REACH and dossier evaluation

REACH
The use and discharge of chemicals is subject to legislation and may vary from the type of use and the area of use. The formal adoption of the EU regulatory framework for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a first step into the harmonisation of requirements for product use. Nevertheless, specific use may require specific notification and apply specific criteria. The European Inventory of existing Chemicals (EINECS list) contains over 100,000 chemicals that are used on the European market. The minimum required data set for the assessment of environmental and human hazards comprises PBT (Persistence, Bioaccumulation and ecoToxicology) and CMR (Carcinogenic, Mutagenic and Reproductive toxicity) properties. However this information is not available for the majority of the existing chemicals.

Testing of these chemicals is expensive. Sometimes testing is inevitable, but as an alternative information from related substances in combination with QSAR models or expert judgement can be used for a sufficiently reliable hazard characterisation. In addition IMARES has developed a method to prioritise chemical substances combining 4 aspects:

1. Evaluation of human risk (CMR)
2. Evaluation of environmental risk (PBT)
3. Application of exposure scenario’s
4. Presence on national or international priority substances lists

IMARES is specialised in the environmental hazard and risk assessment and can advise companies and authorities on data and research requirements concerning environmental issues in REACH.

Pesticides and Biocide dossiers
The evaluation of plant protection products and biocidal products is subjected to specific legislation with specific and extensive requirements described in the EU Directives 91/414/EC and 98/8/EC, respectively. Both product categories are not subjected to REACH.

Several dossiers for plant protection products (pesticides) were evaluated concerning the environmental aspects. These dossiers were compiled by the industrial companies and submitted to either the Dutch or European authorities in order to apply for registration of the product on the market. IMARES was commissioned by the Dutch Board for the Authorisation of Plant Protection Products and Biocides (CTGB) to evaluate the test reports of the dossier concerning the completeness and correctness. In additional ecotoxicological endpoints from these test reports were selected and applied in environmental risk assessments according to the prescribed European guidelines and environmental fate and risk models for pesticides. An environmental risk assessment is performed by comparing the Predicted No-Effect Concentration (PNEC) with the exposure values, the Predicted Environmental Concentrations (PECs). We can select the environmental compartments of relevance and can calculate the PEC values in preparation for the risk assessment. The results of this environmental evaluation, together with the result of the consumer and applicant evaluations conducted by TNO Quality of Life Institute was used by the CTB to compile the Pesticide Monograph.

Biocidal products contain at active substances intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism. Evaluation of biocidal product dossiers is highly comparable with plant protection product dossiers concerning the effect studies and risk assessment methods. IMARES has been involved in the environmental risk evaluation of biocides like desinfection products and wood conservation products.

In some case registration dossiers also contain mesocosm test reports. These tests are high tier studies with aquatic communities. IMARES is specialized in this kind of complex studies. This is the reason that the Dutch Board for the Authorisation of Plant Protection Products and Biocides (CTGB) asked IMARES to evaluate the quality and results of these studies. 

IMARES can also advise international governmental bodies on dossier evaluation. From 2004 to 2005 IMARES was leader of a consortium aimed at assisting the Slovak Republic authorities in meeting the EU requirements for registration and monitoring of pesticides in the environment.