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By Lisa R. Burchi and Zameer Qureshi

On August 23, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) adopted its first decision on a data sharing dispute under the Biocidal Products Regulation (BPR).

Thor GmbH (Thor) lodged the appeal in 2015 after ECHA granted permission to a company to cite studies owned by Thor for the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (CIT/MIT).  According to ECHA, Thor had insisted on a technical equivalence assessment of its substance with the other company’s active substance to check if the companies’ substances had similar chemical composition and hazard profiles.  ECHA stated this was not required under BPR and data owners “do not have the right to demand any form of similarity check as a prerequisite for getting a letter of access.” 

The BoA ruled in favor of Thor, which raised five pleas in law, as the companies had mutually agreed to perform a technical equivalence assessment before sharing data.  The BoA concluded that while ECHA “might be correct” in concluding that the technical equivalence assessment is not a legal requirement for data sharing under BPR, “this legal observation cannot constitute an assessment of the parties’ efforts to reach an agreement within the meaning of Article 63.”  The BoA stated “it is part of the Appellant’s and the prospective applicant’s contractual freedom to insert a clause relating to a technical equivalence assessment in the data sharing agreement.”

The BoA also reviewed the negotiations between the parties to determine whether those parties make every effort to reach an agreement, and found that ECHA “did not consider all the relevant facts in a balanced manner when assessing whether every effort had been made by Appellant and the prospective applicant under Article 63.”  The BOA found that ECHA disregarded some of Thor’s efforts based on its legal conclusion that there was no need to perform a technical equivalence assessment.  Consequently, the BoA concluded that Thor had made every effort to reach an agreement with the other company and ECHA had failed to consider all the facts of the case.

Although ECHA’s decision was annulled, there remains a question whether a new decision is required.  Since the BoA’s decision, the prospective applicant submitted a successful application under Article 95, which may negate the need for the prospective applicant to cite to Thor’s data.  The case was remanded to ECHA to determine whether a new decision is required.  


 

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. 


 

By Lynn L. Bergeson

Not a moment too soon, the European Chemicals Agency (ECHA) released a useful and clearly written Practical Guide on Biocidal Products Regulation, ECHA-14-B-19-EN. ECHA is the European Union (EU) agency tasked with implementing the Biocidal Products Regulation (BPR), along with other EU chemical laws and regulations. Adopted in 2012, the BPR revised the Biocidal Products Directive and imposes requirements on producers of active substances and biocidal products. Starting on September 1, 2013, all legal entities producing active ingredients or biocidal products available in the EU are required to obtain an approval for each active substance in the biocidal product and an authorization for the biocidal product itself. The Guide provides a “how to” comply with the BPR to “help companies to better fulfill their obligations and tasks under the BPR.” The Guide is organized into sections and explains the obligations imposed on regulated entities, who is responsible for the obligations, what are the relevant timelines and the deadlines, which are the information requirements and procedures to follow, and the expected results of the process. The Guide also highlights the exceptions and cases for some of the processes, and lists the relevant fees for each obligation.

The Guide contains the following chapters:

■ Approval of active substance;
■ Article 95: list of active substances and suppliers;
■ Technical equivalence;
■ National authorizations;
■ Mutual recognition;
■ Renewal of national authorization and authorizations subject to mutual recognition;
■ Union authorization;
■ Simplified authorizations;
■ Changes of biocidal products;
■ Data sharing; and
■ Appeals (on ECHA decisions).

The following additional chapters are expected to be published at a later date:

■ Renewal of approval of active substance;
■ Review of an approval of active substance; and
■ Research and development.
 

Tags: BPR, ECHA