Notifying hazardous substances and materials

March 2017 – Updated April 2019

The most important rules concerning the notification of hazardous substances and materials to the Product Registry.

This recommendation relates to when companies producing or importing hazardous substances or materials must notify them to the Product Registry.

Substances is used here as a designation for chemical elements and their compounds, materials is used to denote chemical mixtures, while products is used below as a generic term denoting substances and materials. The Product Registry is a joint system operated by the Danish Working Environment Authority and the Danish Environmental Protection Agency to register the use of chemicals in Denmark.

This recommendation does not include rules on notifying products that are used offshore, or rules on pesticides and biocides which are to be notified in accordance with other legislation.

The most important rules

Enterprises that produce or import hazardous products must notify them to the Product Registry no later than one month after the commencement of production or importation. These notifications must be submitted electronically.

Products that are registered correctly in the Product Registry are automatically as-signed a product registration number (PR no.) by the Danish Working Environment Authority. This number must be indicated on the product's packaging no later than one year after allocation.

1. Products to be notified

Enterprises must notify products to the Product Registry if they meet these four criteria:

1. The Danish Working Environment Authority considers the product to be hazardous
2. A. The material is produced or imported in quantities greater than 100 kg a year
   B. The substance is produced or imported in quantities between 100 and 1000 kg a year, unless the substance is already registered as a pure substance in the enterprise’s own supplier chain pursuant to REACH
3. The product is produced in Denmark or imported from the EU, EEA or a third country
4. The product is for commercial use.

The Danish Working Environment Authority considers the product to be hazardous

Enterprises must notify products that the Danish Working Environment Authority considers to be hazardous. That is to say:

• Substances and materials that meet the criteria for classification as hazardous according to the rules of the CLP Regulation. 
• Substances and materials that are referred to in the Executive Order on Limit Values for Substances and Materials. 
• Materials containing 1% or more of a substance that is recorded with the limit value in the Executive Order on Limit Values for Substances and Materials. This limit is 0.2% for gaseous materials.
• Other substances and materials subject to the safety data sheet requirements in the REACH Regulation. 

The substance is produced or imported in quantities between 100 and 1000 kg a year

Enterprises must notify substances that are produced or imported in quantities be-tween 100 and 1000 kg a year.

The substance does not have to be notified if it is already registered as a pure sub-stance in the enterprise's own supplier chain pursuant to REACH.

Substances that are produced and marketed the EU in quantities of 1000 kg or more per year must be registered with the European Chemicals Agency (ECHA).

The product is produced in Denmark

Enterprises must notify products that are produced in Denmark. The requirement for notification is applicable to both end products and intermediate products produced during a production process, if they meet the criteria for notification.

Intermediate products must be notified regardless of whether or not they are to be marketed. However, an intermediate product must only be notified if it is stored in a separate container.

If a product already notified is marketed under a different trade name or in a dilute form, this is also considered to be production. However, simple mixtures or dilutions for internal use do not have to be notified.

Enterprises must also notify products that have been transferred or handed over to them, even if this has not involved payment. However, this is not applicable if the product has already been notified to the Product Registry.

The product is for commercial use

Enterprises must only notify products that are for commercial use; that is to say, if the product is used industrially or professionally as part of a work process.

Products for commercial use must be notified regardless of whether they are resold in Denmark, used within the enterprise in question or exported.

2. Products that are not to be notified

A number of products do not have to be notified, even if they meet one or more of the criteria. This is applicable to products such as:

• Food, beverages and other non-food products ready for consumption. 
• Medications that have been made ready for consumption. 
• Feedstuffs. 
• Cosmetic products. 
• Waste. 
• Materials containing radioactive substances. 
• Medical equipment that is intended for insertion into or use directly in contact with the human body, provided that the legislation specifies rules on this. 
• Products that are produced or imported in quantities of less than 1000 kg a year and that are to be used by a small number of individuals for research purposes. Research is understood to mean testing, development and trials to a limited extent.
• Items such as thermometers and plastic containers. 
• Products that are only in transit in Denmark. 
• Products for which there is duty of notification because they may give off organic dust or inert mineral dust (that is to say, they are subject to the unspecified limit values in the Executive Order on Limit Values).
• Products in liquid form that are solely considered to be notifiable as they contain one or more of the following substances from the Executive Order on Limit Values: titanium dioxide, Chemical Abstract Service No (CAS no.), 13463-67-7, 1317-70-0, 1317-80-2, iron oxide, CAS no. 13463-40-6, kaolin, respirable, CAS no. 1332-58-7, silicic acid, SiO2, amorphous, CAS no. 1343-98-2, and silicic acid, SiO2, amorphous, respirable, CAS no. 1343-98-2. 

