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
On November 23, 2016, the European Court of Justice (ECJ) issued two landmark judgments in Case C-673/13 P (Commission v Stichting Greenpeace Nederland and Pan Europe) and Case C-442/14 (Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden).
In Case C-673/13 P, the associations Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN Europe) submitted a request to the European Commission (EC) under Regulation (EC) No 1367/2006 for access to a number of documents relating to the initial marketing authorization for glyphosate, one of the most widely used herbicides in the world for agricultural weeding and the maintenance of urban and industrial areas. The EC granted access to the documents, with the exception of part of the draft assessment report prepared by Germany. The EC justified its refusal by stating that the document in question contained confidential information on the intellectual property rights of the applicants for the glyphosate authorization.
The associations brought an action before the General Court of the European Union (EU) for annulment of the EC’s decision. The General Court upheld that action in its judgment of October 8, 2013. The General Court considered that certain segments of the document in question contained information relating to emissions into the environment. Consequently, the EC was not entitled to invoke the confidentiality of commercial and industrial information, and “should have granted the associations access to those parts.” The EC was not satisfied with the judgment and asked the ECJ to set it aside.
In Case C-442/14, Bijenstichting, a Dutch bee protection association, submitted a request to the Netherlands’ authority responsible for authorizing the marketing of plant protection products and biocidal products (i.e., College voor de toelating van gewasbeschermingsmiddelen en biociden (CTB)) for disclosure of 84 documents concerning marketing authorizations issued by the authority. Bayer, a company holding a large number of these authorizations, objected to the disclosure on the basis that it would “infringe copyright and adversely affect the confidentiality of commercial or industrial information.” CTB authorized disclosure of 35 of the 84 requested documents because they contained information on emissions into the environment, “even though such disclosure could have an adverse effect on the confidentiality of commercial or industrial information.” Under Directive 2003/4/EC, commercial and industrial confidentiality may not be invoked to prevent disclosure of such information.
Bijenstichting and Bayer appealed CTB’s decision before the Netherlands courts, which referred several questions to the ECJ for a preliminary ruling regarding, among other things, whether the information requested by Bijenstichting falls within the concept of “information on emissions into the environment” -- with the consequence that it should be disclosed without Bayer being entitled to object on the grounds that such disclosure could adversely affect the confidentiality of commercial or industrial information.
The ECJ’s judgments clarify what must be understood by “emissions into the environment” and “information on [or which relates to] emissions into the environment” within the meaning of the Regulation applicable in Case C-673/13 P and the Directive applicable in Case C-442/14. In both judgments, the ECJ found that the concept of “emissions into the environment” includes the release into the environment of products or substances (e.g., plant protection products or biocides or active substances contained in those products) to the extent that the release is actual or foreseeable under “normal or realistic conditions of use of the product or substance.”
The ECJ concluded, therefore, that this concept is indistinguishable from the concepts of “release” and “discharge” and cannot be restricted to emissions emanating from industrial installations. The ECJ decided that the concept covers emissions resulting from spraying of a product into the air or its use on plants, in water, or in soil. Such limitations, the ECJ opined, would be “at odds with the objective of the regulation and directive for disclosing environmental information as widely as possible.” Additionally, the ECJ decided that Directive 2003/4/EC and Regulation (EC) No 1367/2006 cover information on actual and foreseeable emissions from a product into the environment. The ECJ concluded that “purely hypothetical emissions” are not covered by the laws.
The ECJ stated that the concept of “emissions into the environment” must be interpreted as covering not only information on emissions, but also information enabling the public to “check whether the assessment of actual or foreseeable emissions,” on the basis of which the Competent Authority authorized the product or substance in question, is correct.
In Case C-673/13 P, the ECJ set aside the judgment of the General Court insofar as the General Court considered that it is sufficient that information relates “in a sufficiently direct manner” to emissions into the environment for it to be covered by Regulation (EC) No 1367/2006. The ECJ referred the case back to the General Court of the EU for determination of whether the information at issue relates to emissions into the environment, and, if necessary, for ruling on the parties’ arguments that were not examined in its judgment. Case C-442/14 has also been referred back to the lower court.
The ECJ’s judgments clarify that public interest in “information on emissions into the environment” is important and oftentimes overrides commercial interests. The ECJ’s rulings have potentially significant and widespread implications for companies seeking to protect trade secrets and other sensitive information. The ECJ’s reasoning in its judgment can be applied to information submitted in relation to chemical products other than pesticides that are intended for uses that involve releases into the environment. The ECJ’s judgments have been criticized for not addressing risks of substantial harm to pesticide industry innovators and their proprietary rights if studies are now deemed subject to the EU’s disclosure mandate -- data developers will need to consider this possibility and take measures to protect their sensitive information.
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.
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.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On March 2, 2015, European Union (EU) Ministers approved a Directive previously approved by the European Parliament with regard to genetically modified organisms (GMO). EU Directive 2010/0208, entitled Directive of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, will allow individual Member States to determine whether they will allow, ban, or otherwise restrict the cultivation of GMOs, even in cases where the EU has authorized use of a GMO following the European Food Safety Authority’s (EFSA) assessment of the risks to health and the environment.
Specifically, the Directive provides: “a Member State may adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs defined by crop or trait, once authorised in accordance with Part C of this Directive or with Regulation (EC) No 1829/2003, provided that such measures are in conformity with Union law, reasoned, proportional and non-discriminatory and, in addition, are based on compelling grounds.” The grounds stated include those related to:
* Environmental policy objectives;
* Town and country planning;
* Land use;
* Socio-economic impacts;
* Avoidance of GMO presence in other products without prejudice to Article 26a;
* Agricultural policy objectives; and
* Public policy.
A Member State also can seek to have all or part of its territory excluded from the geographical scope during the authorization procedure for a GMO.
The passage of this Directive is the culmination of years of negotiations between EU Member States that have disagreed over the cultivation of GMOs in their territories. The new rules, which will allow EU countries to opt-out from otherwise approved EU GMOs, are sure to be controversial as Member States, industry, farmers, and the public work out details related to the potentially non-scientific grounds that a particular Member State relies upon in restricting or banning use of a GMO, and as Member States develop measures that allowed GMOs must take to avoid “possible cross-border contamination.”
The legislation will enter into force following its publication in the Official Journal of the EU, which is expected in Spring 2015.
As various members of the EU continue to oppose production of GMO crops, these policies will remain trade irritants to the U.S. and other countries where GMO crops have been widely adopted. This comes as trade negotiations are ongoing and the EU allowance of trade barriers based on the “precautionary principle” remains a major point of disagreement between the EU and the U.S. (with its reliance on “science-based risk assessment policies”). This latest development, which further allows EU Member States to reject GMO crops under various criteria, will not make resolving any current or future trade disagreements any easier.
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.