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Service Information
Compliance services for Regulatory requirements in Japan and all over the world
In Japan, Asia, Europe and the United States, as well as in developing countries around the world, new laws and regulations for chemical substance management are being promoted by countries and regions.
In many of these laws, new application procedures, test data, and assessment reports on applications, etc. are required compared to the past.
In the case of substances that may cause serious harm to humans and the environment, there may be an obligation to submit additional data and evaluation results to the authorities and restrictions may be imposed.
Japan's Chemical Substances Control Law (Kashin-hou), Europe/the UK/ Korea REACH, US-TSCA, etc. are also being reformed in the direction of further strengthening examinations and regulations. For this reason, chemical manufacturers and trading companies around the world are forced to take additional measures that have never been done before.
Furthermore, in Europe and Korea REACH, not only new substances, but also existing substances are required to have test data and risk assessment according to the manufacturing and import amount, and the burden on business operators is increasing further.
RF Chemical Service Co., Ltd. provides best and high-quality services to meet these regulatory requirements towards all over the world.
RF Chemical Services provides registration application services for laws and regulations around the world, such as the Japan Chemical Trials Act, the Occupational Safety and Health Act, the Poisonous Act, US-TSCA, EU-REACH, K-REACH, NICNAS and others.
In the production, import and export of chemical substances, it is necessary to apply for registration in accordance with the applicable laws and regulations and quantity.
On the other hand, in the case of products (articles), R & D applications, natural products, intermediates, etc., registration exemptions or applications themselves may be exempted.
Furthermore, the contents of registration / application differ between existing substances and new substances in many countries and regions.
For this reason, confirmation of existing / new substances is important as prior confirmation of actual production and import.
Furthermore, if it conforms to the standards of the Chemical Substances Control Law, it may be possible to apply for a surveillance test unlike ordinary low molecular weight compounds.
(Japan)
A detailed decision flow has been disclosed to the public by the Ministry of Economy, Trade and Industry (METI) and also by National Institute of Technology and Evaluation (NITE) as to the necessary response under the Japan's Chemicals Substance Control Act (CSCL).
(USA)
In the US, new substances need to be submitted under TSCA. In TSCA, too, the first response is to investigate the presence of TSCA inventory. In addition, we will carry out PMN, LVE, polymer exemption etc. advice, services, application agency depending on the quantity.
(Obtain CAS number)
In RF Chemical Services, we will provide CAS number and CAS name acquisition services in accordance with US-TSCA standards. Even when the structural formula is not clear, there are cases where appropriate CAS names and numbers can be obtained from the raw materials and reaction conditions.
Worldwide SDS（MSDS） services
SDS（MSDS） is an essential document for providing information so that safe handling methods can be ensured in the chemicals business. The items described in the SDS need to reflect the regulatory situation of the country concerned, so simple translation may not meet the requirements of the law.
For example, REACH registration numbers are not required outside the EU nor provide useful information but have legal obligations within the EU.
RF Chemical Services provides SDS creation services in the official language (local language) of Japan, Asia, North America, Europe and other countries in about 50 countries and more around the world through local partners. Alternatively, English-language SDS（MSDS）s can be created in compliance with ISO (ISO 1104-1) for customs purposes.
First of all, please feel free to contact us.
The main target countries are as follows.
| Asia and Russia | Japan, China, Korea, Taiwan, India (English and Hindi), Indonesia, Malaysia (English and Malay), Philippines, Russia, Singapore, Thailand and others |
|---|---|
| North America | USA, Canada (English and French), Mexico (Spanish) and others |
| South America | Argentina (Spanish), Brazil (Spanish), Chile (Spanish) and others |
| Europe | Belgium (Germany / France), Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Switzerland (German or French), Turkey |
| Australia | Australia, New Zealand |
| Africa | Algeria (Arabic), Egypt (Arabic), Kenya (English), Nigeria (English), South Africa (English) and others |
Appropriate testing proposal and implementation of studies to meet regulatory requirements and voluntary safety assessment
Chemical substances include substances that have physical hazards such as flammability, hazards to human health such as acute toxicity, irritation and carcinogenicity, and harm to environmental organisms. Some of these substances are regulated and controlled by various laws in each country.
On the other hand, it is very difficult financially and temporally to conduct examination about all the hazards mentioned above. Therefore, in RF Chemical Services, we propose an optimal and useful test set based on QSAR prediction using chemical structure and conventional rules and application information. As a result, it is possible to communicate information through SDS etc. regarding voluntary GHS classification and handling conditions for users.
For example, if a preparation (product) is determined to be a poisonous substance under the Japanese poisoning law, the test is carried out using the preparation, and if it is clear that the preparation is not a poisonous substance, the designation to the authority is canceled It is also possible to apply for.
In addition, if registration / application is expected in a specific country in the future, we will arrange testing under GLP conditions.
