Intertek is pleased to offer a complimentary webinar series that will focus on pesticide regulations within North America, and biocide regulations within the EU.Intertek offers a wide range of expertise to help companies comply with regulations and bring their product to market efficiently. Throughout these webinars, we will be providing key information regarding the pesticide solutions offered.
This webinar will focus on recent and upcoming changes to registration procedures and requirements for pesticides in the USA, including PRIA updates, changes to the efficacy requirements for antimicrobials, and EPA’s focus moving forward.
This webinar will focus on recent and upcoming changes to registration procedures and requirements for pesticides in Canada, including fees, submission categories, treated articles, and procedural changes during review.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after). Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted. As in the previous directive, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).
The webinar will focus on the regulatory requirements (compliance of actives and labelling obligations) for the marketing of articles treated with biocidal products.
The Biocidal Product Regulation “BPR” (EU no 528/2012) concerning the placing on the market and use of biocidal products, sets rules for the use of articles treated with, or intentionally incorporating, one or more biocidal products. According to the regulation, articles can only be treated with biocidal products containing active substances approved in the EU. This is a change from the Biocidal Products Directive (repealed by the BPR from 1 September 2013), where articles imported from third countries could be treated with substances not approved in the EU.
Companies must be ready to provide the consumers with information about the biocidal treatment of the article they are selling. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days. Manufacturers and importers of treated articles also need to ensure that products are labelled according to both the regulation on Classification, Labelling and Packaging and the additional requirements defined by the Biocidal Products Regulation.
Identity testing requires characterisation of the active including analysis and identification of relevant impurities using common analytical techniques such as titration, HPLC, GC but also other more bespoke analytical techniques if required. Intertek can offer a wide range of techniques in this area. As part of this testing, analytical methods may need to be developed and validated and the requirements for validation will be discussed.
Physico-chemical property testing is also required for both active and biocidal products and the scope of testing required can vary widely based both on the nature and application of the active/product being tested. Choosing the appropriate tests to be performed can be difficult and requires experience to define an experimental program that will provide the appropriate data to meet regulatory requirements.
Work of this nature is required to be performed in a GLP compliant laboratory and Intertek Pharmaceutical Services Manchester are accredited by the MHRA and have provided GLP services for over 25 years.