# L_2007092EN.01000901.xml

| 3.4.2007 | EN | Official Journal of the European Union | L 92/9 |
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3.4.2007

EN

Official Journal of the European Union

L 92/9

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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 establishing the European Community,

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:

| (1) | 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 translated into a specific migration limit (SML) of 60 mg/kg food for plastic materials and articles in Commission Directive 2002/72/EC (2). |
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(1)

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 translated into a specific migration limit (SML) of 60 mg/kg food for plastic materials and articles in Commission Directive 2002/72/EC (2).

| (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. |
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(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.

| (3) | It appears necessary to regulate the placing on the market of those products pending the implementation of Directive 2007/19/EC. |
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(3)

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

| (4) | 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. |
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(4)

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.

| (5) | Recently business operators have shown an interest in using other plasticisers as substitutes for ESBO which either have a higher TDI or migrate to lesser extent. Therefore specific rules for these substitutes are also necessary. |
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(5)

Recently business operators have shown an interest in using other plasticisers as substitutes for ESBO which either have a higher TDI or migrate to lesser extent. Therefore specific rules for these substitutes are also necessary.

| (6) | Moreover, the legal situation of these products is 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 material or article and thus covered by Directive 2002/72/EC or as a plastic coating on a metal substrate, and thus not covered by Directive 2002/72/EC. |
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(6)

Moreover, the legal situation of these products is 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 material or article and thus covered by Directive 2002/72/EC or as a plastic coating on a metal substrate, and thus not covered by Directive 2002/72/EC.

| (7) | As a consequence, Member States currently apply diverging rules that may pose a barrier to trade. |
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(7)

As a consequence, Member States currently apply diverging rules that may pose a barrier to trade.

| (8) | 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. |
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(8)

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.

| (9) | 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. |
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(9)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(10)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

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(1)  
  OJ L 338, 13.11.2004, p. 4.

1

(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).

2

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

3

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ANNEX

Restrictions and specifications related to plasticisers used in gaskets in lids

| Ref. No | CAS No | Name | Restrictions and/or specifications |
| --- | --- | --- | --- |
| (1) | (2) | (3) | (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 the total food contact surface of lid and sealed container.
  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 the total food contact surface of lid and sealed container.
  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 the total food contact surface of lid and sealed container.
  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 the total food contact surface of lid and sealed container.
  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. |
| 56800 | 030899-62-8 | Glycerol monolaurate diacetate | 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 the total food contact surface of lid and sealed container.
  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. |
| 30340 | 330198-91-9 | 12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester | 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 the total food contact surface of lid and sealed container.
  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. |
| 76866 | — | Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol | SML = 30 mg/kg of food or food simulants or 5 mg/dm2 of the total food contact surface of lid and sealed container. |

Ref. No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(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 the total food contact surface of lid and sealed container.

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 the total food contact surface of lid and sealed container.

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

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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 the total food contact surface of lid and sealed container.

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 the total food contact surface of lid and sealed container.

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.

56800

030899-62-8

Glycerol monolaurate diacetate

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 the total food contact surface of lid and sealed container.

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.

30340

330198-91-9

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

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 the total food contact surface of lid and sealed container.

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.

76866

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

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

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(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.

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