Citation, application and commencement1
These Regulations may be cited as the Food Supplements (Wales) Regulations 2003; they come into force on 1st August 2005 and apply to Wales only.
Interpretation2
1
In these Regulations —
“the Act” (“y Ddeddf”) means the Food Safety Act 1990;
“catering establishment” (“sefydliad arlwyo”) means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation;
“Directive 2001/83” (“Cyfarwyddeb 2001/83”) means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as last amended by Directive 2009/53/EC of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products;
“Directive 2002/46” (“Cyfarwyddeb 2002/46”) means Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements as last amended by Commission Regulation (EC) No. 1170/2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements;
“dose form” (“ffurf dogn”) means a form such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids or powders designed to be taken in measured small unit quantities;
“food supplement” (“ychwanegyn bwyd”) means any food the purpose of which is to supplement the normal diet and which —
- a
is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and
- b
is sold in dose form;
- a
“preparation” (“paratoi”) includes manufacture and any form of processing or treatment,
F14“Regulation (EU) No 1169/2011” (“Rheoliad (EU) Rhif 1169/2011”) means Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004;
“sell” (“gwerthu”) includes possess for sale and offer, expose or advertise for sale; and
“ultimate consumer” (“defnyddiwr Olaf”) means any person who purchases otherwise than —
- a
for the purpose of resale;
- b
for the purposes of a catering establishment; or
- c
for the purposes of a manufacturing business.
- a
2
A food supplement shall be regarded as prepacked for the purposes of these Regulations if —
a
it is ready for sale to the ultimate consumer or to a catering establishment, and
b
it is put into packaging before being offered for sale in such a way that the food supplement, cannot be altered without opening or changing the packaging.
3
Other expressions used both in these Regulations and in Directive 2002/46 have the same meaning in these Regulations as they have in that Directive.
F44
In these Regulations any reference to an Annex to Directive 2002/46 is a reference to that Annex as amended from time to time.
Scope of Regulations3
1
These Regulations apply to food supplements sold as food and presented as such.
F52
These Regulations do not apply to medicinal products as defined by Directive 2001/83.
Restriction on form in which food supplements are sold to the ultimate consumer4
No person shall sell any food supplement to the ultimate consumer unless it is prepacked.
Prohibitions on sale relating to composition of food supplements5
1
F6... No person shall sell a food supplement in the manufacture of which a vitamin or mineral has been used unless that vitamin or mineral —
a
is listed in F7Annex I to Directive 2002/46; and
b
is in a form which —
i
is listed in F8Annex II to Directive 2002/46, and
ii
meets the relevant purity criteria.
2
The relevant purity criteria for the purposes of paragraph (1)(b)(ii) are —
a
the purity criteria, if any, specified by F12EU legislation for the use of the substance in question in the manufacture of food for purposes other than those covered by Directive 2002/46; or
b
in the absence of such purity criteria, generally acceptable purity criteria for the substance in question recommended by international bodies.
F93
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Restrictions on sale relating to labelling etc of food supplements6
1
No person shall sell a food supplement which is ready for delivery to the ultimate consumer or to a catering establishment unless the name under which it is sold is “food supplement”..
2
Without prejudice to F15Regulation (EU) No 1169/2011, no person shall sell a food supplement which is ready for delivery to the ultimate consumer or to a catering establishment unless it is marked or labelled with the following particulars —
a
the name of the category of any vitamin or mineral or other substance with a nutritional or physiological effect which characterises the product or an indication of the nature of that vitamin or mineral or other substance;
b
the portion of the product recommended for daily consumption;
c
a warning not to exceed the stated recommended daily dose;
d
a statement to the effect that food supplements should not be used as a substitute for a varied diet;
e
a statement to the effect that the product should be stored out of the reach of young children; and
f
the amount of any vitamin or mineral or other substance with a nutritional or physiological effect which is present in the product.
