General

General training modules

The training modules in this section offer trainees insight based on PFA’s expert knowledge on successful regulatory compliance and safety assessment for industrial chemicals. This section is sub-divided into subject areas. The modules on Regulatory topics include an introduction to the Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) regulation; the Classification, Labelling and Packaging of chemicals (CLP) regulation; Persistent, Bioaccumulative and Toxic (PBT) assessment; Socio-Economic Analysis (SEA); general Risk Assessment; and extended Safety Data Sheets (eSDS). The modules on subject areas of a more Technical nature focus on important aspects of chemical safety assessment such as Substance Identification Profiles (SIPs), data gap analysis, category approaches and literature searching. Quantitative Structure-Activity Relationships (QSARs), analytical chemistry and International Uniform Chemical Information Database (IUCLID) are included under the Technical subject area. The level of detail presented in each module can be tailored to suit individual business needs.

Regulatory: Concepts and practice in safety assessment

Understanding REACH

An informal course designed to explain the key elements of REACH including implications for manufacturers, importers and users of chemicals throughout the supply chain. Ideal for companies who need to understand more about their compliance obligations under the REACH regulation.

Writing and understanding eSDS

In REACH, the extended Safety Data Sheet is an essential communication tool in the supply chain. It is therefore important to present well-written and accurate eSDS, which are easy for downstream users to understand. The key question for the downstream user is: does the current eSDS cover my uses?.

Authorisation and Socio-Economic Analysis

Companies that wish to apply for Authorisation of a specific use will need to provide Socio-Economic Analysis as part of their application for Authorisation. This module sets out the regulatory framework and technical options available under REACH.

Basics of risk characterisation

What is a Risk Characterisation Ratio (RCR), and how important are RCRs? Which environmental and human health protection goals require the calculation of a RCR? The routes to obtaining RCR values are described in basic terms.

PBT and CMR assessment

PBT (Persistent, Bioaccumulative and Toxic), vPvB (very Persistent, very Bioaccumulative) and CMR (Carcinogenic, Mutagenic and Reproductive) assessments in all regulatory contexts: data requirements, interpretation and examples of difficult case studies.

Understanding CLP - Health

The Classification and Labelling of a substance is a requirement under most regulations. Here we explore how to derive C&L for human health properties along with basic understanding of human health hazard assessment.

Understanding CLP - Environment

The Classification and Labelling of a substance is a requirement under most regulations. Here we explore how to derive C&L for the environment along with basic understanding of environmental fate and ecotoxicological hazard assessment.

Technical: Understanding substances and core data

Scientific Literature

This module introduces an expert approach to conducting a comprehensive literature search, data interpretation and presentation within the context of chemical safety evaluation and risk assessment.

Gap analysis and read-across for low tonnage substances

The module covers information on carrying out a gap analysis for single substances and in the context of a category or a group. Examples are provided on how read-across can be a powerful tool in reducing animal testing and how to apply data waivers correctly. Are data requirements of low tonnage substances strictly defined by their Annex requirements?

Substance characterisation and SIPs

The Substance Identification Profile (SIP) concerns the review of compositional data in order to establish the ‘sameness’ of substances from different suppliers in the context of REACH. This course explains the type of information required including naming conventions and analytical information.

QSARs

An introduction to QSARs with regards to how they are used and developed. What are their strengths and weaknesses from a scientific view point and within the regulatory context? The major models available are reviewed.

Dealing with UVCB substances

Expert approaches to data interpretation for multiconstituent and Unknown or Variable composition, Complex reaction products or Biological materials (UVCB) substances in chemical risk assessment and associated regulatory challenges.

Analytical chemistry as part of other studies

Analytical chemistry is an essential aspect of well conducted physicochemical testing and thereafter, of the interpretation of ecotoxicology and mammalian toxicity. Chemical analysis as the basis of valid studies is described, with discussion of what is required for regulatory compliance.

Physicochemical properties and environmental exposure assessment

How do physicochemical properties such as solubility and volatility influence environmental exposure assessment and risk characterisation? Which techniques of measurement are the most useful? When are limit values sufficient? What happens with particularly ‘tricky’ substances? These and more questions on how to successfully monitor and interpret a study are answered.

IUCLID data entry

IUCLID software is used for data compilation under REACH and other EU regulations. The course provides a detailed understanding of IUCLID set up and use. It explains how to relate data entry to regulatory requirements and how to prepare for effective Chemical Safety Report (CSR) generation.