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NEWS LETTER 2019.(VOL.40)

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[Newsletter No.40] 2019 Timeline for Korea Chemical Regulations

2019 Timeline to cope with Korea chemical regulations including K-REACH, K-BPR, CCA and ISHL

Last December 2018, the final versions of K-REACH (Act on the Registration and Evaluation, etc. of Chemical Substances) and K-BPR (Household Chemical Products and Biocides Safety Control Act) were released. Consequently, the relevant public notices and the guidance were also released to the public.

As of January 1stst, 2019, K-REACH and K-BPR have been implemented. In addition, the countermeasures to CCA (Chemical Control Act), IPPC (Act on Integrated Pollution Prevention and Control), and ISHL (Industrial Safety and Health Law) are, indeed, required to comply with.

Chemtopia provides the timeline of the 2019 Korea environmental regulation for each Act in order to industry’s compliance.

ISSUE & FOCUS

I. Act on the Registration and Evaluation, etc. of Chemical Substances: K-REACH
II. Chemical Product Safety Act: K-BPR
III. Industrial Safety and Health Law (ISHL)

I. Act on the Registration and Evaluation, etc. of Chemical Substances: K-REACH

Tasks

Timeline

Remarks

Pre-registration

January 1, 2019 to

June 31, 2019

- Anyone who manufactures or imports more than 1 ton of existing chemicals annually. (Those who manufacture or import more than 1 ton per year even once in 2016, ‘17, ‘18)

From January 1, 2019

- Anyone who manufactures or imports more than 1 ton per year of existing chemicals.

- Pre-registration is required before manufacture or import.

Notification subject to hazardous evaluation exemption under previous Toxic Chemicals Control Act (TCCA)

January 1, 2019

to December 31,

2019

- Those who were exempted from the hazardous evaluation due to annual volume of less than 100kg and were exempted from polymer hazardous evaluation under the previous Toxic Chemical Control Act need to notify by 2020.

- However, only when the subject meets the condition of the polymer compound subject to notification should notify. Required conditions are as followings :

1) Number average molecular weight of 10,000 or more: A polymer with more than 5% of molecular weight with less than 1,000 or more than 2% of molecular weight with less than 500

2) Number average molecular weight of 1,000 ~ 10,000 : A polymer with more than 25% of molecular weight with less than 1,000 or more than 10% of molecular weight with less than 500

3) Number average molecular weight of less than 10,000, hazardous chemicals / priority control substances remaining more than 0.1% of its monomer.

4) Cationic polymer

Notification of substances completed with hazardous assessment

From January 1,

2019

- Those who have received a hazard assessment under Toxic Chemicals Control Act must notify by the following periods :

1) > 1000 tons or more 1 ton of CMR substance: until 2019

2) 100-1000 tons: until 2022

3) 10-100 tons: until 2025

4) 1-10 tons: until 2028

Notification of products containing priority control substance

From July 1, 2019

- Manufacturers and importers of products containing priority control substance shall submit the product notification form from the following day of confirmation that 0.1% of the priority control substance contained in the product and over 1 ton per year as total volume of the substance is confirmed to the day when the product is manufactured or imported.

(204 types of substances to be applied as of July 1st, 2009 and 468 types of substances to be applied as of 2021)

Transitional measures on new Chemicals registration

January 1, 2019 to

June 30, 2019

- A person who registered less than 0.1 ton per year of new chemical but now manufactures or imports less than 0.1 to 1 ton per year is required to submit data corresponding to K-REACH data requirement for new chemicals registration.

Joint registration

After pre-

registration is

completed

- Registration completion until 2021: More than 1000 tons of existing chemical or more than 1 ton of CMR substances

- Until 2024: 100-1000 tons

- Until 2027: 10-100 tons

- Until 2030: 1-10 tons

(However, if the registration grace period is not granted due to failure of pre-registration, registration before manufacture or import is required)

