株式会社DJK

Overseas testing and applications

overseas testing and applications

Biodegradability certification testing and application for certification
1. DJK services related to biodegradability testing and certification About the services related to biodegradability testing and certification which DJK offers
2. What biodegradable plastic is About the demand of biodegradable plastic in the context of the problems of the current waste plastic, and the kind of biodegradable plastic
3. What biodegradable plastic certification is About the call for biodegradable plastic certification, the partner testing institutes (Normec OWS), and the certification authority
3-1. major biodegradable materials and biodegradable environment About the category of biodegradable plastic
3-2. biomass plastic About the characteristics of biomass plastic
4. Certification types of TUV AUSTRIA Explanation on the required specifications for OK compost INDUSTRIAL, OK compost HOME, OK biodegradable SOIL, OK biodegradable WATER, OK biodegradable MARINE OK biobased
5. Comprehensive specifications of biodegradable plastic Explanation on EN 13432, ISO 17088, ASTM D6400
6. Chemical Characteristics EN 13432, ISO 17088, ASTM D6400 Explanation on the required items of chemical characteristics based on the specifications
7. Biodegradation ISO 14855-1, -2 (JIS K 6953-1, -2, ASTM D5338) Explanation on the required items of biodegradation based on the specifications
8. The degree of disintegration ISO 16929(JIS K 6952), ISO 20200(JIS K 6954) Explanation on the required items of the degree of disintegration based on the specifications
9. Ecotoxicity, plants toxicity EN 13432, ISO 17088, ASTM D6400 Explanation on germination and growth test of land plant based on the specifications
10. Test method granted by Marine Biodegradable Plastic Identification System of JBPA About the test specification of biodegradation granted by Marine Biodegradable Plastic Identification System of Japan BioPlastics Association (JBPA)
11. Test to meet EU microplastics regulation DJK handles tests to meet EU microplastics regulation (Commission Regulation (EU) 2023/2055, Annex XVII to Regulation (EC) No 1907/2006). The tests are conducted at Normec OWS in EU (Belgium).
Chemical substance application
EU REACH application It is necessary to get the EU REACH registration in advance when you export more than 1 ton of chemical substances per year to EU.
UK REACH application It is necessary to get the UK REACH registration when you export more than 1 ton of chemical substances per year to UK.
Turkey REACH application It is necessary to get the KKDIK (Turkey REACH) registration when you export more than 1 ton of chemical substances per year to Turkey.
Ukraine REACH (UA REACH) It is necessary to get the Ukraine REACH registration when you export more than 1 ton of chemical substances per year to Ukraine.
Application for registration of chemical substances for Latin America (Central and South America) We support the procedure of applications for registration of the customers who consider exporting chemical substances for Latin America (Central and South America).
China CHINA-REACH new chemical substance application When you manufacture chemical substances in China or export them to China, it is required to confirm if they are new or already in existence by investigating “Inventory of Existing Chemical substances in China (IECSC list), or by making a request to the authority for a novelty search.
Act on Regulation, Evaluation, etc. of Chemicals in South Korea K-REACH chemical substance application When you manufacture chemical substances in South Korea or export them to South Korea, it is required to confirm if they are new or already in existence by investigating “National Chemical Information System (NCIS).”
Overseas SDS & label creation We create SDS compliant with GHS and labels based on the latest laws and regulations in the destination country.
NSF International-related
About certification of NSF International and testing service NSF is a non-profit third-party organization in the United States whose mission is improvement of population health, security, and environment. It has a variety of standards related to food and water. DJK supports customers to obtain the certification of NSF and to apply for the tests.
AMECA application-related
AMECA registration of materials for automotive lamps and 3-year exposure test of SAE J576 DJK supports customers to go through the testing procedure (3-year exposure test of SAE J576) which is necessary when they register their materials for automotive lamps for AMECA. We also help them apply for AMECA.
AMECA registration and DOT number registration of windshield materials for automobiles and motorcycles DJK supports customers to apply for registration of their windshield materials for automobiles and motorcycles for AMECA.
DMF (Drug Master File) in each countries-related, facility registration
DMF application (Drug Master File) We offer representative services of applying documents related to DMF (Drug Master File) for FDA in the United States. ※We also handle the applications for a variety of countries such as South Korea, Taiwan, Australia, as well as Health Canada and NMPA (National Medical Products Administration in China).
BB-MF application (Biologics Master File) We offer representative services of applying documents related to BB-MF (Biologics Master File) for FDA (the United States).
MAF application (Master File for Devices) We offer representative services of applying documents related to MAF (Master Files for Devices) for FDA.
FDA pharmaceutical facility registration (Establishment) and registration application for medication list (NDC) We offer various application services related to Drug Establishment Registration and Drug Listing for FDA.
FDA medical equipment facility registration (Establishment) and registration of medical equipment (NDC) We offer various application services related to Medical Device Establishment Registration and Listing for FDA.
application for certification of suitability to the EP monographs (CEP) We offer various application services related to Certification of Suitability to the EP monographs (CEP) for EDQM and ASMF (Active Substance Master File). Furthermore, we handle eCTD conversion as well.
Application by proxy and consulting of pet food for the United States and veterinary medicine We offer various application services and consulting services related to pet food and veterinary medicine. We can provide the services step by step, therefore it would be appreciated if you send any inquiries to us when you consider exporting them to the United States.
Supports related to MoCRA (Modernization of Cosmetics Regulation Act) of FDA in the United States It is required to have a local representative in the United States and then to apply for the registration through the representative under MoCRA of FDA. We offer various supports related to MoCRA in cooperation with the US agency.
FCN (Food Contact Notification)-related
Indirect food additive Indirect Food Additive Petition Food Contact Notification NON Objection Letter obtaining operations Food related instruction manual
FDA (US Food and Drug Administration)-related
Certificate Report issue FDA third-party compliance report
EPA (US Environmental Protection Agency)-related
PMN application (Premanufacture Notification) It is required to report the new substances other than the polymer exclusion rule to US Environmental Protection Agency (EPA), and the report is called PMN (Premanufacture Notification).
LVE application (Low Volume Exemption) It is allowed to use simplified low volume new substance application (LVE: Low Volume Exemption) in the case where the amount of manufacturing and exporting is lower than 10 ton per year.
Polymer exemption and its report US TSCA requires you to report EPA in advance when you manufacture and import new chemical substances. In this case, if the polymers meet specific conditions, you are exempt from the report in advance and you can file a simple notification after manufacturing and importing.
NOC report (Notice of Commencement) After PMN application is approved, it becomes possible to import (or manufacture), however, it is required to report NOC (Notice of Commencement) to EPA within 30 days.
Confirmation of existing chemical substances by Bona Fide You can confirm whether they are on inventory of TSCA (existing chemical substance list).

