Materials in Contact with Foodstuffs (Amendment) Regulations,

L.N. 57 of 2005

FOOD SAFETY ACT

(CAP. 449)

Materials in Contact with Foodstuffs (Amendment) Regulations,

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>

(1) The title of these regulations is the Materials in Contact Citation and scope.

with Foodstuffs (Amendment) Regulations, 2005, and they shall be

read and construed as one with the Materials in Contact with Foodstuffs

Regulations, 2003, hereinafter referred to as ìthe principal regulationsî. L.N. 138 of 2003.

(2) These regulations implement the provisions of

Commission Directive 2004#13#EC of the 29th January, 2004.

For the Tenth Schedule to the principal regulations there shall Amends the Tenth

Schedule to the

be substituted the following>-

principal

regulations.

“TENTH SCHEDULE

Epoxy derivatives in materials and articles intended to come into contact with

foodstuffs

1. This Schedule constitutes specific provisions within the meaning of regulation

Din l-Iskeda m’g[andhiex tapplika g[al kontenituri jew tankijiet ta’ []in li

jesg[u aktar minn 10,000 litru jew g[al kanen li jkun mag[hom jew konnessi mag[hom,

koperti mill-kisjiet speçjali msej[in ‘heavy-duty coatings’.

2. This Schedule shall apply to materials and articles which, in the finished

product state, are intended to come into contact or are brought into contact with

foodstuffs and are intended for that purpose and 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 ‘BADGE’), and some of its derivatives<

(b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (hereinafter

‘BFDGE’), and some of their derivatives<

(c) other novolac glycidyl ethers (hereinafter ‘NOGE’), and some of their

derivatives.

For the purposes of this Schedule, ‘materials and articles’ are>

(a) materials and articles made of any type of plastics<

(b) materials and articles covered by surface coatings<

(c) adhesives.

(3) This Schedule 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’.

4. The materials and articles referred to in paragraph 2 shall not release the

substances listed in Part I of this Schedule in a quantity exceeding the limit laid down

in that Part. The use and#or presence of BADGE in the manufacture of those materials

and articles may only be continued until 31 December 2005.

The materials and articles referred to in paragraph 2 shall not release the

substances listed in Part II of this Schedule in a quantity which, when added, to the

sum of BADGE and its derivatives listed in Part I, exceeds the limit laid down in Part

II.

The quantity of NOGE components with more than two aromatic rings and

at least one epoxy group as well as their derivatives containing chlorohydrin functions

and having a molecular mass less than 1 000 daltons shall not be detectable in the

materials and articles referred to in paragraph 2 at the detection limit of 0.2 mg#6 dm 2 ,

including analytical tolerance. For the purpose of this Schedule, the detection limit

specified in this paragraph should be verified by a validated method of analysis. If

such a method does not exist, an analytical method with appropriate performance

characteristics may be used, pending the development of a validated method.

Paragraphs 4,5 and 6 shall not apply to the materials and articles referred to

in points (b) and (c) of paragraph 1 which were brought into contact with foodstuffs

before 1 March 2003. Those materials and articles may be placed on the market provided

that the date of filling appears on the materials and articles. However, the date of

filling may be replaced by another indication, provided that this indication permits the

identification of the date of filling. Upon request, the date of filling shall be made

available to the competent authority and any person enforcing the requirements of

these regulations.

Paragraph 7 shall apply without prejudice to the requirements of the Labelling,

Presentation and Advertising of Foodstuffs Regulations, 2004 (L.N. 483 of 2004).

PART I

Specific migration limit for BADGE and certain of its derivatives

(1) 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.H 2 O<

(c)

BADGE.HCl<

(d)

BADGE.2HCl<

(e)

BADGE.H 2 O.HCl

shall not exceed the following limits>

—

1 mg#kg in foodstuffs or in food simulants (analytical tolerance excluded),

or

— 1 mg#6 dm2 in accordance with the cases provided by paragraph 13 of the

Fifth Schedule.

(2) The migration testing shall be carried out in accordance to the rules

established in the Sixth Schedule as well as in the Fifth Schedule. However in aqueous

food simulants, this value should also include BADGE.2H 2 O 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 substances

listed in paragraph 1(a), (b), (c), (d) and (e) cannot exceed the limits provided in

paragraph 1.

(3) For the purpose of this Schedule, the specific migration of the substances

listed in paragraph 1(a), (b), (c), (d) and (e) should be determined by a validated method

of analysis. If such a method does not exist, an analytical method with appropriate

performance characteristics may be used, pending the development of a validated

method.

PART II

Specific migration limit for BFDGE and certain of its derivatives

(1) The sum of the migration levels of the following substances>

(a)

BFDGE (= bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers)<

(b)

BFDGE.H 2 O<

(c)

BFDGE.HCl<

(d)

BFDGE.2HCl<

(e)

BFDGE.H 2 O.HCl

added to the sum of those listed in Part I, shall not exceed the following limits>

—

1 mg#kg in foodstuffs or in food simulants (analytical tolerance excluded),

or

— 1 mg#6 dm2 in accordance with the cases provided by paragraph 13 of the

Fifth Schedule.

(2) The migration testing shall be carried out in accordance to the rules

established in the Sixth Schedule as well as in the Fifth Schedule. However in aqueous

food simulants, this value should also include BFDGE.2H 2 O 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 substances

listed in paragraph 1(a), (b), (c), (d) and (e), added to those listed in Part I, cannot

exceed the limits provided in paragraph 1.

(3) For the purpose of this Schedule, the specific migration of the substances

listed in paragraph 1(a), (b), (c), (d) and (e) should be determined by a validated method

of analysis. If such a method does not exist, an analytical method with appropriate

performance characteristics may be used, pending the development of a validated

method.”.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press