Interview: Trend towards tighter chemical regulations in Korea
The Act on the Registration & Evaluation of Chemicals in South Korea is often referred to as K-REACH. How similar is it to the European REACH?
Dr Dieter Drohmann: In terms of structure, K-REACH or ARECS is very similar to the EU REACH system; essential principles have been adopted. The registration requirements as well as the data requirements of the different volume bands are very much based on the EU REACH requirements, but there are a few fundamental differences:
- There are 4 registration deadlines (2021, 2024, 2027, 2030) and not only three (2010, 2013, 2018) as under EU REACH. The volume bands 1-10 and 10-100 t/a each have an independent deadline.
- There is no re-import exception under K-REACH, if I export a registered substance from Korea and import it again (e.g. to formulation), it has to be registered again.
- For new substances (non-phase ins), notification/registration <1 tonne/year is also required.
- The sole representative assignment must be reported to the Korean Ministry of Environment (MoE) and one receives a written confirmation as OR from the MoE.
- The importers covered by the Only Representative (OR) are part of the (pre-)registrations. Each new importer in the relevant value chain must be registered in the K-REACH-IT system to be covered by the OR. As the update has to be done within 1 month, this is not always easy in case of indirect export and complex supply chains (volume band changes and importer updates within 30 days).
- Polymer registrations or PLC exemption procedures – this means that polymers are not exempt from K-REACH registration obligations. However, “non-problematic” polymers (so-called PLCs – Polymers of Low Concern) can benefit from an exemption but must be applied for and approved. Under EU REACH, polymers are (still) exempted, but the monomers have to be registered. PLC is not yet relevant under REACH.
Drohmann: The pre-registration phase ended on 30.6.2019, but late pre-registrations are possible under the same conditions as under EU REACH. In order to be able to meet the first registration deadline of 31.12.2021, the Korean SIEFs (CICOs in this case) have formed, the respective lead registrants for the high-volume (> 1,000 t/a) and CMR substances have been named and the dossier work and data procurement, the latter above all also via EU REACH consortia, is in full swing. The aim in most CICOs is to submit the lead dossier by 30 June and to be able to submit it to the co-registrants so that the co-registrants can also complete their registrations in time.
Dieter Drohmann will give a presentation on chemical legislation in Korea at the EC Webforum Regulation: Navigating chemical legislation in Asia on April 21. In addition to Korea, the web event will also focus on regulations in China and Japan.
Besides K-REACH, what other regulations are important for importers of chemical products to Korea?
Drohmann: If you have biocides in your products, e.g. as preservatives in paints and varnishes, it is not K-REACH but the Korean Biocide Regulation (K-BPR) that applies to these substances. K-BPR is essentially also a copy of the EU Biocide Regulation (BPR). Here, too, an OR can be commissioned to regulate the necessary regulatory tasks on site.
As a new regulation, the requirement to submit the safety data sheets to the MoE was added in January 2021 via the K-OSHA. The deadlines are based on the quantity placed on the market. To enable non-Korean manufacturers and formulators to ensure the confidentiality of product compositions from the obligation to submit SDSs and CBI applications, the sole representative system under K-REACH and K-BPR has now also been introduced in K-OSHA.
Also relevant for manufacturers and importers in Korea is the Chemical Control Act (CCA), a law that primarily regulates protective measures against chemical accidents, an emissions register and the safe handling of hazardous substances.
You will be speaking about chemical legislation in Korea at the European Coatings WebForum Regulations in April. What can participants expect here?
Drohmann: With the update of K-OSHA and the already existing regulations of K-REACH and K-BPR, the trend of tightening chemical regulations in Korea continues. This is due to the sharp increase in the number of chemical products sold on the Korean market and to chemical accidents in the past.
It is therefore important to always be up to date, especially in complex supply chains, it will be difficult to comply with the new requirements in a timely manner. This applies even more to the protection of confidential information. Through our office in Korea, I am of course always informed about ongoing developments and the “stumbling blocks” and “tricks” in implementing them in practice. I will present this in my lecture on Korean chemical regulations.