Chemtopia Co., Ltd. Sanghee Park, Ph.D.

Current biocides management policy in Korea

Outline - Background - Issues and current situation - Competent authority for biocide regulation - Quasi-phamaceuticals and household chemical product - The National roadmap of biocide management(proposed) - K-REACH - Conclusion

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Background The definition of biocide in K-REACH (Article 2) A biocide is a substance which can kill, inhibit, and exert a controlling effect on any harmful organism except for human or animal such as insecticide, disinfectant or preservative. The estimated biocide market in Korea (Year 2010) - Chemical volume survey every 4 years by the MOE - Use category linked with the biocide use among 71 uses - 460,000 MT (0.1% of total circulated volume of chemical) based on EU identified &

notified A.I. cf. 400,000 MT in EU (EU biocide final report, year 2009)

Use category Manufacture (1,000 MT)

Import

(1,000 MT)

Export

(1,000 MT)

Circulated Volume

(1,000 MT)

# of Active substance # of company

Disinfectants 522 125 233 414 245 1579

Preservatives 20 17 0. 682 36.318 0.139 256

Medicine/Medicine intermediate 0.217 7.4 0.212 7.405 75 79

Non-agriculture pesticide

-

0.15

- 0.15 38

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Biocide use 542 150 233 459 358 <1,924

(1000 MT, 2010)

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The current biocide management - No separate biocide regulation in Korea- Several competent ministries involved. - No active ingredient inventory for national biocide management - No clear product type category (use application) - The limitation of current TCCA focusing on industrial toxic chemicals to

manage biocide and biocidal products (especially for finished biocidal product imported)

New regulatory frame for biocide management is required

Issues and current situation

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The safety of a chemical product; lung damage caused by exposure to humidifier disinfectants.

This tragic accident was the driving force for Congressman to pass K-REACH without any delay covering consumer product (and biocidal product) management. In the vice-minister’s meeting at the end of 2012, the Ministry of Environment decided to take responsibility for some household chemical products. => Cleaning agent, air fresheners, deodorizers, Adhesives, Polish, Synthetic detergents, Bleaching agent, Fabric softenening agent

Issues and current situation

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Main Group 1: Disinfectants

1. Human hygiene PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety)

2. Disinfectants not intended for direct application to humans or animals

PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety) THE QUALITY CONTROL AND SAFETY MANAGEMENT OF INDUSTRIAL PRODUCTS ACT (Ministry of Trade, Industry and Energy)

3. Veterinary hygiene VETERINARY MEDICINE ACT (Ministry of Agriculture, Food and Rural Affair)

4. Food and feed area

FOOD SANITATION ACT (Ministry of Food and Drug Safety) VETERINARY MEDICINE ACT (Ministry of agriculture, food and rural affair)

5. Drinking water DRINKING WATER ACT (Ministry of Environment)

Main Group 2: Preservatives

6. In-can preservative 7. Film preservative

8. Wood preservatives

TOXIC CHEMICAL CONTROL ACT (Ministry of Environment) The STANDARD OF WOOD PRESERVATIVE TREATMENT (Korea Forest Service)

9. Fibre, leather, rubber and polymerised materials preservatives 10. Construction material preservatives 11. Preservatives for liquid-cooling and processing systems 12. Slimicides 13. Working or cutting fluid preservatives

Competent authority and relevant regulation on product type of biocide

Competent authority for biocide management

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Main Group 3: Pest control

14. Rodenticides PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety)

15. Avicides / 16. Molluscicides,/ 17. Piscicides 18. Insecticides, acaricides and products to control other arthropods

PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety)

19. Repellents or attractants PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety)

Main Group 4: Other biocidal products

20. Control of other vertebrates

FOOD SANITATION ACT (Ministry of Food and Drug Safety) FEED MANAGEMENT ACT (Ministry of agriculture, food and rural affair)

21. Antifouling products

TOXIC CHEMICAL CONTROL ACT (Ministry of Environment) MARINE ENVIRONMENT MANAGEMENT ACT (Ministry of Oceans and Fisheries)

22. Embalming or taxidermist fluids

Competent authority for biocide management

Partially regulated in Korea

Not regulated in Korea

Fully regulated in Korea

K-REACH by the MOE will take a key role for biocide which is not properly controlled in other Ministries.

