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SAFEGUARDS | Hardgoods & Food NO. 128/16

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Japan announced a new chapter to regulate food contact polyethylene naphthalate (PEN) materials and articles. The new law will take effect starting December 6, 2016.

In February 2016, we [1] informed you that Japan was proposing to regulate food contact polyethylene naphthalate (PEN) materials and articles falling under the Japan Food Sanitation Law (JFSL). The proposal would amend ‘Specifications and Standards for Foods, Food Additives, etc’ by creating a new section for this category of food contact materials.

On June 8, 2016, the Japan Ministry of Health, Labour and Welfare (MHLW) published Notification No. 245 of 2016 [2] to regulate the use of food contact PEN materials and articles, or food contact materials and articles manufactured with PEN as the principle ingredient. The new law mandates requirements for evaporation residues and migration for germanium.

The new law will take effect on December 8, 2016.

PEN is a polyester polymer with applications in the thermoforming industry and is used in containers for carbonated beverages, beer, water and other liquids.

It is important to note that food contact PEN materials and articles are also obliged to comply with the existing specifications for general plastics, namely cadmium content, lead content, migration of heavy metals expressed as lead and consumption of potassium permanganate.

Highlights of the new law and the requirements for food contact general plastics are summarized in Table 1.

Table 1: MHLW Notification No, 245 of 2016 and requirements for general plastics

Item Food contact material Parameter Requirement Effective date
1 Polyethylene Naphthalene (PEN) Evaporation residue ≤ 30 μg/ml December 8, 2016
2 Specific migration of germanium ≤ 0.1 μg/ml
3 Cadmium content ≤ 100 μg/ml
4 Consumption of potassium permanganate ≤ 10 μg/ml
5 Lead content ≤ 100 μg/ml
6 Migration of heavy metals (as lead) ≤ 1 μg/ml

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. From overall migration test to expert advices on emerging regulations and compliance issues and documentation review, SGS is the partner to trust. Please do not hesitate to contact us for further information or visit our website.

For enquiries, please contact:

Hing Wo Tsang
t: +852 2774 7420

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