overseas testing and applications

1. DJK services related to biodegradability testing and certification

2. What biodegradable plastic is

3. What biodegradable plastic certification is

3-1. major biodegradable materials and biodegradable environment

3-2. biomass plastic

4. Certification types of TUV AUSTRIA

5. Comprehensive specifications of biodegradable plastic

6. Chemical Characteristics

7. Biodegradation

8. The degree of disintegration

9. Ecotoxicity, plants toxicity

10. Test method granted by Marine Biodegradable Plastic Identification System of JBPA

11. Test to meet EU microplastics regulation

EU REACH application

UK REACH application

Turkey REACH application

Ukraine REACH (UA REACH)

Application for registration of chemical substances for Latin America (Central and South America)

China CHINA-REACH new chemical substance application

Act on Regulation, Evaluation, etc. of Chemicals in South Korea K-REACH chemical substance application

Overseas SDS & label creation

About certification of NSF International and testing service

AMECA registration of materials for automotive lamps and 3-year exposure test of SAE J576

AMECA registration and DOT number registration of windshield materials for automobiles and motorcycles

DMF application (Drug Master File)

BB-MF application (Biologics Master File)

MAF application (Master File for Devices)

FDA pharmaceutical facility registration (Establishment) and registration application for medication list (NDC)

FDA medical equipment facility registration (Establishment) and registration of medical equipment (NDC)

application for certification of suitability to the EP monographs (CEP)

Application by proxy and consulting of pet food for the United States and veterinary medicine

Supports related to MoCRA (Modernization of Cosmetics Regulation Act) of FDA in the United States

Indirect food additive

Certificate Report issue

PMN application (Premanufacture Notification)

LVE application (Low Volume Exemption)

Polymer exemption and its report

NOC report (Notice of Commencement)

Confirmation of existing chemical substances by Bona Fide