Questions on Product Safety Continue, Bringing About Strengthened Regulatory Oversight in Biocide Safety
In the midst of growing public concern over the health hazards of certain household chemical products,¹ concerns are now being raised about the safety of chemicals in other types of products, such as "quasi-drugs" (e.g., toothpastes) and cosmetics.
Primarily, these recent concerns focus on the health hazards associated with biocides contained in household products. In particular, Korean people are concerned about chemicals that were used as biocides in some humidifier sterilizers, such as chloromethyl-methylisothiazolone (“CMIT/MIT”).
Korean Government’s Response:
In response to these public concerns, the Ministry of Environment (“MOE”) initiated an exhaustive survey of biocides contained in household chemical products (since June 2016), while the Ministry of Food and Drug Safety (“MFDS”) announced its plan to initiate an exhaustive survey of biocides contained in cosmetics and toothpastes in August and September 2016, respectively (in particular, those biocides used to manufacture certain humidifier sterilizers in the past).
MOE’s Parallel Regulatory Efforts:
As a parallel effort, it appears that the MOE is currently pushing for the legislation of a bill that would separately regulate the health hazards of biocides.
By referring to the EU’s Biocidal Products Regulation (“BPR”), and the U.S.’s Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), the MOE plans to introduce the proposed Biocides Control Act (tentative name) as a separate legislation from the currently enforced Act on the Registration, Evaluation, Etc. of Chemicals (“K-REACH”). With the proposed law, the MOE hopes to strengthen regulatory oversight of products containing biocides.
Additionally, to strengthen the management of potentially risky products (“PRP”s), the MOE announced an administrative notice on the draft amendments to the “PRP Designation & Safety/Labeling Standards” (the “MOE Guidance”) on October 7, 2016.
The draft amendments to the MOE Guidance include: (i) the designation of printer inks/toners, ironing aids, and algicides as new PRPs in addition to the 15 product types already designated as PRPs; and (ii) a more stringent set of safety and labeling standards applicable to PRPs.
MOE’s More Stringent Safety & Labeling Standards on PRPs:
The draft amendments to the MOE Guideline set out the following strengthened safety standards²:
1) Use of CMIT/MIT is prohibited in all spray products and air fresheners;
2) New content limits set for using didecyldimethylammonium chloride (DDAC) and ethylene glycol in spray-type deodorizing agents;
3) Prohibits the use of 1,4 dichlorobenzene in deodorizing agents; and
4) New content limits set for: (i) the use of tetrachloroethylene in spray-type coating agents; and (ii) the use of limonene in fabric softeners.
The draft amendments to the MOE Guideline set out the following strengthened labeling standards³:
1) If a PRP contains a substance having a sterilizing, antibiotic, disinfectant, antiseptic, or preservative function, such a PRP is required to be labeled with the statement: “contains a biocide (name of the chemical substance, toxic)” or with statements of the substance name, the substance function, and its content, irrespective of the substance content.
Further, misleading language relating to the PRP’s hazards and effects on humans, animals/plants, and the environment, as well as terms, such as “low risk”, “non-toxic”, “harmless”, “environmentally friendly” or any similar expressions, cannot be used in the label to describe the PRP;
2) If a MOE-designated hazardous chemical substance is used in a PRP (regardless of its concentration), the PRP’s label must contain: (i) the hazardous chemical substance name; (ii) the reason why the hazardous chemical substance is added; and (iii) the hazardous substance content; and
3) If an allergy-inducing fragrance (26 types, including benzyl alcohol) is used in a detergent product in an amount exceeding the designated concentration limit,⁴ the product must be labeled with: (i) the name of the fragrance substance; and (ii) function of the fragrance substance.
¹ For example, humidifier sterilizers, air fresheners, deodorizers.
² A grace period of 3 months from the effective date of the amended MOE Guideline is provided for companies to become compliant with these strengthened safety standards.
³ A grace period of 6 months from the effective date of the amended MOE Guideline is provided for companies to become compliant with these strengthened labeling standards.
⁴ 0.01% or over for products that are cleansed after use, and 0.001% or over for products that are not cleansed after use.