Regulatory Developments

South Korea’s National Assembly Adopts K-REACH

May 17, 2013

On April 24, 2013, the South Korea National Assembly Environmental and Labor Committee passed the Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances, commonly known as Korea REACH or K-REACH. On April 30, 2013, the National Assembly enacted K-REACH, and it is now scheduled to come into force on January 1, 2015. Information on K-REACH is not yet available on the Ministry of Environment's website. A translation of the Act is available online. This translation is provided as a courtesy and is not an official document. The complete text of the Act is available, in Korean, online.

K-REACH is intended to prescribe the process for chemical registration, evaluation, assessment of hazards and risks of chemical substances and products containing hazardous chemical substances, and to protect public health and the environment. It identifies the principles according to which South Korea will modify and implement its chemical management program, which includes new and existing chemical notification requirements. In principle, K-REACH follows the basic concept of placing the burden on manufacturers and importers to supply data that ensure that the substances being placed on the market are safe for use. As with similar programs, K-REACH contains provisions to allow non-Korean entities to appoint an Only Representative, and The Acta Group professionals are well suited to assist.

K-REACH also contains reporting/notification requirements pertinent to products that contain chemicals identified as toxic substances, and sets forth product safety review provisions, product safety labeling requirements, and sales bans and re-call provisions. As with REACH implementation in other countries, K-REACH's impact extends well beyond the chemical industry.

Summary of Basic Provisions

As adopted by the National Assembly, K-REACH reflects many of the proposals offered by the Environment and Labor Committee. We summarize below the main provisions as adopted:

Basic Plan for Evaluation of Chemical Substance (Article 6) Every five years, the Minister of Environment (MOE) will establish a basic plan for the registration and evaluation of chemical substances, notification of products containing hazardous substances, and safety management of risk concerned products.
 
When establishing or revising a basic plan, the MOE shall deliberate with the Chemical Substance Evaluation Committee after the consultation with the head of central administrative agency in advance.
 
The basic plan shall include the following:
  1. Method and plan to conduct registrationhazard examinationrisk assessment of chemical substances, notification of products containing hazardous substances, and risk assessments of risk concerned products.
     
  2. Matters related to development of technologies required for registration of chemical substances, notification of products containing hazardous substances, and evaluationassessments of hazardrisks.
     
  3. Matters related to investigationresearch on hazards risks of chemical substances and products containing hazardous chemical substances, safety management of risk concerned products, and international cooperation.
     
  4. Matters related to activities of industries to prevent damage to public health or environment caused by chemical substances or risk concerned products, and safety support and training for workers and consumers; and
     
  5. Other matters necessary for the promotion of chemical registration and hazard examination risk assessment.
Chemical Substance Evaluation Committee (Article 7) The Chemical Substance Evaluation Committee will deliberate the following issues concerning chemical registration, notification of products containing hazardous substances, and evaluationassessment of hazardrisks:
  1. Matters related to establishment of the basic plan;
     
  2. Matters related to designation of existing chemical substances subject to registration;
     
  3. Matters related to designation of chemical substances subject to authorization, and restricted or prohibited substances;
     
  4. Matters related to registration of chemical substances manufactured or imported less than one ton per year;
     
  5. Matters related to the standard of safety labeling of risk concerned products; and
     
  6. Other matters prescribed by Presidential Decree related to chemical registration and evaluationassessment of hazardrisks and safety management of risk concerned products.
Definition and Scope of Regulation (Articles 2 and 3) "Chemical substance" means a substance obtained by artificial reactions on elementscompounds and those obtained by modifying or extracting or refining substances existed in nature.
 
