Amendment(draft) of ‘Public notice on Investigation of Harmfulness and Hazardousness of New Chemicals’

On February 19, Korea MoEL(Ministry of Employment and Labour) has announced Public Notice No. 2016-68 ; Amendment(draft) of ‘Public notice on Investigation of Harmfulness and Hazardousness of New Chemicals’

For main revision, please see the details below.

■ Adoption of the definition of ‘Polymer compounds’(Article 2)

: To define term of  ‘polymer compounds’ in accordance with standards of Organization for Economic Cooperation and Development(OCED), etc.

Ÿ   a substance consisting of molecules characterized by the sequence of one or more types of monomer units. Ÿ   Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. Ÿ   Over 50 percent of the weight for that substance consists of polymer molecules that contains a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant. Ÿ   The amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance.

■ Revision on the criteria as ‘Polymer compounds of low concern’ to be exempted from Examination on Harmfulness and Hazardousness (Article 4-3)

: KOSHA has changed the standard for polymer compounds of low concern which to be exempted from examination on harmfulness and hazardousness to combine the international standards and other laws by reflecting the standards of Organization for Economic Cooperation and Development(OCED).

[Article 4-3] Polymer compounds subject to exemption from Examination on Harmfulness and Hazardousness. 1.      Polymer compounds, whose monomers are not new chemicals, and which satisfy one of the following two conditions a.     Polymer compounds with Number Average Molecular Weight(NAMW) greater than 10,000 whose molecular species with below MW1,000 are present at 5% or less, and species with below MW500 are present at 2% or less b.    Polymer compounds with NAMW between 1,000 and 10,000 whose molecular species with below MW1,000 are present at 25% or less, and species with below MW500 are present at 10% or less c.     The polymer consists of 2%(w/w) or more of monomer is not new chemical substance 2.      Exceptions a.     Cationic polymer compounds (excluding polymer compounds only used in solid form and does not dissolved or dispersed in water b.    Polymer compounds with ‘less than Mn 10,000’, as monomers exceeding 2%weight and satisfying one of the following conditions i) New chemicals ii) Prohibition listed in Occupational Safety Health Act(OSHA) iii) Authorization subject listed in OSHA iv) Administration subject listed under OSHA Regulation

■ Set of Specific Conditions of exemption from submission of the test reports (Article 4-2)

: In case where you cannot get test results from the testing including physico-chemical property tests, and if the substance satisfying the conditions of exemption from submission of the test reports, it is available to omit the submission of test reports.

[Article 4-2] Polymer compounds, satisfied with all requirements below, can omit submission of the study report required under Korea OSHA Enforcement Asterisk 11-4-2. a. Polymer compounds are stable in the stability study in acidic and alkaline conditions. b. Polymer compounds meet Article 4-3-1-a or 4-3-1-b, and residual concentration of its monomer which subject to Article 4-3-2-b is less than 0.1%. c. Polymer compounds don’t correspond with Article 4-3-2-a.

At last, today the list of existing chemical substances subject to registration defined by K-REACH has just been officially announced by Korea MoE.

The total 510 existing chemical substances are listed, most of which are not very different from draft version, which had been published in October 2014.

According to K-REACH, such substances should be complied with registration within three-year grace period, if those are imported over 1 ton per year.

Please get to the liked and find the attached list, in order to confirm if your chemical substances are on the list.

Also please be noted that hydrates of the listed chemical substances also should be registered.

If any question, feel free to contact us.

http://www.chemnavi.or.kr/spkreach/archives.asp?b_name=v_data&mode=read&IDX=4728&Page=1&Search_Type=&Search_Value=&Category=3&Parent=&Cate=&Search_Cate=&menu=&top_menu_num=&Order_Name=Ref&Order_Type=Desc

[Polymer] Registration of Polymer under K-REACH

A new polymer which does not satisfy polymer exemption conditions under K-REACH shall be registered like new substance. However, required test data for a polymer are less than those for a substance. Please refer to the following table for data requirements in accordance with tonnage bands.

Volume of manufacture and import	Data requirements
① 0.1 ~ 1ton/yr	- Physicochemical properties (state of substance, water solubility, melting/freezing point, boiling point, vapor pressure) - GPC data - Stability in acidic and alkaline conditions
② 1 ~ 10ton/yr
③ 10 ~ 100ton/yr	- Data requirements of ①, ② - Acute oral toxicity (Acute inhalation toxicity shall be needed in case the main exposure pathway is considered as inhalation) - Ames test - Acute fish toxicity - Ready biodegradability
④ 100 ~ 1000ton/yr	- Data requirements of ③ - Physicochemical properties (octanol/water partition coefficient, density, granulometry) - Skin irritation/corrosiveness - Skin sensitization - Acute daphnia toxicity
⑤ Over 1000ton/yr	- Data requirements of ④ - Physicochemical properties (flammability, explosive properties, oxidizing properties) - Acute dermal toxicity or acute inhalation toxicity - Eye irritation/corrosiveness - In vitro chromosome aberration using mammalian culture cell - Genetic toxicity - 28days repeated dose toxicity - Reproductive and developmental toxicity: screening * can be substituted with test protocol - Freshwater algae growth inhibition - pH hydrolysis

* Polymer compounds with 1,000≤Mn<10,000 whose monomers, which are new chemicals, hazardous chemicals and chemicals with hazard and risk or announced by MoE, exceed 2%weight shall be registered, but if content of residual monomer is less than 0.1%, only physicochemical test data are required.

It is likely ; Deregulation in the required data for KOSHA registration.

▪ With regards to KOSHA registration with tonnage band of ‘over 0.1t/y’, the hazard studies which required to submit would be reduced from three(3) end points at present to one(1) end point.

