21

LIVSFS 2023:5
Published on
6 July 2023
The National Food Agency’s regulations on
materials and articles intended to come into
contact with food;
Adopted on 20 June 2023.
By virtue of Sections 5, 6, 30 and 31 of the Food Ordinance
(2006:813) and Section 30 of Ordinance (2008:245) on chemical
products and biotechnological organisms, the Swedish National Food
Agency lays down1 the following.
Chapter 1 – General provisions
Scope
Section 1 These regulations contain provisions on requirements
concerning materials and articles intended to come into contact with
food, and their import, as well as provisions on the registration of
certain operations that manufacture, process or import materials and
articles intended to come into contact with food.
These provisions supplement, inter alia, the provisions of Regulation
(EC) No 1935/2004 of the European Parliament and of the Council of
27 October 2004 on materials and articles intended to come into contact
with food and repealing Directives 80/590/EEC and 89/109/EEC, and
provisions which have been adopted by virtue of that regulation.
1 See 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.

Section 2 Provisions on:
operations that shall be registered are in Chapter 2;
requirements concerning the handling of food are in Chapter 3;
materials and articles of regenerated cellulose film are in Chapter 4;
ceramic articles are in Chapter 5;
elastomer or rubber children’s dummies are in Chapter 6; and
imports from third countries are in Chapter 7.
Chapter 2 – Activities that shall be registered
Notification for registration
Section 1 Operators that are engaged in an activity other than a food
establishment and that manufacture, process or import from third
countries materials and articles intended to come into contact with food,
shall notify the activity in writing so that it can be registered.
The first paragraph does not apply to activities that during a financial
year are estimated to have a turnover – from materials and articles
intended to come into contact with food – of less than SEK 80 000, and
that are expected to produce, process or import fewer than 1 000 units
of materials and articles intended to come into contact with food.
The first paragraph also does not apply to activities within the
Swedish Armed Forces, the Swedish Fortifications Agency, the
Swedish Defence Materiel Administration, the Swedish National
Defence Radio Establishment, or activities by or on behalf of one of
these authorities.
Content of a notification
Section 2 A notification for the registration of an activity shall contain
the following information.
1. The name and contact details of the operator.
2. The corporate identity, personal identity, or coordination number
of the operator or, in the absence of such, corresponding identification
information.
3. Information on the premises, space or location where the activity is
carried out.
4. A description of the nature and scope of the activity.

5. Where appropriate, information on how long the activity will be
carried out.
An operator shall also provide, upon request, additional information
required by the authority to process the notification.
Authorities handling the notification
Section 3 A notification for registration shall be submitted to the
authority competent to register the activity in accordance with Section
23 of the Food Ordinance (2006:813).
If the conditions for registration of an activity are met, the authority
shall register the activity.
Commencement of activities
Section 4 The activity that shall be notified for registration may
commence once the authority has registered the activity. However, the
activity may commence two weeks after the notification has been
received by the authority if the authority still has not yet registered the
activity.
Chapter 3 – Special requirements for the handling of
foodstuffs
Food handling
Section 1 In the handling of food, the following may not be used:
1.
vessels, lids, barrels or the like, during the use of which the food comes
into contact with:
a) a galvanised surface;
b) a surface giving off more than a total of 3 milligrams of lead
per litre of the vessel’s capacity when boiled out for half an hour three
times, each time with a new 4 % aqueous acetic acid solution;
c) a surface giving off more than 0.1 milligrams of cadmium per
litre of vessel’s capacity when leached with an acetic acid solution as
specified in point b at room temperature for 24 hours;
2. other equipment where the food comes into contact with lead or
cadmium.

