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How to Comply with Consumer Chemical Products and Biocides Safety Act in South Korea (K-BPR)

Little Pro on 2018-02-07 Views:  Update:2018-10-17

The Consumer Chemical Products and Biocides Safety Act is a new chemical regulation proposed by the Ministry of Environment (MOE) in South Korea. Also known as K-BPR, the Act regulates consumer chemical productsbiocidal product and biocide-treated articles. It is promuglated on 20 March 2018 and will come into force on 1 Jan 2019. In this article, we will give you a preview of the Act and summarize how to comply with this new regulation.

Disclaimer: The final text of the new regulation has not been published yet. This article is based on the latest available info from official presentations and ChemicalWatch news.

Overview of Consumer Chemical Products and Biocides Safety Act (K-BPR)

The Consumer Chemical Products and Biocides Safety Act (K-BPR)  can be broken into 2 parts: consumer chemical products and biocides. The consumer chemical product part is transferred from K-REACH while the biocide part is taken from EU biocidal products regulation (BPR). For consumer chemical products designated as products subject to safety confirmation, the Act requires that companies comply with relevant product safety and labelling standards and confirm compliance to authority by carrying out testing in designated labs (KEITI, etc.) once every 3 years. For biocidal products (both active substances and formulated products), the Act requires that companies apply for pre-market approval from the Ministry of Environment (MOE). In addition, the Act has set some rules for biocide-treated articles.

The table below is the break-down of the proposed consumer chemical products and biocides safety act (not final text).

Chapter I

General Provisions

Chapter II

Consumer Chemical Products

  • Safety and Labelling Standards
  • Safety Confirmation Testing

Chapter III

Biocides Approval and Authorization

  • Approval of Active Substances
  • Authorization of Biocidal Products
  • Safe Management of Treated Articles
  • Data Protection and Sharing

Chapter IV

Post-management on Consumer Chemical Products and Biocides

Chapter V to VII

Supplementary Provisions, Penalty and Other

Definition and Scope

The definition of consumer chemical products and biocides is listed as follows:

Consumer chemical products

  • Chemicals that are widely used in daily lives such as households, offices, public facilities and have potential to be exposed to human and the environment.
  • Example: detergents, adhesives, air fresheners

Biocidal active substances

  • Chemical substances, natural substances or organisms that are capable of suppress, remove and control hazardous organisms.
  • Example: CMIT/MIT, PHMG

Biocidal products

  • Products with a primary function of removing or controlling hazard organisms
  • Example: insecticide, anti-septic

Biocide-treated articles

  • Products which biocides are intentionally used for collateral purposes such as hazard organism removal
  • Example: anti-bacteria textile, preserved furniture.  

The following products are out of scope. For example, preservatives used in food and cosmetics will be exempt.

  • Pesticides, technical concentrates and pesticide control equipment in accordance with Pesticide Control Act
  • Food additives in accordance with Food Sanitation Act
  • Feeds in accordance with Control of Livestock and Fish Feed Act
  • Drug and quasi-drugs
  • Cosmetics and its raw materials in accordance with Cosmetic Act
  • Water treatment chemicals in accordance with Drinking Water Management Act

Main Requirements for Consumer Chemical Products

The Act requires that consumer chemical product companies comply with relevant product safety and labelling standards and confirm compliance to authority by carrying out testing in designated labs once every 3 years . Since 2015, the Ministry of Environment (MoE) has designated dozens of products subject to safety confirmation and established relevant labelling and safety standards: cleaning agents, synthetic detergents, bleaching agents, fabric softeners, coatings, adhesives (including glues), fragrances, deodorants, ironing auxiliaries, ink cartridges and toners and algicides. The standards set the list of restricted and banned substances, labelling and packaging requirements.

The table below is the example of the safety and labelling standard for cleaning agents.

Cleaning agents

Chemicals used for cleaning oven, stove hood, bathroom, plates, carpets, building floor, shoes, furniture, automotive, air conditioners, musical instrument, mildew remover, stain remover, etc.

