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European Union legislation

Safety phrases

Experience from setting risk mitigation measures in Member States

Over the last twenty years, Member States have used mitigation measures to reduce the risk to the environment for several purposes and in different ways. Specific rules for protecting areas of drinking water abstraction, or honey bees and birds, and stipulating buffer zones to surface waters are well established tools and have been widely used for regulatory purposes.  Furthermore, new and more specific, tailor-made measures are in use today e.g. for treated seeds, for new groups of organisms such as terrestrial invertebrates. In addition, risk mitigation measures are needed where new protection goals are being developed, for example in relation to biodiversity, as this has become important over the last few years. 

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Under Directive 91/414/EEC rules for Member States existed for setting risk mitigation measures. Partly, legally binding label phrases were stipulated under national laws to facilitate enforcement of specific restrictions regarded as very important. The product label is the main communication vehicle by which the user is informed of the requirements for a safe and effective use of a product.  The Safety Precautions Phrases (SP-phrases) are among the information that appears on the label, and aim at providing pesticide users with directions for use that effectively mitigate the exposure of, and risks to human, animal health, and the environment.  These SP-phrases are most often deduced from the conclusions of risk assessments. Details on these risk assessments may be found in guidance documents on the risk assessment, as for example in the EFSA Guidance Document for Birds and Mammals (EFSA 2009), in the SANCO document on terrestrial ecotoxicology (SANCO/10329/2002 rev 2), or guidance documents for non-target arthropods (Candolfi et al. 2001, Alix et al. 2011).

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In Annex V of the aforementioned Directive, SP-phrases for protecting the environment were listed and afterwards reproduced in Regulation (EU) No. 547/2011.  Table 4.1 reproduces the current SP-phrases with relevance for the protection of the environment, as they may be found in Regulation (EU) No. 547/2011:

Safety precautions phrases with relevance to the environment as in Regulation (EU)  547/2011

* This phrase applies to rodenticide products

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Safety phrases

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Plant protection products (PPP) or pesticides to be used in agriculture are regulated within the framework of European legislation since Directive 91/414/EEC, updated since with Regulation (EC) 1107/2009.  In this context, the authorization and the placing on the market of PPP in the EU relies on a scientific assessment of the potential risk from the use of a PPP. According to Article 4(3) of the Regulation, a PPP shall only be authorized if, among other requirements, it is expected that, consequent to realistic conditions of use, there will be:

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  • No immediate or delayed harmful effects on human health or animal health or on groundwater

  • No unacceptable effects on plants

  • No unacceptable effect on the environment, under particular consideration of its fate and distribution as well as its impact on non-target species, biodiversity, and the ecosystem

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The term "realistic conditions of use" entails two main elements: good practices (e.g. good agricultural practice, good plant protection practice) and risk mitigation measures.  In this context, in the cases where potential risks of a specific nature are identified under certain conditions of the risk assessment, and where there is a way to avoid the occurrence of these conditions through risk mitigation measures, specific conditions of use reflecting these risk mitigation measures can be defined to accompany the authorization and complement the good agricultural practice. In such cases risk mitigation measures are displayed on the label of the product, into the form of safety provisions laid down in Annex III to Regulation (EU) No. 547/2011. These are specific for PPPs and are harmonized (SP-phrases).

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During the MAgPIE workshop, a number of risk mitigation tools were identified for the purpose of reducing transfers from spray drift, among others.  Alongside the building of the toolbox for spray drift mitigation, workshop participants drafted possible safety precaution phrases that would transpose recommendations on the label.  These proposals are reproduced in the following table:

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Table 1: proposal for SPe phrases developed to reflect the the risk mitigation measures (RMM) toolbox specific to spray drift reduction developed in the MAgPIE proceedings. RMM are allocated into the following categories: Buffer Zones (BZ) aimed at reducing exposure of off-crop areas via spray drift, Field Margins (FM), Spray Drift Reduction Technologies (SDRT), which involve any technology associated to sprayers, nozzles, or spraying techniques that will reduce the drift. 

The term "realistic conditions of use" entails two main elements: good practices (e.g. good agricultural practice, good plant protection practice) and risk mitigation measures.  In this context, in the cases where potential risks of a specific nature are identified under certain conditions of the risk assessment, and where there is a way to avoid the occurrence of these conditions through risk mitigation measures, specific conditions of use reflecting these risk mitigation measures can be defined to accompany the authorization and complement the good agricultural practice. In such cases risk mitigation measures are displayed on the label of the product, into the form of safety provisions laid down in Annex III to Regulation (EU) No. 547/2011. These are specific for PPPs and are harmonized (SP-phrases).

During the MAgPIE workshop, a number of risk mitigation tools were identified for the purpose of reducing transfers from spray drift, among others.  Alongside the building of the toolbox for spray drift mitigation, workshop participants drafted possible safety precaution phrases that would transpose recommendations on the label.  These proposals are reproduced in the following table:

Table 1: proposal for SPe phrases developed to reflect the risk mitigation measures (RMM) toolbox specific to spray drift reduction developed in the MAgPIE proceedings. RMM are allocated into the following categories: Buffer Zones (BZ) aimed at reducing exposure of off-crop areas via spray drift, Field Margins (FM), Spray Drift Reduction Technologies (SDRT), which involve any technology associated to sprayers, nozzles, or spraying techniques that will reduce the drift.

 

The wording proposed in the phrases listed above meant to reflect the diversity of options that are available in the risk mitigation toolbox, while reflecting a harmonized language.  The proposed SP-Phrases have also been reviewed by representative users and farmers and corrected where necessary for more clarity. They hence represent a consensual view of what label recommendations could read to be understood and reflect agricultural practices, which are the conditions to a successful implementation by the end users.

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  • EC, 1991.  Council Directive of 15 July 1991 concerning the placing of plant protection products on the market.  L 230/1. 19.08.1991.

  • EC, 2009.  Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.  L 309/1. 24.11.2009.

  • EC, 2011. Commission Regulation  (EU) No. 547/2011 of 8 June 2011 implementing Regulation (EC) No. 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products. OJEU L155/176, 11.6.2011.

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