ARECS and K-BPR
The Korean chemicals and biocide legislation is highly dynamic and has changed dramatically in recent years, resulting in new requirements for potential importers and manufacturers. A pre-registration system for phase-in substances has been implemented in the Korean chemicals legislation? The pre-notification period started on 1st January 2019 and lasts until 30st June 2019.
Companies, intending to place their chemicals on South Korean market, should first check whether their products need to be registered under ARECS, often referred to as K-REACH, with the National Institute of Environmental Research (NIER) and approved by the Ministry of Environment, Republic of Korea (MoE).
In cooperation with our recognised partner in South Korea, we take care of your regulatory needs for the registration of chemicals (K-REACH) and biocides (K-BPR). We are best equipped to deal with Korean IT tools (e.g. “K-REACH IT”), dossier preparation and risk assessment including intelligent testing strategies, read-across, data bridging, etc.
Registration under ARECS
The registration under ARECS is obligatory for:
- Phase-in substances in quantities ≥ 1tpa
- New substances ≥ 0,1tpa (new substances imported below 0.1 tpa must be only notified without providing test data)
- Priority Existing Chemicals (PECs) imported ≥ 1tpa, but not registered by June 2018
The pre-registration period for phase-in substances started on 1st January 2019 and lasts until 30st June 2019.
With the second amendment of ARECS in 2018, all chemical products, which contain substances of very high concern according to the ARECS List of Substances of Priority Control, must be notified to the MoE prior to import to Korea.
Further to ARECS (K-REACH), South Korea’s biocides law (K-BPR) entered into force on 1 January 2019. Previously regulated under K-REACH, biocides now fall under the new regulation. The regulation applies to the following:
Consumer products including household chemical products and products subject to safety check designated by the Minister of Environment
- Biocidal active substances
- Biocidal products
- Biocide-treated Articles
Biocidal actives and products must be authorized before they can be manufactured in or imported into South Korea. Active substances notified by 30th June 2019 enjoy a grace period, during which they can be further manufactured and imported (e.g. as biocidal active substances or biocidal products). By the end of the respective grace period, manufacturers and importers, respectively, have to submit active substance or product dossiers to MoE, providing hazard and risk data, as well as exposure scenarios and efficacy data.
In cooperation with our recognised partner in Seoul, we take care of your regulatory needs for the registration of chemicals (ARECS) and biocides (K-BPR). We are best equipped to deal with Korean IT tools (e.g. “ARECS IT”), dossier preparation and risk assessment including intelligent testing strategies, read-across, data bridging, etc.
SCC services for South Korea:
- Overall ARECS and K-BPR strategy including intelligent testing strategies
- Portfolio analysis, data review/valuation and data gap analysis
- Study planning and monitoring
- Only Representative support
- Consortia management
- Compilation of registration dossiers, Chemical Safety assessments and Chemical Safety Reports
- Classification and labelling
- Submission and defence of registration dossiers at MOE, MOEL (Ministry of Employment and Labor), and NIER level
- Review of existing safety data sheets and extended safety data sheets (eSDS)