This is a time of rapid change for the regulation of chemical safety across East Asia, supporting a thriving industry in the region as well as controlling the import of substances from other markets. The regulatory expectations in the region are extremely diverse and as the regulatory landscape is evolving, keeping up to date is a challenge.
That’s why we’ve compiled these 4 key considerations for companies planning to export ingredients or substances to China, Japan, South Korea, Taiwan or Malaysia.
1. Don’t underestimate the value of local support
Firstly, take time to understand each country’s approach to regulation. Some countries are following a US-type model, eg the Toxic Chemical Substances Control Act (TCSCA) in Taiwan, while others have more similarity to Europe, eg K-REACH in Korea.
Always investigate options for local representation. This is often a legal requirement (eg China and Malaysia) but always advisable (eg Japan).
There are certain prerequisites for an organisation to act as your representative. In China, it must be a Chinese legal entity with fixed office space in the country, appropriate expertise and no history of violating the regulations.
Having a local representative not only guides you through the regulatory process, it also protects you from cultural misunderstandings. In Europe, recommendations and guidance documents are typically optional to follow and simply set out best practice. In China, words like “recommendation” and “guidance” should be interpreted as “compulsory!”
2. Check if your chemical is classed as new or existing
Asian equivalents to the European REACH regulation are at various stages of development. REACH is all about back-filling safety data on all existing chemicals. By contrast, the general focus across Asia is currently on testing new substances, regardless of the amount of available safety data on existing ones.
So how do you find out whether your substance is classed as existing or new in each territory? Many East Asia countries now have formal inventories of existing chemicals – only some are available in English. The number of listed substances varies considerably, from 40,000 in the Inventory of Existing Chemical Substances in China (IECSC) to more than 100,000 in the Taiwan Chemical Substances Inventory (TCSI). The shorter the list, the more likely you are to have to register your substance as “new” if you want to export it to that country – and that usually creates a higher cost including a requirement for testing.
3. Can you, or should you, use in vitro methods?
Across Asia, regulations are changing, with several full or partial bans on animal testing for cosmetics (eg Korea, Taiwan) and the use of some in vitro methods also now permitted across other chemical sectors. In China, some in vitro methods are now gaining acceptance, eg DPRA for skin sensitisation (OECD Test Guideline 442c) and a cell-based eye irritation test (OECD Test Guideline 491). This is likely to accelerate significantly over the next 5-10 years as the Chinese market seeks to ensure adoption of the most scientifically advanced approaches to support its global trade.
4. Adapt your Safety Data Sheets
In most cases, your SDS must be in the local language, so engaging the services of a skilled translator with relevant expertise is critical to avoid technical misinformation finding its way into the document.
In contrast with Europe, it is a common legal requirement across Asia to include a 24-hour emergency contact name and number on the SDS, ensuring that the ultimate responsibility rests with a named individual. Some local organisations offer this as a service. This encourages increased responsibility for the safety information provided and helps to guard against the limited accountability that can often result from the wide availability of safety data online.
Get in touch if you’d like to understand more about how XCellR8 can support you with relevant safety assessments for countries in East Asia. With thanks to Yordas Group for their stimulating and informative training day on this topic.