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 Zameer Qureshi

The fourth Biocides Stakeholders’ Day took place on September 1, 2016, at the European Chemicals Agency’s (ECHA) headquarters in Helsinki, Finland.  The event provided biocides stakeholders with information on the Biocidal Products Regulation (BPR) and the tools and support available.  The focus was on experiences from companies, ECHA, and the European Commission (EC).  ECHA stated “[t]he objective was to equip companies with information about their roles and obligations to meet the legal requirements for biocides.”

The program for the event included three plenary sessions.  Plenary Session 1, “Challenges and Opportunities,” was commenced by ECHA’s Executive Director, Geert Dancet.  Topics discussed in Plenary Session 1 included a “[r]egulatory update from the [EC],” “[a]ctivities in 2016,” and “Union [Authorization] in Practice.”  Plenary Session 2 focused on “IT Tools and Dossier Preparation,” and included discussions on IUCLID 6 and R4BP 3.  IUCLID 6 is used to collect, organize, and store data on active substances and biocidal products.  Dossiers generated through IUCLID 6 are submitted to ECHA and national authorities through R4BP 3, “the central hub through which all biocides applications are made.”  Plenary Session 3 on the “Enforcement of Biocidal Products” consisted of discussions on enforcement by the EC and Member States, and closed with a case study on “Enforcement from an Industry Perspective.”

The Plenary Sessions were followed by Questions and Answers, closing remarks from Jack De Bruun, ECHA’s Director of Risk Management, and an opportunity for attendees to meet the ECHA staff.


 

By Lisa M. Campbell and Lisa R. Burchi

On March 16, 2016, the European Commission (EC) issued its final report on the sustainable use of biocides.  Article 18 of the European Union’s (EU) biocidal products regulation (BPR) directs the EC to issue a report on how the BPR contributes to the sustainable use of biocidal products, and on whether there is a need to introduce additional measures, in particular for professional users, to reduce the risks posed to human health, animal health, and the environment by biocidal products.  Sustainable use for biocidal products is defined in the report as “the objective of reducing the risks and impacts of the use of biocidal products on human health, animal health and the environment and of promoting the use of integrated pest management and of alternative approaches or techniques such as non-chemical alternatives to biocidal products.”

Significantly, the EC’s report does not recommend the creation of further regulations, stating that the  “risks posed to human health, animal health and the environment by biocidal products … are already appropriately addressed by measures imposed through the conditions of approval of active substances or the authorisation of biocidal products.”  The EC also declined to extend the scope of the Framework Directive on the Sustainable Use of Pesticides (Directive 2009/128/EC) to biocidal products, stating: “due to the very diverse nature of biocidal products and the variety of applications, it does not seem appropriate to simply extend the scope of the Framework Directive on the Sustainable Use of Pesticides to biocidal products.”

Instead, the EC states that the “first and main priority” of EU Member States and industry must be “the completion of the on-going assessment of all the active substances that were already on the market when the BPD entered into force and the authorisation of biocidal products containing these active substances … with a view to promoting the sustainable use of biocidal products.”  Further, Member States also should focus on the “need to invest additional resources on enforcement activities to ensure that no product is illegally placed on their market and that biocidal products are properly labelled.” 

The EC’s report concludes by listing the following actions that it intends to pursue, and invites Member States to collaborate with the EC to do the same:

  • Focus and strengthen efforts on the review programme of existing active substances to ensure it is completed at the latest by 2024;
  • Ensure that once active substances are approved, product authorisations are granted, amended, or cancelled within 3 years;
  • Invest additional resources on enforcement activities;
  • Benefit from the legislative tools available, in particular by closely following the developments of best available techniques reference documents (BREF) that can be relevant for biocidal products used in industrial processes;
  • Encourage communication and awareness raising campaigns to inform end users, through websites, in-store leaflets or videos, quick response codes on biocidal products, etc.;
  • Encourage the development and implementation of standards (e.g., under the European Committee for Standardization), that could contribute to the sustainable use of biocidal products; and
  • Welcome research initiatives on the sustainable use of biocides and alternatives to biocidal products.

 

By Lisa M. Campbell and Lisa R. Burchi

On September 2, 2015, the European Chemicals Agency (ECHA) issued an updated list of biocide suppliers as required under Article 95 of the Biocidal Product Regulation (BPR).  Although prior versions of the list were released previously, this list has current legal effect since Article 95 provides that, as of September 1, 2015, a biocidal product cannot be made available in European Union (EU) markets unless the active ingredient supplier or product supplier is listed for the particular product type (PT) (e.g., PT 5 (Drinking water), PT 19 (Repellents and attractants)) to which the biocide product belongs. 

The purpose of Article 95 in creating a list of persons placing active substances in the EU market is to ensure the equal treatment of persons placing active substances on the market and to avoid “free riders.”  Without the requirements in Article 95, a supplier of an active substance that has not supported the approval of that substance (either through the Review Programme of the biocide directive, or as a newcomer under the BPR) could still enter the market without compensating the entity that undertook the costs and effort to have the active substance listed. 

There will be continued updates and revisions made to the list as new suppliers seek inclusion.  In addition, ECHA states that it received 158 applications from suppliers seeking inclusion on the list, and has created a list of pending applications that ECHA is still processing.  ECHA notes:  “The list of pending Article 95(1) applications should not be confused with the list of relevant substances and suppliers (“Article 95 list”) and the presence of a company (per substance/PT/role) on the list of pending applications does not guarantee that the application will be successful and that the company will ultimately be included in the Article 95 list.”  Updates to the list also are expected for certain substances that were not within the scope of the Biocidal Products Directive (BPD) (e.g., some in situ generated active substances, substances benefiting from derogation for food and feed in Regulation 1451/2007), and for which different BPR notification and inclusion dates apply. 

Although enforcement efforts regarding the Article 95 list have not yet been tested, companies placing biocidal products in EU markets must carefully review the list to ensure that they and/or their suppliers are listed not only for the particular active ingredient and/or product at issue, but also for the product’s particular PT.

There is a one year period, until September 1, 2016, to sell existing stocks for biocide products where the suppliers are not included on the List.