Annex 1 - Information for the purpose of notifying substances and materials, cf. section 5
Annex 1 to Executive Order No. 1794 of 18 December 2015 on Special Duties of Manufacturers, Suppliers and Importers, etc. of Substances and Materials pursuant to the Danish Working Environment Act with subsequent amendments issued by the Danish Working Environment Authority - unofficial version.
Headings 1-8 specify the information to be provided in a notification. The information shall be precise and up to date. There must be a signature from the person submitting the notification.
The information on composition shall be precise, unambiguous and complete. The information on composition in the supplier's instructions for use will normally not be sufficient. Information on use and volumes and other information shall also be precise. All information shall be of such a quality that it may serve to assess the classification of the substance or material notified as well as any risks involved in its use and to assess, i.a., the prevalence of chemical substances and materials and the possibilities of substitution.
Concerning heading 3 it should be noted that the ingredients shall be specified when they are a constituent part by at least:
a) 0.1 % for substances classified as dangerous pursuant to the CLP regulation as
acute toxic category 1, 2 and 3,
carcinogenic category 1A and 1B
germ cell mutagenic category 1A and 1B,
reproduction-toxic category 1A and 1B
b) 1 % for all other substances.
Regardless of a) and b), however, the following always applies
Substances that have been added owing to their preservative effect shall be specified irrespective of concentration.
Where a lower limit than the one stated above is stated in annex VI in the CLP regulation for the ingredient in question, or the material is covered by the special labelling rules laid down in Annex 2 in the CLP regulation with a lower percentage limit, these limits shall, however, apply with regard to when the ingredients shall be specified.
- If a substance at a lower limit than the above can trigger requirements for safety data sheets by type 31 of the REACH Regulation, then these limits apply to when the ingredients are to be disclosed.
The manufacture of materials by simple mixing or dilution for internal use in the enterprise shall not be subject to the duty of notification.
For each substance or material that is subject to notification, the following information must be provided
1. Information on the notifying company
1.1. Company name and address
1.2. CVR No.(Only Danish companies)
1.3. Information on the manufacturer.
2. Information on the substance or material
2.1. Trade name.
2.2. Other names (e.g. synonyms or trade name for individual items in framework notifications)
2.3. Original trade name in the event of a change of trade name.
3. Information on the composition of the substance or material
3.1. Chemical name and CAS number of constituent substances
3.2. Trade name, PR no., if any, composition and manufacturer of constituent materials (raw materials)
3.3. Content in % of constituent substances and/or materials.
3.4. Composition of constituent materials (raw materials), if any.
A related group of materials may be notified together in one framework notification if the individual materials differ mutually only by having alternative constituents. The content in % may be stated with minor variations owing to matters relating to production technique. Framework notifications may be submitted only if the individual materials within the framework have the same danger labelling, field of application, code number, if any, and have the same chemical and toxicological properties.
4. Information on the use of the substance or material
4.1. Technical function of the substance or material (preferably function codes)
4.2. Industries in which the substance or material is intended to be used (preferably industry codes)
5. Volume information concerning the substance or material:
5.1. Volume manufactured or imported per year
5.2. This volume distributed on the Danish market, exports or use in own business.
6. Information on the classification/labelling of the substance or material
6.1. Danger symbols, hazard and precautionary statements H- and P-phrases) according to the CLP regulation.
7. Other information on the substance or material
7.1. Material state at 20 ° C.
7.2. Indicate if the product contains technical manufactured nanomaterials.
8. Information regarding confidentiality
8.1 Information that is to be treated as confidential, with justification for this.
The information is treated confidentially in accordance with applicaple rules.