The Act shall not apply to chemical substances that fall under one of the following items:
  1. Radioactive substances pursuant to Article 2 Paragraph 5 of the Atomic Energy Act;
     
  2. Pharmaceutical products and quasi-drugs pursuant to Article 2 Paragraphs 4 and 7 of the Pharmaceutical Affairs Act;
     
  3. Narcotics pursuant to Article 2 Paragraph 1 of the Narcotics Control Act;
     
  4. Cosmetics and raw materials for cosmetics pursuant to Article 2 Paragraph 1 of the Cosmetics Act;
     
  5. Pesticides and active ingredients for pesticides pursuant to Article 2 Paragraphs 1 and 3 of the Pesticides Control Act;
     
  6. Fertilizers pursuant to Article 2 Paragraph 1 of the Fertilizers Control Act;
     
  7. Food, food additives and device and containers packaging pursuant to Article 2 Paragraphs 1, 2, 4 and 5 of the Food Sanitation Act;
     
  8. Feeds pursuant to Article 2 Paragraph 1 of the Feeds Control Act;
     
  9. Gunpowder pursuant to Article 2 Paragraph 3 of the Firearms, Swords and Gunpowder Control Act;
     
  10. Military supplies pursuant to Article 2 of the Military Supplies Control Act and Article 3 Paragraph 2 of the Defense Acquisition Program Act (routine items pursuant to Article 3 of the Military Supplies Control Act are excluded);
     
  11. Health functional foods pursuant to Article 3 Paragraph 1 of the Functional Foods for Health Act; and
     
  12. Medical devices pursuant to Article 2 Paragraph 1 of the Medical Devices Act.
Report of Manufacturing of Chemical Substances (Article 8). A chemical substance business operator1 shall report all of the volume of manufacture/import and purpose etc. of the previous year
  1. All new chemical substances, and;
     
  2. Existing chemical substances in quantities ≥ 1 ton.
Substances Subject to Registration (Articles 8, 9, 10, 11, and 12)
  1. All new chemical substances; and
     
  2. Existing chemical substances ≥ 1 ton subject to registration (applies even if less than 1 ton in cases where concern of risk to human health or environment is serious).
Exemptions are available and require an exemption application be completed and approved by the authority prior to manufacture/import:
  • Imported chemical equipped in machinery
     
  • Imported chemicals with machinery or equipment for its trial run
     
  • Substances present in a finished article but of which are not released during its use
     
  • R&D chemicals
The registration shall be updated to include any new/additional uses.
Data Requirements, Lead Registrant, and Joint Submissions (Article 14, 15, 16, and 17) Data requirements are not specifically outlined, however, the Registration Dossier is to contain the following key elements:
  1. Name, location and company representative who intends to manufacture import
     
  2. Chemical identity information; chemical name, molecular formula structure, etc.
     
  3. Use information of chemical substance
     
  4. Classification and Labeling of chemical substance
     
  5. Physico-chemical properties of chemical substance
     
  6. Hazard information of chemical substance
     
  7. Risk information including exposure scenario describing handling measures, exposure controlmanagement process through the lifecycle of chemical substance (this shall apply only to chemical substance to be manufactured imported 10 tons or more per year)
     
  8. Guidance data for safe use (protective equipment, emergency measures for explosion, fire. release, etc.)
     
  9. Other data prescribed by the Ministerial Decree Testing can be completed by an acceptable Korean Lab or a foreign GLP laboratory.
When data are not available, a test plan is to be submitted.
 
Provisions are in place that allow for a joint submission to occur and Lead Registrant to be appointed.
 
Data compensation period is for 15 years and sharing of vertebrate data is mandated to minimize animal testing.
Hazard and Risk Assesment (Articles 19, 20, 21, 24, 32, and addendum) The MOE shall conduct a hazard assessment. If this hazard assessment is to be used to support registrations in other countries, the person will need to request permission from the MOE.
 
The results of the hazard assessment are to be published and toxic substances identified.
 
A Safety report/risk assessment is required for substances ≥ 10 tons/yr or is deemed necessary from the hazard assessment. Although not explicitly defined, carcinogens, mutagenic, and reproductive/development (CMR); and persistent, bioaccumulative and toxic (PBT) will likely be targeted.
 
Substances registrations are to be performed based on the following manufacture/import volume:
  • ≥100 tons – Jan 1, 2015;
     
  • ≥70 tons after two years – Jan 1, 2017;
     
  • ≥50 tons after three years – Jan 1, 2018;
     
  • ≥20 tons after four years - Jan 1, 2019; and
     
  • ≥10 tons after five years – Jan 2, 2020
     
The MOE is granted the authority to ensure risk minimization, where necessary.
 