Restriction
  • Tetrachloroethylene: < 1,000mg/kg
  • Trichlorethylene: < 1,000mg/kg
  • Formaldehyde: < 40mg/kg
  • Acetaldehyde: <70mg/kg
  • Naphthalene: <30mg/kg
  • Benzene: < 30mg/kg
  • Arsenic: <1mg/kg
  • Nickel: <1mg/kg
  • Hydrochloric acid: <10%
  • Sulfuric acid: <10%
  • Sodium hydroxide: < 5%
  • Potassium hydroxide: <5%
Ban
  • Polyhexamethylene guanidine (PHMG): Banned in spray type;
  • Ethoxyethyl guanidine (PGH) chloride: Banned in spray type;
  • Poly(hexamethylene biguanide) hydrochloride (PHMB): Banned in spray type;
  • Vinyl chloride;
  • Dichloromethane and mixtures containing it more than 0.1%;
  • Substances containing more than 0.1% lead and its compounds;
  • Ethyl bromide;
Labelling

General labelling requirements:

  • Product name;
  • Type;
  • Model;
  • Date of production;
  • Producer name;
  • Producer address and phone no. (only if produced in Korea);
  • Import company (only for import);
  • Import company address and phone no. (import only);
  • Ingredients (function);
  • Weight or volume
  • Liquid (if applicable);
  • Standard amount (if applicable)
  • Precautions.

Additional labelling requirements: If a product contains the following substances, it shall be labelled "toxic" along with the name, feature and content of the substances regardless of the content.

  • Bis (2-ethylhexyl) phthalate;
  • Isopropylbenzene;
  • 2-butoxyethanol;
  • Toluene;
  • 3-iodo-2-propynyl butyl carbamate;
Packaging

Child protection package are required for a liquid product containing any one or more of the following substances or powder product containing more than 2% or more sodium hydroxide/potassium hydroxide.

  • Sodium hydroxide, potassium hydroxide, or hypochlorate 2% w/w or more ;
  • Sulfuric acid 10%w/w or more;
  • Basic oil 10% w/w or more;
  • Mineral oil 10%w/w or more;
  • Methanol 4% w/w or more;
  • Any hydrocarbon or hydrocarbon mixture 10%w/w or more;

Main Requirements for Biocidal Active Substances and Biocidal Products

Like EU BPR, the Act requires that all biocidal products require MOE's approval before they can be placed on the Korean market, and the active substances contained in that biocidal product must also be previously approved by the MOE. Active substances and biocidal products are approved based safety and efficacy.

For biocidal products that have already been placed on Korean market before the Act comes into force, companies are required to notify their market circulation info to authorities. The MOE will then set varied grace periods for those notified biocidal products.

Pre-notification of Biocidal Active Substances

Anyone who manufactuers or imports a biocidal active substance contained in a biocidal product placed on Korean market before 31 Dec 2018 shall notify their company info, the name of the active substance, biocidal product type and composition, manufacturing or import volume to the MOE in order to get grace periods for active substance approval and product authorization.

Main Requirements for Biocide-treated Articles

The Act requires that articles only be treated with biocidal products containing active substances that have been approved in Korea. Any person who purchases treated articles can be provided or ask suppliers for biocidal chemicals info. If manufacturer claims that a treated article has biocidal properties, the manufacturer must label the treated article with info on biocidal products used and potential risks.

Record-keeping and Report

Anyone who imports or manufactures consumer chemical products subject to safety confirmation or biocides shall keep the records for 10 years. In addition, they shall report the following information to the MOE every 2 years

  • A manufacturer/importer of consumer chemical products subject to safety confirmation: name and volume of priority control substances and active substances. 
  • A manufacturer/importer of biocidal active substance or product: name and volume of biocidal active substance.

How to Comply with Consumer Chemical Products and Biocides Safety Act

Suppliers of consumer chemical products

  • Check if there are published safety and labelling standards
  • Comply with relevant safety and labelling standards
  • Conduct testing in qualified labs once every 3 years
  • Comply with registration obligations under K-REACH

Manufacturers and importers of biocidal active substances

  • Check if their uses are within the scope or not
  • Submit pre-notification of existing active substances to the MOE
  • Generate data and apply for approval from MOE within grace periods

Manufacturers and suppliers of biocidal products

  • Check if their uses are within the scope or not
  • Notify their existing uses to MOE
  • Only use approved active substances to formulate products
  • Apply for product approval from MOE within grace periods

Manufactures and suppliers of treated articles.

  • Only use approved biocidal products to treat articles
  • Label treated articles with biocidal info if a biocidal claim is made.

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 Tags: Topics - KoreaBiocidal Products Regulation

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