Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food (Text with EEA relevance)

• CELEX: Regulation (EC) No 1895/2005
• Articles: 10

Article 1 Scope

1.   This Regulation shall apply to materials and articles, including active and intelligent food contact materials and articles, as referred to in Article 1(2) of Regulation (EC) No 1935/2004, which are manufactured with or contain one or more of the following substances:

(a)

2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether, hereinafter referred to as ‘BADGE’ (CAS No 001675-54-3), and some of its derivatives;

(b)

bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers, hereinafter referred to as ‘BFDGE’ (CAS No 039817-09-9);

(c)

other novolac glycidyl ethers, hereinafter referred to as ‘NOGE’.

2.   For the purposes of this Regulation, ‘materials and articles’ are:

(a)

materials and articles made of any type of plastics;

(b)

materials and articles covered by surface coatings; and

(c)

adhesives.

3.   This Regulation shall not apply to containers or storage tanks having a capacity greater than 10 000 litres or to pipelines belonging to or connected with them, covered by special coatings called ‘heavy-duty coatings’.

Article 2 BADGE

Materials and articles shall not release the substances listed in Annex I in a quantity exceeding the limits laid down in that Annex.

Article 3 BFDGE

The use and/or presence of BFDGE in the manufacture of materials and articles are prohibited.

Article 4 NOGE

The use and/or presence of NOGE in the manufacture of materials and articles are prohibited.

Article 5 Written declaration

At the marketing stages other than the retail stages, materials and articles containing BADGE and its derivatives shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004.

Appropriate documentation shall be available to demonstrate such compliance. That documentation shall be made available to the competent authorities on demand.

Article 6 Transitional provisions

1.   Articles 2, 3 and 4 shall not apply to materials and articles referred to in Article 1(2)(b) and (c) which are brought into contact with food before 1 March 2003.

2.   Articles 3 and 4 shall not apply to materials and articles which are in compliance with Directive 2002/16/EC and which are brought into contact with food before 1 January 2005.

3.   Article 5 shall not apply to materials and articles referred to Article 1(2)(a)(b) and (c) which are brought into contact with food before 1 January 2007.

4.   The materials and articles referred to in paragraphs 1, 2 and 3 may be placed on the market provided the date of filling appears on the materials and articles. The date of filling may be replaced by another indication, provided it 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 Regulation.

5.   Paragraphs 1 to 4 shall apply without prejudice to the requirements of Directive 2000/13/EC.

Article 7 Repeal

Directive 2002/16/EC is repealed.

References to the repealed Directive shall be construed as references to this Regulation and be read in accordance with the correlation table set out in Annex II.

Article 8 Entry into force

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

It shall apply from 1 January 2006.

Schedules & Appendices

ANNEX I

ANNEX I

Specific migration limit for BADGE and certain of its derivatives

1.   The sum of the migrations of the following substances:

(a)

BADGE [= 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether] (CAS No = 001675-54-3)

(b)

BADGE.H 2 O (CAS No = 076002-91-0)

(c)

BADGE.2H 2 O (CAS No = 005581-32-8)

shall not exceed the following limits:

—

9 mg/kg in food or food simulants, or

—

9 mg/6 dm 2 in accordance with the cases provided by Article 7 of Commission Directive 2002/72/EC  ( 1 ) .

2.   The sum of the migrations of the following substances:

(a)

BADGE.HCl (CAS No = 013836-48-1)

(b)

BADGE.2HCl (CAS No = 004809-35-2)

(c)

BADGE.H 2 O.HCl (CAS No = 227947-06-0)

shall not exceed the following limits:

—

1 mg/kg in food or in food simulants, or

—

1 mg/6 dm 2 in accordance with the cases provided by Article 7 of Directive 2002/72/EC.

3.   The migration testing shall be carried out in accordance to the rules established in Council Directive 82/711/EEC  ( 2 ) and Directive 2002/72/EC.

( 1 )

OJ L 39, 13.2.2003, p. 1 .

( 2 )

OJ L 297, 23.10.1982, p. 26 .

ANNEX II

ANNEX II

Correlation table

Directive 2002/16/EC as amended by Directive 2004/13/EC

This Regulation

Article 1

Article 1

Article 2

Article 2

Article 3

Article 3

Article 4

Article 4

—

Article 5

Article 5

Article 6

Article 6

Article 7

Article 7

Article 8

Article 8

Article 8

Article 9

—

Annex I

Annex I

Annex II

—

Annex III

Annex II