7. Chemicals
Approx 20,000 chemical substances are estimated to be on the market in Denmark and approx 30,000-50,000 on the market in the entire EU. Furthermore, chemicals are found everywhere in modern society, eg in cosmetics and toys. However, many chemicals may have undesirable effects on the environment as well as human health and as a result, the use of chemical substances is regulated and restricted by a number of rules.
The purpose of such rules is to prevent any harm to human health as well as any damage to the environment and to promote the use of cleaner alternatives, which is in Denmark accomplished by eg imposing indirect taxes on several chemical substances. Two fundamental elements are always included in the regulation of chemical substances. One is the existing knowledge of chemical substances and the other is the precautionary principle, which provides for any lack of knowledge about a chemical substance leading to the use of that substance being subject to the greatest possible restrictions and perhaps being banned entirely.
Danish regulation of the use of chemicals is based on the Danish Act on Chemical Substances and Products regulating the manufacture, storage, use and disposal of chemical substances. In addition, under the authority of the Act on Chemical Substances and Products, more than 50 executive orders have been issued banning or restricting the use of various chemical substances.
In many cases, EU legislation within the field of chemicals means total harmonisation and Danish chemicals legislation is thus to a wide extent merely an implementation of EU rules. Consequently, to a great extent, the same rules apply throughout the EU countries.
Efforts have been made at an EU level to change the chemicals legislation, which has led to the adoption of the new EU Chemicals Regulation, the REACH Regulation. The REACH Regulation involves a considerable revision of the chemicals legislation and means eg the registration of far more substances than previously. The requirements of the REACH Regulation also apply to chemical substances included in other products and the requirements of the Regulation will thus also affect products not traditionally considered to be chemical substances/products if such products contain chemical substances intended to be liberated. That concerns eg substances in ballpoint pens. Consequently, the Regulation will be of exceptional significance for the business sector – including lines of business not generally considered to be part of the chemical industry. For instance, toy producers and importers of eg textiles and cars may be under obligations pursuant to the Regulation as a result of the substances contained in the products manufactured or imported by them. Moreover, the Regulation requires businesses to provide their customers with sufficient information on eg the safe use of their products.
The approach of the REACH Regulation is generally the precautionary principle and the Regulation thus bans any marketing of substances not registered in the common European ECHA register. In addition, the Regulation stipulates that in future, it will be for businesses (producers, importers and professional users) to prove that the production and use of the chemical substances are safe. If the businesses are unable to prove that, the substances in question may not be used. It is thus important that a business wishing to be established in Denmark is abreast of the rules and ensures that the effects of the REACH Regulation on the establishment and operation of the business are investigated. In that connection, a business should at the very least clarify the following issues:
- which chemicals are to be used in the production of the business or will be included in the products to be imported?
- how will the business be subject to the REACH Regulation and what obligations will be imposed on the business by the Regulation?
- what are the time limits applying to the notification and registration of substances?
- have the chemicals to be included in the production by the business already been registered?
- is any additional notification/registration of the use by the business of the substances to be effected anyway?
- what down-stream users of the chemical substances/products does the business have and are changes to be made in consumer information and accordingly in the registration?
The REACH Regulation came into force on 1 June 2007 and will be implemented gradually over a 15-year period. |