Section 2 The provisions of Section 1 shall not apply to plastic lids
covered by the provisions of Commission Regulation (EU) No 10/2011
of 14 January 2011 on plastic materials and articles intended to come
into contact with food.
The provision of Section 1(1)(a) does not apply to vessels or other
equipment for drinking water.
The provisions of Section 1(1)(b) and (c) do not apply to ceramic
articles that are covered by these regulations.
Dispensation
Section 3 The National Food Agency may grant exemptions
(dispensation) from Chapter 3, Section 1.
Chapter 4 – Special requirements for regenerated cellulose
film
Regenerated cellulose film
Section 1 The provisions of this Chapter apply to materials and
articles intended to come into contact with food and which are made of
regenerated cellulose film (cellophane) and which form a finished
product or form part of a finished product which also contains other
materials.
Regenerated cellulose film shall belong to the following groups:
1. uncoated regenerated cellulose film;
2. coated regenerated cellulose film with coating derived from
cellulose; or
3. coated regenerated cellulose film with coating consisting of
plastics.
The provisions of this Chapter do not apply to synthetic intestines made
of regenerated cellulose film.
Section 2 For the purposes of these regulations, the term ‘regenerated
cellulose film’ means thin films made of refined cellulose from new
wood or cotton raw material. To meet technical requirements, other
substances may be added either in the mass or on the surface.
Regenerated cellulose film may be coated on one or both sides.

List of substances authorised for use in manufacturing
Section 3 Regenerated cellulose film referred to in Section 1, second
paragraph, (1) and (2), may only be produced from the substances or
groups of substances listed in Annex 1 and with the restrictions
specified therein.
In addition to that which is stated in Annex 1, dyes (soluble dyes and
pigments) and binders may be used, provided that there is no detectable
transfer (migration) of such substances to food, as determined by a
validated method.
Section 4 In the production of regenerated cellulose film as referred to
in Section 1, second paragraph, (3), prior to coating, only the substances
or groups of substances listed in Section 1 of Annex 1 may be used,
with the restrictions specified therein.
In the production of the coating to be used on the regenerated
cellulose film referred to in Section 1, second paragraph, (3), only the
substances or groups of substances specified in Article 6 and Annex I to
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic
materials and articles intended to come into contact with food may be
used, with the restrictions specified therein.
Regenerated cellulose film specified in Section 1, second paragraph,
(3), shall comply with Articles 12, 17 and 18 and Annex V to
Regulation (EU) No 10/2011.
Section 5 Printed text or images on regenerated cellulose film may
not come into contact with food.
Declaration of compliance
Section 6 Materials and articles intended to come into contact with
food and which are made of regenerated cellulose film shall be
accompanied, at the marketing stage prior to retail, by a written
declaration of compliance certifying that they meet the requirements of
these regulations.
The first paragraph does not apply to materials and articles intended
to come into contact with food which are made of regenerated cellulose
film and are clearly intended to come into contact with food.

Where special conditions of use apply, the material or article shall be
labelled accordingly.
Chapter 5 – Special requirements for ceramic articles
Ceramic articles
Section 1 The provisions of this Chapter apply to materials and
articles intended to come into contact with food and which are made of
ceramics (ceramic articles).
This Chapter contains provisions on the maximum permissible
amounts (thresholds) of lead and cadmium that may be released from
ceramic articles into food.
Section 2 The term ‘ceramic articles’ in these regulations means
articles produced from a mixture of inorganic materials, generally with
a large proportion of clay or silicate, possibly with the addition of small
amounts of organic materials. Such objects are shaped and the shape
thus obtained is permanently fixed by firing. They may be glazed,
enamelled and/or decorated.
Thresholds
Section 3 The maximum permissible amounts of lead and cadmium
that may be released from ceramic articles into food are as follows.
Lead Cadmium
Articles which cannot be filled and 0.8 mg/dm2 0.07 mg/dm2
articles which can be filled but
whose interior depth, from bottom
to upper edge, does not exceed
25 mm
Cookware; packaging and storage 1.5 mg/l 0.1 mg/l
containers of more than 3 litres
Other articles that can be filled 4.0 mg/l 0.3 mg/l

Section 4 If the amount of lead or cadmium released from a ceramic
article does not exceed the threshold in Section 3 by more than 50 %,
the article may be marketed if the following conditions are met:
– at least three other articles of the same shape, dimension, decoration
and glazing shall be examined in accordance with the requirements set
out in Parts 1 and 2 of Annex 2;
– the average amounts of lead and cadmium, respectively, released
from these three articles may not exceed the thresholds laid down in