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PHARMACEUTICAL AFFAIRS ACT - Ministry of Food and Drug Safety

<Article 2> Non-appliance, non-machinery or similar articles which act slightly or do not directly act upon human bodies;

- Toothpaste - Teeth whitening - Mouthwash - Mask, sanitary pad, etc. - Deodorant - Anti-hair loss agent - Contact lens cleaner - Repellent agent, fly or mosquito attracting agent for human or

animal hygiene - Humidifier disinfectant - Disinfectant for dentures

Preparations used for sterilization, insecticide and uses similar thereto for the purpose of preventing communicable diseases;

- Insecticide - Rodenticide - Sterilizer or disinfectant not directly applied to the human

body : alcohols, aldehydes, cresol, soap type disinfectants - Preparation for preventing communicable diseases

Coverage of Quasi-pharmaceutical as biocide

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PHARMACEUTICAL AFFAIRS ACT - Ministry of Food and Drug Safety

Import of quasi-drug: Safety and efficacy test (www.kfda.go.kr)

Subject to safety and efficacy test

No

Yes - Origin - Toxicological data - Efficacy test data - Product efficacy test data - Use information in foreign country

Submit product notification (10d) Yes

Product approval (25 d) No

Identical product(physical state, specification, composition, etc) has been

approved before?

New substance?

Assessment by KFDA(55 d)

Standard product category

Yes

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THE QUALITY CONTROL AND SAFETY MANAGEMENT OF INDUSTRIAL PRODUCTS ACT - Ministry of Trade, Industry and Energy

Subject to Self safety confirmation (Article 2.9) - Battery - Anti-freezing agent - (household) chemical product - Automobile brake fluid - Automobile window washer fluid - Automobile tire - Children’s product made by

synthetic polymer - Adhesive(glue)

- Cleaning agent(floor, bathroom, car, etc) - Room Odorizer(air freshener) - Adhesives - Polish - Deodorizing agent - Synthetic detergents - Bleaching agent - Fabric Softening agent

Coverage of (household) chemical products

- Self-confirmation by performing test in certified laboratory to determine if the chemical product meets safety standard - Report to the Safety Certificate Institute with the test results and product description

Import of (household) chemical product: Safety standard (http://www.safetykorea.kr)

The management of those product will be transferred to the MOE through K-REACH. 10

THE QUALITY CONTROL AND SAFETY MANAGEMENT OF INDUSTRIAL PRODUCTS ACT - Ministry of Trade, Industry and Energy

Safety standard (ex. Cleaning agent (floor, bathroom, car, etc.)) - Application coverage - Safety standard : appearance, content of hazardous substance*(negative approach), container shape - Test method - Examination method for certification (sampling, # of test, etc.) - Labelling : 1) Product name / Product type / Date of manufacture / Importer information / Address and phone No. / Country of manufacture / Composition (surfactant and its content / phosphoric acid salt and its content/ Others) 2) Toxicity (“Toxic” for Toxic chemicals under TCCA) 3) Weight and acidity/basicity 4) Precautionary statement

Hazardous substance

HCl NaOH Tetrachloroethylene Trichloroethylene

Cut off Less than 10% Less than 5% Less than 0.1% Less than 0.1%

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Step-wise management plan (MOE’s national project in 2013)

Biocide management roadmap (proposed) - Ministry of Environment

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Technical aspects (risk assessment) Regulatory aspects Support for industry - Inventory establishment of biocide

active substance - The survey & monitoring of biocide

active substance and biocidal product

- Negative list to be controlled for biocidal product (CMR, PBT, vPvB)

- Priority Biocidal product type for management

- The Sub-ordinance preparation for biocide management(K-REACH) - Organization for biocide management - Public notice of highly concerned product for risk assessment - Pubic notice of product type category for biocidal product - Public notice of guidance for exposure scenario and exposure assessment - Data requirements of biocide substance and biocidal product - Public notice of efficacy test in biocidal product assessment - Public notice of analytical method of biocide active substance

- Registration training program

- Support for establishing an inventory

- Exposure scenario analysis and establishment of exposure assessment of biocidal product type

- Preparation of technical guidance for exposure scenario and evaluation

- Development of Analytical method for active substance

- Data requirements for biocide active substance and biocidal product.

