# Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division 3.4: Method of production and quality control

Extent: E+W+S+N.I.

Full information on how the micro-organism is produced in bulk must be provided.
Both production method/process and product must be subject to a continuous quality control by the applicant. In particular, the occurrence of spontaneous changing of major characteristics of the micro-organism and of the absence/presence of significant contaminants shall be monitored. The quality assurance criteria for the production shall be submitted.
The techniques used to ensure a uniform product, and the assay methods for its standardisation, maintenance and purity of the micro-organism must be described and specified (e.g. HACCP).

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Source: https://www.legislation.gov.uk/eur/2013/283/annex/part/B/division/3/division/3.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-3/division-3.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.