Legal framework for managing chemicals

As an importer, manufacturer or distributor of chemical substances or products, you need to know the rules governing this area. Legislation on chemicals are extensive, with many requirements for the professional user.

The legal framework for managing chemicals is divided between EU legislative acts and national legislative acts. EU Regulations concerning chemicals are directly applicable in Denmark. The REACH (1907/2006) and CLP (1272/2008) Regulations provide the general legislative framework for managing industrial chemicals in the EU.

In addition to EU legislation Denmark has a national Consolidated Act on Chemicals. With this act and also the Consolidated Environmental Protection Act as legal base, Denmark has issued a number of national Statutory Orders covering various aspects of chemical regulation. The Consolidated Acts also provide the legal base for issuing Statutory Orders with a view to transposing EU Directives concerning chemicals into national law.

In Denmark, the chemicals sector is regulated by the Chemical Substances and Products Act. The scope of this Act extends to all chemical substances and products manufactured, imported or sold in Denmark.

The chemicals legislation concerns chemicals in their pure form, such as acetone and hydrochloric acid, as well as products, such as detergents, paint, shampoo, jewellery, toys and refrigerators.

As an importer, manufacturer or distributor of chemical substances or products, you need to know the rules governing this area, of the requirements governing, for example,classification, labelling, packaging and storage. Information is also provided on the retail sale of toxins and on the substances and products for which special rules exist.

Who is responsible

If a chemical product has been manufactured in Denmark, the manufacturer is responsible for that product. If the product has been imported into Denmark, the importer is responsible. 
For the import and sale of chemical substances and products, the manufacturer or importer must assess whether the substance or product is subject to special Danish rules, and whether a substance or product is classified and labelled in another EU country by a foreign manufacturer. Importers must also be aware of whether the imported articles contain prohibited or restricted substances. For example, active ingredients in cosmetics. It is also the responsibility of the importer to ensure the proper packaging and labelling of chemical substances and products. This also 
applies even if the chemical substances/products are delivered direct from abroad to the importer's Danish customers. 

The manufacturer/importer is obliged to keep abreast of new legislation and to ensure that current legislation is always complied with. As there are frequent amendments in legislation it is not enough that the rules are only addressed at the start of marketing or importation. 

Every manufacturer or importer of a chemical substance or product must be in possession of documentation proving the substance or product complies with chemical legislation, including EU regulations. This means that it is necessary to be in possession of a large amount of data on the substance or product, as well as being able to document that the substance or product has been assessed in accordance with the rules. 

If the Danish EPA wishes to see that data, the manufacturer or importer is obliged to supply it.