The 2015 EU BPR Seminar was Successfully Held in Hangzhou
Original Article from CIRS
Jointly held by Hangzhou CIRS Co.,Ltd and Eurofins Regulatory AG, the 2015 EU Biocide Products Regulation (BPR) Seminar was successfully held at Zhejiang Hotel, Hangzhou on Jan 14th,2015. The presentations, in terms of the authorization of biocide products, treated article compliance, Article 95, 5 batch analysis and technical equivalence and GLP lab, were given by BPR experts from Germany, Italy, UK and China.
This seminar has 5 presentations in total, respectively introducing the following topics:
- Nicholas Jarvis, head of biocide regulatory affairs in Eurofins, gave the in-depth analysis on the authorization of biocide products. He mentioned that BPR had very specific classification on biocide products, and strict testing data would be required for different products. Furthermore, data requirements have to contain shelf life testing, efficacy testing, risk assessment and etc. Mr. Jarvis also included the content and formulate of dossier for the registration and procedures of application into his report.
- David Wan, the manager of agrochemical and health products department of CIRS, elaborated the compliance procedure of biocide treated articles. He interpreted that treated article means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. With his rich experience in BPR compliance service, Mr. Wan gave a practical introduction on how Chinese enterprises to deal with this regulatory barrier.
- Dr. Andreas Wais, the managing director of Eurofins Regulatory AG, gave a specific analysis on the 5 batch report and technical equivalence. In his presentation, the exact difference between technical equivalence and technical similarity was elaborated. Also, he presented to us the further definition of technical material (TC) and technical concentrate (TK) respectively and in what situation that technical equivalence check is required.
- Michele Cavalleri, GLP facility manager of Eurofins Biolab Srl, introduced the reason why GLP should be established and how labs operate with this principle. His presentation included the mechanism of mutual acceptance of data between all OECD member countries.
- The last speaker was Dr. Micheal Zhang, the head of R&D Department of CIRS. From several aspects like the background, the definition, the registration of active substances and data requirement, he gave the in-depth analysis on how enterprises comply with the Article 95 under BPR. He also pointed out the barriers that currently faced by Chinese enterprises: the lack of SIEF mechanism and margin system, the high requirement on technical equivalence and heavy capital pressure.
Compared with the 2013 BPR seminar, this time has not only more professional and deep-going topics, but also detailed compliance procedures. There were enough Q&A opportunities for enterprises representatives to present their all kinds of questions. Experts from CIRS and Eurofins remind enterprises that only with a profound understanding about the Biocide Products Regulation can you remove that barrier in a most cost effective way.
What worthy to be mentioned is that biocide products without EU authorization will be completely prohibited in European market since March 1st, 2017. Companies in supply chain have to prepare early to avoid the loss caused by regulatory risk. CIRS provides professional BPR compliance service. If there is anything we can help you, please do not hesitate to send email to: firstname.lastname@example.org
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