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Introduction to the upcoming South Korea chemical safety law for killing biomass (K-BPR) and industry countermeasures
Release time:
2019-09-06 14:48
As part of the K-REACH and Chemical Safety Act, the newly named K-BPR will be enacted in November or December 2018. The Ministry of the Environment of South Korea held a meeting on September 3, 2018, to review the industry's main comments on the K-BPR announcement, and set up the Killing Committee on September 20-21. Some 95 companies participated in the meeting and participated in the Q & A.
In this tweet, we will summarize the main issues raised at the meeting, and two new decrees are expected to be issued within this year.
The following is a summary of the latest information:
1. The following conditions do not apply to biocidal products because they are subject to other regulations.
-Health functional foods governed by the Law on Health Functional Foods;
-Goods listed under article 3 of the Act on the Administration of Military Supplies;
-agrochemicals, natural plant protection agents, agrochemical technical products and equipment regulated under the Agricultural Chemicals Management Act; l
-Water treatment chemicals regulated by the Drinking Water Management Act;
-Single ingredients and their accessory feeders regulated under the Livestock and Fish Feed Act; l
-Treatment substances subject to the Ballast Water Management Act;
-Food, food additives, utensils, containers and packaging materials, etc., regulated by the Food Sanitation Law;
-Drugs, quasi-drugs, veterinary drugs and quasi-veterinary drugs controlled by the Pharmaceutical Affairs Act;
-Sanitary articles as defined in article 2(1) of the Sanitation Administration Act;
-Medical equipment other than those provided for in Article 2(1) of the Medical Equipment Act;
-Cosmetics as defined in Article 2(1) of the Cosmetics Act.
The industry's opinion is that preservatives or disinfectants should be excluded from all the scope of application of the Act, and the Ministry of the Environment replied that if these substances are used in drugs, quasi-drugs, cosmetics and hygiene products, they should be excluded from the scope of application of the Act and will be dealt with in the secondary regulations.
In addition, some industry insiders asked the Ministry of the Environment to eliminate anti-fouling measures, because anti-fouling products do not involve high-risk products and are less harmful to the human body. The Ministry of the Environment replied that this proposal could not be accepted because anti-fouling is one of the main biocides because it is harmful to the environment.
2. The scope of biocide management
Biocides include biocides, biocidal products, treated articles, and the following definitions: 1
"Biocidal substance": refers to non-chemical and natural substances or microorganisms that have the effect or properties of destroying, controlling, rendering harmless or deterring harmful organisms. l
"Biocidal product": A product whose primary purpose is to eliminate harmful organisms, including one of the following two conditions:
1) The product consists of one or more biocides, a mixture containing biocides and non-biocides or microorganisms containing non-chemical/natural substances.
2) The product is made of chemical substances or mixed with chemical/natural substances, biocides or microorganisms. l
"Treated article" means any substance, mixture or article that has been processed or used as a product to kill harmful organisms, but which is not the primary purpose of the product.
In response to the trade's question on whether preservatives already contained in raw materials should be regarded as processed articles, the Ministry of Economic Affairs replied that such preservatives were not processed articles and would be exempted from the guidelines to be published at the end of this year.
3. About the approval of biocidal substances and products
The grace period for approval of biocidal substances shall be specified for each group of biocidal products as follows:
December 31, 2019, the K-BPR began;
December 31, 2022, including the end of the grace period for the first batch of products such as disinfectants, algaecides, rodent killers, pesticides, etc;
December 31, 2024, the grace period for the second batch of products including wood preservatives, vertebrate controllers, other non-vertebrate controllers, etc;
December 31, 2027, including the end of the grace period for the third batch of products, including product preservatives, product surface preservatives, fabric/leather preservatives, etc;
On December 31, 2029, the grace period for the fourth batch of products including building materials preservatives, materials/equipment preservatives, preservative or specimen rosin liquid, antifouling agents, etc.
-The industry asked the Ministry of the Environment to extend the grace period, but the Ministry replied that this request would not be accepted.
4. OR (sole representative)
In response to the comments of the industry that the Act should have a provision for the declaration of existing biocidal substances, applications for approval of biocidal substances and products, etc., by representatives of overseas manufacturers or exporters. However, the Ministry of the Environment replied that they could not impose legal obligations or responsibilities on the sole representative employed by the enterprise, as there was no relevant content on OR in the current law. However, the Ministry of Environment said that they plan to amend the K-BPR regulations to consider in the future. Currently, only third parties can submit notices and approve applications.
5. The draft regulations stipulate that the following data shall be submitted to determine the safety standards for household chemical products
-The name and address of the company and the name and address of the person who produces or imports household chemicals that have been certified safe;
-Product information, such as product photos, instructions for use, etc;
-The composition, content and use of all substances in the product;
-Safety standard test certificate;
-Product packaging samples with labels.
The industry pointed out that it may be problematic to disclose the composition, content and use of all substances contained in household chemical products to private testing agencies rather than government-designated laboratories. Furthermore, the Ministry of Environment accepted this and will amend it so that the composition, content and use of the substance will be submitted to the agency designated and declared by the Ministry of Environment.
The industry also pointed out that it is difficult to declare packaging samples at the product launch stage, and the Ministry of the Environment will revise it to the declaration of label samples.
Based on the information summarized above, we suggest the following industry countermeasures:
1. Preparation of pre-registration of existing biocidal substances
According to K-REACH regulations, the deadline for pre-registration of existing chemicals exceeding 1 ton is the end of June 2019. This time may not be enough, so relevant companies should prepare in advance. In addition, under K-BPR regulations, the pre-registration of existing biocides coincides with the pre-registration of existing chemicals, which may cause confusion. Especially for imports from abroad, it is necessary to determine in advance whether the overseas manufacturer or the domestic importer is responsible for the pre-registration.
2. Clear classification of biocidal substances, biocidal products and processed articles
The products you handle should be clearly divided into biocidal substances, biocidal products and processed articles according to K-BPR definitions. Also, you should be prepared especially for the approval of biocidal substances and biocidal products. Keep in mind that you are not obligated to obtain approval for processed articles and that you should be supplied and used with approved biocidal products.
3. Participation in the Biocidal Committee
The first meeting of the Committee on Biocides was held from 20 to 21 September this year. About 95 companies participated in the conference, which mainly included explanations and questions on K-BRP regulations. Since the Biocide Registration is a joint registration, companies interested in participating in CICO (consortium), please inform the Ministry of the Environment as soon as possible if they are willing to participate. However, if the company is a foreign company, since there is no definition of OR in the current K-BRP regulations, the domestic importer must apply for CICO on behalf of the foreign company. After domestic importers apply to join CICO, foreign companies can participate in CICO through third parties (consulting firms).
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