Commission Directive 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food (Text with EEA relevance)

Link to law: http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32005L0079
Published: 2005-11-18

L_2005302EN.01003501.xml

19.11.2005   

EN

Official Journal of the European Union

L 302/35

COMMISSION DIRECTIVE 2005/79/EC
of 18 November 2005
amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
(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(2) thereof,
After consulting the European Food Safety Authority,
Whereas:

(1)

Commission Directive 2002/72/EC (2) establishes a list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information related to the risk assessment of such substances, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive.

(2)

Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic materials and articles. That list should be amended so as to include other additives evaluated by the European Food Safety Authority (the Authority).

(3)

For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. In particular for epoxidised soybean oil (ESBO) the Authority recommended to decrease its specific migration limit (SML) for PVC gaskets containing that substance which are used to seal glass jars containing infant formulae and follow-on formulae or containing processed cereal-based foods and baby foods for infants and young children. In fact the Authority noted that the exposure of infants who regularly eat such foods may exceed the TDI. Therefore the SML for ESBO is decreased for these particular applications from 60 to 30 mg/kg of food or food simulant while it remains unchanged for all other applications.

(4)

A transitional period should be provided for in respect of PVC gaskets containing epoxidised soybean oil, used to seal glass jars, which are brought into contact with food before the 19 November 2006.

(5)

Directive 2002/72/EC should therefore be amended accordingly.

(6)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annexes II, III, V and VI of Directive 2002/72/EC are amended in accordance with Annexes I to IV to this Directive.
Article 2
PVC gaskets containing epoxidised soybean oil, with reference number 88640 in section A of Annex III to Directive 2002/72/EC, which are used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC (3) or containing processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 96/5/EC (4), filled before 19 November 2006 and which comply with the restrictions and/or specifications provided for in Section A of Annex III to Directive 2002/72/EC as amended by Directive 2004/19/EC, may continue to be placed on the market provided that the date of filling appears on the materials and articles.
The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive.
The first and second subparagraphs shall apply without prejudice to Directive 2000/13/EC of the European Parliament and of the Council (5).
Article 3
1.   Member States shall adopt and publish, by 19 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions 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.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 5
This Directive is addressed to the Member States.

Done at Brussels, 18 November 2005.


For the Commission

Markos KYPRIANOU


Member of the Commission




(1)  OJ L 338, 13.11.2004, p. 4.

(2)  OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive 2004/19/EC (OJ L 71, 10.3.2004, p. 8).

(3)  OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

(4)  OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

(5)  OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

ANNEX I
Annex II to Directive 2002/72/EC is amended as follows:

1.
point 2 of the general introduction is replaced by the following:
‘2.

The following substances are not included even if they are intentionally used and are authorised:
(a)

salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;

(b)

salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

(i)

substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,

(ii)

substances referred to in note 38 of Annex VI.’;

2.
section A is amended as follows:
(a)

the following lines are inserted in the table in numerical order:
Reference No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘11005

012542-30-2

Acrylic acid, dicyclopentenyl ester

QMA = 0,05 mg/6 dm2


11500

000103-11-7

Acrylic acid, 2-ethylhexyl ester

SML = 0,05 mg/kg

12786

000919-30-2

3-Aminopropyltriethoxysilane

Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler. To be used only for the reactive surface treatment of inorganic fillers

13317

132459-54-2

N,N′-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide

SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To be used only as co-monomer (max 4 %) for polyesters (PET, PBT)

14260

000502-44-3

Caprolactone

SML = 0,05 mg/kg (expressed as the sum of caprolactone and 6-hydroxyhexanoic acid)

16955

000096-49-1

Ethylene carbonate

Residual content = 5 mg/kg of hydrogel at a maximum ratio of 10 g of hydrogel to 1 kg of food. The hydrolysate contains ethyleneglycol having an SML = 30 mg/kg

21370

010595-80-9

Methacrylic acid, 2-sulphoethyl ester

QMA = ND (DL = 0,02 mg/6 dm2)

22210

000098-83-9

alpha-Methylstyrene

SML = 0,05 mg/kg

22932

001187-93-5

Perfluoromethyl perfluorovinyl ether

SML = 0,05 mg/kg. Only to be used for anti-stick coatings

24903

068425-17-2

Syrups, hydrolysed starch, hydrogenated

In compliance with the specifications laid down in Annex V

25540

000528-44-9

Trimellitic acid

SML(T) = 5 mg/kg (35)

25550

000552-30-7

Trimellitic anhydride

SML(T) = 5 mg/kg (35) (expressed as trimellitic acid)’

(b)

in the following lines the content of the columns ‘CAS No’ or ‘Restrictions and/or specifications’ is replaced by the following:
Reference No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘10690

