Executive order of Special Duties of Manufacturers, Suppliers and Importers, etc. of Substances and Materials
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.
THE COMPILATION covers the following 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, cf. Executive Order No. 1072 of 7 September 2010, determined by order pursuant to section 73 of the act:
Part 1 - Scope and definitions
1. This Executive Order shall apply to import, manufacturing or transfer of substances and materials available for 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):
- Substances and materials that fulfil the criteria for being classified as dangerous pursuant to the regulations that are stated in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures etc. (the CLP Regulation).
- Substances and materials included with a limit value in the Executive Order on limit values for substances and materials.
- Materials that contain 1% or more (for gaseous materials 0.2%) of a substance included with a limit value in the Executive Order on limit values for substances and materials.
- Other substances and materials included in the requirements regarding safety data sheets pursuant to Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency etc. with subsequent amendments (the REACH Regulation).
- Substances and materials which, as directed by the Director General of the Danish Working Environment Authority shall be considered dangerous to or have an adverse effect on safety or health.
(3) In Article 67 of the REACH regulation, cf. point 47 of Annex XVII, special requirements are stated regarding the marketing of cement with chromate.
(4) The Executive Order is not applicable to the substances and materials mentioned below, which are covered by other legislation:
- Food and stimulants ready for consumption.
- Pharmaceuticals ready 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
(5) §§ 5-12 does not apply to plant protection products
2. 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. Unless otherwise prescribed, dangerous substances and materials shall be packed in such a way that the packaging fulfils the regulations laid down in the CLP Regulation in this regard.
4. The packaging shall be labelled pursuant to the rules laid down in the CLP Regulation regarding labelling and any assigned product registration number (PR no.) cf. section 12.
(2) Regarding labelling of cement and non-hardening products containing cement, reference is made to Article 67 of the REACH Regulation cf. point 47 of Annex XVII.
Part 3 - Notification
5. Those who annually manufacture or import 100 kg and up to 1000 kg a substance or 100 kg or more of a 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 1. However, this shall not apply to substances and materials specified in Annex 2.
(2) Notification shall be submitted no later than one month after manufacturing or import.
(3) Subsection (1) shall not be applicable 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 a few people.
(4) Section II of the REACH Regulation states requirements for registration with the European Chemicals Agency of substances that are marketed in the EU in quantities of 1 tonne or more annually. Substances are defined in Article 3(1) of the Regulation, manufacturing is defined in Article 3(8) and marketing is defined in Article 3(12).
6. The obligation to notify shall also apply to manufacturers and importers of dangerous materials and substance if the substance or material is given a new trade name.
7. In order to prevent damage to health and injuries due to accidents in individual cases, the Danish Working Environment Authority may also require further information than what is stated in Annex 1 regarding substances and materials for special purposes.
8. A manufacturer or importer who has submitted a notification pursuant to section 5(1) or section 6 shall notify the Danish Working Environment Authority about significant changes with regard to what has been notified, including whether the substance or the material is used or is assumed to be used for other purposes, whether there is new toxicological knowledge and similar circumstances.
(2) The manufacturer or importer shall, in addition to what is stated in section (1), submit volume information every other year regarding the previous year’s manufacturing and import of the substance and the material cf. point 5 of Annex 1.
9. A manufacturer or importer who has made a submission pursuant to section 5(1) or section 6 shall, with a view to obtaining further information upon the request of the Danish Working Environment Authority, carry out or have carried out examinations in accordance with section 13.
10. Notifications pursuant to section 5 shall take place electronically to the Danish Working Environment Authority.
11. A notifying company of a substance or a material may refer to another notifyer’s information on the same substance or material. The submitter shall ensure that the other submitter has consented to this.
(2) A notifying company of a substance that the notifyer has previously submitted notification to the Danish Environmental Protection Agency may fulfil its obligation pursuant to section 5(1) by referring to this notification.
12. Notifications regarding the substances and materials are assigned a product registration number (PR no.) when the required information has been received. The number shall be applied on the substance’s or material’s packaging no later than one year after the assignment.
Part 4 - Examination techniques
13. Examination of the substance’s and material’s physico-chemical properties and their toxicity shall be carried out using techniques that can be approved by the Danish Working Environment Authority to the extent that it is consistent with the REACH Regulation and the CLP Regulation.
(2) The Director General of the Danish Working Environment Authority may order that analyses and examinations of substances and materials shall be carried out using specific techniques at accredited laboratories to the extent that this is consistent with the REACH Regulation and the CLP Regulation.
Part 5 - Technical data sheets
14. Technical data sheets and similar information about dangerous substances and materials shall contain all significant information regarding the substance’s or material’s impact on safety and health in the working environment.
Part 6 - Safety data sheets
15. For the substances and materials mentioned in section 1(2) no. 2 and no. 3 that are not covered by Article 31 of the REACH Regulation, the supplier shall prepare a safety data sheet and provide the recipient of these substances and materials with this in accordance with Article 31 and Annex II of this Regulation, with the exception of point 12 on environmental information and point 13 on conditions regarding disposal.
(2) The safety data sheet shall be written in Danish.
Part 7 - Dispensation and complaints
16. In special cases, the Director General of the Danish Working Environment Authority may allow deviations from the provisions in this Executive Order when they are considered to be reasonable and justifiable and to the extent that they are consistent with the REACH Regulation and the CLP Regulation.
17. Complaints may be lodged regarding decisions based on this Executive Agreement pursuant to section 81 of the Danish Working Environment Act.
Part 8 - Penalties
18. Unless a more severe penalty is incurred under the Danish Working Environment Act or any other legislation, anyone who
- contravenes section 5(1) and (2), section 6, sections 8-9, section 12, section 13(1) and sections 14-15
- does not comply with orders or prohibitions, which are notified pursuant to the provisions of the Executive Order, or
- disregards conditions for permissions that have been notified pursuant to the provisions of the Executive Order shall be punished with a fine or prison for up to two years.
(2) Companies etc. (legal persons) may be subject to liability to punishment pursuant to the rules in Part 5 of the Danish Criminal Code.
Part 9 - Entry into force
19. The Executive Order shall enter into force on 1 January 2016.
(2) Executive Order no. 559 of 4 July 2002 on Special Duties of Manufacturers, Suppliers and Importers, etc. of Substances and Materials pursuant to the Danish Working Environment Act shall be rescinded.
The Danish Working Environment Authority, 18 December 2015
Peter Vesterheden /Bent Horn Andersen
*) This Executive Order includes certain provisions implementing certain provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) etc., Official Journal 2006, no. L 396, page 1 as last amended by Commission Regulation (EU) 2015/1494 of 4 September 2015, Official Journal 2015, no. L 233, page 2. According to Article 288 of the Treaty on the Functioning of the European Union, a regulation shall be directly applicable in each member state. Thus, the reproduction of these provisions is only based on practical considerations and does not affect the Regulation’s direct applicability in Denmark.