South Korea Provides Average Quotations for Testing Costs under K-REACH

11 GLP testing institutes in South Korea were evaluated for testing costs of 9 toxicological and 4 eco-toxicological testing items under K-REACH. Average quotations for these testing items were published by the authority on 19 May of 2016. The details are displayed in the table below for your reference.

Test data generation for K-REACH is always of critical concern. Toxicological and eco-toxicological data required for registration under K-REACH should be generated by GLP approved testing laboratories. The above mentioned 13 testing items are only partial testing items required for K-REACH registration. For testing requirements for each tonnage band please refer to ChemLinked chempedia.

As an OECD member country, testing reports generated by GLP labs in other member countries are recognized by South Korea under mutual data recognition program. However, South Korea actually relies on its own labs. The quality of toxicological and eco-toxicological data generated from GLP labs in other member countries will still be evaluated. For countries like China which is not an OECD member country, although some labs are GLP certified by other OECD member countries, they are not qualified to produce the toxicological and eco-toxicological data for K-REACH. Thus toxicological and eco-toxicological tests commissioned to GLP labs in South Korea or other GLP labs of high quality are recommended.

So far there are 16 GLP testing institutions in South Korea, the list of which is available online for your reference (NCIS website). Registrants planning to produce testing data for their K-REACH dossier can design their compliance budget referring to the above information. However, for some testing items the fee in South Korea is much higher than other GLP labs, especially the testing fee for acute oral toxicity and skin sensitization, which is about 50% more than standard. For some other items, the fee is similar to the international standard. In addition, the testing fee differs using different methods. Registrants are still recommended to contact the institutions directly for quotation and should pay attention to the accredited testing items each testing institute is approved to undertake.

For physical and chemical properties, it is not necessary to designate a GLP lab to do these tests. In addition to the n-Octanol/Water Partition Coefficient test, the other PC data can be generated by in-house labs in companies.

Status quo of the testing for new chemical

South Korea’s REACH regulation came into effect on 1 Jan 2015. So far, 527 new chemical substances have been registered and published under K-REACH, of which 296 are issued with corresponding hazard evaluation result (CL news). However, most of the new chemical substances are registered in lower tonnage bands with existing testing data.

Status quo of the testing for PECs

Under K-REACH only the priority existing chemical substances (PECs) are subject to existing chemical registration. The registration tonnage bands are set from 1-10 t/y to 1000 t/y plus. The first batch of PECs was designated based on large annual quantity and high hazard properties. However, the PECs registration progress is slow and so far only 179 PECs completed the very first step of LR election. There are still 331 PECs requiring LR election (CL news). Most registrants are still in the early phase of figuring out productive registration strategies rather than commissioning labs to do tests.

Based on the current situation, the 16 GLP testing institutions in South Korea haven’t been confronted with overcapacity problems. We can expect a high demand for new and existing chemical testing under K-REACH in the future if the authority really adopts a strict approach to the data generated in other GLP labs. If so, concerned companies are recommended to make a reservation with qualified Korean labs early after data gap analysis.