Hanning "Regulations Online"
Henning Regulation Online
Hanning "Regulations Online"(Henning Regulation Online) is a newly launched industry regulations interpretation column by Hanning Chemical in the second quarter of 2022. "Regulations Online" will provide in-depth explanations and discussions on the laws, regulations, policies and measures of the industries served by Hanning on a quarterly basis, aiming to improve awareness and application of industry laws and regulations, and empower customers to organize and carry out production and operation more efficiently and in compliance. activities.
EU Biocides RegulationThe English name is Biocidal Products Regulation (EU) 528/2012), referred to as BPR. BPR has a comprehensive system and complex processes. Today, I will help you simply sort out the framework and key points of BPR.
BPR, as the name suggests, is used to regulate products with biocidal effects. However, due to the existence of other corresponding specific regulations, BPR does not apply to human drugs, veterinary drugs, food, plant protection, cosmetics, toys, etc.
The regulatory scope of BPR can be divided into two categories: biocides and processed products. The basic principles for dividing these two categories are:
biocideThe killing effect is external, such as rodenticides, disinfectant wipes, etc.;
treatment articleAlthough it contains killing ingredients, its effect is only on the inside and is used to protect the processed product itself and cannot kill other external items, such as coatings containing preservatives, antibacterial socks, etc.
There are huge differences in compliance requirements between the two, so they must be correctly classified.
Biocides include two levels: Active Substances and Biocidal Products.
Active substances are substances that have a killing effect; biocide products are products containing active substances for customers.
At the same time, BPR also classifies product types (PT) from an application perspective. There are four categories in total, which can be subdivided into 22 subcategories.
treatment article
A treated article refers to a product that is treated with a biocidal product, or to which a biocidal product is intentionally added.
Since the processed products no longer have external killing functions, BPR's supervision of them is far less than that of biocides. For example, if a sock claimed to be antibacterial and deodorant is to be sold in the European market, only if the active substance used is on the Article 95 list, has a corresponding product category PT9, and the product label meets the requirements.
It can be seen that the compliance requirements for active substances, biocide products, and processed products are completely different, and the processing difficulties are also different. The corresponding requirements of BPR for the three are summarized as follows:
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