COMMISSION DIRECTIVE 1999/91/EC

of 23 November 1999

amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs(1) and in particular Article 3 thereof,

After consulting the Scientific Committee on Food,

Whereas:

(1) Commission Directive 90/128/EEC(2), as last amended by Directive 96/11/EC(3), provides in Article 3(2) for the revision of Annex II thereto.

(2) On the basis of the information available, certain monomers provisionally admitted at national level may be included in the Community list.

(3) Other monomers have been requested for use following the adoption of Directive 90/128/EEC: the technical data supplied permit their inclusion in the Community list.

(4) Annex III to Directive 90/128/EEC includes a list of additives, which should be amended so as to include other additives fully evaluated by the Scientific Committee on Food.

(5) For certain substances, the restrictions already set out should be amended according to the information available.

(6) The current total list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list.

(7) This Directive establishes purity criteria for only a few substances, and therefore the other substances which may require purity criteria remain regulated in this respect by national laws pending a decision at Community level.

(8) The measures contained in this Directive do not go beyond what is necessary to achieve the objectives already provided for in Directive 89/109/EEC.

(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 90/128/EEC is amended as follows:

1. the fourth indent of Article 3(5) is deleted;

2. Article 3a is replaced by the following: "Article 3a

An incomplete list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions on their use, is set out in Annex III";

3. the following Articles 3b and 3c are inserted: "Article 3b

Only the products obtained by means of bacterial fermentation listed in Annex IV may be used in contact with foodstuffs.

Article 3c

1. The specifications relating to some substances appearing in Annexes II, III and IV are laid down in Annex V.

2. The meaning of the numbers between brackets appearing in the Column 'Restrictions and/or specifications' is explained in Annex VI";

4. Annex II is amended as shown in Annex I to this Directive;

5. Annex III is amended as shown in Annex II to this Directive;

6. the texts set out in Annex III to this Directive are added as Annexes IV, V and VI.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 2000. They shall immediately inform the Commission thereof.

Member States shall permit, as from 1 January 2002, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and complying with this Directive.

They shall prohibit, as from 1 January 2003, the manufacture and importation into the Community of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive.

2. 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.

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 23 November 1999.

For the Commission

Erkki LIIKANEN

Member of the Commission

(1) OJ L 40, 11.2.1989, p. 38.

(2) OJ L 75, 21.3.1990, p. 19.

(3) OJ L 61, 12.3.1996, p. 26.

ANNEX I

Annex II is amended as follows: 1. The fourth indent of paragraph 5 is replaced by the following: "- 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 dm2 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;"

2. The title of column 4 is modified to "Restrictions and/or specifications";

3. Sections A and B are amended as shown in Appendices 1 to 5.

"Appendix 1

List of monomers and other starting substances inserted in Section A of Annex II to Directive 90/128/EEC

>TABLE>

Appendix 2

List of monomers and other starting substances in Section A of Annex II to Directive 90/128/EEC for which the content of the column "Restriction and/or specifications" is modified

>TABLE>

Appendix 3

List of monomers and others starting substances deleted from Section B of Annex II to Directive 90/128/EEC

>TABLE>

Appendix 4

List of monomers and other starting substances in Section B of Annex II to Directive 90/128/EEC for which the content of the column "Restrictions and/or specifications" is modified

>TABLE>

Appendix 5

List of monomers and other starting substances transferred from Section B to Section A of Annex II to Directive 90/128/EEC

>TABLE>"

ANNEX II

Annex III is amended as follows: 1. The fourth indent of paragraph 5 is replced by the following: "- Column 4 (Restrictions and/or specifications). These may include:

- specific migration limit (SML),

- maximum permitted quantity of the substance in the finished materil or article (QM),

- maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA),

- any other restriction specifically laid down,

- any type of specification related to the substance or to the polymer;"

2. The title of the column 4 is modified into "Restrictions and/or specifications";

3. "Incomplete list of additives" is amended as shown in Appendices 1, 2 and 3.

"Appendix 1

List of additives inserted in Annex III to Directive 90/128/EEC

>TABLE>

Appendix 2

List of additives in Annex III to Directive 90/128/EEC for which the content of column "CAS No" is modified

>TABLE>

Appendix 3

List of additives in Annex III to Directive 90/128/EEC deleted

>TABLE>"

ANNEX III

The following Annexes IV, V and VI are added:

"ANNEX IV

PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION

>TABLE>

ANNEX V

SPECIFICATIONS

Part A: General specifications

(to be fixed later)

Part B: Other specifications

>TABLE>

ANNEX VI

NOTES RELATED TO THE COLUMN "RESTRICTIONS AND/OR SPECIFICATIONS"

(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 10060 and 23920.

(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650, 89440.

(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 19540, 19960.

(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 14200, 14230.

(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 66560 and 66580.

(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030.

(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 85840 and 95725.

(9) SML(T) = in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances:

(a) Badge (=2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether:

(b) Badge.H2O.

(d) Badge.HCl.

(e) Badge.2HCl

(f) Badge.H2O.HCl

However in aqueous food simulants, the SML(T) should also include Badge.2H2O (c) unless the material or article is labelled for use in contact only with those foods and/or beverages for which it has been demonstrated that the sum of the migration levels of the five abovementioned substances (a)(b)(d)(e)(f) cannot exceed 1 mg/kg.

(10) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC."