Executive Order on Special Duties of Manufacturers, Suppliers and Importers, etc. of Substances and Materials pursuant to the Danish Working Environment Act*)
Executive Order No. 559 issued by the National Working Environment Authority on 4 July 2002 as subsequently amended - unofficial version.
THE COMPILATION covers Executive Orders
Pursuant to section 35(1), section 49(1), section 49 a(1)-(3), section 49 b and section 84 of the Danish Working Environment Act, and by order pursuant to section 73 of the said Act, cf. Consolidated Act No. 268 of 18 March 2005, and pursuant to section 32 a of the Danish Public Administration Act, cf. Act No. 571 of 19 December 1985 as amended by Act No. 215 of 22 April 2002 the following shall be laid down:
- No. 559 of 4 July 2002, which became effective on 30 July 2002,
- No. 229 of 1 April 2004, which became effective on 3 April 2004 and
- No. 162 of 11 March 2004, which became effective on 1 July 2004, and
- No. 497 of 27 Mai 2004, which became effective on 17 January 2005, and
- No. 1252 of 15 December 2008, which became effective 18 December 2008 (amendments pursuant to the REACH regulation).
Part 1 - Scope and definitions
1.(1) This Executive Order shall apply to import, manufacture of and supplying or making available substances and materials for commercial use. Annex 1 to the Executive Order shall, however, also apply to non-commercial use.
(2) For the purpose of this Executive Order, the following materials and substances shall be considered dangerous or otherwise having an adverse effect on safety or health (dangerous materials and substances):
(3) Annex 1 on labelling of chromate in cement lays down specific requirements regardless of whether the substance is covered by section 1 (2).
- Substances and materials meeting the criteria for classification as dangerous pursuant to the rules on classification laid down by the Danish Ministry of the Environment.
- Substances and materials included with a limit value in the Danish Working Environment Service list of limit values concerning air pollution with substances and materials.
- Materials containing 1 % or more (0.2 % for gaseous materials) of a substance included with a limit value in the Danish Working Environment Service list of limit values concerning air pollution with substances and materials.
- Materials containing 1 % or more (0.2 % for gaseous materials) of a substance classified as dangerous to health or the environment according to the rules on classification laid down by the Danish Ministry of the Environment.
- Substances and materials which, as directed by the Director General of the Danish Working Environment Service, shall be considered dangerous or otherwise having an adverse effect on safety and health.
(4) This Executive Order shall not apply to the below substances and materials, which are covered by other legislation:
- Food, beverages and tobacco ready for consumption.
- Pharmaceuticals prepared for consumption.
- Materials containing radioactive substances.
- Medical equipment with the purpose of being placed in or used in direct contact with the human body, provided that rules have been laid down pursuant to other legislation based on EU Directives on classification and labelling of dangerous substances and materials which ensure the same level of information and protection as this Executive Order.
2.(1) Application of the provisions of this Executive Order shall be based upon the following definitions:
- Substances: Elements and their compounds.
- Materials: Mixtures of two or more substances, including biological materials.
Part 2 - Packaging and labelling
3.(1) Unless otherwise prescribed, dangerous substances and materials shall be packed in such a way that the packaging fulfils the relevant rules laid down by Danish Ministry of the Environment.
4.(1) The packaging shall be labelled in accordance with the rules on labelling laid down by Danish Ministry of the Environment and shall be labelled with a possible product registration number (PR no.) assigned, cf. § 11.
(2) Furthermore, cement and non-hardened cement-containing products shall be labelled in accordance with Annex 1.
Part 3 - Notification
5.(1) Manufacturers or importers who annually manufacture or import 100 kg or more of a substance or material covered by section 1(2), point 1 to point 4, shall submit a notification to the Danish Working Environment Authority with the information specified in Annex 2. However, this shall not apply to materials specified in Annex 2a.
(2) The notification shall be submitted no later than one month after manufacture or import.
(3). Subsection (1) shall not apply to substances and materials that are manufactured or imported for research purposes in a volume of less than 1000 kg when the use is limited to few persons.
6.(1) The duty to submit a notification rests moreover with manufacturers and importers of dangerous substances and materials if the substance or material is given a new trade name.
6a. The Danish Working Environment Authority may in order to prevent damage to health and injuries caused by accidents in individual cases demand further information than that stated in Annex 2 for substances and materials for special uses.
7. (1) A manufacturer or importer who has submitted a notification pursuant to section 5 (1) or section 6 shall, moreover, inform the Danish Working Environment Service about any significant changes in the information submitted, including whether the substance or the material is used or is expected to be used for other purposes, whether new toxicological data has become available, etc.
