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LIVSFS 2023:3
Published on
24 May 2023
The Swedish Food Agency’s Regulations on
food supplements;
adopted on 12 May 2023.
By virtue of Sections 5-7 of the Food Ordinance (2006:813), the
Swedish Food Agency lays down1 the following.
Scope
Section 1 These regulations shall apply to foodstuffs placed on the
market as food supplements.
Terms and definitions
Section 2 ‘Food supplements’ means foodstuffs which
1. are intended to supplement the normal diet;
2. are concentrated sources of nutrients or other substances with a
nutritional or physiological effect, alone or in combination; and
3. are supplied in dose form, namely forms such as capsules,
pastilles, tablets, pills and other similar forms, sachets of powder,
ampoules of liquids, drop dispensing bottles and other similar
1 See Directive 2002/46/EC of the European Parliament and of the Council of
10 June 2002 on the approximation of the laws of the Member States relating to
food supplements, as amended by Commission Regulation (EU) 2021/418. See
also Directive (EU) 2015/1535 of the European Parliament and of the Council of
9 September 2015 laying down a procedure for the provision of information in
the field of technical regulations and of rules on Information Society services.

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preparations of liquids or powders designed to be taken in measured
small amounts.
‘Nutrients’ means vitamins and minerals.
Packaging and labelling
Section 3 Food supplements may be delivered to the ultimate
consumer only in pre-packaged form.
Section 4 The name of the food for products covered by these
regulations shall be ‘food supplement’.
Section 5 General provisions on food information can be found in:
1. Regulation (EU) No 1169/2011 of the European Parliament and of
the Council of 25 October 2011 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, and
2. The Swedish Food Agency’s Regulations (LIVSFS 2014:4) on
food information.
Section 6 Without prejudice to application of the provisions laid down
in Section 5, packaging containing food supplements shall be labelled
with the following:
1. the names of the categories of nutrients or other substances that
characterise the product, or the nature of those nutrients or other
substances;
2. the recommended daily dose of the product;
3. that the recommended daily dose must not be exceeded;
4. that food supplements should not be used as a substitute for a
varied diet; and
5. that food supplements should be stored out of the reach of young
children.

The Swedish Food Agency’s Code of Statutes ISSN 1651-3533
Section 7 The labelling and presentation of food supplements may not
include any claim or implication that a balanced and varied diet cannot
provide appropriate quantities of nutrients in general.
Section 8 The amounts of nutrients and other substances with a
nutritional or physiological effect present in the product shall be
declared on the labelling in numerical form. The amounts indicated
shall relate to the content in the recommended daily dose of the product.
The amounts indicated shall be an average based on the
manufacturer’s analysis of the product and shall be expressed in the
units for vitamins and minerals set out in Annex I to Directive
2002/46/EC of the European Parliament and of the Council of 10 June
2002 on the approximation of the laws of the Member States relating to
food supplements.
Section 9 The amounts of vitamins and minerals shall be expressed as
a percentage of the reference values set out in Annex XIII to Regulation
(EU) No 1169/2011 of the European Parliament and of the Council.
The percentage referred to in the first paragraph may also be
expressed in graphical form.
Vitamins and minerals
Section 10 Only vitamins and minerals listed in Annex I to Directive
2002/46/EC of the European Parliament and of the Council may be used
in the manufacture of food supplements.
Section 11 Only those compounds of vitamins or minerals listed in
Annex II to Directive 2002/46/EC of the European Parliament and of
the Council may be used in the manufacture of food supplements.
Such vitamin or mineral compounds shall, where appropriate, meet
the purity criteria which
1. the Commission has adopted in accordance with
Directive 2002/46/EC of the European Parliament and of the Council;
or
2. are established by Union law and are applicable to the manufacture
of foodstuffs for purposes other than food supplements.
In the absence of established purity criteria, the generally accepted
purity criteria recommended by international bodies shall apply.