Reference
In Japan:
Chemical Substances Control Law (Competent authorities; METI, MHLW and MoE)
Industrial Safety and Health Act (Competent authority: MHLW)
Poisonous and Deleterious Substances Control Law (Competent authority: MHLW)
EU REACH、CLP
UN-GHS/ TDG
FAQ
1：Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (ISHL)
- For those chemical substances scheduled to be manufactured and/ or imported, we would like to confirm if it is necessary to apply for the CSCL and the ISHL Furthermore, it is a mixture and there is raw material (starting material) information available, the components of the whole mixture (reaction products) are difficult to identify and quantify. What should we do meet the regulatory requirements?
- First of all, please let us know the substance name, CAS number and preparation amount of the raw materials. We investigate and report to you whether it is an existing substance or a new substance. If the substance is considered as a new substance, it is necessary to test according to the production and import quantity, but in actuality, the test is conducted with only the new substances as the analysis target chemicals.
- We plan to import new substances, which are considered as new chemicals from abroad for the R&D purpose. Please tell me about the necessary procedures.
- In case of the R&D purpose only and not to be placed on the market, no prior notification is required. For more details, please refer to the operation notices by METI (although Japanese pages), or contact RF Chemical Services.
- We plan to manufacture and import substances that have been disclosed under the ISHL but for which the CSCL number is unknown. In this case, do we need notification and examination under CSCL?
- Yes. Even if it is a substance that has been publicized under the ISHL, if it is a substance that has not been publicized under the CSCL, testing and notification is required.
- Can a foreign company carry out a notification of the CSCL directly without passing through Japanese importers?
- Overseas manufacturers and exporters can submit (new applications for) standard new chemical notification (no limits). However, for low volume exemption (up to 10 ton) or small amount new application (1 tons or less) cannot directly notify.
For this reason, in the case of low production or a small amount of new application, it will be done by the Japanese importer or handling company.
If you wish, we can submit the notification on behalf of you where importer’s name are used as notifier but not disclosing chemicals name and/ or structure to the Japanese importer.
- I heard that the method for offering small amounts of new chemical substances (necessary documents) has been changed (as from 2019 for production and import). We have heard that "use certificates" have been added, but specifically how should I enter and submit it?
- Specifically, "use information", "use classification" and "(emission) coefficient" are selected and reported out of 48 types created by the Ministry of Economy, Trade and Industry. Please feel free to contact us if you have any problems. In addition, details are described in the Ministry of Economy, Trade and Industry website (sorry Japanese page).
- There is a test report conducted overseas for the substance to be reported under the Chemical Substances Control Law, but can this be used for application under the Chemical Substances Control Law? Also. Do we need a Japanese translation report?
- This test is in accordance with the test method defined by the CSCL and if it is GLP compliant, it is generally available and no Japanese translation is necessary. On the other hand, in repeated dose toxicity studies, some Japanese translation may be necessary. In any case, it is recommended to make an advance confirmation with the Ministry of Economy, Trade and Industry, the Ministry of Environment, and the Ministry of Health, Labor and Welfare before applying.
2：SDS
- Although downstream users have requested to provide SDS, the information on the ingredients is not provided from upstream, so it is difficult to create accurate SDS. In this case also, is it necessary to create an SDS and provide it downstream users?
- In Japan, following three laws require providing SDS to downstream users; the PRTR Law (Class I Chemical 462 Substances, Class II Chemical Substances 100 Substances), ISHL (673 Substances), Poisonous Substances and the Control of Toxic Substances. In the case of products containing a certain amount or more of designated poisons and harmful substances, downstream operators are obligated to provide them through SDS and labeling. You may also be penalized if you violate this obligation. For this reason, it is necessary to obtain accurate information from upstream. On the other hand, some products (articles) may be exempted from SDS creation. Please feel free to contact us.
- If the recipe is a trade secret, is it not always necessary to describe the component name and content described in the SDS?
- In order to provide accurate and detailed information to users our basic policy is to disclose as much as possible. On the other hand, if the recipe is confidential information, it is possible to create an SDS using a common name (e.g. alcohol, pigment etc.) and a display format with a certain range of content %.
- I would like to create an SDS for the target chemical, but there is almost no hazard information. If it is necessary to carry out a test to prepare SDS, in which case what test should we do?
- It is not essential to conduct the test if it is only for the purpose of SDS preparation. On the other hand, it is recommended to at least conduct the flammability test if it is concerned with the display under the Fire Service Law and the storage amount limit when there is concern about flammable property etc. in the case of almost organic contents and liquid. For other tests, we will propose taking into consideration the exposure route assumed from the usage of chemical substances.
- In the case of a product (article), is it not necessary to create an SDS?
- Generally, for industrial products and products for general consumers, SDS creation is not mandatory, but RF Chemical Services can also create SDS for products if desired. On the other hand, in Japan, Article Management Promotion Council (JAMP) developed a tool called chemSHERPA (formerly MSDS Plus) for articles and recommended information sharing among supply chains regarding harmful substances contained in products. (see more detail below) https://chemsherpa.net/english
3：Safety tests
- With regard to chemical substances under development, we intend to export them not only to Japan but also to Europe and China. I would like you to give some advices so that we do not have to re-perform similar tests later.
- In RF Chemical Services, we will conduct simultaneous examinations and consultancy services for applications in multiple countries. Please contact us without hesitation.
Contact Us
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