Substances and Materials
WEA Guidelines C.0.13
May 2004
This WEA Guidelines deal with the notification of substances and materials for industrial use. It takes effect from 1 July 2004, the same date as the change in the rules for notification of substances and materials.
Production or import is deemed to be "for industrial use" if the substance or material produced or imported is used in work or work processes of an industrial character, or is for re-sale in Denmark, export, or use in the producer’s or importer’s own business.
Notification of substances and materials is required by Danish occupational health and safety legislation.
Allocation of a Product Registration Number (PR No.) constitutes confirmation by the WEA that the substance or material has been entered in the Product Register with the required information (cf. Annex 2).
Definitions of concepts used in this Guidelines can be found in Annex 1.
1. The Product Register
The Product Register was established in 1979 as a joint central register for the WEA and the Danish Environmental Protection Agency. The Register holds information on approximately 38,000 notified products. This information is sent in by companies both in Denmark and abroad. It includes details of the technical functions of the products, the trades/industries in which they are used, hazard labelling, composition, and quantities produced/imported.
2. The purpose of notification
To be able to reduce the risks that chemical substances can cause to health, the environment and working conditions, it is necessary to know where such products are found in the Danish market and in what quantities they occur.
The Product Register provides a useful means of obtaining an overall picture of the distribution of chemical products. This knowledge is used by the authorities for purposes including the prioritising of work, control, risk assessments, supervision, statistics and mass flow analyses.
3. Notifiable products
The registration scheme applies to notifiable products that are produced or imported for industrial use in quantities of 100 kg or more per year.
The following products are notifiable:
- Substances and materials that are classified as hazardous in accordance with the Danish Ministry of the Environment’s regulations. Such products can often be immediately recognised by the presence of a label with a hazard symbol on an orange background. However, products classified as "Flammable" or "Environmental Hazard" do not always bear a hazard symbol. (1, 5)
- Substances and materials assigned an occupational exposure limit in the WEA list of Limit Values for Substances and Materials. (3)
- Materials that contain 1% or more of a substance that has been assigned an occupational exposure limit in the WEA list of Limit Values for Substances and Materials. (3)
- Materials containing 1% or more of a substance classified as a health or environmental hazard according to the rules on classification laid down by the Danish Ministry of the Environment. (5)
However, a limit of 1000 kg applies to substances and materials that are produced or imported solely for research purposes, provided their use is restricted to a small number of persons. By "research" is meant testing, development or experiments on a limited scale, where only a small and defined number of persons will be directly involved with the product(s).
4. Non-notifiable products
The following products are non-notifiable:
- Articles, such as thermometers, plastic buckets, etc.
- Products exclusively used by private individuals.
- Products imported/produced in quantities under 100 kg per year.
- Food, beverages and tobacco ready for consumption.
- Pharmaceuticals prepared for consumption.
- Feedstuffs.
- Cosmetics.
- Waste.
- Products containing radioactive substances.
- Medical equipment for implantation in, or use in direct contact with, the human body, provided rules laid down in other legislation apply.
- Products that are produced or imported exclusively for purposes of research in quantities of under 1000 kg, provided use is restricted to a small number of persons.
- Products that are in Denmark only in transit.
- Products in liquid form that are deemed notifiable solely because they contain one or more of the following substances included in the WEA list of Limit Values for Substances and Materials (3):
Titanium dioxide
Iron oxide
Kaolin, respirable
Silica, SiO2, amorphous
Silica, SiO2, amorphous, respirable
The CAS numbers cited alongside the substances in the WEA list of Limit Values for Substances and Materials are only indicative.
- Also exempt are products regulated only by the general limit values for
Organic dust
Mineral dust, inert.
5 . Who must notify
Whoever produces or imports notifiable products for industrial use has a duty to make notification.
The notification must be submitted no later than one month after the production or import commences.
A foreign producer can make the notification instead of the Danish importer. However, the name of the Danish importer(s) of the product must be stated. Foreign notifiers must satisfy the same requirements as Danish notifiers with regard to updating submitted information.
Notification can be made by consultants on behalf of producers and importers.
