NEWS LETTER 2019.(VOL.35)
Chemtopia thinks ahead of clients
Chemtopia gives honest consultation to clients
ISSUE & FOCUS
- Ⅰ . Key aspects on sub-regulation drafts of K-BPR
- II. Countermeasures from Industry
Ⅰ . Key aspects on sub-regulation drafts of K-BPR
I. Key aspects on sub-regulation drafts of K-BPR
○ Data requirements of approval of biocide a.i. and biocidal products
When applying for approval of biocide a.i. and biocidal product, sub-regulation drafts specify the scope of data requirements that manufacturers and importers have to submit to the Ministry of Environment.
Approval for biocidal product : 13 types of data requirements in total (Physicochemical properties, biological characteristics, efficacy, health hazards and environmental hazards, data verifying that applicants complied with manufacturing/storage facility standard and etc.)
○ Product type of K-BPR
MOE specifies biocidal product types. By establishing biocide product types, biocide a.i. cannot be used in unauthorized product types. K-BPR’s product types are classified into 4 categories, △Disinfectants △Pest control △Preservatives △Other, these categories distinguish total 15 specific types.
| Classification | Korea BPR product type |
| Disinfectants | (1) Disinfectants, (2)Algaecide |
| Pest control |
(3) Rodenticides, (4) Control of other vertebrates, (5)Insecticides, |
| Preservatives |
(8) Product preservative |
| Others | (15) Antifouling agents |
○ Grace period of approval of existing biocide active ingredient
The MOE specifies grace period of existing* biocide a.i. for its approval. *Existing biocide a.i means one contained in biocidal products that is circulated domestically before 18.12.31.
- Existing biocide active ingredients are assigned grace period for approval by setting different deadlines which can be up to 10 years according product types where the biocide active ingredient is used.
- As for product types which have high possibility of being used in everyday by consumers, grace period for approval of existing biocide actives will be relatively shortened. Exceptionally, grace period can be partially revised considering its hazards/risk manufacturing amount/import amount, regulatory status in domestic and foreign countries.
| Classification | Group 1 | Group 2 | Group 3 | Group 4 |
| Grace period of biocide a.i. approval |
3 yrs | 5 yrs | 8 yrs | 10 yrs |
| Product type |
-Disinfectants |
-Wood preservatives |
-Product preservative |
-Construction material preservatives |
○ Label claims of biocidal products
- Biocidal product that eliminates hazardous organism as its main function is made possible to use label or to advertise its ‘biocidal effect’ such as disinfectants, insecticides, preservatives, etc.
- On the other hand, as for treated article that eliminates hazardous organism as its supplementary function, there is limitation to use label or to advertise its ‘biocidal effect’ such as disinfecting/destroying/preserving etc. as indirect expression*.
* Indirect expressions example: ‘sterilized’, ‘antibacterial treated’, ‘using preservatives’
- Be cautious that it is entirely prohibited from using ‘non-toxic‘ ‘safe’, ‘eco-friendly’, ‘animal-friendly’ etc. leading to misconception of consumers about the safety of the product.
○ Support to Industry, especially SMEs
- The government can support SMEs by generating cost-bearing toxicological tests directly.
- In order to streamline administrative procedures, approval of biocide actives and biocidal products, notification of compatibility confirmation whether specific product meets its safety standards and etc will be processed electronically.
II. Countermeasures from Industry
II. Countermeasures from Industry
- Submit industry’s opinions to the MoE by July 9th.
- Firstly, industry is recommended to check if any biocide a.i. contained in manufactured or imported products. Then industry has to understand the obligation, if applicable, depending on the biocidal product type and etc.
- Foreign manufacturer or producers may appoint OR to fulfill K-BPR obligations. It is very important to select a reliable OR as always.
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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
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