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Materials and Articles intended to come into contact with Foodstuff
1. Specific Directives which cover the particular materials
and articles listed in the Framework Directive
1.1
Ceramic Articles
Council Directive 84/500/EEC (OJ L277, p12,
20/10/1984) of
Commission Directive 2005/31/EC (OJ L110, p36,
Under Directive
84/500/EC 'Ceramic articles' means "articles manufactured from a
mixture of inorganic materials with a generally high argillaceous or silicate
content to which small quantities of organic materials may have been
added". These articles are first shaped and the shape thus obtained is
permanently fixed by firing. They may be glazed, enamelled and/or decorated.
The Directive is concerned with the possible migration of lead and cadmium from
ceramic articles which, in their finished state, are intended to come into
contact with foodstuffs, or which are in contact with foodstuffs, and are
intended for that purpose and it sets limits for these compounds which must not
be exceeded.
EU Directive
2005/31/EC (84/500/EEC)
European Council Directive 2005/31/EC
(84/500/EEC) -
Ceramic articles intended to come into contact with foodstuffs
Test
Method: 4% Acetic acid is used.
Ceramic
articles are divided into 3 Categories:
Category
1
Articles
which cannot be filled and articles which can be filled, the internal depth of
which does not exceed
Category
2
Articles,
not in categories 1 or 3, which can be filled
Category
3
Cooking
ware; packaging and storage vessels having a capacity of more than three litres
Limit for Category 1
Released Lead (mg/dm2) 0.8
Released
Cadmium (mg/ dm2) 0.07
Limit for Category 2
Released
Lead (mg/L) 4.0
Released
Cadmium (mg/L) 0.3
Limit for Category 3
Released
Lead (mg/L) 1.5
Released
Cadmium (mg/L) 0.1
Relevant
Test Methods for Ceramic and Enamel Ware intended to come into contact with
foodstuffs
European:
EN 1388:1995
International:
ISO 6486 / ISO 4531 / ISO 7086
1.2
Plastic Material
Commission Directive 2008/39/EC amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
Commission Directive 2002/72/EC (OJ L220, p18,
Amended by:
- Commission Directive 2004/1/EC (OJ L7,
p45,
- Commission Directive 2004/19/EC (OJ L71,
p8,
- Commission Directive 2005/79/EC (OJ L302,
p36,
- Corrigendum to Commission Directive 2007/19/EC
(OJ L97 p50,
EU Directive 2008/39/EC
Commission Directive 2008/39/EC amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
In
general, the permissible limit of migration of extractable matter from plastic is
10 mg/dm2 for the
following 4 food stimulants:
Water extractive
3% acetic acid extractive
10% (or 15%) ethanol extractive
Rectified olive oil extractive
Test Method (Overall Migration)
1.3
Plasticisers in gaskets in lids
Commission Regulation (EC) No 372/2007
(OJ L92, p9, 03/04/2007 ) of 2 April 2007 laying down transitional migration
limits for plasticisers in gaskets in lids intended to come into contact with
foods
Corrected by:
Corrigendum to Commission Regulation (EC)
No 372/2007 (OJ L97, p70, 12/04/2007 ) of 2 April 2007 laying
down transitional migration limits for plasticisers in gaskets in lids intended
to come into contact with foods
Directive 2002/72/EC defines ‘plastics’ as
"organic macromolecular compounds obtained by polymerisation,
polycondensation, polyaddition or any other similar process from molecules with
a lower molecular weight or by chemical alteration of natural macromolecules.
Other substances or matter may be added to such macromolecular compounds".
Only those monomers
and other starting substances listed in Annex II, Sections A and B of the
Directive may be used for the manufacture of plastic materials and articles
subject to the restrictions specified.
Commission Directive 2007/19/EC amending Directive 2002/72/EC relating to plastic materials
and articles intended to come into contact with food clarifies that gaskets in
lids fall under the scope of Directive 2002/72/EC. It stipulates that Member
States have to adopt measures by
Commission Regulation (EC) No 372/2007
sets transitional specific migration limits (SML) for the sum of certain
plasticisers used in gaskets in lids contacting fatty foods, so that the free
circulation of those products is not endangered, the lids and foods that pose a
significant risk are immediately excluded form the market and, at the same
time, industry has sufficient time to finalise the development of gaskets that
are compliant with the SML laid down in Directive 2002/72/EC as amended by Directive 2007/19/EC. The transitional SML is
set at a level ensuring that the tolerable daily intake (TDI) will not be
exceeded, taking into account the average consumption of the foods concerned
and the opinion issued by EFSA on
Commission Directive 2005/79/EC amends Annexes
II, III, V and VI of Directive 2002/72/EC, Member States must apply
those provisions of the Directive in such a way as to:
(a) permit the trade in and use of plastic materials and articles intended to
come into contact with food and complying with this Directive, from 19 November
2006
(b) prohibit the manufacture and importation into the Community of plastic
materials and articles intended to come into contact with food and which do not
comply with this Directive, from 19 November 2007.
