Commission Regulation (EC) No 372/2007 of 2 April 2007 laying down transitional migration limits for plasticisers in gaskets in lids intended to come into contact with foods (Text with EEA relevance)
Date: 2007-04-02
Institutions: European Commission
Subjects: food contamination, food safety, food standard, foodstuffs legislation, health risk, plasticiser

3.4.2007

EN

Official Journal of the European Union

L 92/9

COMMISSION REGULATION (EC) No 372/2007

of 2 April 2007

laying down transitional migration limits for plasticisers in gaskets in lids intended to come into
contact with foods

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to 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 (1),
and in particular Article 5(1) thereof,

After consulting the European Food Safety Authority (the
Authority),

Whereas:

In 1999 the Scientific Committee for food has assigned
to epoxidised soybean oil (ESBO) a tolerable daily intake
(TDI) of 1 mg/kg body weight per day. This TDI
is
(SML) of
translated into a specific migration limit
60 mg/kg food for plastic materials and articles in
Commission Directive 2002/72/EC (2).

Commission Directive 2007/19/EC of 30 March 2007
amending Directive 2002/72/EC relating to plastic
materials and articles intended to come into contact
with food (3) clarifies that gaskets in lids fall under the
scope of Directive 2002/72/EC. It stipulates that Member
States have to adopt measures by 1 April 2008 that
allow free circulation of gaskets in lids if they comply
with SML. Non-compliant gaskets
in lids will be
prohibited as from 1 June 2008.

(1)

(2)

(3)

(4)

It appears necessary to regulate the placing on the market
of
implementation of
Directive 2007/19/EC.

those products pending the

(10)

Indeed, recent data from Member States and Switzerland
showed concentrations of ESBO in fatty food, such as
sauces and vegetables or fish in oil, reaching up to
1 150 mg/kg. With such high values, the TDI may be
exceeded for consumers.

(6)

(7)

(8)

(9)

either have a higher TDI or migrate to lesser extent.
Therefore specific rules for these substitutes are also
necessary.

the legal

situation of

is
these products
Moreover,
currently uncertain. Directive 2002/72/EC applies
to
materials and articles, and parts thereof, which consist
exclusively of plastics or are composed of two or more
layers consisting exclusively of plastics. Gaskets in metal
lids could alternatively be regarded as a plastic part of a
covered by Directive
and thus
material or
2002/72/EC or
coating on a metal
a plastic
substrate, and thus not covered by Directive 2002/72/EC.

article
as

a

consequence, Member States

As
diverging rules that may pose a barrier to trade.

currently apply

It therefore appears proportionate to fix transitional 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 should be set at a level ensuring
that normally the TDI will not be exceeded, taking into
account the average consumption of the foods concerned
and the opinion issued by EFSA on 16 March 2006,
which indicated that the level of plasticisers present in
90 % of the fatty food in glass jars is below 300 mg/kg
food.

The measures provided for in this Regulation are in
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

(5)

Recently business operators have shown an interest in
using other plasticisers as substitutes for ESBO which

(1) OJ L 338, 13.11.2004, p. 4.
(2) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive

2005/79/EC (OJ L 302, 19.11.2005, p. 35).

(3) OJ L 91, 31.3.2007, p. 17.

forming
Lids containing plastic layers or plastic coatings,
gaskets in these lids that together are composed of two or
more layers of different types of materials may be placed on
the market
they comply with the
restrictions and specifications indicated in the Annex to this
Regulation.

in the Community if

L 92/10

EN

Official Journal of the European Union

3.4.2007

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 2

This Regulation shall apply until 30 June 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 2 April 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

3.4.2007

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Official Journal of the European Union

L 92/11

ANNEX

Restrictions and specifications related to plasticisers used in gaskets in lids

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

88640

008013-07-8

Soybean oil, epoxidised
(ESBO)

For materials and articles intended for or brought into contact
with foods for which simulant D testing is required by
Directive 85/572/EEC SML(T) (1) (2) = 300 mg/kg of food or
food simulants or 50 mg/dm2 of
food contact
surface of lid and sealed container.

the total

For materials and articles intended for or brought into contact
with infant formulae and follow-on formulae as defined by
Commission Directive 91/321/EEC on infant formulae and
follow-on formulae and products according to Directive
96/5/EC on processed cereal-based foods and baby foods
for infants and young children SML = 30 mg/kg of food or
food simulant.