000079-10-7

Acrylic acid

SML(T) = 6 mg/kg (36)

10750

002495-35-4

Acrylic acid, benzyl ester

SML(T) = 6 mg/kg (36)

10780

000141-32-2

Acrylic acid, n-butyl ester

SML(T) = 6 mg/kg (36)

10810

002998-08-5

Acrylic acid, sec-butyl ester

SML(T) = 6 mg/kg (36)

10840

001663-39-4

Acrylic acid, tert-butyl ester

SML(T) = 6 mg/kg (36)

11470

000140-88-5

Acrylic acid, ethyl ester

SML(T) = 6 mg/kg (36)

11590

000106-63-8

Acrylic acid, isobutyl ester

SML(T) = 6 mg/kg (36)

11680

000689-12-3

Acrylic acid, isopropyl ester

SML(T) = 6 mg/kg (36)

11710

000096-33-3

Acrylic acid, methyl ester

SML(T) = 6 mg/kg (36)

11830

000818-61-1

Acrylic acid, monoester with ethyleneglycol

SML(T) = 6 mg/kg (36)

11890

002499-59-4

Acrylic acid, n-octyl ester

SML(T) = 6 mg/kg (36)

11980

000925-60-0

Acrylic acid, propyl ester

SML(T) = 6 mg/kg (36)

13720

000110-63-4

1,4-Butanediol

SML(T) = 5 mg/kg (24)

20020

000079-41-4

Methacrylic acid

SML(T) = 6 mg/kg (37)

20080

002495-37-6

Methacrylic acid, benzyl ester

SML(T) = 6 mg/kg (37)

20110

000097-88-1

Methacrylic acid, butyl ester

SML(T) = 6 mg/kg (37)

20140

002998-18-7

Methacrylic acid, sec-butyl ester

SML(T) = 6 mg/kg (37)

20170

000585-07-9

Methacrylic acid, tert-butyl ester

SML(T) = 6 mg/kg (37)

20890

000097-63-2

Methacrylic acid, ethyl ester

SML(T) = 6 mg/kg (37)

21010

000097-86-9

Methacrylic acid, isobutyl ester

SML(T) = 6 mg/kg (37)

21100

004655-34-9

Methacrylic acid, isopropyl ester

SML(T) = 6 mg/kg (37)

21130

000080-62-6

Methacrylic acid, methyl ester

SML(T) = 6 mg/kg (37)

21190

000868-77-9

Methacrylic acid, monoester with ethyleneglycol

SML(T) = 6 mg/kg (37)

21280

002177-70-0

Methacrylic acid, phenyl ester

SML(T) = 6 mg/kg (37)

21340

002210-28-8

Methacrylic acid, propyl ester

SML(T) = 6 mg/kg (37)

21460

000760-93-0

Methacrylic anhydride

SML(T) = 6 mg/kg (37)

24190

008050-09-7

Rosin wood

See “Rosin” (Reference No 24100)’

(c)

the following line is deleted:
Reference No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘11000

050976-02-8

Acrylic acid, dicyclopentadienyl ester

QMA = 0,05 mg/6 dm2’

3.
in section B the following lines are deleted:
Reference No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘11500

000103-11-7

Acrylic acid, 2-ethylhexyl ester

 

14260

000502-44-3

Caprolactone

 

21370

010595-80-9

Methacrylic acid, 2-sulphoethyl ester

 

22210

000098-83-9

alpha-Methylstyrene

 

25540

000528-44-9

Trimellitic acid

QM(T) = 5 mg/kg in FP

25550

000552-30-7

Trimellitic anhydride

QM(T) = 5 mg/kg in FP (expressed as trimellitic acid)’


ANNEX II
Annex III to Directive 2002/72/EC is amended as follows:

1.
point 2 is replaced by the following:
‘2.

The following substances are not included even if they are intentionally used and are authorised:
(a)

salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;

(b)

salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

(i)

substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,

(ii)

substances referred to in note 38 of Annex VI.’;

2.
section A is amended as follows:
(a)

the following lines are inserted in numerical order:
Reference No

CAS No

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

‘30340

330198-91-9

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

 

30401



Acetylated mono- and diglycerides of fatty acids

 

31542

174254-23-0

Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters

QM = 0,5 % (w/w) in FP

43480

064365-11-3

Charcoal, activated

In compliance with the specifications laid down in Annex V, Part B

62245

012751-22-3

Iron phosphide

For PET polymers and copolymers only

64990

025736-61-2

Maleic anhydride-styrene, copolymer, sodium salt

In compliance with specifications laid down in Annex V

66905

000872-50-4

N-Methylpyrrolidone

 

66930

068554-70-1

Methylsilsesquioxane

Residual monomer in methylsilsesquioxane:
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