6. Notification
6.1. In what cases notification is required
- Notification must be made of all products which have not previously been notified and which must be notified according to the present rules (see section 3). The notification requirement thus applies both to new products and to products that have hitherto been exempt from notification.
- A previous exemption from the notification requirement has been withdrawn. The exemption applied to products that were produced or imported before 1 April 1983.
- Products that have already been notified must be re-notified if they are now being marketed under a different trade name. Reference may be made to the previous notification – more information on this is given in section 6.5.2.
- Notification must also be made in respect of a notifiable product that is produced by diluting another notifiable product for marketing purposes.
If a notification has been submitted under the old rules on notification and a PR number has been assigned, re-notification is not required.
6.2. Notifiable intermediate products
An enterprise that produces a substance or product must notify not only the end product, but also any intermediate product arising in the course of the process that falls within the definition of notifiable products, even if that intermediate product is not marketed. However, an intermediate product need only be notified if it is kept in a separate container.
A user who makes a simple mixture or dilution for internal use in the course of a work process need not notify the mixed/diluted material.
6.3. Notification categories
Product notifications can be divided into four main categories:
- A product consisting of a single chemical substance or materials identified by a CAS number.
- A product consisting of several substances/raw materials.
- Several products covered by a "framework notification" (for definition see Annex 1).
- Voluntary notification - can be made in respect of non-notifiable products, if this is done electronically through the Product Registry’s Internet notification system.
It applies to all the above four categories that the notifier of a product that has been assigned a PR number must satisfy all the requirements with regard to keeping information up to date.
6.4. How to notify
Notification can be made electronically via the Product Registry’s Internet notification system, or by sending in a Notification Form.
Only one product can be entered on each Notification Form, except in the case of a "framework notification".
6.4.1. Internet notification
The WEA has an electronic notification system for product registration. This means that notification can be made directly over the Internet.
A company can also use the system to examine and update information on its own products that have been notified via the Internet.
In addition, it is possible to search for a product that has been assigned a PR number by its trade name or PR number, and display the non-confidential information relating to that product.
Searches can also be made for substances. The Register contains about 140,000 CAS numbers with 600,000–700,000 associated names. Searches can be made by CAS number, molecular formula, substance name, EC number or Index number, and the system will display the data relating to the substance in question.
The Internet-based notification system is highly secure. All communication to and from the system is encrypted to a high level (128 bit encryption), and another of the security features is that access to the system is restricted to users who have been issued with a personal digital certificate.
Electronic forms are accessible on the Internet in both Danish and English, and guidance notes and help texts are provided for both the Danish and the English versions.
Registration as an Internet notifier can take place by direct application to the Product Registry, or by e-mailing pd@at.dk stating company name, address, telephone number and user name(s). Danish companies must also state their CVR number.
6.4.2. By Notification Form
Notification Forms cannot be downloaded, but can be ordered from the WEA Sales Office, "At-salg".
Completed forms should be sent to the following address:
Arbejdstilsynet, Produktregistret, Postboks 850, DK-2100 Copenhagen Ø.
6.5. Reference to an earlier notification
6.5.1. Transferring a previously notified product
If a company wishes to have a previously notified product transferred from another company, for example when a company has been taken over complete with its import or production, the transfer must be confirmed by the earlier notifier. The PR number will then be removed from the earlier notifier.
The new notifier must supply the following information for each separate product:
- Trade name (and former trade name, if the trade name is being changed)
- Transfer date
- Quantity in kg for one calendar year, broken down into Danish market/export/own use
- Trade/industry in which the product is used
- Labelling
- Customs tariff number (CN code).
On the basis of an assessment of the other information already held, the new notifier will either be assigned a PR number for the product or will be requested to supply updated information.
6.5.2. Notification by a new notifier of an already notified product
When notifying a product that has previously been notified by another company, it is not necessary to supply the information on composition. In such cases the notification must be accompanied by a declaration from the former notifier or the producer agreeing to the information on composition from the earlier notification being used in the processing of the new notification.
