Sumitomo Chemical (UK) PLC, as the leading supplier of active ingredients for household insecticide products, is committed to supporting a full range of Active Substances through the EU Biocidal Products Directive review programme, under Product Type 18 (PT18, insecticides). The range includes 12 “existing” Active Substances (defined as being on the market in May 2000) and 1 new Active Substance:
A comprehensive dossier containing raw data and data summaries on substance identity, physico-chemical properties, analytical methods, efficacy, toxicology, ecotoxicology and environmental fate was required to be submitted for each Active Substance, together with a thorough risk assessment of each substance and its uses.
We are delighted to confirm that all 13 dossiers have been checked, confirmed to be complete and the actual evaluation is in progress or has been completed. The evaluation period is intended to take 1 year from confirmation of completeness, after which the Competent Authority in each Member State will decide whether the substance has been successful in meeting the requirements of a safe and effective substance under the BPD criteria. Assuming it is successful, the Active Substance will be recommended for inclusion in Annex I. Annex I inclusion is necessary for an active substance, in order to allow the future registration and marketing of any formulated products containing that Active Substance within the European Union.
We are very pleased to announce that in May 2010 our new Active Substance, SumiOne®, was voted for inclusion onto Annex I. The inclusion decision will be published by the European Commission during October 2010, with the Annex I inclusion date of 1st May 2011. After this date, formulated product dossiers for insecticidal products containing SumiOne® may be submitted for authorisation in EU Member States.
4 Sumitomo Chemical Active Substances (Clothianidin, Pralle®, Sumilarv®, Sumithrin®) have successfully reached Community peer review stage, following evaluation by their respective Rapporteur Member States. The draft competent authority reports for each of these 4 Active Substances have been added to CIRCA to be commented upon by other Member States. The next stage of the evaluation for these Active Substances is discussion by representatives from EU Member State Competent Authorities during Biocides Technical Meetings, followed by a recommendation for Annex I inclusion at one or more Competent Authority meetings and then a vote by the Standing Committee on Biocides for Annex I inclusion.