; LIVSFS Published on

adopted

By virtue of Sections 5-7 of the Food Ordinance (2006:813), the Swedish Food Agency lays down the following.

Scope

Section 1  These provisions shall apply to foodstuffs placed on the market as food supplements.

Terms and definitions

Section 2  ‘Food supplements’ means foodstuffs which

are intended to supplement the normal diet;

are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination; and

are supplied in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar preparations of liquids or powders designed to be taken in measured small amounts.

‘Nutrients’ means vitamins and minerals.

Packaging and labelling

Section 3  Food supplements may be delivered to the ultimate consumer only in pre-packaged form.

Section 4  The term ‘food supplements’ shall be used on the products covered by these regulations.

Section 5  The packaging shall be labelled with the following:

the names of the categories of nutrients or other substances that characterise the product, or the nature of those nutrients or other substances;

the recommended daily dose of the product;

that the recommended daily dose must not be exceeded;

that food supplements should not be used as a substitute for a varied diet; and

that food supplements should be stored out of the reach of young children.

Section 6  The labelling and presentation of food supplements may not include any claim or implication that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

Section 7  The amounts of nutrients and other substances with a nutritional or physiological effect present in the product shall be declared on the labelling in numerical form. The amounts indicated shall relate to the content in the recommended daily dose of the product.

The amounts indicated shall be an average based on the manufacturer’s analysis of the product and shall be expressed in the units for vitamins and minerals set out in Annex I to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.

Section 8  The amounts of vitamins and minerals shall be expressed as a percentage of the reference values set out in Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 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.

The percentage referred to in the first paragraph may also be expressed in graphical form.

Vitamins and minerals

Section 9   Only vitamins and minerals listed in Annex I to Directive 2002/46/EC of the European Parliament and of the Council may be used in the manufacture of food supplements.

Section 10  Only those compounds of vitamins or minerals listed in Annex II to Directive 2002/46/EC of the European Parliament and of the Council may be used in the manufacture of food supplements.

Such vitamin or mineral compounds shall, where appropriate, meet the purity criteria which

the Commission has adopted in accordance with Directive 2002/46/EC of the European Parliament and of the Council; or

are established by Union law and are applicable to the manufacture of foodstuffs for purposes other than food supplements.

In the absence of established purity criteria, the generally accepted purity criteria recommended by international bodies shall apply.

Vitamin D and iodine

Section 11  The recommended daily dose of a food supplement placed on the market in Sweden must not contain levels of

vitamin D exceeding 80 μg; or

iodine exceeding 200 μg.

Section 12  For individual products, the Swedish Food Agency may grant derogations from the limit values for vitamin D or iodine set out in Section 11 if the Agency considers the level of vitamin D or iodine proposed by the applicant in a recommended daily dose of the product not to present a risk to human health.

Any derogation shall be made conditional on compliance with the limit value for vitamin D or iodine laid down in the decision concerned.

Section 13  An application for derogation for individual products under Section 12 shall contain the following information:

the name, address and contact details of the applicant;

the name and composition of the product;

a proposed amount of vitamin D or iodine in the recommended daily dose of the product; and

scientific evidence demonstrating that the proposed amount of vitamin D or iodine in the recommended daily dose of the product does not pose a risk to human health.

These regulations shall enter into force on 1 January 2024 in respect of Section 11 and otherwise on 1 November 2022.

These regulations repeal the Swedish Food Agency’s Regulations (LIVSFS 2003:9) on food supplements.

Food supplements which do not comply with Section 11 may be marketed until stocks are exhausted, provided that they have been placed on the market or labelled before 1 January 2024.

1. These regulations shall enter into force on 1 July 2023.
2. These regulations repeal the Swedish Food Agency’s Regulations
(LIVSFS 2003:9) on food supplements.
ANNICA SOHLSTRÖM

Elin Häggqvist

(Legal Affairs)

LIVSFS 2022:xx