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Malaysia Issues Guidelines for Voluntary Certification of Food Contact Materials and Articles

Time：

2022-09-21

The Ministry of Health Malaysia (Kementerian Kesihatan Malaysia, KKM) has issued a guideline on the application process for food-grade certification of food contact materials and products. This voluntary guide aims to provide KKM food-grade certification for products that meet the certification requirements.

1. Scope and Objects

Food grade certification applies to all food grade products used in food production, processing, packaging, storage, transportation or/and exposure. The person applying for certification can be a manufacturer, importer or any individual who is engaged in product sales activities.

2. Definitions

According to the guideline definition, any equipment, hardware, packaging or cleaning agent that is safe to use in contact with food can be certified as "food grade".

3. Product Guide

The food grade guidelines stipulate the following for four types of products: food packaging, food colorants and diluents, food gloves and food insulation bags:

(1) Food Packaging

Any food container that protects food from contamination is food packaging, including plastic, paper, metal, etc. The guidelines state that any food packaging must not: use toxic, destructive raw materials in production; accelerate food degradation, alter food composition or organoleptic properties; migrate in excess of the maximum allowable amount.

For plastic food packaging, the guidelines require compliance with migration limits for 7 metal elements and migration limits for 22 specific substances.

Metal Element	Specific Migration LimitsSML）
Barium	1 mg/kg
Cobalt	0.05 mg/kg
Copper	5 mg/kg
Iron	48 mg/kg
Lithium	0.6 mg/kg
Manganese	0.6 mg/kg
Zinc	25 mg/kg

Table 1 Metal migration limits for plastic packaging

(2) Food Colorants and Diluents

Food colorants are any substances that are added to food to color it. Diluent refers to a liquefying agent added to a colorant to facilitate mixing. The guideline allows the use of colorants (lists I and II in appendix 5 of the guideline) and diluents (lists III in appendix 6 of the guideline) permitted in the Malaysian Food Regulations 1985 and its subsidiary legislation. Colorants in list I need to meet the guidelines Purity requirements specified in .

(3) Food Gloves

This guideline specifies 7 main materials for food contact gloves: natural rubber, synthetic rubber, polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), neoprene and nitrile. ISO 14285:2014(E) "Rubber and plastic gloves for food service - Limitation of extractable substances", as shown in the table below, but ISO 14285:2014(E) does not apply to gloves exposed to greasy food or fat under extreme conditions .

Project		Limited
Heavy metal	Arsenic	0.05 µg/mL
	Cadmium	0.05 µg/mL
	Chromium	0.5 µg/mL
	Lead	0.5 µg/mL
	Zinc	15.0 µg/mL
Potassium permanganate consumption		10 µg/mL
Evaporation residue		≤100µg/mL（distilled water）, ≤100 µg/mL（10% Ethanol）
Phthalates (limited to PVC gloves)		The total content must not exceed 0.1%（BBP、DBP、DEHP、DIDP、DINP和DNOP）

(4) Insulation Bags

Insulation bag refers to the bag used to temporarily store food during the meal delivery process. It has insulation effect. Its main materials are polyethylene terephthalate (PET), polystyrene, synthetic or natural fabrics, non-woven fabrics , Polyethylene, Polyurethane, Polypropylene, Nylon, Polyvinyl Chloride (PVC), the material of the insulation bag must comply with (EU) 10/2011 "Food Contact Plastics" and Regulation (EU) 1907/2006 "Chemical Registration, Evaluation, Authorization and Restriction (REACH)”, the inner layer of the insulation bag must not use polyvinyl chloride (PVC) or other potentially harmful materials.

4. Application and Registration

The guidelines stipulate the standards and procedures for application and registration. Applicants can obtain the application form from the official website of the Ministry of Food Safety and Quality Malaysia (BKKM), and submit the completed application form to the Ministry of Health Malaysia (KMM). The applicant is required to send the food grade product to a laboratory accredited by the Ministry of Standards Malaysia or an equivalent agency for testing, and the analytical parameters depend on the type of product.
After a compliance analysis by the approval team, the certificate of certification will be issued within 10 business days of receipt of the application. The validity period of the certificate is 3 years. To renew the certificate, you need to submit an application within 3 months before the certificate expires.

The food grade certification marks are as follows: