켐토피아 뉴스레터

NEWS LETTER 2019.(VOL.38)

Chemtopia thinks ahead of clients

Chemtopia gives honest consultation to clients

[Newsletter No.38] Summary of meeting with MoE and industries for K-BPR

Sub-regulations for K-REACH and Chemical Product Safety Act, newly named K-BPR, will be promulgated in November or December 2018.

MOE had held a meeting on the review result of the major opinions from industries on pre-announcement of sub-regulations of K-REACH and K-BPR on Sep. 3, 2018. Also, on last Sep. 20-21, the biocide committee was established therefore approximately 95 corporates participated and had Q&A with MoE.

In this newsletter, we would like to summarize the main issues raised in the meeting as they will affect chemical industry. The final sub-regulations of these two Acts are expected to be promulgated within this year.

● Aug-Oct: Completion of preliminary examination of regulation of sub-regulation Act and examination by the Office of Legislation
● Nov-Dec: Announcement after the vice-minister meeting and cabinet meeting
● Sep-Oct : Notification of amendments to the notification system
● Nov-Dec : Examination and Announcement of Legislation Supervision Regulation

ISSUE & FOCUS

I. K-BPR
II. Countermeasures of the industry

I. K-BPR

The followings are the main issues presented.

1. The followings are excluded from application of biocidal products as they are governed by the other Acts.

● Functional foods for health governed by 「Functional Foods for Health Act」
● Commodity set forth in Article 3 of 「Act on the Management of Military Supplies」
● Agrochemicals, Natural plant protectives, Technical products and Apparatus for agrochemicals which are governed by 「Agrochemicals Control Act」
● Water treatment chemicals governed by 「law for the management of drinking water」
● Single ingredient and subsidiary feeder governed by Control of 「Livestock and Fish Feed Act」
● Treatment substances governed by 「Act on Ballast Water Management
● Foods, food additives, apparatus and containers and packaging governed by 「Food Sanitation Act」
● Drugs, quasi-drugs, veterinary drugs and veterinary quasi-drugs governed by 「Pharmaceutical Affairs Law」
● Sanitary items set forth in Article 2 (1) of 「Sanitation Control Act」
● Medical equipment set forth in the paragraphs other than Article 2 (1) of 「Medical Equipment Act」
● Cosmetics set forth in Article 2 (1) of 「Cosmetics Act」

- The opinion of the industry was that preservatives or disinfectant shall be excluded from all application of this Act and the MoE replied that if those are used for drugs, quasi-drugs, cosmetics and sanitary items, etc., they shall be excluded from application of this Act and that it will be addressed in the sub-regulation.

- Also, some people of the industry requested the MoE to exclude the antifouling as it is not high risk concerned product and less detrimental to human body. The MOE answered that it cannot be accepted, because the antifouling is one of the major biocides to be concerned as detrimental to the environment.

2. Scope of Biocide management
Biocide management includes biocidal substance, biocidal products, treated article and follows below definition:

● “Biocidal substance”: A chemical and natural substances or microorganisms that have the effect or property of eliminating, controlling, rendering harmless or deterring harmful organism

● "Biocidal product”: A Product that has the primary purpose of eliminating harmful organisms and that includes one of bellows :

1) A product consists of one or more biocidal substances, a mixture with biocidal substance and product containing with non-chemical/natural substances that are not biocide, or microb.

2) A product consists of chemical or a mixture with chemical/natural substance biocidal substance, or with microb.

● "Treated article” is any substance, mixture or article which has been treated with, or which works as biocidal products for the purpose of eliminating harmful organisms, but it is not main purpose of product.

- In reply to the question of the industry whether the preservatives already contained in the raw materials shall be considered as a treated article or not, the MOE replied that it is not considered as a treated article, the guidance will be issued at the end of this year and that such preservatives included in the raw materials shall be exempted.

3. Concerning the approval of biocidal substance and product
The grace period for approval of biocidal substances shall be as follows in accordance with each group of biocidal products.

Classification	Group 1(3 years)	Group 2(5 years)	Group 3(8 years)	Group 4(10 years)
Product type	Disinfectants, algaecide, rodenticides, insecticide, repellents	Wood preservative, vertebrates controller, other non-vertebrates controller	Product preservative, product surface preservative, fabric/ leather preservative	Construction material preservatives, material/equipment preservatives, embalming or taxidermist fluids, antifouling agents

4. OR (Only representative)
In reply to the opinion of the industry that there shall be an Article in the Act regarding only representative by the overseas manufacturer or exporters to carry out declaration of the existing biocidal substance, application for approval of biocidal substance and products, etc. But the MoE replied that they are not in a position to impose legal obligation or responsibility on hiring an only representative as there is no contents in the current law yet. But the MoE mentioned they have a plan to amend K-BPR regulation to consider OR in the future and at the moment, only third party can submit the notification, approval application instead.

5. It is stipulated in the draft sub-regulations that the following data shall be submitted to confirm safety standard of household chemical products.

● Company name and address, and name and address of person who manufactures or imports the household chemical products subject to safety confirmation
● Product information, such as photo of product, instruction to use, etc.
● Compositions, content of all the substances contained in the product, purpose of use
● Test certificate for safety standards
● Packaging sample of the product with labeling

- The industry pointed out that there is a problem to disclose composition, contents, and use of all the substances contained in household chemical products subject to safety confirmation to a private testing institute instead of the government designated lab. And, the MoE accepted this and it is to be amended to submit ingredients and content, and use of substances specified and announced by the MoE

II. Countermeasures of the industry

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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