 For the substance registration under KOSHA, it is required in principle to submit the 3 end points of toxicity(acute toxicity test-oral / inhalation, Ames test, and micronucleus test), even though micronucleus test is usually waived. But Korea Ministry of Employment and Labor(MoEL) has a plan to substitute those requirement with only the acute toxicity test. Also other genotoxicity studies like Ames test, micronucleus test could be ordered to submit by MoEL for the chemical substance that is expected to cause harmful risk to the health like mutagenicity.

▪ In addition, MoEL has a plan to shorten the duration for examination of registration dossier with tonnage band of ‘over 0.1t/y’ from 45 days at present to 14 days, i.e. MoEL will respond to each application of substance registration within 14 days.

▪ Expected schedule by MoEL

- 2015.4 : Preparation for amendment of the enforcement rule

- 2015.5 : Legislative notice

- 2015.7 : Review for regulatory and legislative purpose

- 2015.9 : Enactment and enforcement.

Registration of new chemical substance ; K-REACH vs KOSHA

▪ For the new chemical substance, which is defined as not-listed substance onto Korea Inventory of Existing Chemical Substance, it should comply with registration under both K-REACH and KOSHA, since K-REACH has come into enforcement as of January 1 2015.

▪ With the tonnage band of ‘over 1t/y’ before beginning of 2020, the dossier for K-REACH registration can be also submitted to MoEL for KOSHA registration without further hazard data development.

▪ However, be noted that there is conflict in the required hazard data for registration between K-REACH and KOSHA, only regarding registration with tonnage band of ‘0.1 to 1t/y’

▪ please refer to the comparison in the table for the details

Before 2020	K-REACH (MoE)		KOSHA (MoEL)
Tonnage	< 0.1t/y	01t/y~1t/y	< 0.1t/y	0.1t/y <
Required Data	Basic Information Only “No Hazard Data”		Exempted from registration		Basic Information + “Hazard Data1” Required

▪ Unlike K-REACH, because KOSHA does not have the legal definition of ‘Representative’(similar concept to Only Representative in EU REACH), the registration under KOSHA should be conducted by the name of Korea importer. Nevertheless KOSHA registration could be completed via the authorized 3^rd Party by the overseas manufacturer, without risk to disclose the worthy information of the substance(CBI) to Korea importers. 

How to register intermediates under K-REACH

▪ Intermediate means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance.

-          Non-isolated intermediate : an intermediate that is not intentionally removed from the equipment in which the synthesis takes place, during synthesis.

-          Isolated intermediate : other intermediate that is not falling in definition of Non-isolated intermediate.

▪ K-REACH compliance subject to Non-isolated intermediate

-          Exempted from the obligation of ‘Annual Reporting’

-          Exempted from the obligation of ‘Registration’, but prior confirmation of the registration exemption shall be required (just once at first time)

▪ K-REACH compliance subject to Isolated intermediate

-          Only “isolated intermediate which blocked from release or exposure by functional method” can be exempted from the obligation of ‘Registration’ but prior confirmation of the registration exemption shall be required (just once at first time)

-          Other isolated intermediates are subject to Registration. But, the submission of hazard data,  risk and exposure assessment, or safe use guidance could be exempted.

▪ According to consultation with the competent Korea Government, the authority is most likely to only consider ‘On-site, Isolated intermediate’ as ‘Isolated intermediate’ which defined under K-REACH. This means that in adverse ‘Transport, Isolated intermediate’ is considered as ‘Substance’. Therefore ‘Isolated intermediate’ imported into Korea should comply with K-REACH obligation as ‘Substance’, not as ‘Isolated intermediate’, even though the same substance is considered as ‘Isolated intermediate’ in the relevant regulations of other countries, like EU-REACH.

[Polymer] Comparison of Polymer Exemption Conditions between K-REACH and KOSHA

There are considerable differences in polymer exemption conditions between K-REACH and KOSHA. Therefore, if business entity intends to get confirmation of polymer exemption, they should consider exemption conditions of both K-REACH and KOSHA. If a new polymer satisfies exemption conditions under K-REACH but does not satisfy those under KOSHA, and vice versa, business entity should proceed registration or apply for confirmation of exemption from registration under K-REACH and KOSHA respectively. However, if a new polymer satisfies exemption conditions under both K-REACH and KOSHA, business entity has only to apply for confirmation of exemption from registration under K-REACH, which covers counterpart under KOSHA. Please refer to the following table for details.

K-REACH

KOSHA

Ø  Polymer compounds with Mn≥10,000 whose molecular content of MW<1,000 is less than 5% and that of MW<500 is less than 2% Ø  Polymer compounds with 1,000≤Mn<10,000 whose molecular content of MW<1,000 is less than 25% and that of MW<500 is less than 10% (Exception: polymer compounds whose monomers, which are new chemicals, hazardous chemicals and chemicals with hazard and risk or announced by MoE, exceed 2%weight) Ø  Exception: Cationic polymer compounds (excluding polymer compounds only used in solid form and not dissolved or dispersed in water)

Ø  Polymer compounds, whose Mn≥1,000, which  do not make cation, whose monomers are neither new chemicals, prohibited substances, substances subject to permission nor hazardous substances subject to control and which satisfy one of the following two conditions -       If insoluble in water or organic solvent, polymer compounds should not contain any metal, except sodium, magnesium, potassium or calcium -       If soluble in water or organic solvent, molecular content of MW<1,000 in polymer compounds should be less than 1%. If polymer compounds’ Mn<10,000, the monomers should not include double bond between carbons, triple bond between carbons, double bond between carbon and nitrogen, triple bond between carbon and nitrogen, aziridine group, epoxy group, sulfonic acid group, hydrazine group, phenolic hydroxyl group, or fluorine group