Manufacturer or importer
If you are a manufacturer or an importer of chemical products, pesticides and articles, you need to know what the products contain and if they pose potential risks. You must be able to inform customers and other users. You may also need to report your kind of activity and your products. Pesticides require authorisation.
You are a manufacturer if you yourself manufacture a substance or an article or have it manufactured by another party. As a manufacturer you must be aware of several different pieces of legislation, and your obligations and your role may differ from each other depending on the legislation.
You are an importer if you import a substance, a mixture of substances or an article from a country outside the EU and import it into the EU/EEA. As an importer you must be aware of several different pieces of legislation, and your obligations and your role may differ from each other depending on the legislation. If you transfer a chemical product or an article from another EU country you are not regarded as an importer, but as a distributor.
What is the difference between products and articles?
The following definitions are based on the REACH Regulation and explain the difference between a chemical product and an article. Depending on whether the item in question is a chemical product or an article, different requirements apply according to different regulations.
A chemical product is a chemical substance or a mixture of several chemical substances. Examples of substances are acetone, acetic acid and ethanol. Examples of mixtures are paint, glue and detergent.
An article is defined as an object which during production is given a special shape, surface or design during production which determines its function to a greater degree than does its chemical composition.
The saddle of a bicycle, for instance, often contains softeners and it may be painted. Chairs and tables may be painted or varnished. Mobile phones and toys may contain many chemical substances such as paints, softeners and flame retardants.
You are responsible for your particular activity
In your capacity as manufacturer and importer you need to monitor your particular activity and the risk it may entail. In case you sell the products to another party, you are responsible for ensuring that they comply with the requirements made in other pieces of legislation. Consider in advance what it is you are purchasing. Avoid hazardous chemical products and articles which can be replaced by less hazardous ones, or use alternative techniques. This is called the substitution or product choice principle.
The tool for substitution, PRIO, is a tool to help you dispense with hazardous substances and products and thus reduce the risks to health and the environment.
The Swedish Work Environment Authority is responsible for issuing rules on the working environment in workplaces where chemical risks are present.
Activities that are subject to permit and notification obligations according to the Environmental Code require self-monitoring in line with the Operators’ Self Inspection Ordinance (1998:901).