Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) (repealed) (c. 72)

[X1 ANNEX II U.K. LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES

Editorial Information

X1 Substituted by Corrigendum to Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal of the European Communities L 220 of 15 August 2002).

GENERAL INTRODUCTION U.K.

1. This Annex contains the list of monomers or other starting substances. The list includes: U.K.

• substances undergoing polymerisation, which includes polycondensation, polyaddition or any other similar process, to manufacture macromolecules,

• natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesise them are not included in the list,

• substances used to modify existing natural or synthetic macromolecular substances.

[F1 2. The following substances are not included even if they are intentionally used and are authorised: U.K.

(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.]

Textual Amendments

F1 Substituted by 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).

3. The list also does not include the following substances although they may be present: U.K.

(a)

substances which could be present in the finished product as:

• impurities in the substances used,

• reaction intermediates,

• decomposition products;

(b)

oligomers and natural or synthetic macromolecular substances as well as their mixtures, if the monomers or starting substances required to synthesise them are included in the list;

(c)

mixtures of the authorised substances.

The materials and articles which contain the substances indicated under points (a), (b) and (c) shall comply with the requirements stated in Article 2 of Directive 89/109/EEC.

4. Substances shall be of good technical quality as regards the purity criteria. U.K.

5. The list contains the following information: U.K.

• column 1 (Ref. No): the EEC packaging material reference number of the substances on the list,

• column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number,

• column 3 (Name): the chemical name,

• column 4 (Restrictions and/or specifications): These may include:

  • specific migration limit (SML),

  • maximum permitted quantity of the substance in the finished material or article (QM),

  • maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm ² of the surface in contact with foodstuffs (QMA),

  • any other restriction specifically mentioned,

  • any type of specifications related to the substance or to the polymer.

6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound. U.K.

7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the CAS Registry, the CAS number in the CAS Registry shall apply. U.K.

8. A number of abbreviations or expressions are used in column 4 of the table, the meanings of which are as follows: U.K.

DL

=

Detection limit of the method of analysis;

FP

=

Finished material or article;

NCO

=

Isocyanate moiety;

ND

=

not detectable. For the purpose of this Directive ‘ not detectable ’ means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method;

[F2 QM

=

Maximum permitted quantity of the ‘ residual ’ substance in the material or article. For the purpose of this Directive the quantity of the substance in the material or article shall be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;]

QM(T)

=

Maximum permitted quantity of the ‘ residual ’ substance in the material or article expressed as total of moiety or substance(s) indicated. For the purpose of this Directive the quantity of the substance in the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;

QMA

=

Maximum permitted quantity of the ‘residual’ substance in the finished material or article expressed as mg per 6 dm ² of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;

QMA(T)

=

Maximum permitted quantity of the ‘residual’ substance in the material or article expressed as mg of total of moiety or substance(s) indicated per 6 dm ² of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;

SML

=

Specific migration limit in food or in food simulant, unless it is specified otherwise. For the purpose of this Directive the specific migration of the substance should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;

SML(T)

=

Specific migration limit in food or in food simulant expressed as total of moiety or substance(s) indicated. For the purpose of this Directive the specific migration of the substances should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.]

Textual Amendments

F2 Substituted by Commission Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance).