94285 - Chemical Regulation

Learning outcomes

Students will develop a comprehensive understanding of international chemicals management regulations, focusing on chemical regulation. This course unit integrates European, non-EU, and biocide regulations, providing insights into the legal frameworks and processes governing the management of hazardous substances. The student is expected to be able to: 1. Understand the REACH and CLP regulations in the EU, including processes for classification, labelling, registration, and authorization of chemicals, as well as their implications for health, safety, and the environment; 2. Analyze and compare international chemical control frameworks, including GHS implementation and regulatory systems in countries such as the US, Japan, China, and Brazil, and their alignment or divergence from EU regulations; 3. Evaluate the regulatory frameworks specific to biocides, including their classification, usage, and safety requirements, as well as their impact on public health and the environment.

Course contents

This CU is composed of three modules:

(1) REACH and CLP

The course provides an overview of the remit of REACH and the increased responsibility it places on industry to manage chemical risks. The course introduces to the aims and core principles of REACH: protection of human health and the environment; enhance EU chemical industry competitiveness; and the promotion of alternative methods of dangerous substance assessment.

The Classification, Labelling and Packaging (CLP) Regulation (EC) No. 1272/2008, is another column of the Chemical Management Program in the European Union and provides the rules for the classification of hazardous compounds, their labelling, and Safety Data Sheet (SDS) information. The course provides an overview of this important regulation.

(2) Non-EU Regulations: US, Japan, Brazil and China

This module provides a comprehensive overview of the chemical control framework in US, Japan, Brazil and China and other countries and regions. It covers current regulations concerning hazardous chemical substances and their production, import, and use, as well as some essential hazard communication requirements including the GHS-based labelling and SDS requirements implemented by these countries.

(3) Biocides Regulations

This module provides a comprehensive overview of the Biocides control framework

Readings/Bibliography

Slides will be available for students.

Teaching methods

The Course Unit is divided in three modules. Each module is organized in theoretical classes where main concepts are explained, as well as tutorial classes with discussion of case-study examples.

Assessment methods

Each module learning is evaluated independently, exploiting: i) written tests; ii) oral presentations or interviews; iii) written assignments or combinations of them. The Course Unit grade will be the arithmetic mean of grades from the three modules. ChIRS grades scale goes from 1 to 100, pass grade is
40, and will be translated into ECTS and different University scales. Criteria: knowledge on a very limited number of topics covered in the course and analytical ability that emerges only with the help of the instructor, using generally correct language → 40-45;
Knowledge on a limited number of topics covered in the course and independent analytical ability only on purely executive
issues, using correct language → 45-60;
Knowledge on a large number of topics covered in the course, ability to make independent critical analysis choices, mastery
of specific terminology → 60-80;
Essentially comprehensive knowledge on the topics covered in the course, ability to make independent critical analysis and
connection choices, full mastery of specific terminology, and ability for argumentation and self-reflection → 80-100.

Teaching tools

Lectures slides and notes will be available on the course moodle https://emmcchir-learning.ualg.pt

Office hours

See the website of Daniel Sainz Garcia

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