- Building fundamental factors for Efficacy test

- Communication in supply chain to confirm hazardous substance in biocidal product

1st step: Building fundamental factors (2013-2015)

Biocide management roadmap (proposal)

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Technical aspects Regulatory aspects Support for industry

- Adoption of product notification of biocidal product

- Establishment of hazard and risk database of biocide active substance

- Step-wise risk assessment of biocidal product by Government

- Guidance of safety and labelling standard for biocidal product type

- Guidance of efficacy test for biocidal product assessment

- Gathering exposure factors and enhanced risk assessment for biocidal product type

- Development of risk assessment modelling and assessment system

- The adoption of an Eco-mark for biocidal products that do not contain hazardous substances

- Public notice of safety and labelling standard through risk assessement for biocidal product - Regulatory adoption of biocidal

product notification - Registration and assessment of

biocide substance under K-REACH

- Authorization process for hazardous substance in biocidal product

- Urgent suspension of use of highly concerned product

- Regulatory adoption of an Eco-mark for biocidal products that do not contain hazardous substances

- Information sharing of biocidal product

- Training for product risk assessment

- Test laboratory incubator for biocide assessment

- Voluntary participation of eco-friendly biocidal product use

- Support for sound chemical management in industry

- Database of substitutes for highly concerned biocide active substances

- Training program for safety and labeling of biocidal product

Biocide management roadmap (proposal) 2nd step: The registration of biocide and assessment of biocidal product (2015-2019)

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Technical aspects Regulatory aspects Support for industry

- Registration guidance of biocidal product

- Positive list preparation and maintenance for biocide management

- Technical development for re-registration of biocidal product

- Regulatory adoption of the

industry led registration of a biocidal product

- Maintenance of Regulatory positive list

- Adoption of re-evaluation of biocidal product

- Registration training program for biocidal product

3rd step: The registration of biocidal product led by industry (2020-)

Biocide management roadmap(proposal)

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Reporting of Manufacture, etc.

Existing Chemicals (≥ 1ton/year)

All New Chemicals

Registration Completeness Check

Hazard Evaluation

Risk Assessment

Toxic Chemical Substance for Authorization

Restricted/ Prohibited Chemical

Chemical Product

Notification of hazardous chemicals contained in a

product exceeding 1 ton/year

Risk assessment of products with high

risk concerned product

Safety standard and labeling

criteria & recall

Existing Priority Substance ≥ 1ton/year and All New Chemical

Communication in supply chain

K-REACH - Ministry of Environment

K-REACH overview

<Substance> <Product- consumer product>

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K-REACH Main obligation K-REACH Biocide*

Reporting - Chemical business (manufacturer, importer and seller) shall

report the volume and use information of all new chemicals and existing chemicals over 1 ton/year every year. Biocide

substance & Ingredient of industrial/ consumer biocidal product

Registration

- Manufacturer and importer - All new chemicals and existing chemicals subject to

registration over 1 ton/year are required to be registered (3 year batch system).

Communication in supply chain

- Supplier is required to provide information related to registered substance to downstream users and sellers. Downstream users and sellers shall provide chemical information to supplier upon request.

Product notification

- Manufacturer and importer of consumer product - When hazardous chemicals are present in a product at

quantities greater than the specific tonnage (≥1 ton/year), name of chemical, content, hazard information, use, etc. shall be reported.

