Jul. 24, 2018
A Eurobarometer opinion poll asked representatives from 25 European Union (EU) countries to list the environmental issues that they were worried about. Nearly half of respondents indicated that water pollution was a key concern. A number of key regulations across the EU aim to regulate water pollution and products that may cause damage to our water systems. Here, David Phillips, strategic portfolio director, regulatory services at translational science and research organisation, Fera Science Limited looks at what the regulations are and how smaller manufacturers can comply.
Ecotoxicology is the study of the effects of toxic chemicals on biological organisms, particularly at the ecosystem level. The primary goal of ecotoxicology testing is to predict the effects of potential contaminants in the environment, so that the most efficient and effective actions can be identified to prevent or correct any damaging effects. To support the prevention of potential contaminants a series of EU directives and industry specific registration requirements are in place to test and monitor the lasting effects of any new product being introduced to the market.
Water Framework Directive and REACH
In 2000, the Water Framework Directive, or Directive 2000/60/EU, superseded the European Water Policy and set objectives for water protection across the EU. The Water Framework Directive establishes a legal framework to protect and restore clean water across Europe and ensures its long-term sustainable use. The directive has several key aims including expanding the scope of water protection to all waters, surface waters and groundwaters, providing a combined approach of emission limit values and streamlining water management legislation.
Chemical manufacturers must also be registered with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) database. REACH applies to all chemical substances and is a regulation across the European Economic Area (EEA).
REACH covers substances in isolation, mixtures and substances used in goods and ensures that the industry takes responsibility for managing any risks that chemicals may pose to health and the environment, providing users in the supply chain with appropriate safety information.
Any company developing chemical substances must fully assess the risks posted by the product to the wider environment and natural ecosystem. Strict regulations and restrictions are in place to protect the environment, which often requires multiple stage testing and result analysis to be submitted to the Referentials Management Service (RMS) before products are authorised for use.
Dependent on the industry in question, whether that be agrochemicals, biocides, general chemicals or veterinary medicines, each industry has a set of European Union (EU) legislation that outlines the requirements for products to be approved for use. Human pharmaceuticals, in comparison, must adhere to the European Medicines Agency (EMEA) regulations, which provides a centralised authorisation procedure for medicinal products for human use.
For instance, plant protection products (PPPs) or pesticides are commonly used to prevent damage to agricultural crops, however, they are potentially hazardous. The European Commission has set maximum levels of pesticide residues in food and feed as well as the residues in water that are subject to the Water Framework Directive rules.
According to the Library of the European Parliament, there are some 25,000 agricultural pesticides with approximately 700 active substances on the world market. The EU regulation 1107/2009 deals with the authorisation for placing pesticides on the market, whereas directive 2009/128/EC establishes a framework for the sustainable use of pesticides and aims to reduce the risks and impacts of pesticide use.
In comparison, the EU Animal Health Law and the Committee for Medicinal Products for Veterinary Use (CVMP), sets maximum residue limits (MRL) to the permitted concentration of residue that can be found in food products for veterinary medicine or pharmacologically active substances in biocidal products for use in animal husbandry.
Human pharmaceuticals fall under EMEA regulation EC 726/2004. The regulation comprises of a centralised procedure where companies submit a single marketing authorisation application to the EMEA, which conducts a thorough evaluation. If proven to fulfil the requirements for quality, safety and efficacy, the Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion and marketing authorisation is granted.
Seal of approval
All industries have frameworks where you must show the human and environmental health implications through rigorous testing. The results of these tests are submitted in a dossier put forward to a member state in Europe. That member state then assesses the data and testing results and determines whether sufficient evidence has been provided to approve the product or chemical for use.
However, it is important to ensure that the data requested in the dossier is the data that is supplied at submission. Often, poorly designed scientific studies can provide more questions than answers regarding the safety of the tested chemical. Therefore, it is important to understand exactly what is required before any testing begins – it can be expensive, both in time and cost, if not.
Working to comply with the relevant industry regulations and testing requirements can be a difficult and daunting task, particularly for smaller chemical companies who may not have the breadth of knowledge or expertise in house that is often present in multi-national businesses.
By working with expert organisations, like Fera, who have a long track record of developing and providing ecotoxicology services and environmental risk assessments, the most appropriate and accurate level of testing needs can be developed to the required standard.
Ecotoxicology testing at Fera is supported through a variety of testing methods, including non-target arthropod studies, lab aquatic ecotoxicology testing and with the use of our new mesocosm facility, scheduled to open in 2018. The E-Flows mesocosm is a ground-breaking project developed in partnership by the translational research organisation Fera Science Limited, the Centre for Crop Health and Protection (CHAP) and supported by Innovate UK. It is designed, developed, managed and operated by Fera for use by the agri-tech industry and researchers and will support the race to improve crop productivity.
Mesocosm test studies provide a wide range of benefits in comparison to traditional lab testing, particularly in regard to long term studies that deal with overall water quality. By testing the developed product in a real-life testing and more natural environment as opposed to a laboratory, the test results provide more realistic and diverse data that gives a broader understanding of effects at the dossier submission stage.
The aquatic laboratory provides limited data and can be misleading as the water quality often degrades rapidly or needs replacing throughout the study to provide realistic results. By using the mesocosm study, organisms are not unnaturally stressed or handled because they are not being placed in unrealistic environments and there is less risk of inaccurate results from water quality issues due to degradation of water quality.
Robust, realistic, diverse and accurate data leads to a higher level of understanding during member state evaluation of products. While the levels and depth of regulations and requirements across the agrochemicals, biocides, general chemicals or veterinary medicines industries can seem strenuous, they are in place to protect our human and environmental safety. We all want a safe environment to live in, and aquatic pollution, risk and safety is clearly at the top of all EU member states minds.