For materials and articles intended for or brought into contact
with all other types of foods SML(T) (2) = 60 mg/kg of food
or food simulants or 10 mg/dm2 of the total food contact
surface of lid and sealed container.

30401

—

Acetylated mono- and
diglycerides of fatty
acids

For materials and articles intended for or brought into contact
with foods for which simulant D testing is required by
Directive 85/572/EEC SML(T) (2) = 300 mg/kg of
food or
food simulants or 50 mg/dm2 of
food contact
surface of lid and sealed container.

the total

For materials and articles intended for or brought into contact
with all other types of foods SML(T) (2) = 60 mg/kg of food
or food simulants or 10 mg/dm2 of the total food contact
surface of lid and sealed container.

76815

—

Polyester of adipic acid
with glycerol or
pentaerythritol, esters
with even numbered,
unbranched C12-C22
fatty acids

For materials and articles intended for or brought into contact
with foods for which simulant D testing is required by
Directive 85/572/EEC SML(T) (2) = 300 mg/kg of
food or
food simulants or 50 mg/dm2 of
food contact
surface of lid and sealed container.

the total

For materials and articles intended for or brought into contact
with all other types of foods SML(T) (2) = 60 mg/kg of food
or food simulants or 10 mg/dm2 of the total food contact
surface of lid and sealed container.

93760

000077-90-7

Tri-n-butyl acetyl citrate

For materials and articles intended for or brought into contact
with foods for which simulant D testing is required by
Directive 85/572/EEC SML(T) (2) = 300 mg/kg of
food or
food simulants or 50 mg/dm2 of
food contact
surface of lid and sealed container.

the total

For materials and articles intended for or brought into contact
with all other types of foods SML(T) (2) = 60 mg/kg of food
or food simulants or 10 mg/dm2 of the total food contact
surface of lid and sealed container.

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Official Journal of the European Union

3.4.2007

(1)

(2)

(3)

(4)

For materials and articles intended for or brought into contact
with foods for which simulant D testing is required by
Directive 85/572/EEC SML(T) (2) = 300 mg/kg of
food or
food simulants or 50 mg/dm2 of
food contact
surface of lid and sealed container.

the total

For materials and articles intended for or brought into contact
with all other types of foods SML(T) (2) = 60 mg/kg of food
or food simulants or 10 mg/dm2 of the total food contact
surface of lid and sealed container.

For materials and articles intended for or brought into contact
with foods for which simulant D testing is required by
Directive 85/572/EEC SML(T) (2) = 300 mg/kg of
food or
food simulants or 50 mg/dm2 of
food contact
surface of lid and sealed container.

the total

For materials and articles intended for or brought into contact
with all other types of foods SML(T) (2) = 60 mg/kg of food
or food simulants or 10 mg/dm2 of the total food contact
surface of lid and sealed container.

SML = 30 mg/kg of food or food simulants or 5 mg/dm2 of
the total food contact surface of lid and sealed container.

56800

030899-62-8

Glycerol monolaurate
diacetate

30340

330198-91-9

12-(Acetoxy)stearic
acid, 2,3-bis(acetoxy)-
propyl ester

76866

—

Polyesters of 1,2-
propanediol and/or 1,3-
and/or 1,4-butanediol
and/or polypropylene-
glycol with adipic acid,
also end-capped with
acetic acid or fatty acids
C12-C18 or n-octanol
and/or n-decanol

(1) ‘SML’ means specific migration limit.
(2) SML(T) in this specific case means that the specific migration limit shall not be exceeded by the sum of the migration levels of the

substances mentioned with reference numbers 88640, 30401, 76815, 93760, 56800 and 30340.