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Chapter 3.4.3
Module:  3.
Novel bioproducts development and validation in an operational environment
Unit:  3.4.
Environmental assessment of bioproducts: towards sustainable production process
Chapter:  3.4.3.
Regulatory aspects of environmental assessment – biological and chemical hazards

It is common knowledge that there are certain biological and chemical hazards associated with animal side-streams, whether disposed of or utilized with new value added applications. The organic components of fish waste (flesh, skin bones, etc.) have a high biological oxygen demand and, if not managed properly, can pose environmental and health problems. It is well recognized that waste can be reduced by utilization of animal side-streams. However, this also involves the handling of significant amounts of hazardous materials, e.g. raw materials and intermediate/final products. For example, the processing steps may involve certain chemical hazards; animal side-streams and bioproducts derived from side-streams might be a vector for the transmission of microbial or viral illnesses. Therefore the disposal, transport, storage and handling of such materials must be managed properly to avoid or minimize the environmental impacts.

The management and control of hazards (biological and chemical ones) in aquaculture requires specific strategies, including the identification of hazard, control of the hazard and monitoring of the effectiveness of the controls. Governments need to enforce proactive policies and legislation towards EIA to ensure problem prediction and preventive measures. There should be clear-cut guidelines on how to achieve a basic level of environmental protection in the vicinity of aqua farms.

In the EU, environmental impact assessment (EIA) is regulated by the so-called EIA Directive, its current version being Directive 2014/52/EU. The EIA Directive aims to ensure that a high level of environmental protection is achieved and that environmental considerations are integrated into the preparation and authorization of projects. Historically, the first version of the EIA Directive (85/337/EEC) came into force in 1985, applying to a wide range of defined public and private projects. The EIA Directive of 1985 was amended three times: in 1997 (Directive 97/11/EC), in 2003 (Directive 2003/35/EC) and in 2009 (Directive 2009/31/EC). The initial Directive of 1985 and its three amendments have been codified by Directive 2011/92/EU of 13 December 2011. Directive 2011/92/EU was amended in 2014 by Directive 2014/52/EU. The latest amendments aim to achieve better optimized administrative process, improved level of environmental protection together with sustainable business decisions on public and private projects, and relevant consideration of newly emerged threats and challenges, adding focus on resource efficiency, climate change, disaster prevention and so on. The main amendments are listed in more 3.4.3.

Box 3.4.2 Main amendments in Directive 2014/52/EU (21; 7).
  • EU countries can simplify their different environmental assessment procedures.
  • Timeframes are introduced for the different stages of environmental assessments.
  • The screening procedure, determining whether an EIA is required, is simplified.
  • Decisions must be duly motivated in the light of the updated screening criteria.
  • EIA reports are to be made more understandable for the public, especially as regards assessments of the current state of the environment and alternatives to the project in question.
  • The quality and the content of the reports is improved. Competent authorities also need to prove their objectivity to avoid conflicts of interest.
  • The grounds for development consent decisions must be clear and more transparent for the public.
  • If projects do entail significant adverse effects on the environment, developers are obliged to avoid, prevent or reduce those effects. These projects must be monitored.

The EIA Directive classifies all projects into Annex 1 or Annex 2 projects. Annex 1 includes large-scale projects (e.g. motorways, bridges, power stations etc.), which always require EIA. Annex 2 encompasses projects of a smaller scale, which could be subject to EIA according to the criteria laid out in Annex 3, as determined by each Member State (more 3.4.4).

The EIA Directive covers all the steps of the EIA process. At the scoping stage, the project developer may request the competent authority to specify what should be covered by the EIA information to be provided. The developer is required to provide an EIA report drafted in accordance with Annex IV of the Directive. The environmental authorities (including local and regional ones as well as other affected EU countries) and the public must be informed and consulted. The competent authority makes a decision based on the results of consultations and the conclusions about the significant effects of the project. The authority informs the public of its decision. Public consultations are an essential part of EIA process. Effective public participation must be ensured by providing the EIA report and other information electronically, by public notices, or via local newspapers, etc. The public can challenge the decision before the courts. EU countries may lay down more stringent conditions and fix penalties for any infringements.

The transboundary aspects of EIA are specifically laid out in the Convention on Environmental Impact Assessment in a Transboundary Context (the so-called Espoo Convention), which was signed by the European Community on 25 February 1991 and was ratified on 24 June 1997. According to this Convention, member states are obliged to carry out EIA of certain activities at an early stage of planning and to notify and consult each other on all major projects that are expected to have significant adverse environmental impact across boundaries. The Convention has had several amendments (more 3.4.5).

Specific guidelines for assessment of fish waste, or material resulting from industrial fish processing operations are laid out in the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter, or the so-called London Convention. This Convention is one of the first international conventions for the protection of the marine environment from human activities. It came into force on 30 August 1975 and was followed by amendments and the so-called London Protocol of 1996, which entered into force in 2006. The London Protocol takes an approach that prohibits all dumping, except for a "reverse list" of possibly acceptable wastes.

Another EU policy document that is focused on the protection of water resources (fresh and water ecosystems and drinking water) is the "Blueprint to safeguard Europe's water resources", (COM/2012/0673). Data about impact on biodiversity are reported by EU Member States under the Marine Strategy Framework Directive (MSFD). The new Common Fisheries Policy (CFP). is a set of rules for managing European fishing fleets and for conserving fish stocks to guarantee stable, secure and healthy food supply for the long term.

The control of biological and chemical hazards associated with the usage and disposal of fish side-streams is governed by the regulations applying to animal side-streams. Regulation (EC) No 1069/2009. aims to prevent any risk from animal side-streams to public and animal health or the environment. It acknowledges that "Disease outbreaks could also have negative consequences for the environment, not only due to the disposal problems posed, but also as regards biodiversity" . The Regulation controls the collection, transport, storage, handling, processing and use or disposal of animal side-streams. It encourages the utilization of side-streams for other purposes (if safe), as an alternative to disposal whenever possible. If animal side-streams need to be disposed of, this should be done in accordance with the associated risk, as set in the environmental legislation on landfilling (Council Directive 1999/31/EC) or industrial emissions in the case of incineration (Directive 2010/75/EU). In order to prevent potentially detrimental effects for the environment, the export of animal side-streams and derived products intended for disposal by incineration and by landfill should be prohibited. The export of animal side-streams and derived products should also be prevented where the objective is to use them in a biogas or composting plant to third countries which are not members of the Organization for Economic Cooperation and Development (OECD), in order to prevent potentially adverse environmental impacts and health risks.

Commission Regulation (EU) No 142/2011, also covers the disposal (by incineration or landfilling) and use of animal side-streams and derived products; restrictions on the use of animal side-streams and derived products; hygiene requirements for processing plants and other establishments, e.g. in the case of transformation of animal side-streams and derived products into biogas and composting; and some derogations from certain provisions of Regulation (EC) No 1069/2009.

To prevent transmission of diseases, Commission Regulation (EC) No 1234/2003 does not allow feeding farmed animals intended for food with processed animal proteins with the exception of fishmeal, hydrolysed proteins and dicalcium phosphate for feeding of non-ruminants or fur-producing animals, upon certain conditions.