3. Notification

Any enterprise in Denmark that produces or imports a product for which there is duty of notification is obliged to notify the product to the Product Registry. This must take place no later than one month after the commencement of production or importation.

The product must be notified electronically to the Product Registry (probas.amid.dk).

The foreign manufacturer or supplier may notify the product. In this case, the notification must include the CBR number of the Danish importer of the product, and the importer must also confirm the importation.

Consultants may notify products on behalf of producers and importers if they are authorised to do so by the enterprise that is notifying the product.

Products that are registered correctly in the Product Registry are automatically as-signed a product registration number (PR no.) by the Danish Working Environment Authority. This number must be indicated on the product's packaging no later than one year after allocation and be stated in the safety data sheet for the product.

Contents

The notification must include information on the enterprise notifying the product, as well as a series of information on the product – its composition, use, quantities and classification/labelling.

This information is treated as confidential. The information may be excluded from access if it is of significant financial importance to the enterprise.

The requirements regarding the contents of the notification are specified in Annex 1 to the Executive Order on Special Duties of Manufacturers, Suppliers and Importers, etc. of Substances and Materials pursuant to the Danish Working Environment Act (the Executive Order on Suppliers).

Information on the composition of the product must be precise, unambiguous and complete. This means, among other things, that the stated percentages by weight must total 100%. However, this is not applicable to framework notifications – see below.

Substances that are included in the product in less than a given concentration do not have to be notified with unique information in the form of a CAS no. These substances must be notified using a general technical designation such as perfume, filler or dye. The limit with regard to when a general technical designation can be used is dependent on factors such as the classification of the substance. There is a distinction between concentration limits of 0.1% for the most hazardous substances and 1% for other substances. However, substances that are added due to their preservative effect must always be notified unambiguously regardless of their concentration.

Products that are included in the composition of a product must be notified with their full trade names and composition. Non-notifiable products are notified as raw materials if they are included in the composition of a notifiable product.

Information must be provided in the notification if the product contains a technically produced nanomaterial. Nanomaterials are interpreted as materials containing particles in unbound state as an aggregate or agglomerate, if at least 50% of the particles have one or more dimensions in the range from 1 to 100 nm. Nanomaterials that are produced for a purpose, e.g. a further production process, are considered to be technically produced nanomaterials. Examples are pigments or fillers where at least 50% of the particles have one or more dimensions in the range from 1 to 100 nm.

The product does not have to be notified if it contains naturally occurring or randomly occurring nanomaterials.

Framework notifications

Products that resemble one another can be notified under the same PR no. in what is known as a framework notification. This may, for example, be a series of products with various shades in a series of colours.

For the products to be registered under the same PR no., they have to have the same hazard labelling and it must be possible for them to be covered by the same safety data sheet. They must also have the same application and function. Finally, the products must resemble one another in purely chemical terms. In other words, they must only differ in terms of a small number of alternative components (e.g. pigments), or in terms of variations in the concentration of the individual ingredients.

4. Updating notifications

Enterprises must update their notifications in the Product Registry when significant changes are made to the notified product. This is the case when, for example:

• The enterprise ceases to import/produce the notified product 
• Significant changes are made to the composition of the product
• There is a change to the trade name of the notified product
• The foreign producer or supplier that notified the product changes its name or address
• There is a change to the application of the notified product 
• There is a change to the hazard labelling of the notified product. 

Enterprises in Denmark are obliged to update quantity information for the notified products every two years. This means that enterprises must update quantity information for the previous even calendar year by 1 April in odd calendar years.