Biocidal product only for consumer use Risk assessment of

highly concerned product

- Government (MOE) - The manufacturer and importer should follow Safety

standard and labelling criteria

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K-REACH - Ministry of Environment

Exclusion from K-REACH application • Exclusion (Article 3) - Radioactive substances - Medicines and quasi-pharmaceuticals - Narcotics - Cosmetics and active ingredient used for cosmetics - Agrochemicals and active ingredient - Fertilizer - Food and food additives, food instrument, food container, package - Livestock feeds - Explosives - Military supplies - Health functional food - Medical devices

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Definition (Article 2)- Registration of existing substance - Existing chemicals subject to registration for its hazard assessment or risk assessment - Existing chemicals subject to registration will be designated and announced based on its amount and hazard/exposure information through the deliberation of the assessment committee

Priority

Criteria for registration of an Existing chemical

HAZARD EXPOSURE # of substances

1st CMR or PBT HPV

20-20,000 ton ≥20,000 ton

372

2nd CMR or PBT H410(R50/53) or Toxic chemical

HPV

1-20 ton 10-20,000 ton

1,000-20,000 ton

791

3rd H410(R50/53) or Toxic chemical HPV

1-10 ton 100-1000 ton

923

(June 27. 2011. Public hearing, MOE)

K-REACH

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Data requirements for biocide substance

① Company information -Company name, address, name of representative, telephone no., -Only representative information (Company name, address, contact point, etc.) - Information of lead registrant (in case of joint submission)

② Chemical identity -Chemical name, molecular formula, chemical structure, CAS No. -Product name -Purity (%) -Identified impurity, by-product information (Chemical name, content)

③ Use information

-Use category -Brief description of chemical’s specific use -Uses advised against

④ Classification and labelling

-GHS classification and labelling

⑤ Physicochemical properties ⑥ Toxicological information ⑦ Risk assessment report for substance ≥ 10 ton/year ⑧ Method of Safe Handling (Protective equipment, emergency measures for explosion, fire or release) - Data generated by Domestic & Foreign GLP laboratories can be acceptable (logKow : GLP) - Test plan report for tests for high level submitted instead

K-REACH

Biocide Physico-chemical property & Toxicological data 0.1-1 ton (Starting from Jan. 1, 2020)

General Data requirements for 1-10 ton/year

1-10 ton General Data requirements for 10-100 ton/year

10-100 ton General Data requirements for 100-1000 ton/year

>100 ton

General Data requirements for >1000 ton/year

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K-REACH

Data requirements for Biocide substance registration

K-REACH

Data requirements 0.1-1 1-10 10-100 >100

Physico-chemical properties

1) Physical status O O O O

2) Water solubility O O O O

3) Melting/freezing point O O O O

4) Boiling point O O O O

5) Vapor pressure O O O O

6) Octanol/water partition coeff. O O O O

7) Relative density O O O O

8) Granulometry O O O O

9) Flammability O O O

10) Explosive property O O O

11) Oxidizing property O O O

12) Viscosity O O

13) Dissociation constant O O

(Starting Jan. 1, 2020 for new biocide)

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Data requirements 0.1-1 1-10 10-100 >100

Human health effect

1) Acute oral toxicity O O O O

2) Acute dermal toxicity O(or inh) O(or inh) O(or inh)

3) Acute inhalation toxicity O(or dermal) O(or dermal) O(or dermal)

4) Ames test O O O O

5) In vitro Mammalian Chromosomal Aberration Test O O O

6) In vitro gene mutation test in mammalian cells O(In case positive only in ④)

O(In case positive only in ④)

O(In case positive only in ④)

7) In vivo mammalian gene mutation test (micronucleous test)

O(In case positive in ④ and/or⑤)

O(In case positive in ④ and/or⑤)

O(In case positive in ④ and/or⑤)

8) Additional mutation test( germ cell mutagenicity etc.) O O

9) Eye corrosion/irritation O O O

10) Skin corrosion/irritation O O O O

11) Skin sensitization O O O O

12) Screening for Reproductive/ developmental toxicity O O O

13) Repeated dose toxicity (28 days) O O O

14) Sub‐chronic toxicity study (90‐day) O

15) Pre‐natal developmental toxicity study O

16) Two‐generation reproductive toxicity O

17) Carcinogenicity study O

K-REACH (Starting Jan. 1, 2020 for new biocide)

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Data requirements 0.1-1 1-10 10-100 >100 Ecotoxicity

