Executive Order concerning the Danish Product Registry
Executive Order – Danish Working Environment Authority Executive Order No. 103 of 9 February 2018.
Pursuant to Sections 49a(4), 80 and 84 of the Danish Working Environment Act, cf. Consolidation Act. no. 1084 of 19 September 2017, and after consultation with the Minister for the Environment and Food, the authority has decided:
Objective and scope
SECTION 1 The Danish Working Environment Authority and the Danish Environmental Protection Agency shall maintain a digital registry of substances and materials (the Product Registry).
Para. 2 The Product Registry is administered by the Danish Work Environment Authority, which is responsible for maintaining and developing the registry.
SECTION 2 The objective of the Product Registry is to gather information on the use of hazardous substances and materials, including on their occurrence and use. The information contained in the Product Registry forms the basis for assessing and preventing the harmful effects of substances and materials.
SECTION 3 The Product Registry contains data and assessments that are significant to the performance of those tasks assigned to Danish Working Environment Authority and the Danish Environmental Protection Agency pursuant to applicable environmental and working environment legislation. The Product Registry also provides access to such information and assessments of significance to those persons, etc. who are required to perform functions pursuant to this legislation.
SECTION 4 Data is collected in accordance with specific regulations, including those laid down in Executive Order No. 1794 of 18 December 2015 on Special Duties of Manufacturers, Suppliers and Importers, etc. of Substances pursuant to the Danish Working Environment Act with subsequent amendments issued by the Danish Working Environment Authority.
Para. 2 Registration must be performed in such a way that the notified substances and materials can be identified by registration number (PR no.), tradename, synonymous names, etc.
Registration and storage of data
SECTION 5 The Danish Working Environment Authority is responsible for processing the data contained in the register.
Para. 2 Anyone with a duty to provide notification regarding substances and materials in accordance with Section 4(1) shall register all information directly in the Product Registry.
Para. 3 The Danish Working Environment Authority conducts random checks to ensure that information entered in the Product Registry is in accordance with the provisions contained in Section 4(1).
SECTION 6 The Director of the Danish Working Environment Authority shall, after discussion with the Director of the Danish Environmental Protection Agency, prepare internal security regulations for users, cf. Section 7(1). These regulations shall not be made public.
Para. 2 The internal regulations shall cover organisational conditions, as well as physical and electronic security measures, including user administration and guidelines for ensuring compliance with those security measures established for the Product Registry. The regulations shall also stipulate that only those employees of the Danish Working Environment Authority who are employed to work with the Product Registry, and who have been appointed by the Director of the Danish Working Environment Authority for this purpose, have access to the Product Registry and can make changes therein.
Para. 3 The public authorities referred to in Section 1 shall designate those persons who shall have direct access to the Product Registry. The Director of the Danish Working Environment Authority shall participate in this work. Only those whose work necessitates direct access to the Product Registry shall be authorised, and then only to access that data the person in question requires for the performance of their duties.
Access to data
SECTION 7 The Danish Working Environment Authority, the Danish Environmental Protection Agency, the Poison Control Hotline (Bispebjerg Hospital), the Danish National Research Centre for the Working Environment (NFA) and the Danish Emergency Management Agency (chemical preparedness) have direct access to the registered data pursuant to applicable security regulations.
Para. 2 Other public authorities may receive data that is necessary for the proper performance of their duties. The same applies to individuals who perform tasks pursuant to environmental and working environment legislation and who have a duty of confidentiality.
SECTION 8 The data contained in the Product Registry may otherwise be supplied pursuant to the Danish Access to Public Administration Files Act and Danish Environmental Information Act, with the provisos stated in paragraph 2 below.
Para. 2 The following data is normally considered to be confidential:
1) Detailed information regarding the complete composition of a material.
2) The exact use or function of a substance or material, including detailed information on its use as an intermediate product.
3) The exact amount of a substance or material being manufactured or marketed.
4) The relationships between a manufacturer or importer and their distributors or downstream users.
Para. 3 If immediate action is required to protect human health or safety or the environment, for example in emergency situations, the data described in paragraph 2 above may be made public.
Duty of confidentiality
Section 9 Public authorities or individuals performing tasks pursuant to this Executive Order, and anyone who otherwise provides assistance thereto, are subject to the regulations on confidentiality contained in Chapter 16 Section 152-152c of the Danish Criminal Code.
Right of appeal
Section 10 Decisions made by the Danish Working Environment Authority pursuant to this Executive Order may be appealed to the Council of Appeal on Health and Safety at Work in accordance with Section 81 of the Danish Working Environment Act.
Section 11 Unless a more severe penalty is prescribed by the Danish Working Environment Act or other legislation, a person shall be liable to a fine or imprisonment of up to one (1) year or both, where
1) contrary to the truth, they claim to have fulfilled the conditions stated in Section 7 above, thereby gaining access to confidential information, or
2) they use data for purposes other than those for which it has been provided.
Para. 2 A company or organisation, etc. (legal person) may be held criminally liable pursuant to Chapter 5 of the Danish Criminal Code.
Entry into force
Section 12 This Executive Order enters into force on 1 March 2018.
Para. 2 Executive Order no. 466 of 14 September 1981 concerning the Register of Substances and Materials is repealed.
Danish Working Environment Authority, 9 February 2018
/ Katrine Krone