(2) In addition to what is stated in subsection (1) above, the manufacturer or importer shall also submit information on volume every second year starting on 1 April 2005 concerning the previous year’s manufacture and import of the substance and the material, cf. heading 5 of Annex 2.
8.(1) A manufacturer or importer who has submitted a notification pursuant to section 5 (1) or section 6 shall carry out tests or have carried out tests in accordance with section 12 in order to obtain further information as requested by the Danish Working Environment Service.
9.(1) Notifications pursuant to section 5 shall be made electronically or on paper on special forms which can be obtained from the Danish Working Environment Authority.
10.(1) Any person notifying a substance or material may refer to information submitted by another person in connection with a previous notification concerning the same substance or material if it is proved that the person who has submitted this previous notification agrees to such a procedure.
(2) Any person notifying a substance which he has already previously notified to the Danish Environmental Protection Agency, may discharge his duty under section 5 (1) by referring to the previous notification.
11.(1) Notified substances and materials shall be assigned a product registration number (PR no.) by the Danish Working Environment Service when the necessary information has been received. This number shall be indicated on the packaging of the substance or material one year after the assignment of the number at the latest.
Part 4 - Techniques of examination
12. (1) The examination of the physico-chemical properties of the substances and materials and their toxicity shall be carried out in accordance with methods which can be recognised by the Danish Working Environment Service.
(2) The Director General of the Danish Working Environment Service may direct that analyses and examinations shall be carried out in accordance with specific methods at accredited laboratories.
Part 5 - Technical data sheets
13.(1) Technical data sheets, etc., on dangerous substances and materials shall contain all information of importance concerning the effect of the substance or material on safety and health in the working environment.
Part 6 - Instructions for use (safety data sheets)
14.(1) With respect to the substances and materials mentioned in section 1(2), items 2) and 3) not covered by Article 31 of Regulation (EC) No 1907/2006 (REACH) of the European Parliament and of the Council, the supplier shall compile a safety data sheet and provide this to the recipient of such substances and materials in accordance with Article 31 and Annex II of this Regulation with the exception of heading 12: ecological information, and heading 13: disposal considerations.
(2) The safety data sheet shall be drawn up in Danish.
Part 7 - Exemptions and appeals
15.(1) Under special circumstances, the Director General of the Danish Working Environment Authority may grant exemptions from the provisions of this Executive Order when this is deemed reasonable and fully acceptable.
16.(1) Any decisions made under this Executive Order may be appealed in accordance with section 81 of the Danish Working Environment Act.
Part 8 - Penalty provisions
17.(1) Unless a more severe penalty is incurred under the Danish Working Environment Act or any other legislation, anyone who
(a) contravenes section 4(2), section 5(1) and (2), sections 6 to 8, section 11, section 13 and section 14,
(b) fails to comply with an improvement notice or prohibition notice issued pursuant to the provisions of this Executive Order, or
(c) disregards the terms of authorisations issued pursuant to the provisions of this Executive Order
shall be punishable by fine or imprisonment for up to two years.
(2) Companies, etc. (legal persons) may be held criminally liable pursuant to the rules set out in part 5 of the Danish Penal Code.
Part 9 - Entry into force
18. (1) This Executive Order shall enter into force on 30 July 2002, cf. also subsections 2 and 3.
(2) With regard to pesticides and biocides, cf. Executive Order No. 241 of 27 April 1998 issued by the Danish Ministry of the Environment as most recently amended by Executive Order No. 692 of 23 June 2001, the Executive Order shall not become effective until 30 July 2004.
(3) With regard to the substances and materials covered by subsection 2, Parts 3 and 4 of Executive Order No. 540 of 2 September 1982 on Substances and Materials as amended by Executive Order No. 485 of 16 June 1995 and section 2 (1), points 1-4, and section 2 (2) and (3) of Executive Order No. 52 of 13 January 1988 on Materials Containing Volatile Substances, Including Organic Solvents, shall continue to be applicable.
(4) Section 5 (1) shall not apply where a notification has been submitted pursuant to the rules previously in force.
(5) Executive Order No. 407 of 18 September 1979 on Smoke Classification, Labelling and Testing of Welding Electrodes shall be repealed.
The Danish Working Environment Service, 4 July 2002
Jens Jensen/Charlotte Skjoldager
*) This Executive Order includes provisions implementing certain provisions in Council Directive 2003/53/EC of 18 June 2003 amending for the 26th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (nonylphenol, nonylphenol ethoxylate and cement), Official Journal 2003, L 178, p. 24.