Understanding Acts, Statutes, Treaties, Regulations, Directives and Standards in the context of Product Safety Compliance – Which of these apply to the products I am developing? How do they relate to each other? Do these differ between countries?

There are a number of different documents that contain requirements for developing safe products.

In satisfying Global Regulatory Product Safety Compliance requirements, we are exposed to a lot of different terms and pieces of legislation. How they all relate to one another can be confusing. Different countries seem to use different terms and have different ways of working, so what are the basics?

If we sort things into Primary Legislation, Secondary Legislation and Product Standards as a starting point we can begin to see how things relate to one another and this can help us make sure we in compliance with all mandatory requirements.

What is an Act?
Acts are laws that have been passed by a Parliament, Congress or State/Provincial Legislatures. For example, the Consumer Guarantees Act. These can also be called Statutes and are sometimes referred to as Primary Legislation. Acts protect everyone. For the EU, Treaties are the fundamental laws. All treaties must be ratified (passed and agreed) by member states. An Act will be people focused so will not usually refer directly to a product.

What is a Regulation or Directive?
Regulations are made under the delegated authority of an Act (or Treaty for the EU), such as an administrative agency. They can be considered to be supplementary to the Act or Treaty. They are designed to aid in the application of the principles of the primary Act. Regulations provide protection in specific areas. For example, the Electrical (Safety) Regulations. Regulations are sometimes referred to as Secondary legislation, Subordinate Legislation or Delegated Legislation. In the UK the term Statutory Instrument is used. In the EU Regulations are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety across all EU countries. The EU also generate Directives which differ from regulations in that they are a legislative act that sets out a goal that EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Regulations can include some requirements that relate directly to specific or general categories of products. As a product development business you should understand the relevant regulations.

How do Acts and Regulations Differ?
An Act is generally a broader piece of legislation that outlines the general principles and rules of law, while a regulation is a more specific set of rules and requirements to enforce the provisions of the Act.  Regulations are usually more specific and prescriptive, often providing detailed guidance on how the provisions of the Act should be implemented in practice. However, it is possible for an Act to be prescriptive also and in some instances to refer directly to a product safety standard. This means there may not always be a relevant Regulation.

What is a Product Safety Standard?
A Product Safety Standard is not, of itself, mandatory or legally required. A standard has to be incorporated by reference in an Act or delegated legislation in order to be mandatory. Once referenced, it becomes part of the technical regulation framework. In the EU, this is done through publication in the Official Journal of the European Union (OJEU) with respect to a particular Directive or Regulation. The product standard can then be used to derive a presumption of conformity with the essential requirements of that Directive or Regulation. This is what is referred to as a harmonised standard. In the UK these are called designated standards and their reference is published on GOV.UK in a formal notice of publication. In other countries standards are usually referenced from within an Act or Regulation. In Australia the ACCC (Australian Competition and Consumer Commission) release what they refer to as Mandatory Safety Standards (formally Consumer Protection Notices) directly under the Competition and Consumer Act 2010. These standards could be considered to be a cross between a Regulation and a Standard as they usually reference or duplicate sections of existing safety standards while also adding additional requirements. Product safety standards may prescribe a products form, construction, finish or packaging; tests the products must go through; and the form and content of any markings, warnings or instructions that must accompany the product.

Do I need to be aware of the Acts and Regulations that apply to my products or can I just apply the relevant Standards?
Acts often contain definitions which are important for the interpretation of Regulations and in some instances can refer directly to product safety standards, mandating them. Therefore, having a quick scan over the Act(s) that are relevant to your products is useful. Regulations can directly reference Standards and Regulations or Directives can often contain general requirements relating to your product or your responsibilities as a product developer/manufacturer, importer, distributor or retailer. It is also important to understand how your product standard(s) relate to the regulation. Are they referenced or harmonised? Which version is mandated or which clauses? Note that in different countries, slightly different versions of product standards may be referenced and it is important to ensure you cover the correct version of standard for each market you are selling in, in reference to that countries Regulation or similar.

Have further questions or need some help in working out what is relevant to your product? Get in contact with us.

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