1) Acute fish toxicity O O O O

2) Acute daphnid toxicity O O O O

3) Acute algae toxicity O O O

4) Ready biodegradability O O O O

5) Inherent biodegradability O O

6) Hydrolysis as a function of pH O O O

7) Identification of degradation products O O

8) Chronic fish toxicity O O

9) Chronic daphnid toxicity O O

10) Activated sludge respiration inhibition test O O

11) Adsorption/desorption screening test O O

12) Addtional Adsorption/desorption screening O

13) Short‐term toxicity to plants O O

14) Short‐term toxicity to invertebrates(earthworm) O O

15) Fate and behaviour in the environment O

16) Bioconcentration O

17) Long‐term toxicity to sediment organisms O

18) Long-term toxicity testing on plants O

19) Long‐term toxicity testing on invertebrates (earthworm) O

K-REACH (Starting Jan. 1, 2020 for new biocide)

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The transition period for registration - An existing substance is subject to registration : 1) Three years from the publication of the priority list 2) During transition period, manufacturer and importer can continue their business without registration - New substance : No transition period given

2013

Publication of K-REACH sub-ordinance

Public notice of existing chemical subject to registration

2014 2016 2015 2017 2018 2019 2020 2021 2022 2023

First batch & registration Second batch & registration

2024

Third batch & registration

K-REACH

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K-REACH

Joint Submission of Registration dossiers (Article 15) - Joint submission of registration dossiers on the same chemicals is mandatory - Opt out due to CBI protection, cost, etc. is possible, but approval by MOE is required in advance

- In case the registered tonnage band changes, the updated dossier shall be submitted within 1 month after the change takes place

- In case the registered use category and specific use changes, the updated dossier shall be submitted within 1 month after the recognized changes

- In case the physicochemical information, toxicological data and CSR changes, the updated dossier shall be submitted within 6 months after the recognized change

Registration update (Article 12)

Definition (Article 2)

Product: Articles for consumer use, its parts or component with potential exposure

of chemicals including the following items:

- Product in mixture

- Article having specific function in solid form which is not released during its use

High risk product of concern: Product with risk to human health and environment

and published by MOE through consultation with relevant Ministries.

- Household product for general consumer use such as cleansing agent, air freshener,

adhesive, polish, deodorizer, detergent, whitener and softener

- Biocidal products such as insecticide, disinfectant, and preservative

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K-REACH

Product notification (Article 32) - Product notification is required when hazardous chemicals are present in a product at

quantities greater than the specific tonnage (≥ 1 ton/year). The hazardous chemical name, content, hazard information and use in the product shall be declared in advance. (Article exempt)

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1. Legal entity for product notification: - Manufacturer and Importer (Only representative) of Product 2. Hazardous chemicals - Toxic chemical, Chemicals requiring authorization, Restricted/Prohibited chemicals - The number of hazardous chemicals will be over 2,000-3,000 substances when compounds or salts are taken into consideration 3. Product notification condition: ① + ② ① Total amount of each hazardous chemical contained in a manufactured or imported product yearly, (Jan. 1 – Dec. 31) that exceeds 1 ton/year ② Content of the hazardous chemical contained in a product exceeding 0.1%(w/w)

K-REACH

Product risk assessment (Article 33) - Product risk assessment is required for a product with a high risk concern* that will be

published by the MOE. This risk assessment will be performed by a specialized institution appointed by the Ministry of Environment.

- After the risk assessment, the Ministry of Environment will issue the safety standard and labeling criteria.

* Consumer products such as cleaning agent, air freshener, adhesive, polish, detergent, bleaching agent, softener and biocidal product Grace period(Article 4 of Presidential decree, supplement) - The grace period of Safety standard and labeling criteria for High risk concerned

product will be given until the MOE’s public notice for those products and current MOTIE’s standard according to the Quality control and Safety management of industrial products act should be followed in between.

K-REACH

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No separate biocide regulation and no biocide product type category exists in Korea

Biocide is managed by different ministries according to its use application. The MOE will take a key role in biocide management under K-REACH K-REACH requires registration only of biocide substances and the MOE assesses

the risk assessment of highly concerned product including biocidal product. Pay attention to the transition of 8 household products from MOTIE to MOE’s

control and keep you update the MOE’s publication of Safety standard and Labelling criteria.

Treated article is not considered yet. Still gray zone exists in the application scope of K-REACH concerning registration

of biocide substance.

Conclusion

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