II. Chemical Product Safety Act: K-BPR

Tasks	Timeline	Remarks
Notification of existing biocides(active substance/ingredient)	January 1, 2019 to June 30, 2019	- Notification of active substance/ingredient (a.i.) contained in biocidal products circulated in Korea until December 31, 2018 (Grace period will be granted for only the notified substances) - Within six months from the end of notification period, the Ministry of Environment will publicly notify the existing biocidal substances that receive grace period for a.i. approval. - Subsequently, approval of a.i. is required depending on product type and its grace period (corresponding product needs to be approved within 2 years after approval of the a.i.).
of public notice on grace period for approved existing a.i.	Until December 31, 2019	Prohibition of manufacture or import of a.i., if not notified beforehand, therefore cannot be granted for grace period
Applying safety standards and labeling standards for new items to be managed	From July 1, 2019	New items to be managed : 1. Disinfectant (Only for air disinfection, children's products, and disinfection for toothbrush and tongue cleaner) 2. Repellent agent (only for flying insects) 3. Artificial snow spray 4. Filter type of preservation treatment products 5. Candles (only for candles using soy wax other than conventional paraffin)
Transitional Measures on the labelling Standard for un-notified products of safety standard	Until December 31, 2019	If an item has been approved under the former Pharmaceutical Affairs Law or the item notification has been received, it can be labelled according to the previous regulations.
Applying on restrictions of labelling and advertising	From January 1, 2020	Applying to household chemicals subject to safety confirmation or biocidal products manufactured or imported from January 1, 2020
Tasks	Timeline	Remarks
Applying on safety standards for child protection packaging	From January 1, 2020	Applying to products manufactured or imported after January 1, 2020. However, detergents, coatings, adhesives, fragrances, antifreeze need to follow the standard of risk concerned product subject to child protection package until December 31st, 2019.
Submission of approval plan for the active substance/ingredient	Until December 31, 2020	- The a.i. approval plan should be submitted within 1 year from the date when the a.i. is designated as existing a.i. receiving grace period of approval. : The plan includes procedures, methods to prepare application of a.i. approval, etc.
Exceptional rules to safety standards and labeling standards for products used in multi-use facilities	From July 1, 2020	Applying to household chemical products subject to safety confirmation such as sanitizers and disinfectants used professionally by workers who are self-employed or contractors for purpose of sanitation of multi-use facilities.
Transitional Measures for Household Chemical Products Subject to Safety confirmation	Until January 1, 2022	Anyone who manufactures or imports risk concerned products managed under former K-REACH may manufacture or import products without the confirmation of safety standards from the testing or inspection authorities.
Transitional measures on safety standards and labeling standards for the former products of risk concern	-	It is allowed to label according to the previous Annex 7 " Designation of products of risk concern and safety, labelling standard"
Step 1 of approval of biocidal substances/ingredient	Until December 31, 2022	Fungicides, algaecides, rodenticides, insecticides, repellents
Step 1 of approval of biocidal products	Until December 31, 2024	Fungicides, algaecides, rodenticides, insecticides, repellents
Step 2 of approval of biocidal substances	Until December 31, 2024	Wood preservative, other vertebrates controller, other non-vertebrates controller
Step 2 of approval of biocidal products	Until December 31, 2026	Wood preservative, other vertebrates controller, other non-vertebrates controller
Step 3 of approval of biocidal substances	Until December 31, 2027	Product preservative, product surface preservative, fabric/ leather preservative
Step 3 of approval of biocidal products	Until December 31, 2029	Product preservative, product surface preservative, fabric/leather preservative
Step 4 of approval of biocidal substances	Until December 31, 2029	Construction material preservatives, material/equipment preservatives, embalming or taxidermist fluids, antifouling agents
Step 4 of approval of biocidal products	Until December 31, 2031	Construction material preservatives, material/equipment preservatives, embalming or taxidermist fluids, antifouling agents

III. Industrial Safety and Health Law (ISHL)

On December 28th, 2018, a full amendment (draft) of Industrial Safety and Health Law (ISHL) has been passed by parliament and the subordinate act will be expected to be prepared and shared soon. The major amendments are as follows.

- Submission of all (M)SDS to the MOEL
Currently, the person who transfers or supplies the chemicals and its mixture containing the chemicals is required to prepare and provide the material safety data ((M)SDS) to the recipient. However, in the future, the person who manufactures or imports the chemical substance should provide the (M)SDS not only to recipient but also to Minster of Empolyment and Labor (MOEL), so that the authority can strengthen the management of chemical substances causing health hazards to workers, thereby preventing industrial accidents and responding quickly to accidents that may occur.

- (M)SDS deliberation system for trade secret protection
Any person who transfers or provides chemicals, at present, do not write the information in the Material Safety Data Sheet for chemicals that are deemed worthy of protection as trade secrets. However, from now on, anyone who wants to hide the name and the content of the chemicals with regard to trade secrets should use the alternative name and content of the chemical substance with the approval of the Minister of Employment and Labor.

- Strengthening sanctions against violations
Currently, a person who committed an employee's death in violation of safety or health care obligations has been sentenced to 7 years imprisonment or a fine of up to 100 million won. However, from now on, anyone who commits the same offense again within five years will be punished one half of the sentence additionally.

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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