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In accordance with OECD and other international regulatory requirements such as CIBRC, OCSPP, SANCO, ASTM, EPA, JMAFF, EMEA, etc., CEBIS USA offers comprehensive regulatory testing services for registration of agrochemicals and chemicals.
New tests are conducted in accordance with Commission Regulation No. 440/2008’s test recommendations or another international test method acknowledged by the European Commission or ECHA, according to Article 13(3) of the REACH Regulation. Additionally, when there is no EU test method available, the adoption of certain OECD test guidelines (such as OECD TG 414, 421, and 422) is mandated in Annexes VII to X on standard information requirements.
Additionally, according to Article 13(3), information can be produced using other techniques as long as the requirements outlined in Annex XI of the REACH Regulation are satisfied. These include the need for proper and trustworthy documentation of the used method, as well as the fact that the result is sufficient for the purposes of categorization, labelling, and/or risk assessment (for further details, see Annex XI of the REACH Regulation).
Additionally, the REACH Regulation adds a specific obligation for ecotoxicological and toxicological tests in Article 13(4). Since no other international standard has been determined to be similar as of yet, new tests of this kind must be performed as per the Good Laboratory Practise (GLP) guidelines outlined in Directive 2004/10/EC as of June 1, 2008. It may be preferable but is not required to perform physical and chemical tests in accordance with GLP standards.
Before conducting new tests, one should refer to the Guidance on Information Requirements and Chemical Safety Assessment, which offers particular Integrated Testing Strategies for each endpoint (such as for aquatic toxicity, mutagenicity, etc.).
To gain clearance from the CIB (Central Insecticide Board), Ministry of Agriculture, Government of India for import, production, sale, or export, as the case may be, a test battery made up of analytical, ecotoxicity, in vivo, and in vitro toxicology studies is necessary. The Insecticides Act has specified standards for each end use.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
