5.3: Topic 3: Regional Regulatory Toxicology

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Learning Objectives

1: Define what is meant by a “regional regulatory toxicology”
2: Give an example of a regional regulation

What is Regional Regulatory Toxicology?

Regional regulatory toxicology exists between global and national regulatory toxicology. It deals with regulatory toxicology that includes multiple countries. Often these countries are adjacent or in close proximity (e.g., United States and Canada) but that is not a requirement.

A group of nations that frequently exert regulations on a regional scale is the European Union (EU). The EU started in 1951 with six European countries agreeing to cooperate and has expanded over the ensuing decades to the current list of 28 member countries. -One current member of the EU, the United Kingdom has decided through a popular vote to eventually exit the EU (i.e., Brexit).

It started as a paper in 2001 and entered into force on June 1, 2007. It's a new approach for the regulation of chemicals in the EU. Required key hazard information to be obtained for existing chemicals to remain in commerce, or for a new chemicals to enter into commerce.

Information falls into three broad hazard categories: physical-chemical, human health and environmental health. The types and amounts of information varies depending on the volume of chemical used in commerce. The more the chemical is used, the more the data.

In addition to hazard information, REACH requires assessments to determine if chemicals in commerce pose unreasonable risk(s). REACH has resulted in the assessment and/or re-assessment of 1000s of chemicals. A large database of toxicity information was created. Some countries are using REACH as a model to develop new, or update existing, chemical regulations, for example, South Korea with K-REACH.

Topic 3: Key Points

In this section, we explored the following main points:

1: What is Regional Regulatory Toxicology?
2: The Registration, Evaluation, Authorization and restriction of CHemicals (REACH) regulation

Knowledge Check

1. Which of the following generally is a trait commonly found in a regional regulatory toxicology initiative?

Involvement of multiple regulatory agencies within a country

Involvement of all/most countries around the globe

Involvement of multiple states within the United States

Involvement of two or more countries in a regulatory initiative

Answer: Involvement of two or more countries in a regulatory initiative

2. Which of the following is an example of a regional regulatory toxicology initiative?

GHS

REACH

K-REACH

FQPA

Answer: REACH