EU EU BPR and Korea K-BPR: FAQs on Biocide Product Compliance

The EU EU BPR and the Korean K-BPR are two similar biocide regulations, both created to protect human health and the environment, but they are actually quite different
.
This is not only reflected in the development and improvement of the two systems, but also in aspects such as the scope of registration and the regulatory process
.

In order to help enterprises clarify the registration process of EU BPR and Korean K-BPR regulations, and effectively avoid the non-compliance risk of enterprises entering the target market
.
Ruiou has sorted out the frequently asked questions about the compliance of EU & Korea BPR regulations for reference by enterprises, hoping to help you better understand the regulatory situation and access principles of EU BPR and Korea BPR, and do a good job of product and market compliance
.

Q1: Can the Chinese test report be used in the BPR registration?

A1: The test reports carried out in China, such as drug efficacy reports, which do not have the qualification requirements of OECD GLP laboratories, can be used for BPR registration if the quality is qualified
.
However, data such as human health require laboratory qualification requirements such as OECD GLP, so they cannot be used for BPR registration
.

Q2: Can data from EU BPR registration be used for registration in other countries?

A2: The data registered in the EU BPR can be used for registration in the United States and South Korea
.

Q3: For antibacterial active substances, is it for chemicals? Are natural substances also handled in accordance with BPR regulations?

A3: For natural substances, if the claimed use is also within the jurisdiction of BPR (ie 22 use types of EU BPR, 15 use types of K-BPR), then BPR should also be dealt with
.
 

Q4: Does Korean K-BPR have a 95 list like EU BPR?

A4: Currently, Korean K-BPR does not have a 95 list similar to EU BPR in a strict sense
.
On the one hand, Korean K-BPR can also be included in a list as long as the pre-registration is completed.
The list includes substance names, uses, applicant information, etc.
This list is similar in form to the Art 95 list of the EU EU BPR.
It’s just that the meaning of listing is different; on the other hand, K-BPR is relatively new compared to EU BPR regulations, and the possibility of subsequent Art 95 list requirements is not ruled out
.

Q5: Can the processed products in progress (belonging to PT2) be directly sold in the EU? Do you still need to go to all the different countries in the EU to be recognized?

A5: If the active substance contained in the treated article is under evaluation, and the treated article also needs to meet the requirements of EU BPR labeling, drug efficacy, etc.
, it can be sold in the EU
.
Treated items do not need to be approved by all the different EU countries in order to be sold
.

Q6: Is the buffer sales at the time of registration only available in Korea?

A6: The buffered sales period at the time of registration is not unique to Korea, such as those mentioned under the EU BPR for products containing existing active substances under evaluation (such as ethanol, bisdecyldimethylammonium chloride, chlorine dioxide) , on the basis of completing the product registration of a specific member state, it can also enjoy a buffer period, that is, before the active substance is approved, the product that has completed the product registration can be sold in a specific member state
.
In any case, the buffer period in South Korea ranges from 3 to 10 years, which is an excellent buffer period
.
 

Q7: Does this BPR regulation overlap with Pesticide Regulation 1107/2009? Because pesticides also include pesticides
.

A7: For pesticides, etc.
, the EU BPR regulation regulates insecticidal products related to people's living environment, including products used in small gardens; the pesticide regulation 1107/2009, which is the EU PPP regulation, is a plant protection regulation , regulating the use of pesticides in the field,
etc.
Therefore, the two regulations generally do not overlap
.
 

Q8: Do the disinfection products refer to sanitary insecticides? Are such products classified as pesticides in China and chemicals in Korea?

A8: Disinfection products are mainly under the jurisdiction of disinfection products in China, and sanitary insecticides are under the jurisdiction of Chinese pesticides in China.
These two categories are under EU BPR supervision in Europe and K-BPR supervision in South Korea
.

Q9: What is Product Feature Summary SPC?

A9: The summary of the biocidal product characteristics for biocidal products (SPC, the summary of the biocidal product characteristics for biocidal products) is a summary document of product information, mainly including the product name, the name and address of the authorized holder, product formula, type of use, hazards and protective measures Information on declarations, methods of use, storage conditions, waste disposal,
etc.
SPC (summary of product characteristics) needs to be produced and provided to the official when the product is authorized
.

Q10: If there is a declaration of a biocide product, what documents are required? such as antiviral activity
.

A10: For active substances or products with bactericidal claims, it is routine to provide a complete set of dossiers and application documents for declaration
.
The dossier will contain physicochemical, human health, environmental and other data, labels, risk assessment reports and other information
.

Under the different strategies for substance and product suppliers introduced this time, the data requirements can be less/much less, for example, to carry out the inclusion of the Art 95 list.
If a full set of data can be purchased, then only the data citation letter (ie LoA) needs to be submitted.
) and supporting documentation will do
.