6.6. Data processing and storage
The information submitted will be treated as confidential, in accordance with the regulations on the Register of Substances and Materials. (2)
Special safety precautions will be applied in the processing and storage of the information. An Instruction specifying security requirements has been laid down for the system. The information will be stored in separate and monitored archives, and only personnel who have security clearance to do so will handle notifications.
The notifier can request that certain items of information, for example, quantities imported and chemical composition, be recorded as confidential, stating grounds for the request.
7. Processing of notifications
When a notification is received at the Product Registry, it is recorded and examined, and if all the required information is present, a PR number is assigned. Otherwise, the notifier is requested to supply the missing information.
Allocation of a PR number does not constitute an approval of the product, but is evidence that the product has been registered with the required information in the Product Register.
8. Updating information
The notifier must inform the Product Registry of any subsequent significant changes. Notifiers of products undertake to keep the information submitted up to date, whether the products concerned are notifiable or non-notifiable.
The Product Registry must be informed in the following cases:
- If the company discontinues import/production of a product.
- When the proportions of the constituents of a product are changed, and whenever a constituent is replaced by a substitute.
- When the trade name of a notified product is changed.
- If the notifying company changes its name or address.
- When the area of application of a notified product is changed.
- When the hazard labelling of a notified product is changed.
- When specific products are added or removed from a group covered by a "framework notification".
- If there is a significant change in the quantities of a notified product produced or imported.
- The notifier is also required to update the quantity information every second year on request from the Product Registry. This entails submitting the quantity data for the previous calendar year by 1 April.
Certain changes to the notified information - for example, a change in chemical composition resulting in different labelling - may mean that the product has to be given a new PR number. Updating may thus lead to the PR number of a product being withdrawn and a new number being assigned.
The product’s PR number, trade name and file number should be stated when updating information relating to a product. Depending on the nature of the changes, updating can be carried out by means of a Notification Form, via the Internet notification system, or by letter.
9. Other notification/registration
Special notification rules may apply to substances or materials that are notifiable under the Danish Environment Protection Agency’s regulations, for example, offshore chemicals, pesticides, biocides and new chemical substances.
Raw material ingredients of notifiable products can also be notified.
Annex 1 - Definitions
Substances: "Substances" is to be understood to mean elements and their compounds.
Materials: A "material" is to be understood to mean a mixture of two or more substances.
Products: A "product" is to be understood to mean a substance or a material that is stored in its own packaging, has its own trade name and its own producer/supplier/importer.
Frameworks: Products which are similar can be notified under the same PR number and covered by a "framework notification".
The requirements for this are:
-
they must belong to a coherent group, a product range, for example, different shades in a range of colours.
-
they must have the same use and function.
-
they must be chemically similar, in other words they may only differ
- by having few alternative constituents, such as pigments, and/or
- by variations in the concentration of the various ingredients, and/or
- by variation in their physical properties
-
they must have the same hazard labelling
-
they must have the same code number if a code number has been assigned
-
they must have the same chemical/toxicological properties.
Specific products: Individual products covered by a "framework notification", for example, different shades in a range of colours.
Annex 2 - Information that must be supplied on the Notification Form
1. Notifying company
Name, address, telephone number, and Danish Central Business Register (CVR) number of the notifying company, i.e., the company wishing to be assigned a PR number.
2. Producer
Name, address and telephone number of the producer of the product (if possible).
3. Supplier
Name, address and telephone number of the supplier of the product. The supplier may be the producer, but may also be a different company.
4. Trade name
The full trade name under which the product is to be marketed, including the framework name. The following other information can also be stated in this space on the Form:
-
Trade names of specific products covered by a "framework notification".
-
Other trade names under which the product is marketed.
-
Original trade name and associated PR number, when the trade name is being changed.
5. Notifier
The name of the contact person in the notifying company, the notifier’s signature, and date.
6. Composition of the product
The information about the composition of the product must be precise, unambiguous and complete, cf. section 6.1.
To ensure that the information on composition is precise and unambiguous, the substances and raw materials/materials should be identified as follows:
- Pure substances: by stating their unambiguous chemical name and CAS number. This also applies to materials that have been allocated a single CAS number.
