By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
Beginning on January 23, 2018, the European Commission (EC) opened a consultation period on the European Food Safety Authority (EFSA) risk assessment process (scientific advice). The EC states it is seeking feedback on its process both as a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the industry and this in particular where the industry seeks an authorisation, e.g. for pesticides, GMOs etc.”
The General Food Law Regulation established EFSA, an independent scientific agency, to provide the risk assessment component of its risk analysis principle; the other two components are risk management and risk communication. EFSA provides its scientific opinions “which form the basis for the measures taken by the [European Union (EU)] in the food chain.” The EC states the General Food Law Regulation “is the cornerstone of the EU regulatory framework covering the entire food chain: ‘from farm to fork.’” The EC is requesting feedback to help it “look into how [the EC] can improve the current system and to address citizens’ expectations about independence and transparency of the EU risk assessment system.” The EC is specifically requesting views and experiences on the following:
- The transparency and independence of the EU risk assessment system with respect to the underlying industry studies and information on which EFSA's risk assessment/scientific advice is based;
- Risk communication; and
- The governance of EFSA, in particular the involvement of the EU Member States (MS) in the EU risk assessment system.
To contribute, interested parties must fill out the online questionnaire available here. All stakeholders and EU as well as non-EU citizens are welcome to contribute to this consultation. The consultation period will close on March 20, 2018.
This Consultation is of significant interest to stakeholders, particularly in balancing the potential need for increased transparency with the need to protect confidential business information, trade secret information, and proprietary expensive data investments. Decisions made by EFSA also could have a global impact on data protection, as any decisions made by EFSA to increase transparency could affect whether certain data can continue to be protected under other regulatory programs.
Outside of the transparency issues that are receiving much attention of late, it is important to note generally that views about risk assessment policies across governments tend to be driven by underlying political disagreements, with support or criticism somewhat predictable depending on how the resultant decisions are “for or against” the view of an interested constituency.
The transparency issue here should be considered not only on its own merits, but also within the controversy that surrounded the EU assessment approach for glyphosate, an herbicide which is widely used in production of genetically modified crops. As a stalking horse for the EU debate about biotechnology crops, the EU glyphosate assessment has, for example, become embroiled as part of the glyphosate carcinogenic classification of the International Agency for Research on Cancer (IARC). See our blog item IARC Announces Cancer Classification for Glyphosate and Other Pesticides. The IARC review concluded that glyphosate is a “probable human carcinogen,” contrary to most other assessments done by the U.S., Canada, and some EU Member States. Comments on the general EU risk assessment process can be expected to be intertwined with the perspective that any commenter has on the glyphosate assessment, even though the request is for public comment on the assessment process generally, and not only specifically about glyphosate.
More information on glyphosate is available on our blog under key word glyphosate.
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 June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential.
The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information be treated as confidential, and not included in the EFSA’s peer reviewed draft assessment report on potassium phosphonate. The European Commission agreed with EFSA. EFSA stated that under the Plant Protection Product Regulation No. 1107/2009 (and Article 14 of its predecessor Directive 91/414) and European Union (EU) Regulation No. 199/2011 setting forth procedures for reviewing certain active substances including EFSA’s peer review of draft assessment reports, confidential status cannot be extended to: information on the composition of the substance at issue; the analysis method for that substance; the analysis methods for residues; the scientific information on the basis for the evaluation and risk assessments performed; and information already in the public domain. After EFSA refused the confidentiality request, Luxembourg sought reconsideration by the European Commission, who found that the sanitization principles applied by EFSA “reflect a common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414/EEC.”
In its decision, the Court dismissed the lawsuit because Luxembourg brought the case against the European Commission when the appropriate party was EFSA. The Court agreed with the Commission that the decision at issue was an act of and attributable to EFSA, stating that while the Commission “indicated to EFSA the legislation and principles applicable to the requests for confidentiality at issue, the fact remains that the Commission did not apply that legislation and those principles in order to determine those claims itself.” The Court stated that Article 7(2) of Regulation No. 188/2011 grants EFSA to make confidentiality determinations “in its own right” and that Articles 12(1) and 60 of Regulation No. 1107/2009 show that EFSA is “competent to adopt a decision on a request for confidentiality.”
While this decision does not provide certainty or guidance to industry regarding the type of information that can be claimed, and accepted, as confidential, it does add to a growing pool of cases addressing complex issues regarding the confidential treatment of information related to agrochemicals. This includes, but is not limited to, the ongoing case following the European Court of Justice’s October 8, 2013, ruling that the European Commission erred by refusing access to documentation about the pesticide glyphosate.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the European Union (EU) from the use of the three neonicotinoid pesticide active substances: clothianidin, imidacloprid, and thiamethoxam (the substances).
The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to restrict the use of the substances, which at the time included prohibiting use of the active substances clothianidin, thiamethoxam, and imidacloprid as a seed or soil treatment and for pre-flowering applications on crops attractive to bees and for cereals other than winter cereals. In May 2013, the Commission also stated that within two years it would initiate a review of any new scientific information.
EFSA is urging national authorities, research institutions, industry, and other interested parties to submit all information on the effects, exposure, and risks of the three substances regarding bees -- honeybees, bumble bees, and solitary bees -- when used as seed treatments and granules. This can include:
- Literature data, including grey literature and any other data from research activities relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules. Data that have been provided and identified as relevant by EFSA in its published systematic literature review report need not be submitted, however.
- Study reports conducted specifically to assess the risk to bees from the three substances applied as seed treatments and granules, and not yet considered under the previous EFSA assessments (EFSA Journal 2013;11(1): 3066, 3067, 3068).
- National evaluations and/or monitoring data relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules that are available at the Competent Authorities of Member States and not yet considered under the previous EFSA assessments, listed in the above bullet.
- Data that EFSA stated were not relevant in its published systematic literature review report may be submitted only if accompanied with a scientific rationale supporting their relevance.
The notice states that all information should be submitted by September 30, 2015. Any information submitted can be claimed as confidential by following procedures set forth in Article 63 of Regulation (EC) No 1107/2009. EFSA will review the material provided from this call for data and offer conclusions concerning an updated risk assessment following receipt of a follow-up mandate from the European Commission.