1.4
Testing Migration
of Plastic Materials
Council Directive 82/711/EEC (OJ L097, p26,
23/10/1982) of
Amended by:
- Commission Directive 93/8/EEC (OJ L090,
p22, 14/4/1993) of
- Commission Directive 97/48/EC (OJ L222,
p10, 12/8/1997) of
Implementing
measures:
- Council Directive 85/572/EEC (OJ L372,
p14, 31/12/1985) of
2 Directives on Individual Substances
2.1
Materials
Containing Vinyl Chloride Monomer
Council Directive 78/142/EEC (OJ L44, p15,
15/2/1978) of
Implementing
measures:
- Commission Directive 80/766/EEC (OJ L213,
p42, 16/8/1980) of
- Commission Directive 81/432/EEC (OJ L167,
p6, 24/6/1981) of
This Directive
concerns the presence of vinyl chloride monomer in, and possible migration
from, materials and articles prepared with vinyl chloride polymers or
copolymers, which in their finished state are intended to come into contact
with foodstuffs, or which are in contact with foodstuffs and are intended for
that purpose. Materials and articles must not contain vinyl chloride monomer in
a quantity exceeding that laid down in Annex I of the Directive which is
currently one milligram per kilogram in the final product.
2.2 Regenerated Cellulose Film
Commission Directive 2007/42/EC (OJ L172, p71,
Commission Directive 2007/42/EC published on
Commission Directive 2007/42/EC applies to
regenerated cellulose film within the meaning of the description given in Annex
I of the Directive, which is intended to come into contact with foodstuffs or
which, by virtue of its purpose, does come into such contact and which either:
(a) constitutes a finished product in itself; or
(b) forms part of a finished product containing other materials.
The Directive does
not apply to synthetic casings of regenerated cellulose.
The rules to be
applied to the regenerated cellulose films are specific to the nature of the
layer in contact with the foodstuff. Accordingly, the requirements for
regenerated cellulose films coated with coatings consisting of plastics are
different from those provided for regenerated cellulose films uncoated or
coated with coatings derived from cellulose. In the case of regenerated
cellulose films coated with coatings consisting of plastics, the layer in
contact with foodstuffs consists of a material similar to plastic materials and
articles intended to come into contact with foodstuffs. Therefore the rules
provided for in Commission Directive 2002/72/EC relating to
plastic materials and articles intended to come into contact with foodstuffs
apply also to such films.
2.3
Elastomers or Rubber Teats and Soothers: Release of
N-nitrosamines and N-nitrosable Substances
Commission Directive 93/11/EEC (OJ L093, p37
17/4/1993) of
This Directive is a
specific directive within the meaning of Article 3 of Directive 89/109/EEC and establishes the basic
rules and general criteria for determining the release of N-nitrosamines and
N-nitrosatable substances. It concerns the release of N-nitrosamines and of
substances capable of being converted into N-nitrosamines, from teats and
soothers, made of elastomer or rubber.
2.4
Materials Containing Certain Epoxy Derivatives
Commission Regulation (EC) No 1895/2005 (OJ
L30, p28, 19/11/2005 ) of 18 November 2005 on the restriction of use of certain
epoxy derivatives in materials and articles intended to come into contact with
food
Repeals
- Commission Directive 2002/16/EC (OJ L51,
p27,
Amended by:
- Commission Directive 2004/13/EC (OJ L27,
p46,
Regulation (EC) 1895/2005 applies to materials
and articles, including active and intelligent food contact materials and
articles, as referred to in Article 1(2) of Regulation (EC) No 1935/2004, which are
manufactured with or contain one or more of the following substances:
(a)
2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether, ( ‘BADGE’ (CAS No
001675-54-3)), and some of its derivatives;
(b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers, ( ‘BFDGE’ (CAS No
039817-09-9));
(c) other novolac glycidyl ethers, hereinafter referred to as ‘NOGE’
For the purposes of
the Regulation, ‘materials and articles’ are:
(a) materials and articles made of any type of plastics
(b) materials and articles covered by surface coatings; and
(c) adhesives.
This Regulation
does not apply to containers or storage tanks having a capacity greater than 10
000 litres or to pipelines belonging to or connected with them, covered by
special coatings called ‘heavy-duty coatings’.
At the marketing
stages other than the retail stages, materials and articles containing BADGE
and its derivatives must be accompanied by a written declaration in accordance
with Article 16 of Regulation (EC) No 1935/2004. Appropriate documentation must
be available to demonstrate such compliance and that documentation shall be
made available to the competent authorities on demand. However, this
requirement does not apply to materials and articles referred to Article
1(2)(a)(b) and (c) which were brought into contact with food before
Annex 1 of the
Regulation sets out the specific migration limit for BADGE and certain of its
derivatives. Certain transitional arrangements are set out for materials and
articles which were brought into contact with food before
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