Article 95 Response: The BPR regulation clearly stipulates that any active substance sold in the EU market must be added to the list of qualified suppliers before September 1, 2015, otherwise, it will not be able to be put into the EU market. Non-eu manufacturers of active substances can be added to the list of qualified suppliers through a designated Representative located in the EU, at which time the published list will include the names of both non-EU companies and EU representatives.
Authorization of biocidal products: Any biocidal products sold on the EU market must apply for authorization at the Member State or EU level in advance before they can be sold on the EU market. If a company wants to list in multiple EU member states, it can obtain authorization through one country first, and then obtain authorization through the form of mutual recognition of member states. It is also possible to apply to ECHA for authorisation of products at EU level. In addition, each biocidal product must ensure that the supplier of the active substance contained in it is included in the list of qualified suppliers (Article 95).
Active substance licensing: Any active substance placed on the EU market must submit a large number of physical and chemical, toxicological and ecotoxicological data to ECHA, and undergo a detailed assessment before it is licensed and can be placed on the EU market. In addition, CMR, PBT, vPvB, endocrine disruptors will not be approved in principle. Article 58 (3) and (6) of the EU Biocidal Regulation BPR (EU 528/2012) clearly stipulate that enterprises responsible for the sale of treated articles shall provide corresponding labels, mainly providing information on the biocides used and related active substances.
Biocidal treated articles refer to substances, mixtures and articles that have been treated with biocides or have been intentionally added with biocides. In general, items directly treated with corrosion protection and sterilization need to be considered whether they are biocidal treated items.
Biocides treat a very wide range of items, involving a variety of industries. Electronic appliances, textile decoration, clothing, shoes and socks, ink paper, antibacterial plastics, paints and coatings and furniture wood, etc., are very typical biocidal treatment items.
Due to the complexity of BPR regulations, many involved enterprises are unable to figure out their obligations in the face of the requirements of importers.
In order to help enterprises efficiently and quickly cope with all the regulatory issues arising from BPR, we have launched the following services:
1, biocidal treatment of goods labeling service
According to Article 58 (3) and (6) of the EU Biocidal Regulation BPR (EU 528/2012), enterprises responsible for the sale of treated articles shall ensure that the label of treated articles provides information such as the claim of treated articles, biocidal characteristics, the name of the active substance for biocidal use and preventive measures.
2. Compliance Report on the use of biocidal treated articles
Domestic biocidal products are often confused about whether their products can be legally sold in the EU, and are often consulted by their EU importers about the compliance of the product. However, domestic manufacturers often do not understand the BPR regulations, and the answers given to importers may not be convincing.
Zhongbang will conduct a specific analysis of the compliance status of the processed items according to the information provided by the enterprise and the detailed provisions of the BPR regulations, and give the exact compliance status of the products and the accurate sales deadline. When the enterprise receives the consultation of the importer, it can directly issue a report to inform its compliance status (the compliance report can be written in English).