, p.15.back
[10] O.J. No. L47, 19.2.2000, p.34.back
[11] S.I. 1996/1499; the relevant amending instruments are S.I. 1998/1398,
1999/747, 1483.back
[12] S.I. 1997/1335; to which there are amendments not relevant to
these Regulations.back
ISBN 0 11 059303 0
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