T.C.

TARIM ve KÖYÝÞLERÝ BAKANLIÐI

Koruma ve Kontrol Genel Müdürlüğü

 

Communiqué on Epoxy Derivates Materials and Articles that are in Contact with the Foodstuffs Print

 

 

Authorization Law: Turkish Food Codex

The Official Gazette: 04.07.2005-25865

Communication No : 2005/32

Objective

Article 1- The objective of this Communiqué is to determine the characteristics of epoxy derivatives in materials and articles that are in contact with foodstuffs in order to ensure that the production, processing, storage, transportation, and marketing thereof is carried out hygienically and according to proper techniques.

Scope

Article 2- This Communiqué covers the materials and articles, which in their finished product state, are in contact with foodstuffs and are manufactured using one or more of the following substances:

- 2.2-bis (4-hydroxyphenyl)propane bis (2,3-epoxypropyl)ether and some of its derivatives

- Bis (hydroxyphenyl)methane bis (2,3epoxypropyl)ethers and some of their derivatives

- Other novolac glycidyl ethers and some of their derivatives

This Communiqué does not cover 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’.

Legal basis

Article 3- This Communiqué has been prepared in accordance with the “Turkish Food Codex Regulation” published in the Official Gazette dated 16/11/1997 and with repetitive number 23172.

Abbreviations

Article 4- The following abbreviations used in this Communiqué shall have the meanings designated thereto;

BADGE stands for 2,2-bis(4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether

BFDGE stands for bis (hydroxyphenyl) methane bis (2,3epoxypropyl) ether

NOGE stands for novolac glycidyl ether.

Definitions

Article 5- The materials and articles referred to in this Communiqué are:

- Materials and articles made of any type of plastics,

- Materials and articles covered by surface coatings,

- Adhesives

Product characteristics

Article 6- Characteristics of the products that fall within the scope of this Communiqué are given below:

a) Migration of the substances listed in Annex 1 for the materials and articles referred to in Article 2 of this Communiqué shall not be in quantities more than the limits given in the same annex.

b) Migration of the substances listed in Annex 2 shall not, when the materials and articles referred to in Article 2 of this Communiqué are added to the sum of BADGE and its derivatives listed in Annex 1, be in a quantity that exceeds the limits given in Annex 2.

c) 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 1000 Daltons shall not be detectable in the materials and articles referred to in Article 2 at the detection limit of 0.2 mg/6 dm2, including analytical tolerance.

For the purpose of this Communiqué, the detection limit specified in paragraph (c) of Article 6 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.

Packaging, labelling and marking

Article 7- The packaging, labelling and marking of the products that fall within the scope of this Communiqué must be in conformity with the rules laid down in the section on Packaging and Labeling-Marking of the Turkish Food Codex Regulation.

Sampling and methods of analysis

Article 8- Sampling from the products that fall within the scope of this Communiqué shall be performed in accordance with the rules described in the section on Sampling and Methods of Analysis the Turkish Food Codex Regulation, and samples must be analysed by internationally recognized methods.

Compliance with European Union

Article 9- This Communiqué has been prepared within the framework of compliance with European Union, taking into consideration Commission Directive 2002/16/EC on “the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs”.

Registration and inspection

Article 10- Establishments that produce and sell the products within the scope of this Communiqué are obligated to comply with the provisions of this Communiqué during registration and authorisation, importation procedures, control and inspection. Legal action shall be taken against establishments that fail to comply with these provisions according to “Law No. 1579 dated 27/5/2004 on the Adoption of the Amendment to the Decree Law concerning the Production, Consumption and Inspection of Food”.

Inspection

Article 11- The inspection related to the implementation of the provisions laid down in this Communiqué is carried out by the Ministry of Agriculture and Rural Affairs according to Law No. 1579 dated 27/5/2004 on the Adoption of the Amendment to the Decree Law concerning the Production, Consumption and Inspection of Food”.

Provisional article 1- Establishments that are currently operating, which produce and sell the products within the scope of this Communiqué are obligated to comply with the provisions of this Communiqué within 1 year as of the date of publication thereof.

Enforcement

Article 12- This Communiqué enters into force on the date of its publication.

Execution

Article 13- The provisions of this Communiqué are executed by the Minister of Agriculture and Rural Affairs.



ANNEX 1

Specific migration limits for BADGE and certain of its derivatives

1) The sum of the migration limits of the following substances:

(a) BADGE (= 2,2 bis (4-hydroxyphenylpropane bis (2,3-epoxypropyl) ether;

(b) BADGE.H2O

(c) BADGE.HCl

(d) BADGE.2HCl

(e) BADGE.H2OHCl

shall not exceed 1mg/kg in foodstuffs or in food simulants excluding analytical tolerance or 1mg/6dm2 in accordance with paragraph (k) of Article 5 of the “Turkish Food Codex Communiqué on Plastic Materials and Articles that come into Contact with Foodstuffs”.

2) The migration testing shall be carried out in accordance with the rules established in the “Turkish Food Codex Communiqué on the Basic Rules for Testing Migration of the constituents of Plastic Materials and Articles intended to come into Contact with Foodstuffs” as well as the “Turkish Food Codex Communiqué on the Plastic Materials and Articles that come into Contact with Foodstuffs”. However, in aqueous food simulants, this value should also include BADGE.2H2O unless the material or article is labelled for use in contact 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 paragraphs (a), (b), (c), (d) and (e) of Article 1 of Annex 1 can not exceed the limits provided in Article 1 of Annex 1.

3) For the purpose of this Communiqué, the specific migration of the substances listed in paragraph (a), (b), (c), (d) and (e) of Article 1 of Annex 1 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.



ANNEX 2

Specific migration limits for BFDGE and certain of its derivatives

1) The sum of the migration levels of the following substances:

(a) BFDGE (=bis (hydroxyphenyl) methane bis (2,3epoxypropyl) ether

(b) BFDGE.H2O

(c) BFDGE.HCl

(d) BFDGE.2HCl

(e) BFDGE.H2OHCl

shall not exceed 1mg/kg in foodstuffs or in food simulants excluding analytical tolerance or 1mg/6dm2 in accordance with paragraph (k) of Article 5 of the “Turkish Food Codex Communiqué on Plastic Materials and Articles that come into Contact with Foodstuffs”.

2) The migration testing shall be carried out in accordance with the rules established in the “Turkish Food Codex Communiqué on the Basic Rules for Testing Migration of the constituents of Plastic Materials and Articles intended to come into Contact with Foodstuffs” as well as the “Turkish Food Codex Communiqué on Plastic Materials and Articles that come into Contact with Foodstuffs”. However, in aqueous food simulants, this value should also include BADGE.2H2O unless the material or article is labelled for use in contact 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 paragraphs (a), (b), (c), (d) and (e) of Article 1 of Annex 1 can not exceed the limits provided in Article 1 of Annex 1.

3) For the purpose of this Communiqué, the specific migration of the substances listed in paragraph (a), (b), (c), (d) and (e) of Article 1 of Annex 1 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.

 

©KKGM - Akay Cad. No:3 Bakanlýklar/ANKARA   Tel: (009)-0312-4174176