The MOE is granted the authority to perform risk assessments on risk concerned products.
Provision of Information – Supply Chain Communications (Article 29 and 30) The downstream user and supplier shall provide to the manufacturer/importer and the manufacturer/importer shall provide to the downstream user and seller information on the chemical substance, mandating bilateral information provisions.
 
Types of information to be shared:
 
Supplier to downstream user:
  • Registration number;
     
  • Chemical name;
     
  • Hazard information; and
     
  • Safe use.
Downstream user to supplier:
  • Use;
     
  • Exposure details;
     
  • Volume details; and
     
  • Safe use.
Information shall be provided in a MSDS.
Product Management – Hazardous Substances (Article 32) Notification of products that contain hazardous substances at ≥ 1 ton/yr is required. Articles with no releases are exempt from this provision.
 
Product safety/risk assessment is required and will be published by MOE. The safety/risk assessment is performed by experts appointed by the MOE. Safety labeling and standards will be identified and can include product sales ban and recall orders.
Other Key Provisions:  
Authorization (Articles 25 and 26) Substances subject to Authorization will need to submit and have its use authorized prior to the sunset date.
Restrictions and Bans (Article 27) The MOE is granted the authority to designate and is to publish substances that are restricted or banned in the government gazette with sufficient advanced warning.
Registration Fees (Article 47) Registration fees are to be established.
Priority Existing Substances Transition time will be determined and communicated in statues/amendments.
1 Chemical business means the person who manufactures, imports, uses, or sells/supplies chemicals for commercial purposes.

Comments on K-REACH and Lessons from EU REACH

As with many countries, Korea is pursuing a chemicals management approach that ensures substances being placed on its market are assessed for risk potential based on its use patterns while placing the burden of safe use on chemical businesses.1 Although K-REACH differs slightly from the European Union's (EU) REACH, the basic principles remain the same. There is also a grandeur principle to take away, entities placing chemical substances on the market need to be prepared for additional fees to be incurred that will assist governmental agencies involved in registration activities to gain a "self funded/sufficient" presence. We often refer to this as "pay to play." Fees have not yet been discussed or presented in association with K-REACH.

Industry has begun to recognize the "pay to play" principles, where higher supplied volumes require greater data requirements, which increase the cost of the registration. Costs may be reduced for higher tonnages by creating Consortia or "Lead Groups" for specific substances, which share, in the short term, the costs of testing and dossier preparation between the larger or more active companies. Expenses can be recouped by selling the right to refer to data in the initial submission to other registrants in a "Letter of Access."

Letter of Access fees can be anticipated for K-REACH as the need to share data is inherent in the regulation. The EU has set 12 years from the time of submission to the European Chemicals Agency as the time period in which compensation is to be paid to the data owner by other registrants to refer to data, while K-REACH establishes a 15-year period. Wording of Letters of Access must be specific, limiting the use of data to particular jurisdictions and uses.

The longevity of EU REACH-related dossier preparation in the IUCLID 5 system has been assured. Dossiers prepared for EU REACH can be updated and revised with minimal effort for K-REACH, which will reduce the costs for global registration strategies.

Korean entities sharing data and expecting ongoing compensation for that data must plan to be active within the regulatory landscape for the duration of the regulation. Many of the Lead Registrants and Consortia created as a result of EU REACH did not envision the need to continue to remain cohesive until the end of the EU's registration structure. Many Lead Registrants and larger companies active in the first round of EU REACH have already withdrawn from Substance Information Exchange Forums (SIEF) and consortia to avoid continued fees.

K-REACH has been planned and debated for several years and as such is not unexpected, although due to the complexities of the discussions, some aspects of K-REACH may not be expected by some interested parties. K-REACH will likely see slightly different substances being registered in South Korea as opposed to the EU as the South Korean market is key to the electronics industry, whereas the EU is primarily consumer lead.

The global chemical regulatory landscape is ever evolving, and while K-REACH represents a significant change for chemical regulation in South Korea, the EU REACH regulatory program is familiar to many chemical manufacturers, formulators, distributors, and users globally. This familiarity, and the investment made by the global chemicals industry in EU REACH, will likely facilitate the implementation of K-REACH to the benefit of industry and the government.


 
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