# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 1.4.2: Identity and content of impurities, additives, contaminating micro-organisms

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

It is desirable to have a plant protection product without contaminants (including contaminating micro-organisms), if possible. The level and nature of acceptable contaminants shall be judged from a risk assessment point of view, by the competent authority.
If possible and appropriate, the identity and maximum content of all contaminating micro-organisms, expressed in the appropriate unit, must be reported. The information on identity must be provided where possible as outlined in point 1.3 of Part B of this Annex.
Relevant metabolites (i.e. if expected to be of concern to human health and/or the environment) known to be formed by the micro-organism shall be identified and characterised at different states or growth stages of the micro-organism (see point (viii) of the introduction to this Part).
Where relevant detailed information on all components such as condensates, culture medium, etc. must be provided.
In the case of chemical impurities that are relevant for human health and/or the environment, the identity and maximum content, expressed in appropriate terms, must be provided.
In the case of additives, the identity and content in g/kg must be provided.
The information on identity of chemical substances such as additives must be provided as outlined in point 1.10 of Part A of this Annex.

---
Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/1/division/1.4/division/1.4.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.4/division-1.4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.