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.