Reporting Guidance chemicals

Member State (s) (IB3). Also included are separate expert reports on chemical and pharmaceutical (IC 1), toxicopharmacological (preclinical) (IC2) and clinical documentations (IC3). These expert reports are summaries of the dossier with a critical appraisal of the data presented by an expert on behalf of the applicant and are a mandatory requirement. Detailed regulatory guidance, supported by various Directives, is available on the content of each of these documents. 

ECHA (2008c). Guidance on information requirements and chemical safety assessment. Part E Chemical Safety Report. Guidance for the Implementation of REACH, htq) //reach.jrc.it/docs/guidance docu-ment/information requirements part f en.pdf vers=20 08 08, 1—10. 

Workplace exposures are reportable under this prong of the 2003 Reporting Guidance if there is a sudden release of a large quantity of a chemical, but known workplace exposures are not reportable. 

Sterilization, Disinfection and Cleaning of Medical Equipment Microbiology Advisory Committee (1993) Guidance on Decontamination fixMnttie Microbiology Advisory Committee to Department of Health Medical Devices Directorate. Part 1 Principles. London HMSO. van Bueren J., Salman H. Cookson B.D. (1995) The Efficacy of Thirteen Chemical Disinfectants against Human Immunodeficiency Virus (HIV). Medical Devices Agency Evaluation Report. 

This was the first part of TSCA which impacted the industry. The responsibility of 8(e) reporting has been with the industry since Day One of TSCA. While not required to, the Agency did publish a guidance document in March of 1978 to assist industry in understanding its responsibilities. To date, some 400 notices have been submitted to the Agency. While the Agency has followed up with the notifiers, no other action has been taken by the Agency to date on the chemicals involved. 

EC (2003) Technical guidance on risk assessment, TGD Part 11. Technical Report, Institute for health and consumer protection, European Chemicals Bureau, European Commission (EC)... 

OECD. 2007b. Guidance document on the validation of (quantitative) structure-activity relationships [(Q) SAR] models. ENV/JM/MONO(2007)2. 15 February 2007. Paris OECD http //www.oecd.org/ searchResult/0,2665,en 2649 201185 l l l l L00.html OECD. 2007c. Report on the regulatory uses and applications in OECD member countries of (quantitative) structure activity relationship (Q)SAR models in the assessment of new and existing chemicals. ENV/JM/MONO(2006)25. 15 February 2007. Paris OECD http //www.oecd.org/searchResult/ 0,2665,en 2649 201185 l l l l L00.html... 

An OECD Guidance Document on Reporting Summary Information on Environmental, Occupational and Consumer Exposure (OECD 2003b) provides guidance for the reporting of summary exposure information (quantitative and qualitative), which can be used in various chemical assessment programs. 

For the toxicity studies needed, internationally accepted methods as those reported within EU7 or in accordance with the OECD Guidelines for testing of chemicals are recommended. Tests for assessing photomutagenicity, photoirritationcy, photosensitization, and skin absorption have not been included so far in abovementioned guidelines. Guidance to the types of tests could also be found in the document from SCCNFP.3... 

EU (2002b) Human exposure to biocidal products. User guidance version 1. Annex 4 in Technical notes for guidance Human exposure to biocidal products—Guidance on exposure estimation. Ispra, European Union, European Chemicals Bureau, 76 pp. (http //ecb.jrc.it/Documents/Biocides/TECHNICAL NOTES FOR GUIDANCE/TNsG ON HUMAN EXPOSURE/Users guidance to Report 2002.doc). 

EU (2005) Work Package 1. Development of the concept of exposure scenarios. General framework of exposure scenarios. Scoping study for technical guidance document on preparing the chemical safety report under REACH, final report. European Union, European Chemicals Bureau (REACH Implementation Project 3.2-1A Lot 1 Commission Service Contract No. 22551-2004-12 FISC ISP BE ... 

USEPA] US Environmental Protection Agency. 2002. Guidance for comparing background and chemical concentrations in soil for CERCLA sites. Washington Technical report EPA 540-R-01-003, OSWER9285.7-41. 

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