Regulation of Industrial Use of Algae or Cyanobacteria in Europe (part 2)

Introduction

This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in the European Union. This entry is one of several posts that provide additional information in support of a poster I’m presenting at the 2013 Algae Biomass Summit on the regulations in various countries around the world that may be applicable to the use of naturally-occurring or genetically modified algae or cyanobacteria in fuel production. These include three general categories of regulation: biotechnology or biosafety regulations, aquaculture regulations, and renewable fuel standards or volume mandates. You can access the poster on my SlideShare site, and please refer back to my September 16 introductory post for links to posts on the regulatory situation in other countries. Although this discussion centers on algae and cyanobacteria, much of the discussion (other than the section on aquaculture) would be applicable to the use of other genetically modified microorganisms for production of fuel or chemicals.

The discussion of the situation in the European Union is in two parts. This blog entry discusses aquaculture and renewable fuels regulations, and the previous entry discussed biotechnology regulations.

Aquaculture Regulation

The following is a brief summary of aquaculture regulations in the European Union and how they may apply to industrial uses of algae or cyanobacteria. This is necessarily a very brief overview, meant to convey general guidance as to what applicants might expect in the country. More detailed information is available at the websites linked below, particularly including the very useful Fact Sheets maintained for individual countries by the U.N. Food and Agriculture Organization (FAO), which can all be accessed at http://www.fao.org/fishery/nalo/search/en.

Use of algae might be covered by Directive 2007/708/EC on Alien and Locally Absent Species in Aquaculture. This directive requires EU member states to adopt regulations that require risk assessment and permitting for the proposed introduction into aquatic habitats of nonnative or locally absent species of aquatic organisms. Article 3(4) of this Directive defines “aquatic organism” as:

  1. ‘aquatic organisms’ means any species living in water belonging to the animalia, plantae and protista kingdoms, including any part, gametes, seeds, eggs or propagules of their individuals that might survive and subsequently reproduce;

The inclusion of “protista” within this definition means that alien or locally absent species of algae would potentially be included. However, since cyanobacteria are prokaryotic, they would not fall within the Protista Kingdom and therefore would arguably not be covered by this definition or this Directive.

Article 6 of the Directive requires member nations to establish procedures by which applicants proposing the introduction of an alien or locally absent species of aquatic organism to obtain a permit from the applicable national regulatory agency. Annex I of the Directive provides guidelines for the information recommended to be submitted to the applicable agency in such permit applications.

In the European Union, the EU-wide directives are meant to be translated into national law in each of the EU member states. There may therefore be some nation-by-nation variability in the specific requirements of these laws, and so it would be advisable for companies contemplating activities in any given EU member state to identify the agency having regulatory authority and to consult with the agency in advance of any introduction of a novel or nonnative strain into the country.

Fuels Regulation

New fuels must meet the requirements of the Renewable Energy Directive (RED) and the Fuel Quality Directive (FQD) to count towards EU renewable target volumes.  The RED was put in place to ensure that all the 27 member states of the European Union achieve specified targets for use of renewable fuels and reduction of greenhouse gas (GHG) emissions across all energy sectors, with specific requirements for the subset of fuels used for transportation. Its companion directive, the FQD, has additional, complementary requirements for GHG reductions within the transport sector. These directives place obligations on EU member states, but also create certain requirements with which developers or producers of renewable fuels must comply in order for their fuels to qualify as “renewable” under the regulations.

The Renewable Energy Directive, EU Directive 2009/28/EC of  April 23, 2009, addresses the adoption of renewable energy within overall energy markets in EU member states (i.e., electricity, heating and cooling, transport). The RED sets targets for the use of renewable fuels which member states must meet, by enacting national laws consistent with the Directive. These targets are as follows:

  • Derive 20% of overall energy consumption, across all sectors, from renewable sources by 2020.
  • Derive 10% of energy consumption within the transport sector from renewable sources by 2020.
  • Achieve greenhouse gas emission reductions of at least 35%, relative to fossil fuels, by mid-2010, with this target rising to 50% in 2017 and 60% in 2018, for fuels produced in 2017 or later. However, fuel production plants that were in operation as of January 2008 had until April 2013 to meet the 35% GHG reduction requirement.

The Fuel Quality Directive, EU Directive 2009/30/EC, which amended Directive 98/70/EC, was also adopted on April 23, 2009. It establishes the specifications (standards) for transportation fuels to be used across the EU. The Directive also requires that all fuel suppliers (e.g. oil companies) must meet a 6% reduction of GHG emissions by 2020, relative to 2010 baseline levels, across all fuel categories. This reduction in emissions could be achieved using any low-carbon fuel options, such as hydrogen or electricity, but it is generally expected that the use of biofuels will account for most of the targeted reductions.

Although the obligations in the Directives to meet the specified targets are placed on national governments, these obligations are passed down to the entities that sell fuel to the public, as well as the companies that manufacture or import fuels for eventual sale in the EU. Specifically, there are defined requirements that a fuel and its production pathway must meet in order for the fuel to be considered a “renewable fuel” that qualifies to count towards fulfillment of the targets set in the Directives. The RED specifies that “renewable fuels” are not to be produced from raw materials obtained from land having a “high biodiversity status” or “high carbon content”.

Furthermore, in order for a fuel to be considered as “renewable”, it must show a reduction in GHG emissions over the lifecycle of its production, such that the carbon intensity of the fuel is known and can be applied towards the national targets. The European Commission calculated default carbon intensities for a number of specific biofuel production pathways, which can be found in Annex V of the RED, and these can be used in reporting by regulated entities without providing any additional information to any national government. However, for fuel production pathways not included within this list, carbon intensities must be calculated using acceptable methods for developing life cycle analyses (LCAs).

More importantly, renewable fuels must be produced sustainably: that is, in order for a fuel to be considered as “renewable” under the RED, it must be analyzed and certified to be in compliance with sustainability criteria established in the Directive. The required sustainability analysis incorporates, but goes well beyond, considerations addressed in typical LCAs. There are twelve different factors which must be considered in these analyses, including Local Food Security, Human and Labor Rights, Rural and Social Development, and others including lifecycle GHG emissions. The EU has established a requirement that any proposed scheme or methodology for conducting sustainability analyses under the RED must be certified by the EU before any fuel provider can rely on such a scheme to establish its eligibility. A number of  such schemes that have been approved, which are listed here. Fuel producers can conduct these analyses themselves, or have them done by third parties, but in either case the regulations require that the analysis be verified by competent, independent auditors that follow international standards.

Companies that are producing fuels that are included within the “look-up table” within the RED can rely on the carbon intensities specified in the regulations. However, companies developing a new pathway must not only conduct an LCA to establish the carbon intensity but must also have the fuel pathway certified as sustainable.

On October 17, 2012, the European Commission proposed revisions to the RED and the FQD that embody some substantial changes to the EU’s approach to certain biofuels, specifically in proposing to institute incentives for the use of second generation biofuels that are not derived from food crops. This proposal, which has generated significant controversy both within the industry and also from other interested parties, was discussed in a post on my Biofuel Policy Watch blog. After many months of debate and consideration by parliamentary committees, the EU Parliament voted on September 11, 2013 to adopt a revised version of this amendment, which I have described in a new post on Biofuel Policy Watch . This version of the amendment must still be approved by the European Council before it can take effect, which is not expected until sometime in 2014 at the earliest.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation,  are available at www.slideshare.net/djglass99 and  at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

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