(1)Reasons for Proposal
With the revision of the Act (promulgated on Jan. 15, 2019), the system for the Preliminary Examination on the Entry of Alternative Data of Materials Safety Data Sheets (MSDS) has been introduced. This amendment aims to provide detailed standards for matters entrusted by statutes for the enforcement of the system (to be enforced on Jan. 16, 2021) and, in addition, improve the problems that have occurred in the operation of the system.
(2) Major Provisions
A. Substances excluded from the entry of alternative data (Article 16)
- Add substances subject to working environment measurements and special medical examinations, and substances excluded under the Act on Registration, Evaluation, etc. of Chemicals
B. Criteria for approval of the entry of alternative data (Article 17 and attached Table 7)
- (Need for replacement) Establish the judgment criteria for trade secret constitution requirements* prescribed by the Unfair Competition Prevention and Trade Secret Protection Act
* Non-publicity, secrecy protection, and economic usefulness
- (Appropriateness of alternative data) Stipulate the naming method of “alternative names” replacing original names and the scope of applications of the “alternative content” replacing the original content
* Following the “naming method for generic names” of the Ministry of Environment / ** Regulating ±10%P when the original content is less than 25% and ±20%P when it is 25% or more
- (Appropriateness of MSDS) Review items such as hazard/risk information, the name and content of ingredients, and legal regulation status
C. Define chemicals or chemical products for research and development (Article 19)
- Prescribe them as being used for scientific experiments/analysis or research, chemical (product) development, production process improvement/development, chemical application field testing, and pilot manufacturing (production)
D. Improve and supplement other matters
- As the preparation subject was changed from a transferor/provider to a manufacturer/importer so that some interpretations are changed, improve exclusions, etc., to maintain the original condition (Articles 3 and 11)
- When submitting MSDS, require selecting and submitting one of the classification systems for use (Article 11)
- Allow one MSDS to be prepared when chemicals such as perfume/fragrance are limitedly added to the same various mixtures (Article 12)
- Reflect the classification/labeling standard (an integrated standard, jointly prepared by ministries) for chemicals in accordance with the international standard (UN GHS) (Article 6, Article 6-2, and attached Tables 1 and 2)
