Key Confirmation Matters Revealed Before Submission of Registration Data by UVCB of South Korea Petroleum Department

Release time:

2021-10-27 16:35

Recently, the Chemical Substance Registration and Evaluation Group of the National Academy of Environmental Sciences of South Korea held a seminar to discuss the key confirmation items before the petroleum UVCB (substances with unknown or variable components, complex reaction products or biological materials) submitted for registration. This article will sort out and explain these key confirmation items.

According to the discussion results of the seminar, the key confirmation items before submitting the registration data of the petroleum department UVCB include the following five parts:

01
information identification

-Basic information on the composition or type of composition of the registered chemical substance is required (can be included in the data of the cross-reference method)

-Since most petroleum-based substances are grouped by category and cross-referenced, detailed composition information for registered chemical substances is also required.

02
Description of use

-Description of use needs to be specified (content)

(Example: detergent, petrochemical production, etc.: specific examples (instructions), additional technology)

03
Cross-referencing information

-Requires extensive data supplementation for similarity, hypothesis and hypothesis proof data

-Basic similarity data (including QSAR data) for all reference and registered substances are required.

-In general, each hazard term requires an explanation of assumptions.

-In the case of subgroups of substances such as petroleum substances, it is almost impossible to justify each registered substance with only one reference substance (key data).

※ in particular, if a reference is selected and submitted as a representative, the reasons for the selection (justification) and explanatory data on similarity must be submitted together.

-If there are multiple test data (multiple data are also described on the CSR) but not submitted, it is best to submit additional data to prove its rationality (WoE; Evidence Method). In this case, if only the main test result values are briefly summarized in a table (which can be included in the cross-reading evidence), there is no need to submit a separate Korean summary.

-When submitting multiple test data, you need to explain the reason for selecting the key data

⇒ It is the responsibility of the registrant to judge whether it is similar to the hypothetical setting. In principle, for each item submitted as similar data, assumptions and a basis for judging similarity must be submitted.

⇒ The process is similar to the data of Europe or the United States does not make much sense. This is because similar processes or similar specific physicochemical properties are unlikely to have similar toxicity.

04
Classification and Indication

-Must be consistent with the submitted hazard information, such as adding classification labels based on the composition and content (%) of the main hazardous substances.

-Most petroleum-based substances contain components that affect the classification label (e. g., 1,3-butadiene, benzene, toluene, n-hexane, etc.).

-In addition to hazard classification based on registered test results, additional hazard classification and labeling based on the composition and content of hazardous substances are required (based on petroleum composition data).

For example:

Benzene 0.1 or more: Carcinogenicity category 1 and Mutagenicity category 1, Benzene 1% or more: Target Organ Repeat category 1(10% or more) or category 1(1-10%) Add.

05
Manufacturing process condition

-Process flow diagram of the production process of the substance (including information on the possible processes and characteristics of the production substance, because the composition information of most registered substances is lacking).

If you have any other questions about K-REACH and K-BPR, please feel free to contact us.

Our services:

(1) South Korea MSDS production

(2) K-REACH of existing chemical substance registration/pre-registration

(3) Registration of K-REACH new chemical substances

(4) Application for exemption from registration

(5) Supply chain information communication

(6) K-BPR South Korea Life Chemicals and Biocides Declaration

(7) OR agency services

(8) PEC priority control substances registered separately

(9) Declaration of Chemicals Containing Key Management Substances

New Anrun Chemical Regulations Advisory Services: