Guidance documents, European

European Commission (2007) Surface Water Monitoring, CIS Guidance Document, European Commission, Brussels, in press. 

EEC Commission Regulation (EC) No 1488/94 EEC 1994 Risk Assessment of Existing Substances Techn. Guidance Document European Commission DG XI, Brussels, 1994. 

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk. Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances, European Commission, 1996. 

European Medicines Agency non-harmonised guidance documents http //www.emea.europa.eu/htms/human/humanguidelines/nondinical.htm. 

European Commission, Guidance Document on Residue Analytical Methods, SANCO/ 825/00/rev. 6, 20.06.00. European Commission, Bmssels (2000). This guidance document and also the following ones are available on the World Wide Web http //europa.eu.int/comm/ food/fs/ph ps/pro/wrkdoc/index en.htm. 

European Commission, Guidance Document on Aquatic Ecotoxicology, 8075WI/97 rev. 7, 08.07.2000 (Draft), European Commission, Brussels (2000). 

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. 

The text will be based on an interpretation of the legislative requirements and will include consideration of many of the available guidance documents. In addition, consideration has also been taken of published EPARs and the author s own experience of the European regulatory system (which extends over some 25 years). In case of doubt or disagreement, readers are referred to the original texts of the legislation, notes for guidance, and EPARs. 

Finally, in the risk characterization step, the PEC/PNEC quotient that defines the risk of the substance in the environment is calculated. If the quotient (PEC/PNEC) is less than 1, the substance do not present risk to the environment. More information is available in the European Commission Technical Guidance Document on Risk Assessment [3] and in the United States Environmental Protection Agency s Guidelines for Ecological Risk Assessment [6]. 

The European Union System for the Evaluation of Substances (EUSES) [8] is the software provided by European Chemical Bureau (ECB) to implement the EU Technical Guidance Documents on Risk Assessment for new notified substances, existing substances, and biocides [3]. The development of EUSES 2.1 was commissioned by the European Commission to the National Institute of Public Health and the Environment (RIVM) of the Netherlands. The work was supervised by an EU working group comprised of representatives of the JRC-European Chemicals Bureau, EU Member States, and the European chemical industry. 

Institute for Health and Consumer Protection (2003) Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances Commission Regulation (EC) No 1488/94 on risk assessment for existing substances Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market... 

European Commission, Common Implementation Strategy fort the Water Framework Directive (2000/60/EC), Guidance Document No.7 Monitoring under the Water Frame Work Directive, Produced by Working Group 2.7 - Monitoring, 2007... 

European Commission (2002) Guidance document on aquatic ecotoxicology., Health and Consumer Protection Directorate - General, Bmssels, Sanco/3268/2001 rev 4 (final), pp 62... 

This chapter uses the formal EU risk assessment methodology laid down in the European Commission Regulation (1488/94) and follows closely the principles of the technical Guidance Document [1] of the Existing Substances Regulation (793/93). 

EC. Guidance document on dermal absorption, European Comission Health Consumer Protection Directorate—General Directorate E—Food Safety Plant health, animal welfare, international questions El—Plant health, 2004. 

Institute for Health and Consumer Protection - European Chemicals Bureau Technical Guidance Document on Risk Assessment, European Communities 2003 Ibid., Part 1, p. 10... 

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