Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa R. Burchi

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.

The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.

The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
 


 

By Lisa R. Burchi

On January 27, 2015, the European Union (EU) Standing Committee on Plants, Animals, Food and Feed agreed to a proposed list of 77 pesticide active substances to be classified as Candidates for Substitution (CFS). The draft list of CFS is available online.  A Question and Answer (Q&A) document regarding the CFS list is available online. Additional information regarding the proposed list is also available online.

This list is an important and long-awaited development under the Plant Protection Product (PPP) Regulation (EC) No. 1107/2009. The Standing Committee clarifies that the CFS active substances are not banned and that approved CFS active substances will remain on the EU market, although there are potentially significant consequences for those listed active substances. Most challenging is the requirement that Member States do the following for new applications for authorization of PPPs containing CFS active substances that are submitted after August 1, 2015: (1) conduct a comparative assessment when evaluating an application for authorization for a PPP containing an active substance approved as a CFS; and (2) not authorize or restrict the use of a PPP containing a CFS for use on a particular crop where the comparative assessment weighing up the risks and benefits demonstrates that safer alternatives exist. In addition, substances not evaluated by the Standing Committee (e.g., substances approved after January 1, 2013) can be identified as a CFS under Article 24 of the PPP Regulation. In those cases, any approval will be limited to a maximum of seven years, compared to 10 or 15 years for other active substances.

The next step will be review and adoption of the CFS list by the European Commission, and then publication of the list as a Commission Regulation in the Official Journal.
 

 


 

By Lisa M. Campbell and Lisa R. Burchi


On January 13, 2015, the Court of Justice (Grand Chamber) of the European Union (EU) overturned a judgment of the General Court of the European Union (General Court) in Stichting Natuur en Milieu and Pesticide Action Network Europe v. Commission.

The case concerned the non-governmental organizations’ (NGO), the Plaintiffs, interest in having the European Commission review Regulation (EC) 149/2008 amending Regulation (EC) 396/2005 of the European Parliament and of the European Council by establishing Annexes II, III, and IV setting maximum residue levels (MRL) for pesticides in or on certain products. In a June 14, 2012, decision, the General Court found that the European Commission was erroneous when it refused the NGOs’ request to review internally its regulation and found that the EU’s Aarhus Regulation 1367/2006 (setting forth how EU institutions would apply the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters) conflicted, in part, with Article 9(3) of the Convention in that it too narrowly limited the concept of an “administrative act” and the ability of the public to have access to administrative or judicial procedures to challenge acts by public authorities that contravene provisions of national law related to the environment. The European Commission and the European Council appealed the General Court’s decision, arguing in part that the Aarhus Regulation was not incompatible with the Aarhus Convention. In the January 13, 2015, decision, the Court of Justice agreed with the European Commission and the European Council, stating: “It follows from paragraph 47 of this judgment that Article 9(3) of the Aarhus Convention lacks the clarity and precision required for that provision to be properly relied on before the EU judicature for the purposes of assessing the legality of Article 10(1) of Regulation No 1367/2006.” This decision will have an impact on NGOs’ rights to seek review of EU environmental acts and, potentially, other pending cases brought by NGOs invoking rights under the Aarhus Regulations.
 


 
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