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K-REACH regulation came into effect on 1 Jan 2015 and stipulated the basic notification requirements for consumer products. Product notification is required for manufacturers or importers if the hazardous chemical substance content contained in the product exceeds 1 ton per year and the content exceeds 0.1% weight ratio threshold. However, some direct and indirect exemption conditions can be applied.
1. Products Subject to Notification under K-REACH
1.1 Definition of product under K-REACH
According to Article 2 of K-REACH regulation, products as defined under K-REACH refer to the followings for consumer use.
(1) Product consisting of mixture
(2) Article in which chemical substance is contained, it performs a certain function in solid form and does not release during normal use
1.2 Conditions subject to notification
The products actually cover all types of consumer products. According to Article 32 of K-REACH, persons who manufactures or import products containing hazardous chemical substances shall notify the authority in cases where both the two conditions below are met:
(1) Total amount of each hazardous chemical substance contained in manufactured or imported product ≥ 1t/y
(2) Content of the hazardous chemical substance contained in a product ≥ 0.1% (w/w)
Given the CBI issues, non-Korean manufacturers can appoint an OR based in South Korea to do the notification work.
1.3 Definition of hazardous chemical substances
(1) Toxic chemical substances
(2) Chemical substances subject to authorization
(3) Restricted substances
(4) Prohibited substances
So far, there are about 3000 hazardous chemical substances, which are searchable through the NCIS website and will be updated by the MoE after the hazard evaluation and risk assessment of registered substances under K-REACH.
1.4 Direct and indirect exemptions
However, for products with a certain function in solid form and containing hazardous chemicals which are not released during normal use, notification requirements do not apply. It means that although the “Article” defined as above is a product under K-REACH, it is directly exempt from notification obligations, e.g. the additives contained in tires.
In addition, there are another two cases applicable to indirect exemption, which requires an exemption confirmation in advance, including
(1) The hazardous substance without exposure to human or environment when the product is normally used
(2) The hazardous substance is already registered for the use of product
*In summary, the notification applies to consumer products consisting of mixtures (contains hazardous chemical substances) which would pose exposure risk to human or environment during normal use, in cases where the contents and annual amount of each hazardous substance exceed the limitation.
2. Notification Details
2.1 Situations of notification
In practical cases, whether the product contains a hazardous chemical substance and its content exceeds 0.1%(w/w) in the product is easily can be confirmed. However, the total amount of the hazardous chemical substance contained in the product in a calendar year (from 1 Jan to 31 Dec) isn’t always easily verified so careful assessment is necessary before you start your manufacture or import activities. To deal with such cases, the authority has specified in Article 41 of K-REACH Enforcement Rules that:
Criteria 1: In case of a notifier can identify the total amount per hazardous substance contained in a product in a calendar year
Notification should be made to the regional environmental office during the period from the date when the amount is identified as exceeding 1 ton to the date of next manufacture or import of the product in this calendar year.
Criteria 2: In cases where a notifier cannot identify the total amount of each hazardous substance contained in a product, while expecting to exceed 1 ton in this calendar year
Pre-notification should be made to the regional environmental office prior to the actual manufacture or import, which will guarantee the smooth activities afterwards. However, the actual notification (same submission requirement as situation 1) should be made no later than April 30 of the next year.
Basically speaking most cases match criteria 2. The authority recommends notifiers to firstly make a pre-notification when unable to estimate whether the annual amount would exceed 1 ton or remain less than 1 ton.
2.2 Notification requirements
Below is a summary of the basic information for notification of products containing hazardous chemical substances.
Legal entity for notification | Korean manufacturer, importer or OR |
Competent authority | Regional environmental office |
Conditions subject to notification (both condition “a” and “b” should be met) | (a) Total amount of each hazardous chemical substance contained in manufactured or imported product ≥ 1t/y (b) Content of the hazardous chemical substance contained in a product ≥ 0.1% (w/w) |
Pre-notification submission
| Appendix Form No.1 of Operating Rules for the Act of Registration and Evaluation of Chemical Substances |
Processing period of pre-notification application | Immediately
|
Cost for pre-notification | Free |
Notification submission
| Appendix Form No.28 of K-REACH Enforcement Rules, attached with: 1. User manual of the product 2. Photo of the product 3. Certificate of the appointment by non-Korean manufacturer (only applies when OR is designated) 4. Application form of data protection (only applies for data protection case) 5. Proof document for consignment, e.g. copy of consignment agreement (only applies when OR is designated) |
Processing period of notification application | 7 working days |
Cost for notification | 50,000 won (25,000 won for medium-sized firms and 10,000 won for small-sized firms) |
Certificate for approved notification | In the form of Appendix Form No.29 of K-REACH Enforcement Rules |
3. Exemption Confirmation
As for the application for exemption from the notification of products containing hazardous chemical substances, the application form as well as some proving documents should be submitted to the Korean Chemicals Management Association (KCMA) prior to actual manufacture or importation activities. Below is the summary of exemption confirmation issues.
Legal entity for notification | Korean manufacturer, importer or OR |
Competent authority | KCMA |
Conditions subject to exemption confirmation (either condition “a” or “b”) | (a) The hazardous substance without exposure to human or environment when the product is normally used (b) The hazardous substance is already registered for the use of product |
Submission requirements | Appendix Form No.30 of K-REACH Enforcement Rules, attached with: 1. Composition list 2. Document proving that it applies to exemption confirmation 3. Certificate of the appointment by non-Korean manufacturer (only applies when OR is designated) 4. Application form of data protection (only applies for data protection case) 5. Proof document for consignment, e.g. copy of consignment agreement (only applies when OR is designated) |
Processing period | 7 working days |
Cost | 20,000 won (15,000 won for medium-sized firms and 4,000 won for small-sized firms) |
Certificate for exemption confirmation | In the form of Appendix Form No.29 of K-REACH Enforcement Rules |
4. Penalty
According to Article 50 Subparagraph 4 of K-REACH, any person who manufacture or import a product containing hazardous substances without notification in advance or making false notification shall be punished by imprisonment with prison labor for not more than 5 years or by a fine not exceeding 100 million won.
In addition, according to Article 51 Subparagraph 4 of K-REACH, for those manufacture or import without obtaining an exemption confirmation or obtained the exemption confirmation in false means shall be punished by imprisonment with prison labor for not more than 3 years or by a fine not exceeding 50 million won.
5. Post-notification Requirements
The manufacturer of a product containing hazardous substances shall prepare and provide the below information to the downstream importers/distributors and the end consumers.
Name of the product
Name and content of hazardous substance contained in the product
Applicable use or restricted use of the product
Proper use methods and use conditions of the product
Precautions in handling, e.g. measures in case of exposure
For products classified as high risk concerned product (15 kinds), there are corresponding safety and labeling standards stipulated by the MoE should be additionally complied with.
In addition, the annual report for the previous year (1.1~12.31) may be required in case any of the existing chemical substances contained in the product exceeds 1 t/y or any new chemical substance is contained in the product.
