Plant protection: regulatory context
Before registering a new phytopharmaceutical product in the European Union, you need to ensure that the active substance is included in Annex of Regulation (EU) No.540/2011 as per the requirements of European Regulations (EC) No.1107/2009 and (EU) No.283/2013. Submissions of active substance dossiers are made in the new MCA/MCP format.
For products, since 01/01/2016, a “dRR” (“draft Registration Report”) meeting the requirements of European Regulations (EC) No.1107/2009 and (EU) No.284/2013, must be submitted in a new format. This dossier summarises all the studies and tests, which are used firstly to prepare a specific assessment of human health, environmental and ecotoxicological risks resulting from the use of your product, and secondly to assess the biological efficacy of your product.
In Europe, despite the attempt to harmonise the dossiers as per Regulation (EC) No.1107/2009, differences between Member States remain in dossier presentation. Most countries have their own requirements in terms of risk assessment for risk mitigation measures determination and data needed for efficacy assessment. In addition, the regular updates of regulations and guidance documents define new “cut-off criteria”, new regulatory zones, new mutual recognition conditions within and between zones, and new means of risk assessment.
Authorisation of these products outside Europe entails variable levels of complexity, but in any case, the “draft Registration Report” is the most stringent model.
In the future, Regulation (EC) No.1107/2009 will stipulate new rules extending the scope to plant protectors, synergists, adjuvants and co-formulants.
- Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21/10/2009 concerning the placing of plant protection products
- Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 concerning the list of approved active substances
- Commission Regulation (EU) No 283/2013 of 1/03/2013 setting out the data requirements for active substances
- Commission Regulation (EU) No.284/2013 of 1/03/2013 setting out the data requirements for plant protection products