3
The information required by paragraph (2)(f) shall —
a
be given in numerical form;
F10b
in the case of a vitamin or mineral listed in Annex I to Directive 2002/46 be given using the relevant unit specified in brackets after the name of that vitamin or mineral;
c
be the amount per portion of the product as recommended for daily consumption on the labelling of the product;
d
be an average amount based on the manufacturer’s analysis of the product; and
4
No person shall sell any food supplement which is ready for delivery to the ultimate consumer or to a catering establishment if the labelling, presentation or advertising of which includes any mention, express or implied, that a balanced and varied diet cannot provide appropriate quantities of vitamins or minerals in general.
Manner of marking or labelling7
1
No person shall sell any food supplement which —
a
is ready for delivery to the ultimate consumer, or
b
is ready for delivery to a catering establishment and is prepacked,
unless the particulars with which it is required to be marked or labelled by regulation 6(2) shall appear —
i
on the packaging;
ii
on a label attached to the packaging; or
iii
on a label which is clearly visible through the packaging,
save that where the sale is otherwise than to the ultimate consumer such particulars may, alternatively, appear only on the commercial documents relating to the food supplement where it can be guaranteed that such documents, containing all such particulars, either accompany the food supplement to which they relate or were sent before, or at the same time as, delivery of the food supplement, and provided always that the particulars required by F18points (a), (f), (g) and (h) of Article 9(1) Regulation (EU) No 1169/2011 shall also be marked or labelled on the outermost packaging in which that food supplement is sold.
2
No person shall sell any food supplement which is ready for delivery to a catering establishment and is not prepacked unless the particulars with which it is required to be marked or labelled by regulation 6(2) appear —
a
on a label attached to the food supplement;
b
on a ticket or notice which is readily discernible by the intending purchaser at the place where he or she chooses the food supplement; or
c
in commercial documents relating to the food supplement where it can be guaranteed that such documents either accompany the food supplement to which they relate or were sent before, or at the same time as, delivery of the food supplement.
3
No person shall sell any food supplement which is ready for delivery to the ultimate consumer or to a catering establishment unless the particulars with which a food supplement is required to be marked or labelled by regulation 6(2) shall be easy to understand, clearly legible and indelible and, when a food is sold to the ultimate consumer, those particulars shall be marked in a conspicuous place in such a way as to be easily visible.
4
No person shall sell any food supplement which is ready for delivery to the ultimate consumer or to a catering establishment if the particulars with which it is required to be marked or labelled by virtue of regulation 6(2) are in any way be hidden, obscured or interrupted by any other written or pictorial matter.
Enforcement8
Each food authority shall enforce and execute these Regulations in its area.
Offences and penalties9
Any person who contravenes regulation 4, 5, 6 or 7 shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.
Defence in relation to exportsF110
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Application of various provisions of the Act11
The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations —
a
section 2 (extended meaning of “sale” etc.);
b
section 3 (presumptions that food is intended for human consumption);
c
section 20 (offences due to fault of another person);
d
section 21 (defence of due diligence) as it applies for the purposes of section 8, 14 or 15;
e
section 22 (defence of publication in the course of business);
f
section 30(8) (which relates to documentary evidence);
g
section 33(1) (obstruction etc. of officers);
h
section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by paragraph (g) above;
i
section 35(1) (punishment of offences) in so far as it relates to offences under section 33(1) as applied by paragraph (g) above;
j
section 35(2) and (3) in so far as it relates to offences under section 33(2) as applied by paragraph (h) above;
k
section 36 (offences by bodies corporate); and
l
section 44 (protection of officers acting in good faith).
F2Transitional provision12
In any proceedings for an offence under regulation 9 relating to a breach of regulation 6 or 7 consisting of a contravention of or a failure to comply with regulation 6(3)(e), it shall be a defence to prove that—
a
the food supplement concerned was sold before the 31st October 2012; and
b
the matters constituting the alleged offence would not have constituted an offence under those Regulations if the amendments made by regulation 2(2) and (6)(b) of the Food Supplements (Wales) and Addition of Vitamins, Minerals and Other Substances (Wales) (Amendment) Regulations 2009 had not been in operation when the food was sold.
M1 Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998 .