- Polymers that have not been assigned a CAS number: by stating the unambiguous chemical names and CAS numbers for all the monomers in the polymer (its "building blocks").
- Raw materials: by stating their full trade names, producers and composition. Raw materials/materials that have been assigned a PR number can also be identified by citing that number. The information requirements relating to raw materials/materials are the same as for the product that is the subject of the notification.
6.1. Substances and materials for which unambiguous information is required
- Substances and materials constituting 1% or more of the product.
- Substances and materials classified as very toxic, toxic, carcinogenic category 1 or 2, mutagenic category 1 or 2, or reprotoxic category 1 or 2, and which constitute 0.1% or more of the product.
- Substances included in the "List of Dangerous Substances" (4) or which are subject to the special labelling rules set out in Annex 2 of the Executive Order on Classification and which have a lower percentage threshold than those mentioned above, and which constitute a percentage of the product equal to or exceeding that percentage threshold. (5)
- There is no minimum threshold for added preservatives.
6.2. Other substances and materials
Other substances and materials can be declared by a general technical term, for example perfume, filler, colouring.
6.3. General information on completion of item 6
The composition of the product is entered on the form by completing a space for each constituent substance or material stating:
- its CAS number, chemical name and percentage of the product by weight; or
- the trade name of the raw material/material, its PR number (if any), producer and percentage of the product by weight; or
- the general technical description of the substance or material and its percentage of the product by weight.
Percentages of substances and materials contained must be stated in precise values, i.e., it is not sufficient to give concentration intervals. An exception to this is made where technical grounds connected with the production process call for it, for example adjustment of viscosity or pH. In such cases the percentage content may be stated with a relative deviation of up to a few per cent. The grounds for use of intervals must then be stated.
Notifiers who are unable to obtain access to the necessary information on composition from the supplier can arrange for the supplier or producer to submit the information directly to the Product Registry.
6.4. Framework notifications
Products which are similar to each other can be notified under the same PR number in a "framework notification".
For such registration, the materials must satisfy the requirements set out in the definition of "frameworks" in Annex 1.
The Notification Form does not provide for "framework notifications". The simplest way of dealing with this is to set out the information in tabular form; but it is also possible to complete a form for each of the specific products which it is desired to have registered under the same PR number.
7. Technical function
It should be stated specifically what the product is used for, e.g., degreasing agent, priming paint, engine oil. The technical function must always be specified in words, but the Product Registry function code (see under the
Product Register) can be added if desired.
8. Trades/industries
It should be stated specifically in what trades/industries it is intended the product will be used. For example, for a floor coating for use in the food industry which is to be applied by specialist painters, "painters" must be entered, not "food industry". If the product is also for use by private individuals, this too should be stated.
If more than one trade/industry is named, their respective percentages should be stated, as far as is possible. The trade(s) or industry/-ies in which the product is used must always be specified in words, but the Statistics Denmark industrial classification/NACE code (see under the
Product Register) can be added if desired.
9. Customs tariff number (CN code)
The customs tariff number (CN code) applying to the product should be stated, for statistical purposes.
10. Quantities produced or imported
Danish notifiers must state anticipated quantities for the whole of the coming year, broken down into export, Danish market, and own use (if applicable). The quantities must be stated in units of weight (kg or tonnes).
11. Danish importer
Foreign notifiers must state the names and addresses of all Danish importers and the quantity imported by each. Again, the quantities must be stated in units of weight (kg or tonnes).
12. Hazard labelling
A description of the product’s hazard labelling should be given, including hazard symbol(s) (for danger of fire, explosion, or harm to health or the environment) and R and S phrases with associated text. If the product is not subject to labelling, a cross should be placed in the box.
13. Physical state
The state of the product at 20°C: liquid, solid (including powders and pastes), or gaseous.
14. Confidentiality
Information requested to be treated as confidential, stating grounds for the request.
Note that all fields in the Notification Form must be completed, except the item "Danish importer", if the notifying company is a Danish company, and the item "Producer", if the producer is not known.