Chemistry expert unit
Plant Protection Products
Overview:
The identity of the active substance, as well as co-formulants in the case of products, is fundamental to the evaluation. For active substances and products, data must be provided to demonstrate that the physical, chemical and technical properties will be acceptable.
Analytical methods are assessed to ensure they are fit for purpose and fully validated, in compliance with EU guidelines.
Storage stability studies are assessed to ensure that the product is still within specification at the end of the claimed shelf life, usually two years. The suitability of the packaging should also be checked in the storage tests (e.g. by checking for corrosion, leakage or malformation).
Pesticide residue refers to the pesticides that may remain on or in food after they are applied to food crops. A residue definition for plant products is derived from assessing plant metabolism studies. Residue definitions for animal products are derived from assessing metabolism studies in livestock. The residue definition is usually made up of the active substance and/or metabolites.
Crop residue trials are used in the European Union to derive Maximum Residue Limits (MRLs) in plant products and must be carried out in accordance with the directions for use of the product, Good Agricultural Practice (GAP). Maximum Residue Limits are used to ensure that the products are used in accordance with the label.
A consumer risk assessment is also carried out to ensure the application of a plant protection product according to the GAP has no adverse consequences for public health.
Legislation and Guidance:
In order to qualify for inclusion of an active substance in Commission Implementing Regulation (EU) No 540/2011 a dossier that meets the provisions laid down in Commission Regulation (EU) No 283/2013 and Commission Regulation (EU) No 284/2013 of Regulation (EC) No 1107/2009 must be submitted for the active substance as well as for the representative product.
Regulation (EC) No 1107 of 2009 of the European Parliament and of the Council. Concerning the placing of plant protection products on the market
Regulation (EU) No 283/2013 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.
Regulation (EC) No 284/2013 setting out the data requirements for plant protection products, 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.
Biocides
Overview:
The identity of the active substance, as well as co-formulants in the case of products, is fundamental to the evaluation process. For active substances and products, data must be provided to demonstrate that the physical, chemical and technical properties will be acceptable.
Analytical methods are assessed to ensure they are fit for purpose and are fully validated, in compliance with the guidelines.
Storage stability studies are assessed to ensure that the product is still within specification at the end of the claimed shelf life, usually two years. A justification for the packaging (type, materials, size etc.) and the compatibility of the product with proposed packaging materials must be provided.
Legislation and Guidance:
A comprehensive guidance document describing what must be included in the dossier for chemistry is available from the European Chemicals Agency.
(https://echa.europa.eu/documents/10162/23036412/bpr_guidance_vol_i_parts_abc_en.pdf/31b245e5-52c2-f0c7-04db-8988683cbc4b) This document describes the BPR Information Requirements, Evaluation and Assessment and how to fulfil them for Identity of the active substance, physico-chemical properties, analytical methodology and storage stability/shelf life.
This guidance provides technical scientific advice on how to fulfil the information requirements set by the Biocidal Products Regulation (BPR – Regulation (EU) No 528/2012)
(https://echa.europa.eu/regulations/biocidal-products-regulation/legislation)