How to Meet the Registration Requirements under China REACH, EU REACH and K-REACH with Minimum Data

K-REACH,China REACH,EU REACH,China,Registration,Requirements

Background:

The last REACH registration was closed on 31 May 2018. A total of 88,319 registration dossiers had been submitted and the registrations cover 21,551 substances. Now, ECHA’s database has become the largest physiochemical/ toxicological/ eco-toxicological database around the world.

South Korea started to amend the K-REACH regulation. The amended K-REACH aligns with EU REACH regulation: all the existing chemicals over 1 t/y and new chemicals over 0.1 t/y shall be registered. According to the estimation, about 7000 existing substances shall be registered in South Korea.

In China, new chemical substances also need to complete notification under Provisions on Environmental Administration of New Chemical Substances. However, there are only about 40000 substances listed in China existing chemical inventory, which is far less than that listed in the existing chemical inventories of other countries. This may lead to a situation that some substances may be regarded as new substances in China yet they are considered as existing chemicals in other countries. 

Data Requirements

To complete new chemical substance notification, related enterprises need to provide required physiochemical/toxicological/eco-toxicological data.

Some enterprises may ask, if their full set of data in one country can be used in other countries/ regions? Truth is, the data requirements in different countries/regions are not the same, so theoretically, this cannot be realized. However, the data requirements in different countries more or less share some similarities. The common part of data can be applied. If the country still has extra requirements, related enterprises only need to supplement extra data.

To comply with different regulation requirements in different countries, enterprises shall also take the following aspects into consideration before designing test programs: alternative methods in different countries, requirements of GLP laboratories as well as the registration requirements for polymers.

Take polymer as an example, China and South Korea require enterprise to register polymers themselves while EU countries require enterprises to register the monomer and other substances for polymers, if concentrations of these substances are over 2% and the volume over 1t/y. For this reason, the registration requirements of polymers in these countries are different.

GLP is an internationally accepted laboratory management system. For this reason, most of the countries will accept data generated by OEDC GLP Laboratories. Besides, China has specific requirements on eco-toxicological data:

Aquatic Toxicity Data:

Level I: Submit at least one endpoint (fish acute toxicity test is recommended)

Level II or higher: Each level higher, at least one endpoint of aquatic toxicity test per level shall be added.

Biodegradation Data

Readily biodegradation test is recommended.

If related enterprises have completed this test in foreign countries, they can choose readily biodegradability test or inherent biodegradability test.

If related enterprises have completed this test in foreign countries yet result show that the substance does not have readily biodegradability, then inherent biodegradability test shall be carried out.

Physiochemical Data

Korea requires enterprises to provide n-Octanol-water partition coefficient tested by a GLP laboratory while other countries do not have such requirements.

Alternative Method

Alternative Method is also very popular around the world. In this field, European countries are ahead of other countries. As long as relevant premises are met, in-vitro, read-across and QSAR can all be applied in REACH registration. In terms of skin corrosion/ irritation, eye irritation and skin sensitization, European countries even require that enterprises must carry out in vitro test first. Only when the result of in vitro tests cannot be used for the classification, in vivo tests are allowed.         

China only accepts the positive results from skin corrosion/ irritation test and eye irritation tests. If the result is negative, then corresponding in vivo tests shall be carried out. Read-across can only be applied in serial notification. Generally, if the data is from an existing substance, then the data cannot be used in read-across. As China takes priority for testing data, the use of QSAR is limited in China.

In South Korea, in-vitro, read-across and QSAR are all accepted. However, as there are no explicit requirements on the application of these alternative methods, it is still not sure whether alternative methods can be fully applied in K-REACH registration.

Registration Scheme for 10-100t/y

Based on the above requirements, the registration proposal shall be:

1. Physiochemical property: all the tests can be carried out in both GLP laboratories and non-GLP laboratories (yet non-GLP laboratories shall satisfy the requirements of CNAS, CMA or GLP under Ministry of Agriculture in China), except the n-Octanol-water partition coefficient. This endpoint shall be carried out in a GLP laboratory.

2. Toxicological property: all tests shall be carried out in GLP laboratories. In terms of skin corrosion/ irritation, eye irritation and skin sensitization test, in vitro test shall be carried out in GLP laboratories first. Enterprises shall decide whether to carry out in vivo test in China based on the results of in vitro tests.  

3. Eco-toxicological property: Eco-toxicological tests shall be carried out in GLP laboratories. Besides, some tests including inherent biodegradability test, fish acute toxicity test, daphnia magna reproduction test must be carried out in china.

Summary

China has strict requirements on test data. As a result, in terms of some data, China requires enterprises to provide testing data while EU countries and South Korea only require enterprises to submit Testing Proposal at first. For this reason, there may be some data gaps. CIRS warmly reminds that related enterprises should better think about the order of registration in different countries/regions, so as to avoid repeated tests.

In order to minimize the registration cost, enterprises must try to avoid repeated tests by taking into consideration of the registration band, property of the substances as well as the data gap.

Related information

China REACH Registration

EU REACH Registration

K-REACH Registration